 |
 |
 |
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
November 5, 2008
08-44
___________________________________
PRODUCT
"Kyosai Sengiri Daikon" Dried Radish, 3.5oz, clear plastic package,
UPC Code 0 11152 42327 2, Recall # F-016-9
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Jfc International, Los Angeles, CA, by letter on October 8, 2008
and by press release on October 10, 2008.
Manufacturer: Dalian D.S. Food Stuff Co., Ltd., Dailian, China. Firm initiated
recall is ongoing.
REASON
Product contains undeclared sulfites based on the Florida Department of Agriculture
and Consumer Services’ analysis.
VOLUME OF PRODUCT IN COMMERCE
154 cases (40/3.5oz/case)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Major Pharmaceuticals Lisinopril Tablets, USP; 10 mg; packaged in 45-ct. bottles
and 90-ct. bottles; Rx only; NDC 0904-5808-43 (45 ct bottle); NDC 0904-5808-89
(90 ct bottle), Recall # D-021-2009
CODE
Lot L-1406 (45-ct. bottles) and L-1406A (90-ct. bottles). Expiration for both
sizes is 06/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Legacy Pharmaceutical Packaging LLC, Earth City, MO, by
letters dated June 23, 2008 and July 9, 2008
Manufacturer: Sandoz Inc., Wilson, NC. Firm initiated recall is ongoing.
REASON
Some of the tablets may contain metal.
VOLUME OF PRODUCT IN COMMERCE
36,922/45-ct. and 2,273/90-ct. bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Premier Value Children's Non-Aspirin Oral Suspension; Acetaminophen suspension;
160 mg/5 ml; 4 FL. oz. bottle; Grape Flavor; NDC 68016-317-05 Also packaged
for Price Chopper: NDC 66879-702-05, Recall # D-022-2009
CODE
Lot # B0736, Exp. 2/09; Lot # H07016, Exp 8/09 and Lot # K07051, Exp 10/09
RECALLING FIRM/MANUFACTURER
Medico Labs, Inc., Hamilton, NJ, by letters on September 22, 2008. Firm initiated
recall is ongoing.
REASON
Complaints received of color change and clumps in some bottles.
VOLUME OF PRODUCT IN COMMERCE
11,436 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Anectine (succinylcholine chloride injection, USP) 200 mg/10 mL, Warning: Paralyzing
Agent. Causes Respiratory arrest., Rx only, Sterile, Packaged in box of 10
x 10 mL Multiple-Dose Vials, Box NDC 0781-3009-95, Vial NDC 0781-3009-70, Recall
# D-029-2009
CODE
Lot numbers: 136197, 136329, 136490, 136778, 137095
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz, Inc., Princeton, NJ, by letter on October 1, 2008.
Manufacturer: Sandoz Canada Inc., Boucherville, Canada. Firm initiated recall
is ongoing.
REASON
Drug may be out of specification for impurities prior to expiry.
VOLUME OF PRODUCT IN COMMERCE
34,495 boxes
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
QC Quality Choice Non-Drowsy Daytime Cold Medicine, Multi-Symptom Relief for
Colds/Flu, 10 fl oz bottle, Active ingredients per 15mL: Acetaminophen 325mg,
Dextromethorphan HBr 10mg, Phenylephrine HCl 5mg, NDC 63868-0245-10, Recall
# D-030-2009
CODE
Lots: F0701, exp. 6/2009; K07012, exp. 10/2009
RECALLING FIRM/MANUFACTURER
Medico Labs, Inc., Hamilton, NJ, by letter on September 10, 2008. Firm
initiated recall is ongoing.
REASON
Product failed assay specification for Phenylephrine HCl during shelf life
stability testing.
VOLUME OF PRODUCT IN COMMERCE
9,636 units
DISTRIBUTION
MI
___________________________________
PRODUCT
Actidose-Aqua Activated Charcoal Suspension, 25 grams Activated Charcoal, Contents: 120
mL (4 fl oz). NDC 0574-0121-74, Recall # D-031-2009
CODE
Lot: 2008122554
RECALLING FIRM/MANUFACTURER
Paddock Laboratories, Inc., Minneapolis, MN, by letter dated June 16, 2008.
Firm initiated recall is ongoing.
REASON
Presence of foreign substance; presence of ink on inside of tube.
VOLUME OF PRODUCT IN COMMERCE
5,432 tubes
DISTRIBUTION
AZ, CA, GA, KS, LA, MN, TN
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0023-09
CODE
Unit: 3872869
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by fax on November 24, 2006.
Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for
variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0067-09
CODE
Units: 004C46583, 004LQ96003
RECALLING FIRM/MANUFACTURER
ARC Blood Services-New England Region, Springfield, MA, by fax and email on
May 23, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0068-09
CODE
Unit: 004FS11875
RECALLING FIRM/MANUFACTURER
Recalling Firm: ARC Blood Services, New England Region, Dedham, MA, by fax
on June 10, 2008.
Manufacturer: American Red Cross Blood Services, New England Region, Portland,
ME. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0070-09
CODE
Unit: 019GP32211
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by
fax and electronic mail on February 5, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Granulocytes Pheresis, Recall # B-0121-09
CODE
Unit: W084608000474
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by fax on June 7, 2008. Firm initiated
recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0126-09
CODE
Unit: 2805266
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on March 16, 2007 and letter on
April 3, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking an antibiotic, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0127-09
CODE
Unit: 2806711 (Part 1 and 2)
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on May 10, 2007 and letter on May
25, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a body piercing within
12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0130-09
CODE
Unit: 2847593
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on May 10, 2007 and letter on May
25, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic
area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-0155-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0156-09
CODE
a) and b) Unit: 1319467
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter on May 25, 2006. Firm initiated
recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility
of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-0157-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0158-09
CODE
a) and b) Unit: 2846399
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on May 10, 2007 and letter on May
25, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0190-09
CODE
Unit: 9633587
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by facsimile on November 2, 2007. Firm
initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving post donation information
concerning a history of exposure to an individual with hepatitis B, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0191-09
CODE
Unit: 172063855 (2 units)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Mcallen, TX, by telephone on May 12, 2006. Firm initiated
recall is complete.
REASON
Blood products, for which the apheresis procedure records were discrepant,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0066-09
CODE
Units: 004C46583, 004LQ96003
RECALLING FIRM/MANUFACTURER
ARC Blood Services-New England Region, Springfield, MA, by fax and email on
May 23, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MA
___________________________________
PRODUCT
Plasma, Recall # B-0069-09
CODE
Unit: 019GP32211
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN,
by fax and electronic mail on February 5, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
___________________________________
PRODUCT
Source Plasma, Recall # B-0071-09
CODE
Unit: 363035497
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Fort Worth, TX, by fax on October 8, 2007.
Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0168-09
CODE
Unit: 170790536
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., McAllen, TX, by telephone and fax on September 27,
2007. Firm initiated recall is complete.
REASON
Blood product, which did not have documentation of red cell preservative solution
addition, but was labeled as AS-3, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Source Plasma, Recall # B-0170-09
CODE
Unit: 363015169
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Fort Worth, TX, by fax on November 29, 2006.
Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0188-09
CODE
Unit: 007FN52503
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Arizona Region, Tucson, AZ, by telephone on
May 9, 2006. Firm initiated recall is complete.
REASON
Blood product, incorrectly labeled as to red cell antigen type, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0189-09
CODE
Units: W085208000036, W085208000037, W085208000070, W085208000085
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on June 18, 2008. Firm initiated
recall is complete.
REASON
Blood products, collected using expired blood collection sets, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
PA
*****CORRECTION*****
September 3, 2008 Enforcement Report: Smash Balloon Dilatation Catheter,
Recall # Z-1652-2008. This recall classification has been deleted, because
the devices were not manufactured or sold in the United States.
___________________________________
PRODUCT
Fabius Trio Gas machine, anesthesia or analgesia. Catalog number 8606000. The
product is used in operating rooms and ER, for patient intubation, Recall #
Z-2338-2008
CODE
Serial numbers: ARYA-xxxx, ARYB-xxxx, ARYC-xxxx, ARYD-xxxx, ARYE-xxxx, ARYF-xxxx,
ARYH-xxxx, ARYJ-xxxx, ARYK-xxxx, ARYL-xxxx, ARYM-xxxx,ARYN-xxxx, ARZA-xxxx
ARZB-xxxx (where xxxx represents any 4 digit number)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Draeger Medical, Inc., Telford, PA, by letter dated July
7, 2008.
Manufacturer: Draeger Aerospace Gmbh, Lubeck, Germany. Firm initiated recall
is ongoing.
REASON
The parent company became aware of instances where the lower side rail of the
frame of the machine broke inwards when being moved across a threshold; resulting
in the machine being unstable.
VOLUME OF PRODUCT IN COMMERCE
111 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications
System), version 3.5.x. The system is a software package used with general
purpose computing hardware to acquire, store, distribute, process and display
images and associated data throughout a clinical environment. The software
performs digital imaging, measurement, communication and storage, Recall #
Z-2346-2008
CODE
All products with software versions 3.5.x
RECALLING FIRM/MANUFACTURER
Philips Healthcare Informatics, Inc., Foster City, CA, by letter on July 3,
2008. Firm initiated recall is ongoing.
REASON
Scout line and localizer crosshair on MPR images will display in the incorrect
position under certain circumstances.
VOLUME OF PRODUCT IN COMMERCE
198 units
DISTRIBUTION
Nationwide, Canada, UAE, UK, New Zealand, Netherlands, Germany, France, Denmark,
Belgium, and Austria
___________________________________
PRODUCT
a) Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA,
cobas c systems; 03038866322. An in-vitro diagnostic reagent system intended
for use on COBAS Integra systems for the quantitative determination of LDL-Cholesterol
concentrations in serum and plasma, Recall # Z-0006-2009;
b) Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, cobas c systems; 03183696122.
An in-vitro diagnostic reagent system intended for use on COBAS Integra systems
for the quantitative determination of iron in serum and plasma, Recall # Z-0007-2009;
c) Roche Diagnostics CREP2, Creatinine Plus Ver. 2, COBAS INTEGRA, cobas c
systems; 03263991190. An in-vitro diagnostic reagent system intended for use
on COBAS Integra systems for the quantitative determination of creatine in
serum, urine and plasma, Recall # Z-0008-2009;
d) Roche Diagnostics STFR Tina-quant Soluble Transferrin Receptor, COBAS INTEGRA,
cobas c systems; 20763454122. An in-vitro diagnostic reagent system intended
for use on COBAS Integra systems for the quantitative determination of soluable
transferrin receptor in serum and plasma, Recall # Z-0009-2009;
e) Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA,
cobas c systems; 04399803190. An in-vitro diagnostic reagent system intended
for use on COMAS Integra systems for the quantitative determination of HDL-cholesterol
in serum and plasma, Recall # Z-0010-2009;
f) Roche Diagnostics ALBT2, Tina-quant Albumin Gen. 2, COBAS INTEGRA, cobas
c systems; 04469658190. An in-vitro diagnostic reagent system intended for
use on COBAS Integra systems for the quantitative determination of albumin
concentration in serum and plasma, Recall # Z-0011-2009;
g) Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS Integra. An in-vitro
diagnostic reagent system intended for use on COBAS Integra systems for the
qualitative determination of NAPA in serum or plasma, Recall # Z-0012-2009
CODE
a) Lot 69740501;
b) Lot 60017301;
c) Lot 60064001;
d) Lot 60108701;
e) Lot 69535801;
f) Lot 60087801;
g) Lot 60115501
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated
June 11, 2008.
Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. Firm initiated recall
is ongoing.
REASON
Some of the labels are glossy, resulting in the bar code being difficult to
read by the bar code reader.
VOLUME OF PRODUCT IN COMMERCE
3,624 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Edwards Lifesciences***Fogarty Fortis***Arterial Embolectomy Catheter is indicated
for the removal of fresh, soft emboli and thrombi from the vessels in the arterial
system, Recall # Z-0013-2009
CODE
Lots # 58320651, 58320652, 58323511, 58323512, 58323513, 58326739, 58326740,
58326741, 58329130, and 58329131
RECALLING FIRM/MANUFACTURER
Recalling Firm: Edwards Lifesciences, LLC, Irvine, CA, by letter dated
June 23, 2008.
Manufacturer: Edwards Lifesciences Technology SARL, Anasco, PR. Firm initiated
recall is ongoing.
REASON
Potential for tubing fracture near the tip of the catheter.
VOLUME OF PRODUCT IN COMMERCE
2,975 units
DISTRIBUTION
Austria, Belgium, Bulgaria, Switzerland, Czech republic, Germany, Denmark,
United Kingdom, Italy, Luxembourg, Netherlands, Sweden, Slovak Republic, South
Africa, and Taiwa
___________________________________
PRODUCT
Mobetron Model 1000, mobile electron linear accelerator, a device system which
delivers radiation to an intraoperative site. Recall # Z-0014-2009
CODE
All units
RECALLING FIRM/MANUFACTURER
Intraop Medical Corp., Sunnyvale, CA, by letter on June 20, 2008. Firm
initiated recall is ongoing.
REASON
Docking screw/nut failure, which may result in a treatment head dropping, potentially
impacting the patient.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Medline Latex Free C-Section CDS-LF, 1) Reorder # CDS820056A, 2) reorder
# CDS820118B, 3) reorder # CDS820118C, and C-Section Supplemental CDS-LF; a
single patient prescription procedure pack and disposables, including a Gerber
Nuk Pacifier; 4) reorder #CDS820024F, 5) reorder #CDS820024G, Recall
# Z-0015-2009;
b) Medline Latex Free Vaginal Delivery CDS-LF; a single patient prescription
procedure pack and disposables, including a Gerber Nuk Pacifier; 1) Reorder
# CDS830006A, 2) reorder # CDS830014I, 3) reorder #CDS830014K, 4) reorder #
CDS830161B, Recall # Z-0016-2008;
c) Medline Latex Free Labor Kit & Postpartum CDS-LF; a single patient prescription
procedure pack and disposables, including a Gerber Nuk Pacifier; 1) Reorder
# CDS830074D, 2) reorder # CDS830074F, Recall # Z-0017-2008;
d) Medline Latex Free Labor & Delivery CDS-LF; a single patient prescription
procedure pack and disposables, including a Gerber Nuk Pacifier; 1) Reorder
# CDS830142, 2) reorder # CDS830142A, 3) reorder # CDS830142A, 4) reorder #
CDS830142D, Recall # Z-0018-2009;
e) Medline Latex Free Mom/Baby Admit Kit - LF; a single patient prescription
procedure pack and disposables, including a Gerber Nuk Pacifier; 1) reorder
# CDS981005, 2) reorder # CDS981005A, Recall # Z-0019-2009
CODE
a) 1) Lot: 05BD1698; 2) lots: 05IB0778, 05JB0082, 05KB0104, 06AB1030, 06AB2380,
06CB1531, 06EB0704, 06FB1115, 06GB1927, 06HB1461, 06HB2418, 06HB2777, 06IB0097,
06IB2563, 06JB0041, 06KB2184, 07AB2727, 07AB3311, 07BB1516, 07CB1820, 07EB0471;
3) lots: 06KG0719, 06KG1087, 07AG0244, 07DG0851, 07FG1471, 07IG0560, 07JG0122,
08BG1227, 06DD3830, 06ED3336, 06FD4857, 06HD0004; 4) lots: 08CG1139, 08EG1366;
5) lots: 06KD0503, 06LD0368, 07CD2689, 07ED4161, 07ID0877, 07JD3499; 6) lots:
08BD3947, 08ED3486;
b) 1) Lots: 05CD1909, 05ED0962, 05FD1796; 2) lots: 06KD2998, 07AD2164, 07CD0437, 07ED0711, 07FD2205, 07GD3892, 07ID1876, 07ID2031; 3) lots: 07LD3284, 08DD0454, 08DD2313, 08FD1231, 08FD3833; 4) lots: 06JG0627, 06KG0324, 06KG0769, 06LG0181, 07BG0190, 07EG1256, 07FG0454, 07FG0684, 07FG0686, 07IG1497, 07LG191, 08AG2182, 08DG0043, 08FG1527, 06ED2094, 06FD0326, 06HD0006;
c) 1) Lots: 05HB0427, 05IB0654, 05IB1857, 05KB0229, 06AB1244, 06BB0159, 06CB0593, 06CB1926, 06CB2197, 06FB0015, 06FB0476, 06GB0916, 06HB0704, 06HB2791, 06IB1312, 06IB1922, 06IB2566, 06KB0020, 06KB1042, 06KB2322, 06LB2102, 07AB0437, 07BB2798, 05AD3274, 05BD4131, 05CD3200, 05FD2631; 2) Lots: 07DB1578, 07GB1509, 07IB0792, 07JB0627, 07JB1829, 07LB0150, 07LB0508, 08BB0151;
d) 1) Lot: 05CD1070, 2) Lots: 05ED0630, 05ED3423, 05FD4160, 3) Lot: 05ID2386, 4) Lots: 05KD3498, 05LD0193, 05LD1753, 06AD3708;
e) 1) Lots: 07KB4947, 07LB1748, 08CB4728; 2) Lots: 08EB1474, 08FB3264, 08FB3383
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medline Industries Inc., Mundelein, IL, by letters dated
August 4, 2008.
Manufacturer: Medline Industries, Inc., Waukegan, IL. Firm initiated recall
is complete.
REASON
The latex free labor & delivery packs contain a latex Nuk pacifier. The
pacifier is packaged separately and offers no risk of exposure of latex particles
to other components of the pack.
VOLUME OF PRODUCT IN COMMERCE
1,930 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc., a General Electric Company going
to market as GE Healthcare, Datex-Ohmeda Aisys Intended to provide general
inhalation anesthesia and ventilatory support to a wide range of patients.
The device is intended for volume or pressure control ventilation. The Aisys
is not suitable for use in a MRI environment, Recall # Z-0020-2009
CODE
Number: ANAK00225 ANAK00890 ANAK00926 ANAL00101 ANAL00102
ANAL00303 ANAK00284 ANAK00285 ANAK00286 ANAK00287 ANAK00288 ANAK00289 ANAK00290
ANAK00291 ANAK00292 ANAK00293 ANAK00294 ANAK00295 ANAK00296 ANAK00298 ANAK00299
ANAK00300 ANAK00301 ANAK00302 ANAK00303 ANAK00304 ANAK00305 ANAK00306 ANAK00307
ANAK00308 ANAK00309 ANAK00310 ANAK00311 ANAK00312 ANAK00313 ANAK00314 ANAK00315
ANAK00316 ANAK00317 ANAK00318 ANAK00319 ANAK00478 ANAK00479 ANAK00480 ANAK00297
ANAL00411 ANAK00774 ANAK00775 ANAL00490 ANAL00491 ANAL00492 ANAL00493 ANAL00494
ANAL00495 ANAL00496 ANAL00497 ANAL00498 ANAL00499 ANAL00500 ANAL00501 ANAL00315
ANAL00316 ANAL00317 ANAL00318 ANAL00319 ANAL00320 ANAL00321 ANAJ00251 ANAJ00248
ANAK00162 ANAK00163 ANAK00164 ANAK00165 ANAK00166 ANAK00167 ANAK00226 ANAK00227
ANAK00228 ANAK00229 ANAK00230 ANAK00231 ANAK00232 ANAK00233 ANAJ00120 ANAJ00121
ANAJ00125 ANAJ00126 ANAJ00127 ANAJ00128 ANAJ00129 ANAJ00134 ANAJ00135 ANAJ00136
ANAJ00137 ANAL00573 ANAL00574 ANAL00575 ANAL00576 ANAL00577 ANAL00578 ANAL00579
ANAL00580 ANAL00581 ANAL00582 ANAL00583 ANAH00115 ANAJ00100 ANAJ00106 ANAJ00110
ANAJ00200 ANAJ00201 ANAJ00204 ANAJ00214 ANAJ00215 ANAJ00216 ANAJ00217 ANAJ00218
ANAJ00219 ANAJ00220 ANAJ00221 ANAJ00222 ANAJ00223 ANAJ00224 ANAJ00225 ANAJ00226
ANAJ00227 ANAJ00231 ANAJ00232 ANAJ00233 ANAJ00234 ANAJ00235 ANAJ00236 ANAJ00237
ANAJ00238 ANAJ00239 ANAJ00240 ANAJ00241 ANAJ00242 ANAJ00243 ANAJ00244 ANAJ00245
ANAJ00246 ANAJ00247 ANAJ00249 ANAJ00250 ANAL00121 ANAK00409 ANAL00248 ANAL00426
ANAL00427 ANAL00428 ANAL00429 ANAL00430 ANAL00431 ANAL00433 ANAL00434 ANAL00435
ANAL00436 ANAL00437 ANAL00438 ANAL00439 ANAL00209 ANAL00210 ANAL00416 ANAL00417
ANAL00418 ANAL00167 ANAL00215 ANAL00216 ANAL00217 ANAL00218 ANAL00219 ANAL00220
ANAL00221 ANAL00222 ANAL00223 ANAL00224 ANAL00225 ANAL00226 ANAL00227 ANAL00228
ANAK00638 ANAK00639 ANAK00659 ANAK00660 ANAK00661 ANAK00662 ANAK00663 ANAK00664
ANAK00665 ANAL00211 ANAL00212 ANAL00213 ANAL00214 ANAK00506 ANAK00724 ANAK00725
ANAK00726 ANAL00623 ANAL00624 ANAK00748 ANAK00749 ANAK00750 ANAK00751 ANAK00752
ANAK00753 ANAK00754 ANAK00755 ANAK00756 ANAL00202 ANAL00203 ANAL00204 ANAL00205
ANAL00206 ANAL00207 ANAL00208 ANAK00238 ANAK00239 ANAL00480 ANAL00481 ANAL00482
ANAL00483 ANAL00484 ANAL00485 ANAL00486 ANAL00487 ANAJ00141 ANAJ00142 ANAJ00164
ANAJ00165 ANAJ00166 ANAJ00167 ANAJ00168 ANAJ00169 ANAJ00170 ANAJ00171 ANAJ00172
ANAJ00173 ANAJ00174 ANAJ00175 ANAJ00176 ANAJ00177 ANAJ00178 ANAK00160 ANAK00202
ANAK00203 ANAK00121 ANAK00241 ANAK00402 ANAK00403 ANAK00404 ANAK00405 ANAK00406
ANAK00407 ANAK00408 ANAK00590 ANAL00651 ANAL00508 ANAL00509 ANAK00269 ANAJ00105
ANAL00638 ANAL00639 ANAL00640 ANAL00641 ANAK00526 ANAK00527 ANAK00528 ANAK00529
ANAK00530 ANAK00762 ANAK00763 ANAK00764 ANAK00765 ANAJ00179 ANAK00658 ANAJ00143
ANAL00586 ANAL00589 ANAL00590 ANAL00591 ANAL00461 ANAL00462 ANAL00463 ANAL00464
ANAK00322 ANAK00323 ANAL00649 ANAL00650 ANAK00640 ANAK00641 ANAK00681 ANAK00682
ANAK00683 ANAK00689 ANAL00122 ANAL00123 ANAL00124 ANAL00125 ANAJ00109 ANAJ00112
ANAJ00196 ANAJ00266 ANAJ00267 ANAK00266 ANAK00275 ANAK00276 ANAK00277 ANAK00278
ANAK00324 ANAL00166 ANAL00354 ANAL00356 ANAK00887 ANAK00888 ANAK00889 ANAK00358
ANAK00359 ANAK00360 ANAK00361 ANAK00362 ANAK00363 ANAK00364 ANAK00365 ANAK00366
ANAK00367 ANAK00393 ANAK00394 ANAK00395 ANAK00906 ANAK00907 ANAK00908 ANAK00909
ANAK00910 ANAJ00253 ANAJ00254 ANAJ00255 ANAK00847 ANAK00848 ANAK00849 ANAK00800
ANAK00801 ANAK00811 ANAK00816 ANAK00818 ANAK00828 ANAK00844 ANAK00853 ANAK00866
ANAK00867 ANAK00868 ANAK00871 ANAK00875 ANAK00877 ANAK00882 ANAK00802 ANAK00805
ANAK00806 ANAK00808 ANAK00810 ANAK00812 ANAK00813 ANAK00815 ANAK00817 ANAK00819
ANAK00820 ANAK00821 ANAK00822 ANAK00823 ANAK00824 ANAK00825 ANAK00826 ANAK00827
ANAK00829 ANAK00830 ANAK00831 ANAK00832 ANAK00833 ANAK00834 ANAK00835 ANAK00836
ANAK00837 ANAK00838 ANAK00840 ANAK00841 ANAK00842 ANAK00843 ANAK00845 ANAK00861
ANAK00863 ANAK00864 ANAK00865 ANAK00869 ANAK00870 ANAK00872 ANAK00873 ANAK00874
ANAK00876 ANAK00878 ANAK00879 ANAK00880 ANAK00881 ANAK00883 ANAK00884 ANAK00885 ANAK00886 ANAK00798
ANAK00799 ANAK00809 ANAK00814 ANAK00839 ANAK00803 ANAK00804 ANAK00807 ANAL00142
ANAL00143 ANAL00144 ANAL00145 ANAK00471 ANAK00320 ANAK00321 ANAK00758 ANAK00759
ANAK00760 ANAK00761 ANAK00771 ANAK00772 ANAK00773 ANAK00776 ANAK00777 ANAK00778
ANAK00779 ANAK00780 ANAK00781 ANAK00782 ANAK00783 ANAK00784 ANAK00785 ANAK00786
ANAK00787 ANAK00788 ANAK00789 ANAK00790 ANAK00791 ANAK00792 ANAL00361 ANAL00362
ANAL00363 ANAL00364 ANAL00365 ANAL00366 ANAL00367 ANAL00368 ANAL00369 ANAL00370
ANAL00371 ANAL00372 ANAL00373 ANAK00368 ANAK00369 ANAK00370 ANAK00371 ANAK00372
ANAK00373 ANAK00374 ANAK00375 ANAK00376 ANAK00377 ANAK00380 ANAK00381 ANAK00382
ANAK00383 ANAK00384 ANAK00385 ANAK00387 ANAK00388 ANAK00389 ANAK00390 ANAK00391
ANAK00392 ANAL00270 ANAK00456 ANAK00457 ANAK00458 ANAK00580 ANAK00581 ANAK00582
ANAK00583 ANAK00584 ANAK00585 ANAK00586 ANAK00587 ANAK00588 ANAK00625 ANAK00626
ANAK00627 ANAK00628 ANAK00629 ANAK00630 ANAK00631 ANAK00632 ANAK00633 ANAK00634
ANAK00635 ANAK00636 ANAK00637 ANAL00384 ANAL00385 ANAL00386 ANAL00387 ANAL00388
ANAL00389 ANAL00390 ANAL00391 ANAL00392 ANAL00393 ANAL00394 ANAK00396 ANAK00397
ANAK00398 ANAK00399 ANAK00400 ANAK00401 ANAL00322 ANAL00323 ANAL00324 ANAL00325
ANAL00326 ANAL00327 ANAL00328 ANAL00329 ANAL00330 ANAL00331 ANAL00332 ANAL00333
ANAL00334 ANAL00335 ANAL00336 ANAL00337 ANAL00338 ANAL00339 ANAL00340 ANAL00341
ANAL00342 ANAL00343 ANAL00344 ANAL00345 ANAL00346 ANAL00347 ANAL00348 ANAL00349
ANAL00350 ANAL00351 ANAK00459 ANAK00492 ANAK00465 ANAJ00107 ANAJ00108 ANAJ00111
ANAK00337 ANAK00338 ANAK00339 ANAK00340 ANAK00434 ANAK00435 ANAK00436 ANAK00437
ANAK00438 ANAK00439 ANAK00440 ANAL00190 ANAL00191 ANAL00192 ANAL00193 ANAL00194
ANAL00195 ANAL00196 ANAL00197 ANAK00428 ANAK00429 ANAK00430 ANAK00431 ANAK00432
ANAK00433 ANAL00311 ANAL00312 ANAL00313 ANAL00314 ANAK00156 ANAK00157 ANAK00158
ANAK00159 ANAK00511 ANAK00512 ANAK00513 ANAK00514 ANAK00250 ANAL00269 ANAK00598
ANAK00599 ANAK00600 ANAK00601 ANAK00602 ANAL00156 ANAL00157 ANAL00158 ANAL00664
ANAL00665 ANAK00168 ANAK00169 ANAK00100 ANAK00101 ANAK00102 ANAK00103 ANAK00104
ANAK00105 ANAK00106 ANAK00425 ANAK00426 ANAK00427 ANAK00224 ANAL00626 ANAJ00147
ANAK00279 ANAL00106 ANAL00107 ANAL00108 ANAL00109 ANAL00116 ANAJ00145 ANAJ00205
ANAK00170 ANAK00171 ANAK00172 ANAK00173 ANAK00174 ANAK00175 ANAK00176 ANAK00177
ANAK00178 ANAK00179 ANAK00180 ANAK00181 ANAK00182 ANAK00183 ANAK00184 ANAK00185
ANAK00186 ANAK00187 ANAK00188 ANAK00189 ANAK00190 ANAK00191 ANAK00192 ANAK00193
ANAK00194 ANAK00195 ANAK00196 ANAK00197 ANAK00198 ANAK00199 ANAK00200 ANAK00201
ANAL00642 ANAL00643 ANAL00644 ANAL00645 ANAL00646 ANAL00647 ANAL00551 ANAL00552
ANAH00116 ANAK00643 ANAK00644 ANAK00927 ANAK00928 ANAK00929 ANAK00930 ANAK00931
ANAK00932 ANAK00933 ANAK00934 ANAK00935 ANAK00936 ANAK00937 ANAJ00146 ANAK00260
ANAK00262 ANAK00263 ANAK00273 ANAK00117 ANAL00271 ANAL00272 ANAL00275 ANAL00273
ANAL00274 ANAJ00190 ANAK00111 ANAJ00180 ANAJ00181 ANAJ00182 ANAJ00183 ANAJ00184
ANAJ00185 ANAJ00186 ANAJ00187 ANAJ00188 ANAJ00189 ANAL00449 ANAL00450 ANAL00451
ANAL00452 ANAL00453 ANAL00454 ANAL00455 ANAL00456 ANAH00114 ANAJ00265 ANAJ00197
ANAJ00198 ANAJ00199 ANAJ00202 ANAJ00228 ANAJ00229 ANAJ00230 ANAJ00256 ANAJ00257
ANAJ00258 ANAJ00259 ANAK00254 ANAK00255 ANAK00256 ANAK00257 ANAK00258 ANAJ00195
ANAL00100 ANAL00631 ANAL00632 ANAL00633 ANAL00634 ANAL00635 ANAL00636 ANAL00662
ANAL00663 ANAK00657 ANAK00249 ANAK00463 ANAK00464 ANAK00123 ANAK00124 ANAK00125
ANAK00126 ANAK00127 ANAK00128 ANAK00129 ANAK00130 ANAK00131 ANAK00132 ANAK00133
ANAK00134 ANAK00135 ANAK00136 ANAK00137 ANAK00138 ANAK00139 ANAK00140 ANAK00721
ANAK00722 ANAL00444 ANAL00445 ANAL00446 ANAL00447 ANAL00448 ANAL00404 ANAL00405
ANAL00244 ANAL00146 ANAL00147 ANAL00148 ANAL00149 ANAL00150 ANAL00151 ANAL00152
ANAL00153 ANAL00154 ANAL00155 ANAK00717 ANAJ00101 ANAK00261 ANAK00264 ANAK00268
ANAK00270 ANAK00271 ANAK00272 ANAK00274 ANAL00597 ANAL00598 ANAL00599 ANAL00600
ANAL00601 ANAL00406 ANAL00407 ANAL00408 ANAL00409 ANAL00410 ANAJ00208 ANAJ00209
ANAJ00210 ANAJ00211 ANAJ00212 ANAL00308 ANAK00461 ANAK00710 ANAK00711 ANAK00712
ANAK00713 ANAK00714 ANAK00715 ANAH00125 ANAH00117 ANAJ00102 ANAJ00113 ANAJ00203
ANAJ00264 ANAK00213 ANAK00214 ANAK00242 ANAK00247 ANAK00248 ANAK00259 ANAK00265
ANAK00280 ANAK00325 ANAK00326 ANAK00327 ANAK00922 ANAK00923 ANAK00924 ANAK00925
ANAL00165 ANAL00168 ANAL00246 ANAL00247 ANAL00250 ANAL00251 ANAL00252 ANAL00253
ANAL00254 ANAL00255 ANAL00256 ANAL00257 ANAL00258 ANAL00259 ANAL00260 ANAL00261
ANAL00262 ANAL00263 ANAL00279 ANAL00309 ANAL00353 ANAL00355 ANAL00357 ANAL00358
ANAL00381 ANAL00397 ANAL00398 ANAL00412 ANAL00654 ANAH00124 ANAH00126 ANAK00215
ANAK00345 ANAK00723 ANAK00727 ANAK00728 ANAK00850 ANAK00851 ANAK00852 ANAK00346
ANAK00347 ANAL00380 ANAJ00122 ANAK00615 ANAK00616 ANAK00617 ANAK00618 ANAK00619
ANAK00620 ANAK00621 ANAK00622 ANAK00623 ANAK00509 ANAK00510 ANAL00105 ANAK00591
ANAK00592 ANAK00593 ANAK00594 ANAK00768 ANAK00769 ANAK00770 ANAK00793 ANAK00794
ANAK00795 ANAK00796 ANAK00797 ANAL00637 ANAK00603 ANAK00604 ANAK00605 ANAK00606
ANAK00607 ANAK00608 ANAK00609 ANAK00610 ANAK00611 ANAK00612 ANAK00613 ANAK00614
ANAK00109 ANAK00107 ANAK00108 ANAK00243 ANAK00244 ANAK00246 ANAL00238 ANAK00647
ANAK00648 ANAK00649 ANAK00666 ANAK00667 ANAK00668 ANAK00245 ANAK00422 ANAK00734
ANAK00735 ANAK00736 ANAL00307 ANAK00146 ANAL00432 ANAK00575 ANAK00234 ANAK00470
ANAL00395 ANAL00440 ANAL00441 ANAJ00124 ANAJ00104 ANAJ00123- ANAK00118 ANAK00119
ANAK00120 ANAK00441 ANAK00442 ANAK00443 ANAK00444 ANAK00445 ANAK00446 ANAK00447
ANAK00448 ANAK00449 ANAK00450 ANAK00451 ANAK00452 ANAK00453 ANAK00454 ANAK00455
ANAL00295 ANAL00296 ANAK00207 ANAK00720 ANAL00510 ANAL00511 ANAL00512 ANAL00513
ANAL00514 ANAL00515 ANAL00516 ANAL00517 ANAL00518 ANAL00519 ANAL00520 ANAL00521
ANAL00522 ANAL00523 ANAL00524 ANAL00525 ANAL00526 ANAL00527 ANAL00528 ANAL00529
ANAL00530 ANAL00559 ANAK00281 ANAK00282 ANAK00531 ANAK00532 ANAK00533 ANAK00534
ANAK00535 ANAK00536 ANAK00537 ANAK00538 ANAK00539 ANAK00540 ANAK00541 ANAK00542
ANAK00543 ANAK00544 ANAK00545 ANAK00546 ANAK00547 ANAK00548 ANAK00549 ANAK00550
ANAK00551 ANAK00552 ANAK00553 ANAK00554 ANAK00555 ANAK00556 ANAK00557 ANAK00558
ANAK00559 ANAK00560 ANAK00561 ANAK00562 ANAK00563 ANAK00564 ANAK00565 ANAK00566
ANAK00567 ANAK00568 ANAK00569 ANAK00570 ANAK00571 ANAK00572 ANAK00573 ANAK00742
ANAK00743 ANAL00306 ANAK00466 ANAK00467 ANAK00468 ANAK00469 ANAK00507 ANAK00508
ANAL00278 ANAL00489 ANAL00602 ANAL00603 ANAL00604 ANAL00605 ANAL00606 ANAL00607
ANAL00608 ANAL00609 ANAL00610 ANAL00611 ANAL00612 ANAL00613 ANAL00614 ANAL00625
ANAL00629 ANAL00630 ANAK00854 ANAK00152 ANAK00153 ANAK00154 ANAK00155 ANAK00645
ANAK00646 ANAL00488 ANAL00655 ANAL00656 ANAL00657 ANAL00658 ANAL00659 ANAL00660
ANAK00357 ANAK00341 ANAK00729 ANAK00730 ANAK00731 ANAK00732 ANAK00733 ANAK00283
ANAK00498 ANAK00499 ANAK00500 ANAK00893 ANAK00894 ANAK00895 ANAK00896 ANAK00897
ANAK00898 ANAK00899 ANAK00900 ANAK00901 ANAK00902 ANAK00335 ANAK00336 ANAK00654
ANAK00655 ANAK00656 ANAJ00114 ANAK00216 ANAK00766 ANAK00767 ANAK00212 ANAL00277
ANAJ00118 ANAK00211 ANAL00276 ANAK00423 ANAJ00117 ANAK00576 ANAK00577 ANAK00578
ANAJ00103 ANAL00533 ANAL00547 ANAL00548 ANAL00549 ANAL00550 ANAL00553 ANAL00554
ANAL00555 ANAL00556 ANAL00557 ANAL00558 ANAL00565 ANAJ00206 ANAK00460 ANAK00501
ANAK00502 ANAK00855 ANAK00856 ANAK00857 ANAK00858 ANAK00859 ANAK00860 ANAK00862
ANAK00913 ANAK00914 ANAK00915 ANAK00916 ANAK00917 ANAK00918 ANAK00919 ANAK00920
ANAL00128 ANAL00129 ANAL00130 ANAL00131 ANAL00132 ANAL00133 ANAL00134 ANAL00135
ANAL00136 ANAL00137 ANAL00138 ANAL00139 ANAL00231 ANAL00232 ANAL00233 ANAL00234
ANAL00235 ANAL00236 ANAL00237 ANAL00103 ANAL00111 ANAL00112 ANAL00113 ANAL00114
ANAK00150 ANAK00151 ANAK00217 ANAK00218 ANAK00219 ANAK00220 ANAK00504 ANAK00505
ANAK00348 ANAK00349 ANAK00350 ANAK00351 ANAK00352 ANAK00353 ANAK00235 ANAL00374
ANAL00375 ANAL00376 ANAL00402 ANAL00403 ANAL00546 ANAK00424 ANAL00401 ANAL00267
ANAK00221 ANAK00222 ANAL00652 ANAL00653 ANAK00208 ANAK00209 ANAK00210 ANAK00718
ANAK00719 ANAK00737 ANAK00738 ANAK00739 ANAK00740 ANAK00741 ANAL00162 ANAL00163
ANAL00164 ANAL00299 ANAL00300 ANAL00301 ANAL00302 ANAL00303 ANAL00304 ANAL00305
ANAL00352 ANAL00592 ANAL00593 ANAL00594 ANAL00595 ANAL00596 ANAJ00252 ANAK00161
ANAL00458 ANAJ00119 ANAK00251 ANAK00252 ANAK00589 ANAK00891 ANAK00892 ANAL00159
ANAL00183 ANAL00185 ANAL00186 ANAL00187 ANAL00502 ANAJ00191 ANAJ00194 ANAK00142
ANAK00143 ANAK00144 ANAK00145 ANAK00205 ANAK00379 ANAK00493 ANAK00494 ANAK00518
ANAK00519 ANAK00521 ANAK00522 ANAK00747 ANAL00239 ANAL00240 ANAL00413 ANAL00414
ANAL00415 ANAL00419 ANAL00587 ANAK00204 ANAL00245 ANAK00515 ANAK00516 ANAK00520
ANAK00574 ANAL00118 ANAL00119 ANAL00120 ANAK00523 ANAK00524 ANAK00344 ANAL00588
ANAK00595 ANAK00596 ANAK00597 ANAL00560 ANAL00561 ANAL00562 ANAL00563 ANAL00564
ANAK00744 ANAK00745 ANAK00746 ANAL00160 ANAL00161 ANAL00115 ANAK00147 ANAK00148
ANAJ00262 ANAJ00263 ANAK00206 ANAK00378 ANAK00517 ANAK00525 ANAL00104 ANAL00110
ANAK00354 ANAK00355 ANAK00356 ANAL00566 ANAL00567 ANAL00568 ANAL00569 ANAL00570
ANAL00571 ANAL00572 ANAL00459 ANAL00460 ANAJ00192 ANAJ00193 ANAJ00207 ANAK00237
ANAL00425 ANAK00149 ANAL00420 ANAK00678 ANAK00679 ANAL00249 ANAL00627 ANAL00628
ANAL00298 ANAL00310 ANAL00661 ANAL00421 ANAL00503 ANAL00504 ANAL00505 ANAL00506
ANAL00507 ANAJ00116 ANAL00268 ANAL00457 ANAK00386 ANAK00669 ANAK00670 ANAK00671
ANAK00672 ANAK00673 ANAK00674 ANAK00675 ANAK00676 ANAK00677 ANAK00680 ANAK00690
ANAK00691 ANAK00692 ANAK00693 ANAK00694 ANAK00695 ANAK00696 ANAK00697 ANAK00698
ANAK00699 ANAK00700 ANAK00701 ANAJ00115 ANAK00653 ANAK00716 ANAK00267 ANAK00650
ANAK00651 ANAK00652 ANAK00911 ANAK00912 ANAL00360 ANAJ00123 ANAL00198 ANAL00648
ANAJ00144 ANAJ00160 ANAK00684 ANAK00685 ANAK00686
ANAK00687 ANAK00688 ANAL00280 ANAL00282 ANAL00283 ANAL00285 ANAK00116
ANAK00702 ANAL00286 ANAL00287 ANAL00288 ANAL00289 ANAL00290 ANAL00291 ANAL00292
ANAL00293 ANAL00294 ANAJ00131 ANAJ00133 ANAK00110 ANAK00111 ANAK00112 ANAK00113
ANAK00114 ANAK00115 ANAL00169 ANAJ00132 ANAK00112 ANAK00223 ANAL00170 ANAL00171
ANAL00172 ANAL00173 ANAL00174 ANAL00175 ANAL00176 ANAL00177 ANAL00178 ANAL00179
ANAL00180 ANAL00181 ANAL00182 ANAL00184 ANAL00188 ANAL00189 ANAL00281 ANAL00284
ANAK00236 ANAJ00138 ANAJ00139 ANAJ00140 ANAJ00148 ANAJ00149 ANAJ00150 ANAJ00151
ANAJ00152 ANAJ00153 ANAJ00154 ANAJ00155 ANAJ00156 ANAJ00157 ANAJ00158 ANAJ00159
ANAJ00161 ANAJ00162 ANAJ00163 ANAL00359 ANAL00127 ANAL00442 ANAL00443 ANAK00122
ANAK00141 ANAK00757 ANAK00921 ANAL00117 ANAL00584 ANAL00585 ANAK00329 ANAK00330
ANAK00331 ANAK00332 ANAK00333 ANAK00334 ANAK00342 ANAK00476 ANAK00477 ANAK00496
ANAK00497 ANAK00503 ANAK00624 ANAK00642 ANAK00903 ANAK00904 ANAK00905 ANAL00199
ANAL00229 ANAL00230 ANAL00241 ANAL00242 ANAL00243 ANAL00379 ANAL00396 ANAL00399
ANAL00400 ANAL00531 ANAL00532 ANAJ00260 ANAK00343 ANAK00579 ANAK00846 ANAL00126
ANAL00200 ANAL00201 ANAL00422 ANAL00423 ANAL00424 ANAJ00213 ANAJ00261 ANAK00472
ANAL00140 ANAL00141 ANAL00471 ANAL00475 ANAL00465 ANAL00466 ANAL00467 ANAL00468
ANAL00469 ANAL00470 ANAL00472 ANAL00473 ANAL00474 ANAL00476 ANAL00477 ANAL00478
ANAL00479 ANAL00534 ANAL00535 ANAL00536 ANAL00537 ANAL00538 ANAL00539 ANAL00540
ANAL00541 ANAL00542 ANAL00543 ANAL00544 ANAL00545 ANAL00264 ANAL00265 ANAL00266
ANAK00410 ANAK00411 ANAK00412 ANAK00413 ANAK00414 ANAK00415 ANAK00416 ANAK00417
ANAK00418 ANAK00419 ANAK00420 ANAK00421 ANAK00703 ANAK00704 ANAK00705 ANAK00706
ANAK00707 ANAK00708 ANAK00709 ANAK00462 ANAK00481 ANAK00482 ANAK00483 ANAK00484
ANAK00485 ANAK00486 ANAK00487 ANAK00488 ANAK00489 ANAK00490 ANAK00491 ANAK00253
ANAL00615 ANAL00616 ANAL00617 ANAL00618 ANAL00619 ANAL00620 ANAL00621, and
ANAL00622
RECALLING FIRM/MANUFACTURER
Datex – Ohmeda, Inc., Madison, WI, by letters dated August 12, 2008.
Firm initiated recall is ongoing.
REASON
The electronic vaporization system in the GE Aisys Anesthesia machine contains
the following components: Backpressure Valve, Inflow Check Valve and Cassette
Interface Board, that can contribute to independent failures.
VOLUME OF PRODUCT IN COMMERCE
1,571 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Vicryl Rapide (polyglactin 910) Braided Coated Synthetic Absorbable Suture,
Undyed, Non-USP. The product is used for Soft Tissue approximation. a) Product
code V2920G; b) Product code PN1695H; c) Product code V2920H; d) Product code
V4731H; e) Product code VR214; f) Product code W9947; g) Product code VR214;
h) Product code V4851H, and i) Product code VR426, Recall # Z-0021-2009
CODE
a) Lot ZE8KPMR0, Exp 6/30/2012; b) Lot ZG8BDZQ0, Exp. 6/30/2012; c) Lot ZG8BJQR0,
Exp 6/30/2012; d) Lot ZG8BSSQ0, Exp 6/30/2012; e) Lot ZG8BTSD0, Exp. 6/30/2012;
f) Lot ZG8BHPQ0, Exp 6/30/2012; g) Lot ZG9CJXD0, Exp. 6/06/2012; h) Lot ZG8BZWQ0,
Exp. 6/30/2012 and i) Lot ZG9BSPE0, Exp. 6/4/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon, Inc., Somerville, NJ, by letters on August 11
2008.
Manufacturer: Ethicon GmbH, Norderstedt, Germany. Firm initiated recall is
ongoing.
REASON
Package defect compromised the integrity of the primary seal, which could lead
to premature suture degradation and/or impair the sterile barrier of the product.
VOLUME OF PRODUCT IN COMMERCE
6,912 units
DISTRIBUTION
Nationwide, Australia, New Zealand and Indonesia
___________________________________
PRODUCT
BD Visitec High Viscosity Injector, 4 mm Ref: 585173. The product is intended
for Vitroretinal Surgery. Recall # Z-0022-2009
CODE
Lot number: 8018591
RECALLING FIRM/MANUFACTURER
Becton Dickinson and Co., Waltham, MA, by telephone on September 15, 2008.
Firm initiated recall is ongoing.
REASON
Product labeled as 4 mm High Viscosity Injector tip contains a 6 mm tip.
VOLUME OF PRODUCT IN COMMERCE
1,485 units
DISTRIBUTION
AZ, CA, CO, IL, OH, FL, PA, TN, TX, VA, Australia and Japan
___________________________________
PRODUCT
a) Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm
Non-threaded Separator System with Universal Seal, for laparoscopic procedures,
Recall # Z-0023-2009;
b) Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded
Separator System with Universal Seal, for laparoscopic procedures, Recall #
Z-0024-2009;
c) Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded
Separator System with Universal Seal, for laparoscopic procedures, Recall #
Z-0025-2009;
d) Applied Medical, Separator Abdominal Access System REF:
C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic
procedures, Recall # Z-0026-2009;
e) Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm
Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System
w/Universal Seal, for laparoscopic procedures, Recall # Z-0027-2009;
f) Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm
Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium
Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded
Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors
(2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic
procedures, Recall # Z-0028-2009;
g) Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm
Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled
(2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded
Cannula System, for laparoscopic procedures, Recall # Z-0029-2009
CODE
a) Product/Kit Batch Numbers: 1061480, 1061127, 1060184, 1058796, 1058108,
1056578, 1056709, 1054094, 1054837;
b) Product/Kit Batch Numbers: 1061115, 1058102, 1057096;
c) Product/Kit Batch Number 1059804;
d) Product/Kit Batch Numbers: 1060178, 1056644, 1056045;
e) Product/Kit Batch Numbers: 1057269, 1057814, 1058172, 1058834, 1059466,
1059823, 1060637, 1061254, 1062450, 1062867, 1063561, 1063797, 1064872;
f) Product/Kit Batch Numbers: 1059718, 1060488, 1061516, 1062296, 1063810;
g) Product/Kit Batch Numbers: 1059636, 1060354, 1061309, 1062314
RECALLING FIRM/MANUFACTURER
Applied Medical Resources Corp., Rancho Santa Margarita, CA, by letter
on June 25, 2008. Firm initiated recall is ongoing.
REASON
Potential inability to insufflate through the stopcock. Under certain circumstances,
a flexible elastomeric component inside the 15mm trocar can stretch into a
configuration that blocks the flow of insufflation gas (C02).
VOLUME OF PRODUCT IN COMMERCE
14,113 devices
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond
coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile; REF 114813.
The product intended use is for Orthopedic implant, Recall # Z-0032-2009;
b) Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond
coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile; REF 114817.
The product intended use is for Orthopedic implant, Recall # Z-0033-2009
CODE
a) Lot: 440360;
b) Lot: 440370
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated May 28, 2008. Firm initiated recall
is complete.
REASON
The component in the package is not the correct size.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
CA, IL, IN, MA, OH, PR, Canada, Germany and Great Britain
___________________________________
PRODUCT
1) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree; Model EX060201CD, Recall # Z-0035-2009;
2) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree; Model EX060203CD, Recall # Z-0036-2009;
3) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree. Model EX060301CD, Recall # Z-0037-2009;
4) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX060303CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Z-0038-2009;
5) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX060401CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0039-2009;
6) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX060403CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0040-2009;
7) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Model EX060601CD, Recall # Z-0041-2009;
8) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX060603CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0042-2009;
9) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree; Model EX060801CD, Recall # Z-0043-2009;
10) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree. Model EX060803CD, Recall # Z-0044-2009;
11) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Model EX070201CD, Recall # Z-0045-2009;
12) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System;
Model EX070203CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0046-2009;
13) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX070303CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0047-2009;
14) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX070401CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0048-2009;
15) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX070403CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0049-2009;
16) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX070601CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0050-2009;
17) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX070603CD, Recall # Z-0051-2009;
18) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX070801CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0052-2009;
19) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX070803CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0053-2009;
20) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX080201CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0054-2009;
21) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX080203CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0055-2009;
22) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX080301CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0056-2009;
23) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX080303CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0057-2009;
24) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX080401CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0058-2009;
25) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX080403CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0059-2009;
26) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX080601CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0060-2009;
27) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX080603CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0061-2009;
28) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX080801CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0062-2009;
29) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX080803CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0063-2009;
30) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX090201CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0064-2009;
31) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX090203CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0065-2009;
32) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX090301CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0066-2009;
33) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX090303CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0067-2009;
34) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX090401CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0068-2009;
35) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX090403CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0069-2009;
36) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX090601CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0070-2009;
37) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX090603CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0071-2009;
38) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX090801CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0072-2009;
39) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX090803CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0073-2009;
40) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX100201CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0074-2009;
41) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX100203CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0075-2009;
42) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX100301CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0076-2009;
43) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX100303CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0077-2009;
44) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX100401CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0078-2009;
45) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX100403CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0079-2009;
46) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX100601CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0080-2009;
47) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX100603CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0081-2009;
48) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX100801CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0082-2009;
49) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX100803CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0083-2009;
50) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX100903CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall #Z-0084-2009;
51) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System,
Model EX070301CD. The LifeStent FlexStar self-expanding biliary stent system
is intended for use in the palliation of malignant strictures (neoplasms) in
the biliary tree, Recall # Z-0085-2009
CODE
1) Lot Numbers: FR6J0255, FR6K0341, and R58284565;
2) Lot Numbers: 58270990, FR6H0165, and FR6J0230;
3) Lot Numbers: FR6H0175, FR6J0256, and FR6K0303;
4) Lot Numbers: FR6H0141, FR6H0211, and FR6K0302;
5) Lot Numbers: 58279713, 58293031, and FR6H0207, R58270988;
6) Lot Numbers: 58285866, 58293037, and 58296524, 58311148, FR6H0137, FR6H0203,
FR6H0212, FR6J0232;
7) Lot Numbers: 58273028, 58285828, 58319742, 58422455, and RFR6K0283;
8) Lot Numbers: 58289987, 58298660, R58315412, 58333466, 58338746, 58347645,
58407267, 58419030, 58423549, 58432229, RFR6K0269, FR6H0213, and FR6K0346;
9) Lot Numbers: 58285832, 58410757, 58430091, RFR650278, and RFR6K0314;
10) Lot Numbers: 58294818, 58306516, 58311615, 58337133, 58338748, 58404088, 58410765, 58419031, 58432230, FR6J0217, and FR6J0234;
11) Lot Numbers: FR6J0251, and FR6K0315;
12) Lot Numbers: 58294838, FR6H0158, FR6K0288, FR6K0325, R58274189, R58279729,
FR6K0279, and FR6K0335;
13) Lot Numbers: FR6H0150, FR6K0271A, FR6K0326, R58279730, and R58308182;
14) Lot Numbers: FR6H0156 FR6H0209 FR6K0304 R58283591 and R58286397;
15) Lot Numbers: 58289990, 58298661, FR6H0181, FR6J0218, FR6J0235, FR6K0327,
and FR6K0348;
16) Lot Numbers: R58270989, R58284563, R58285860, R58293765, FR6J0244, and
FR6K0336;
17) Lot Numbers: R58289766, R58289767, R58293038, R58295135, R58301758, 58315414,
58325057, 58407270, 58412480, 58419033, 58430096, RFR6J0219, and FR6K0328;
18) Lot Numbers: 58298658, 58406012, RFR6J0257, FR6K0284, and FR6K0316;
19) Lot Numbers: R58279091, 58288280, 58289993, 58290196, 58308185, R58321778,
58401900, 58410766, 58432236, 58437453, FR6J0238, and RFR6J0263;
20) Lot Numbers: FR6J0252, FR6K0342, and FR6K0347;
21) Lot Numbers: 58266138, 58274193, FR6J0266, FR6K0308, and FR6L0349;
22) Lot Numbers: FR6J0258, and FR6K0337;
23) Lot Numbers: 58289994, FR6J0267, FR6K0287, FR6K0309, and FR6K0339;
24) Lot Numbers: 58316534, FR6J0261, FR6K0282, FR6K0317, R58266135, R58280596,
and R58285861;
25) Lot Numbers: FR6H0214, RFR6J0220;
26) Lot Numbers: R58266137, R58279720, R58296523, 58325045, 58406018, 58410764,
58415739, FR6H0210, FR6K0293, RFR6K0297, and RFR6K0318;
27) Lot Numbers: R58280597, 58289995, 58316538, 58412483, 58425340, 58435212,
FR6J0268, and RFR6K0329;
28) Lot Numbers: 58266130, 58285862, R58315409, B58433721, FR6J0259, and FR6K0285;
29) Lot Numbers: R58274194, R58279723, R58279092, 58315415, 58338578, 58346286,
58423554, FR6J0265, FR6K0310, and FR6K0334;
30) Lot Numbers: 58266133, FR6H0187, and FR6J0245;
31) Lot Number: FR6K0275;
32) Lot Numbers: FR6H0169, FR6J0227, and FR6K0320;
33) Lot Numbers: 58266279, FR6H0184, and FR6K0290;
34) Lot Numbers: FR6H0142, FR6J0246, FR6K0321, and R58301781;
35) Lot Numbers: FR6J0264, and FR6K0311;
36) Lot Numbers: R58287298, 58290067, R58327648, 58415744, B58452193, FR6J0247,
and FR6K0299;
37) Lot Numbers: R58346066, and FR6J0253;
38) Lot Numbers: R58340557, FR6J0248, FR6K0300, and FR6K0344;
39) Lot Numbers: BR58429040, BR58429176, R58432237, FR6J0254, and FR6K0313;
40) Lot Numbers: 58285863, FR6H0185, and FR6J0249;
41) Lot Number FR6K0276;
42) Lot Numbers: FR6H0172, FR6J0250, FR6K0322, FR6K0340, and R58287299;
43) Lot Numbers: 58290197, and FR6K0330;
44) Lot Numbers: FR6K0277A, FR6K0307, FR6K0323, R58279724, R58285864, R58308046,
and R58316537;
45) Lot Numbers: FR6H0153, FR6K0289, and FR6K0331;
46) Lot Numbers: R58285865, R58312972, 58337682, 58415748, FR6J0229, and RFR6K0303;
47) Lot Numbers: 58266139, 58332065, 58424739, FR6J0241, and FR6K0332;
48) Lot Numbers: R58300437, R58330672, and FR6K0286;
49) Lot Numbers: R58266280, 58406020, FR6K0280, FR6K0333, and FR6J0242;
50) Lot Number: FR6K0281;
51) Lot Numbers: FR6K0279, and FR6K0335;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bard Peripheral Vascular Inc., Tempe, AZ, by letters on
August 29, 2008.
Manufacturer: Edwards LifeSciences, LLC, Irvine, CA. Firm initiated recall
is ongoing.
REASON
Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery
system and the primary sheath such that the guidewire lumen is visible.
VOLUME OF PRODUCT IN COMMERCE
9,899 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions
2.0.1 to 2.0.05, 3.0.01 and 3.0.02 ultrasound system with onscreen display,
Recall # Z-0086-2009
CODE
Sonovista: 10133170 (Japan only) Acuson: 10037409 (potentially affected but
no volume: 10132987, 10038837). Software revisions 2.0.1 to 2.0.05, 3.0.01
and 3.0.02
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on August
19, 2008. Firm initiated recall is ongoing.
REASON
Incorrect value calculations by the device may result in inaccurate aortic
stenosis estimates.
VOLUME OF PRODUCT IN COMMERCE
169 units total
DISTRIBUTION
Nationwide, Singapore, Germany, Denmark, Romania, Sweden, Poland, Portugal,
Australia, Chile, India, Spain, Thailand, Malaysia, South Africa, Hungary,
Saudi Arabia, Qatar, Peru, Italy, Azerbaijan, Greenland, Austria, Venezuela,
Puerto Rico, Brazil and Japan
___________________________________
PRODUCT
Draeger Medical Apollo Anesthesia Machine, catalog number 8606500, Recall #
Z-0087-2009
CODE
Serial numbers: ARZC-0142, ARZC-0143, ARZC-0144, ARZC-0145, ARZC-0146, ARZC-0147,
ARZC-0148, ARZC-0149, ARZC-0150, ARZC-0151, ARZC-0152, ARZC-0153, ARZC-0172,
ARZC-0173, ARZC-0174, ARZC-0175, ARZC-0176, ARZC-0177, ARZC-0192, ARZC-0193,ARZC-0196,
ARZC-0197, ARZC-0198, ARZC-0199, ARZC-0200, ARZD-0001, ARZD-0002, ARZD-0003,
ARZD-0010, ARZD-0011, ARZD-0012, ARZD-0013, ARZD-0014, ARZD-0015, ARZD-0016,
ARZD-0017, ARZD-0018, ARZD-0019, ARZD-0020, ARZD-0021, ARZD-0022, ARZD-0023,
ARZD-0024, ARZD-0025, ARZD-0026, ARZD-0027, ARZD-0028, ARZD-0029, ARZD-0030,
ARZD-0031, ARZD-0032, ARZD-0033, ARZD-0034, ARZD-0035, ARZD-0036, ARZD-0037,
ARZD-0038, ARZD-0039, ARZD-0040, ARZD-0041, ARZD-0042, ARZD-0043, ARZD-0044,
ARZD-0058, ARZD-0059, ARZD-0060, ARZD-0061, ARZD-0062, ARZD-0063, ARZD-0064,
ARZD-0065, ARZD-0066, ARZD-0067, ARZD-0068, ARZD-0069, ARZD-0070, ARZD-0071,
ARZD-0072, ARZD-0073, ARZD-0074, ARZD-0075, ARZD-0076, ARZD-0077, ARZD-0078,
ARZD-0079, ARZD-0080, ARZD-0081, ARZD-0082, ARZD-0083, ARZD-0084, ARZD-0085,
ARZD-0086, ARZD-0087, ARZD-0117, ARZD-0118, ARZD-0119, ARZD-0120, ARZD-0121,
ARZD-0122, ARZD-0125, ARZD-0126, ARZD-0127, ARZD-0128, ARZD-0129, ARZD-0130,
ARZD-0131, ARZD-0132, ARZD-0133, ARZD-0134, ARZD-0135, ARZD-0136, ARZD-0183,
ARZD-0184, ARZD-0185, ARZD-0186, ARZD-0187, ARZD-0188, ARZD-0189, ARZD-0190,
ARZD-0191, ARZD-0192, ARZD-0193, ARZD-0194, ARZD-0195, ARZD-0196, ARZD-0197,
ARZD-0198, ARZD-0199, ARZD-0200, ARZD-0201, ARZD-0202, ARZD-0203, ARZD-0255,
ARZD-0256, ARZD-0257, ARZD-0258, ARZD-0259, ARZD-0260, ARZD-0261, ARZD-0262,
ARZD-0263, ARZD-0264, ARZD-0265, ARZD-0266, ARZD-0267, ARZD-0268, ARZD-0269,
ARZD-0270, ARZD-0271, ARZE-0001, ARZE-0002, ARZE-0003, ARZE-0004, ARZE-0005,
ARZE-0008, ARZE-0009, ARZE-0010, ARZE-0023, ARZE-0024, ARZE-0025, ARZE-0026,
ARZE-0027, ARZE-0028, ARZE-0029, ARZE-0030, ARZE-0059, ARZE-0060, ARZE-0061,
ARZE-0062, ARZE-0063, ARZE-0064, ARZE-0065, ARZE-0115, ARZE-0116, ARZE-0173,
ARZE-0174, ARZE-0175, ARZE-0176, ARZE-0189, ARZE-0190, ARZE-0191, ARZE-0192,
ARZE-0193, ARZE-0194, ARZE-0195, ARZE-0196, ARZE-0197, ARZE-0198, ARZE-0199,
ARZE-0200, ARZE-0201, ARZE-0202, ARZE-0203, ARZE-0204, ARZE-0214, ARZE-0215,
ARZE-0216, ARZF-0011, ARZF-0012, ARZF-0013, ARZF-0014, ARZF-0015, ARZF-0016,
ARZF-0017, ARZF-0018, ARZF-0019, ARZF-0020, ARZF-0021, ARZF-0022, ARZF-0023,
ARZF-0024, ARZF-0025, ARZF-0026, ARZF-0027, ARZF-0028, ARZF-0029, ARZF-0030,
ARZF-0031, ARZF-0084, ARZF-0087, ARZF-0088, ARZF-0089, ARZF-0090, ARZF-0091,
ARZF-0092, ARZF-0093, ARZF-0094, ARZF-0095, ARZF-0096, ARZF-0097, ARZF-0098,
ARZF-0099, ARZF-0100, ARZF-0101, ARZF-0102, ARZF-0103, ARZF-0104, ARZF-0105,
ARZF-0106, ARZF-0107, ARZF-0108, ARZF-0109, ARZF-0110, and ARZF-0111
RECALLING FIRM/MANUFACTURER
Recalling Firm: Draeger Medical, Inc., Telford, PA, by letter on August
22, 2008.
Manufacturer: Draeger Aerospace Gmbh, Lubeck, Germany. Firm initiated recall
is ongoing.
REASON
Sporadic errors in various device functions, including low readings of the
single gas flows for oxygen, nitrous oxide, or air delivery, or mechanical
ventilation failure. Alarms and error messages function as designed.
VOLUME OF PRODUCT IN COMMERCE
214 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Envision E700 Low Airloss Therapy Surface. The Envision E700 Low Airloss Therapy
Surface helps prevent and treat stage III and stage IV pressure ulcers in patients
who weigh between 70 lb and 400 lb and are between 4'11" and 6' 4" in
height, Recall # Z-0088-2009
CODE
Serial numbers DB100527 thru DB101305.
RECALLING FIRM/MANUFACTURER
Hill-Rom Manufacturing, Inc., Charleston, SC, by Modification Notice dated
September 1, 2008. Firm initiated recall is ongoing.
REASON
A defect in the software of the device may not allow the patient bed exam alarm
or the patient movement alarm to function correctly.
VOLUME OF PRODUCT IN COMMERCE
779 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Coherence AG Therapist Part number 5863506, equipped with a Coherence Therapist
R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1 Medical charged-particle radiation
therapy system, Recall # Z-0089-2009;
b) Coherence Therapist System Part number 7339125 Medical charged-particle
radiation therapy system, Z-0090-2009;
c) Coherence Impression Therapist System equipped with a Coherence Therapist
R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7341410; Medical charged-particle
radiation therapy system, Recall # Z-0091-2009;
d) PRIMEVIEW 3i System equipped with a Coherence Therapist R2.0 or R2.1, and
PRIMEVIEW 3iR2.0 or R2.1, part number 7341428 Medical charged-particle radiation
therapy system, Recall # Z-0092-2009;
e) AG Therapist 3rd party V&R equipped with a Coherence Therapist R2.0
or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7345411 Medical charged-particle
radiation therapy system, Recall # Z-0093-2009;
f) Impression Therapist 3rd party V&R equipped with a Coherence Therapist
R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7345429 Medical charged-particle
radiation therapy system, Recall # Z-0094-2009;
g) Syngo Based WS for 3rd party equipped with a Coherence Therapist R2.0 or
R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7345437 Medical charged-particle
radiation therapy system, Recall # Z-0095-2009;
h) Coherence Therapist 2.0 equipped with a Coherence Therapist R2.0 or R2.1,
and PRIMEVIEW 3iR2.0 or R2.1, part number 8139839 Medical charged-particle
radiation therapy system, Recall # Z-0096-2009;
i) PRIMEVIEW 3i System 2.0 equipped with a Coherence Therapist R2.0 or R2.1,
and PRIMEVIEW 3iR2.0 or R2.1, part number 8139847 Medical charged-particle
radiation therapy system, Recall # Z-0097-2009;
j) Coherence Therapist System 2.1 equipped with a Coherence Therapist R2.0
or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8147667 Medical charged-particle
radiation therapy system, Recall # Z-0098-2009;
k) PRIMEVIEW 3i System 2.1 equipped with a Coherence Therapist R2.0 or R2.1,
and PRIMEVIEW 3iR2.0 or R2.1, part number 8147675 Medical charged-particle
radiation therapy system, Recall # Z-0099-2009
CODE
All serial numbers associated with RTT2.0 and RTT2.1
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Concord, CA, by letter on November 6,
2007. Firm initiated recall is ongoing.
REASON
Flat panel positioning calibration could be off by as much as 4 mm without
the machine discovering detail.
VOLUME OF PRODUCT IN COMMERCE
192 active systems
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
M3811B Philips Telemonitoring Clinical Review Software part of Philips Telemonitoring
System, M3810A, software revision identified as Build 1.1.2.11d, B.02.07. Prescriptive
medical device used to automatically collect and transmit medical information
(weight, blood pressure, non-diagnostic ECG) over phone lines between provider
and patient, Recall # Z-0100-2009
CODE
Build 1.1.2.11d, B.02.07
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA, by letters on September 11, 2008. Firm
initiated recall is ongoing.
REASON
Multiprint report may contain incorrect vital data for patients.
VOLUME OF PRODUCT IN COMMERCE
52 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
AXIOM Luminos TF, model number 10093902 Intended to be used for procedures that
involve high skin doses, which can result in deterministic effects, Recall #
Z-0101-2009
CODE
Serial numbers: 1100, 1101, 1102, 1104, 1105, 1106, 1108, 1109, 1110, 1201, 1204,
1205, 1206, 1207, 1208, 1209, 1210, 1211, 1212, 1214, 1215, 1216, 1217, 1218,
1219, 1222, 1224, 1225, 1229, 1230, 1232, 1233, 1237, 1238, 1239, 1241, 1242,
1245, 1246, 1247, 1248, 1249, 1251, 1252, 1254, 1255, 1256, 1258, 1260, 1261,
1262, 1264, 1265, 1266, 1267, 1450, 1451, 1452, 1453, 1454, 1455, 1456, 1457,
1458, 1459, 1460, 1461, 1462, 1463, 1464, 1465, 1468, 1469, 1471, 1472, 1473,
1476, 1477, 1478, 1479, 1480, 1481, 1482, 1483, 1484, 1485, 1486, 1487, 1488,
1489, 1490, 1491, 1494, 1495, 1496, 1497, 1498, 1499, 1500, 1501, 1502, 1503,
1505, 1506, 1507, 1508, 1509, 1510, 1511, 1512, 1513, 1514, 1515, 1517, 1518,
1519, 1520, 1521, 1522, 1523, 1524, 1525, 1527, 1528, 1529, 1530, 1532, 1533,
1534, 1535, 1536, 1537, 1538, 1539, 1540, 1541, 1542, 1543, 1544, 1545, 1547,
1548, 1549, 1550, 1551, 1552, 1553, 1555, 1556, 1559, 1560, 1562, 1563, 1564,
1567, 1568, 1569, 1570, 1571, 1572, 1574, 1575, 1576, 1577, 1578, 1581, 1701,
1702, 1703, 1704, 1705, 1706, 1707, 1708, 1709, 1710, 1711, 1712, 1713, 1714,
1715, 1716, 1717, 1718, 1719, 1720, 1721,1722, 1723, 1724, 1725, 1726, 1727,
1728, 1729, 1730, 1731, 1732, 1733, 1734, 1736, 1738, 1739, 1740, 1741, 1743,
1744, 1745, and 1746
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter
dated June 18, 2008.
Manufacturer: Siemens Medical Solutions Inc., Erlangen, Germany. Firm initiated
recall is ongoing.
REASON
Liquids may enter the system and cause potential malfunction and possible hazard
to patients, user or other persons.
VOLUME OF PRODUCT IN COMMERCE
211 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Syngo Imaging with versions VB20B, VB20D, VB20F, VB20G, VB25B, VB30A, VB30A-SP1,
and VB30A-SP2. Model number: 10014063, Recall # Z-0102-2009
CODE
Serial numbers: 1005, 1039, 1040, 1041, 1049, 1053, 1055, 1056, 1057, 1058, 1061,
1064, 1065, 1067, 1071, 1074, 1076, 1079, 1080, 1081, 1082, 1083, 1084, 1086,
1089, 1090, 1095, 1105, 1107, 1112, 1116, 1119, 1124, 1174, 1188, 1198, 1202,
1203, 1210, 1218, 1226, 1227, 1229, 1240, 1246, 1247, 1258, 1269, 1271, 1278,
1279, 1282, 1316, 1322, 1329, 1334, 1343, 1351, and 1353
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter
dated August 22, 2008.
Manufacturer: Siemens Medical Solutions Inc., Erlangen, Germany. Firm initiated
recall is ongoing.
REASON
Image may not be visible after merge.
VOLUME OF PRODUCT IN COMMERCE
59 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Zyoptix XP Microkeratome maxon motor, Ref #ZXP09183, Recall # Z-0103-2009;
b) Zyoptix XP Microkeratome tray, Ref. #ZXP1000, which contains a number of components,
one of which is the maxon motor, Recall # Z-0104-2009
CODE
a) Serial numbers: 77318901, 77318902, 77318903, 77318904, 77318905, 77318907,
77318910, 77318911, 77318913, 77318914, 77318915, 77318917, 77318918, 77318919,
77318922, 77318923, 77318924, 77318929, 77318930, 77318931, 77318932, 77504010,
77504012, 77504017, 77732304, 77732306, 77732308, 77732309, 77732310, 77732311,
77732312, 77732313, 77732314, 77732315, 77898709, 77898711, 78080303, 78080307,
78080308, 78080309, 78080310, 78080312, 78080313, 78080314, 78080315, 78080320,
78080322, 78080331, 78080337, 78207103, 78207104, 78207106, 78207107, 78207108,
78207111, 78207113, 78207114, 78207115, 78207116, 78207117, 78207118, 78207119,
78207120, 78207121, 78207122, 78207123, 78207124, 78207125, 78207129;
b) Serial numbers: 11061/77318906, 10980/77318909, 11019/77318920, 11029/77318925,
11084/77318926, 10969/77504001, 11046/77504002, 11000/77504005, 11088/77504006,
11045/77504007, 11068/77504008, 11108/77504009, 10972/77504011, 11106/77504014,
11021/77504015, 11177/77732302, 11202/77732307, 11091/77732316, 11031/77732318,
11066/77898701, 11026/77898702, 11077/77898704, 11120/77898705, 11103/77898706,
11040/77898707, 11192/77898708, 11190/77898712, 11174/77898713, 11153/77898714,
11030/77898715, 11111/78080317, 11047/78080319, 11150/78080321, 10904/78080323,
11149/78080324, 11096/78080325, 11041/78080333, 11081/78080334, 11064/78080335,
11221/78080339, 11122/78080340, 11034/78080341, 11140/78080342, 11089/78207127
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bausch & Lomb Inc., Rochester, NY, by letter dated April
23, 2008 and by telephone on April 28, 2008.
Manufacturer: Maxon Motor Interlectric Ag, Sachseln, Switzerland. Firm initiated
recall is ongoing.
REASON
The plastic tip on the drive shaft may come off the shaft and cause the blade
to stop oscillating.
VOLUME OF PRODUCT IN COMMERCE
156 motors
DISTRIBUTION
Nationwide, Brazil, The Netherlands, Canada, India, Malaysia, Mexico, and Singapore
___________________________________
PRODUCT
a) Boston Scientific FilterWire EZ" Embolic Protection System, Model FW
EZ 190cm, 3.5-5.5 mm, US, Material H749201001900, Catalog # 20100-190, Sterilized
with irradiation, Made in USA. Filter wire EZ" Embolic Protection System
is indicated for use as a guide wire and embolic protection system to contain
and remove embolic material (thrombus/debris) while performing angioplasty and
stenting procedures in coronary saphenous vein bypass grafts and carotid arteries.
The diameter of the vessel at the site of filter loop placement should be between
2.25 mm and 5.5 mm for coronary saphenous vein bypass graft procedures and between
3.5 mm and 5.5 mm for carotid procedures, Recall # Z-0105-2009;
b) Boston Scientific FilterWire EZ" Embolic Protection System, Model FW
EZ 300cm, 3.5-5.5 mm, US, Material H749201003000, Catalog # 20100-300, Sterilized
with irradiation, Made in USA. Filter wire EZ" Embolic Protection System
is indicated for use as a guide wire and embolic protection system to contain
and remove embolic material (thrombus/debris) while performing angioplasty and
stenting procedures in coronary saphenous vein bypass grafts and carotid arteries.
The diameter of the vessel at the site of filter loop placement should be between
2.25 mm and 5.5 mm for coronary saphenous vein bypass graft procedures and between
3.5 mm and 5.5 mm for carotid procedures, Recall # Z-0106-2009;
c) Boston Scientific FilterWire EZ" Embolic Protection System, Model FW
EZ 190cm, 3.5-5.5 mm, OUS CV, Material H749201003990, Catalog # 20100-399, Sterilized
with irradiation, Made in USA. Filter wire EZ" Embolic Protection System
is indicated for use as a guide wire and embolic protection system to contain
and remove embolic material (thrombus/debris) while performing angioplasty and
stenting procedures in coronary saphenous vein bypass grafts and carotid arteries.
The diameter of the vessel at the site of filter loop placement should be between
2.25 mm and 5.5 mm for coronary saphenous vein bypass graft procedures and between
3.5 mm and 5.5 mm for carotid procedures, Recall # Z-0107-2009;
d Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ
300cm, 3.5-5.5 mm, OUS CV, Material H749201004000, Catalog # 20100-400, Sterilized
with irradiation. Filter wire EZ" Embolic Protection System is indicated
for use as a guide wire and embolic protection system to contain and remove embolic
material (thrombus/debris) while performing angioplasty and stenting procedures
in coronary saphenous vein bypass grafts and carotid arteries. The diameter of
the vessel at the site of filter loop placement should be between 2.25 mm and
5.5 mm for coronary saphenous vein bypass graft procedures and between 3.5 mm
and 5.5 mm for carotid procedures, Recall # Z-0108-2009;
e) Boston Scientific FilterWire EZ" Embolic Protection System, Model FW
EZ 190cm, 3.5-5.5 mm, MT OUS PV, Material H749201051900, Catalog # 20105-190,
Sterilized with irradiation, Made in USA. Filter wire EZ" Embolic Protection
System is indicated for use as a guide wire and embolic protection system to
contain and remove embolic material (thrombus/debris) while performing angioplasty
and stenting procedures in coronary saphenous vein bypass grafts and carotid
arteries. The diameter of the vessel at the site of filter loop placement should
be between 2.25 mm and 5.5 mm for coronary saphenous vein bypass graft procedures
and between 3.5 mm and 5.5 mm for carotid procedures, Recall # Z-0109-2009;
f) Boston Scientific FilterWire EZ" Embolic Protection System, Model FW
EZ 300cm, 3.5-5.5 mm, MT OUS PV, Material H749201053000, Model # 20105-300, Sterilized
with irradiation, Made in USA: 2011 Stierlin Court, Mountain View, CA 94043-4655.
Filter wire EZ" Embolic Protection System is indicated for use as a guide
wire and embolic protection system to contain and remove embolic material (thrombus/debris)
while performing angioplasty and stenting procedures in coronary saphenous vein
bypass grafts and carotid arteries. The diameter of the vessel at the site of
filter loop placement should be between 2.25 mm and 5.5 mm for coronary saphenous
vein bypass graft procedures and between 3.5 mm and 5.5 mm for carotid procedures,
Recall # Z-0110-2009
CODE
a) Lot numbers: 729905, 730208, 730316, 731207, 731905, 803705, 803712, 805203,
805704, 806405, 806605, 807008, 807205, and 807905;
b) Lot numbers: 728206, 731007, 731704, 731809, and 807108;
c) 731901, 803510, 803602, and 805603;
d) Lot number: 730903;
e) Lot numbers: 728107, 728212, 730406, 730505, 731101, 731201,
731610, 802806, 802904, 803605, 804505, 805007, 805105, 805902, 806310, 806507,
806602, 807902, 808004, 808501, and 808602;
f) Lot numbers: 731004, 731803, and 805701
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Maple Grove, MN,
by letter dated May 20, 2008.
Manufacturer: Boston Scientific/EPI, Mountain View, CA.
Firm initiated recall is ongoing.
REASON
Boston Scientific is initiating a field correction for 48 lots/batches of the
Filter Wire EZ" Embolic Protection System. Boston Scientific has determined
that the Directions for Use (DFU), which accompanies each packaged device,
may be missing. If the product does not include a DFU and the user is unable
to find a copy, the user will have to seek another product box containing the
DFU. This may cause a delay in the procedure and hence risk of an injury to
the patient.
VOLUME OF PRODUCT IN COMMERCE
4,338 units
DISTRIBUTION
Nationwide, Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France,
Great Britain, Germany, Greece, Hungary, Italy, Latvia, Luxembourg, Netherlands,
Norway, Poland, Portugal, Russia, Slovakia, Spain, Sweden, and Switzerland,
Intercontinental: Taiwan, Korea, Australia, China, Singapore, Canada, Columbia,
and Mexico
___________________________________
PRODUCT
Acuson X300 ultrasound systems, ultrasound system with onscreen display. Model
numbers 10037409, 10038837, 10348531. Potentially affected, but no volume currently:
10132987, 10133170, 10348532, 10348533, Recall # Z-0111-2009
CODE
Software revisions 2.0.1 to 2.0.05, 3.0.01 and 3.0.02
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on August
19, 2008. Firm initiated recall is ongoing.
REASON
Thermal Index cranial (TIC) is not displayed for the Neo-Head exam type with
the C8-5 transducer. This is a required display to support the alara principle
when imaging cranial structure.
VOLUME OF PRODUCT IN COMMERCE
72 units
DISTRIBUTION
Nationwide, France, Colombia, Poland, Taiwan, Saudi Arabia, Austria, Malaysia,
India, Czech Republic, Croatia, Argentina, Venezuela, Italy, Philippines, Mauritius,
Spain, Bolivia, Germany, Ukrain, Russia, United Kingdom, Brazil, South Africa
and Canada
___________________________________
PRODUCT
Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total
Precision software; automatic patient data management providing clinical information
at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive
Care Unit, Recall # Z-0112-2009
CODE
Software version 6.70.6
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letters dated April
20, 2007 and August 29, 2008. Firm initiated recall is ongoing.
REASON
On the I&O chart, the IN, OUT and NET fluid totals values will not honor
the numeric precision configuration, always displaying a whole number, losing
decimal point accuracy.
VOLUME OF PRODUCT IN COMMERCE
470 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm,
Stent Length: 6cm, Introduction System: 7 FR., Disposable-Single Use Only,
Rx Only. The device is used in palliation neoplasms in the biliary tree, Recall
# Z-0113-2009
CODE
Lot number: W2528796
RECALLING FIRM/MANUFACTURER
Cook Endoscopy, Winston Salem, NC, by letter on/about September 11, 2008.
Firm initiated recall is ongoing.
REASON
A section of the introduction system may detach after the stent has deployed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
Nationwide and China
___________________________________
PRODUCT
Safety Lancet for capillary blood sampling, 1.6 mm x 28G, Mini, Sarstedt. (Blood
lancet). Product #85.1015.050, Recall # Z-0114-2009
CODE
Lot # M40C219A7
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sarstedt Inc., Newton, NC, by letter on August 27, 2008.
Manufacturer: Sarstedt Ag & Co., Numbrecht, Germany. Firm initiated recall
is complete.
REASON
The product from this lot may not retract the lancet into the safe position
inside the lancet body after the trigger is actuated.
VOLUME OF PRODUCT IN COMMERCE
1,000 pieces
DISTRIBUTION
NC
___________________________________
PRODUCT
Scorpio Series 7000 Tibial Impactor/Extractor, Catalog number 3770-000 Non
Sterile Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 The
Impactor/Extractor is used for insertion and removal of a tibial baseplate
during total knee arthroplasty, Recall # Z-0115-2009
CODE
All lot codes
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letters on July 2 and July
9, 2008. Firm initiated recall is ongoing.
REASON
Stryker Orthopaedics became aware that there is a potential inability to release
the Scorpio Series 7000 Tibial Impactor/Extractor from a tibial baseplate during
use.
VOLUME OF PRODUCT IN COMMERCE
5,126 units
DISTRIBUTION
Nationwide, Asia Pacific, Canada, Europe, Middle East, Africa, Japan and Latin
America
___________________________________
PRODUCT
Artiste MV system, Part number 8139789, medical linear accelerator equipped
with COHERENCE therapist RTT4.1. Medical Linear accelerator for radiation therapy.
The device utilizes a console system for selecting various treatment sequences
and manages commands for all motorized movement, Recall # Z-0116-2009
CODE
All products with COHERENCE Therapist RTT4.1
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Concord, CA, by letters dated July 4,
2008 and July 11, 2008. Firm initiated recall is ongoing.
REASON
Three issues: unexpected rotation of gantry, unexpected movement of table between
beams during patient setup, and single exposure images will be overwritten
by double exposure images.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
Nationwide, Netherlands, Germany, Poland, Norway, Australia, Hungary, Belgium
and France
___________________________________
PRODUCT
Exact Couch with Exact Couch Top, a component of the C-Series Clinacs, Acuity
and Ximatron treatment systems. Model numbers H14, H18, H27, H72, H77. A powered
radiation therapy patient support assembly is an electrically powered adjustable
couch intended to support a patient during radiation therapy, Recall # Z-0117-2009
CODE
Serial numbers: H140001 H140044 H140086 H180113 H180439 H180505 H180544 H180586
H180631 H140002 H140045 H140087 H180114 H180446 H180506 H180545 H180587 H180632
H140003 H140046 H140088 H180115 H180448 H180507 H180546 H180588 H180633 H140004
H140047 H140089 H180130 H180449 H180508 H180547 H180590 H180634 H140005 H140048
H140090 H180132 H180452 H180509 H180548 H180591 H180635 H140006 H140049 H140091
H180136 H180468 H180510 H180549 H180592 H180636 H140007 H140050 H140092 H180138
H180469 H180511 H180550 H180593 H180637 H140008 H140051 H140093 H180141 H180470
H180512 H180551 H180594 H180638 H140009 H140052 H140094 H180147 H180471 H180513
H180552 H180595 H180639 H140010 H140053 H140095 H180157 H180472 H180514 H180553
H180596 H180640 H140011 H140054 H140096 H180167 H180473 H180515 H180554 H180597
H180641 H140012 H140055 H140097 H180170 H180474 H180517 H180555 H180598 H180642
H140014 H140056 H140098 H180172 H180475 H180518 H180556 H180599 H180643 H140015
H140057 H140099 H180173 H180476 H180519 H180557 H180600 H180644 H140016 H140058
H140100 H180183 H180477 H180520 H180558 H180601 H180645 H140017 H140059 H140101
H180186 H180478 H180521 H180559 H180602 H180646 H140018 H140060 H140102 H180197
H180479 H180522 H180560 H180603 H180647 H140019 H140061 H140103 H180204 H180480
H180522 H180561 H180604 H180648 H140020 H140062 H140105 H180207 H180482 H180523
H180561 H180605 H180649 H140021 H140063 H140106 H180208 H180483 H180524 H180562
H180606 H180650 H140022 H140064 H140107 H180210 H180484 H180525 H180563 H180607
H180651 H140023 H140065 H140108 H180222 H180485 H180526 H180564 H180610 H180652
H140024 H140066 H140109 H180231 H180486 H180527 H180565 H180611 H180653 H140025
H140067 H140110 H180242 H180487 H180528 H180566 H180612 H180654 H140026 H140068
H140111 H180248 H180488 H180529 H180568 H180613 H180655 H140027 H140069 H140112
H180256 H180489 H180529 H180569 H180614 H180656 H140028 H140070 H140113 H180260
H180490 H180530 H180570 H180615 H180657 H140029 H140071 H140114 H180283 H180491
H180531 H180571 H180616 H180658 H140030 H140072 H140115 H180285 H180491 H180532
H180572 H180617 H180659 H140031 H140073 H180007 H180292 H180492 H180533 H180573
H180618 H180660 H140032 H140074 H180018 H180298 H180493 H180534 H180574 H180619
H180661 H140033 H140075 H180029 H180300 H180494 H180535 H180575 H180620 H180662
H140034 H140076 H180045 H180309 H180494 H180536 H180576 H180621 H180663 H140035
H140077 H180053 H180313 H180495 H180537 H180577 H180622 H180664 H140036 H140078
H180058 H180404 H180496 H180538 H180578 H180623 H180665 H140037 H140079 H180064
H180409 H180498 H180539 H180579 H180624 H180667 H140038 H140080 H180066 H180412
H180499 H180539 H180580 H180625 H180668 H140039 H140081 H180073 H180413 H180500
H180540 H180581 H180626 H180669 H140040 H140082 H180082 H180425 H180501 H180541
H180582 H180627 H180670 H140041 H140083 H180087 H180426 H180502 H180542 H180583
H180628 H180671 H140042 H140084 H180102 H180427 H180503 H180543 H180584 H180629
H180672 H140043 H140085 H180104 H180436 H180504 H180543 H180585 H180630 H180673
H180674 H180716 H180758 H180799 H180841 H270243 H270439 H270667 H270808 H180675
H180717 H180759 H180800 H180842 H270244 H270449 H270668 H270817 H180676 H180718
H180760 H180801 H180843 H270251 H270461 H270671 H270822 H180677 H180719 H180761
H180802 H180844 H270260 H270463 H270672 H270826 H180678 H180720 H180762 H180803
H180845 H270264 H270477 H270675 H270827 H180679 H180721 H180763 H180804 H180846
H270269 H270485 H270679 H270829 H180680 H180722 H180764 H180805 H180847 H270280
H270489 H270685 H270830 H180681 H180723 H180765 H180806 H230004 H270281 H270491
H270687 H270833 H180682 H180724 H180766 H180807 H230097 H270296 H270496 H270689
H270836 H180683 H180725 H180767 H180808 H230143 H270299 H270499 H270690 H270837
H180684 H180726 H180768 H180809 H230205 H270302 H270501 H270692 H270840 H180685
H180727 H180769 H180810 H230250 H270311 H270503 H270695 H270842 H180686 H180728
H180770 H180811 H260902 H270316 H270504 H270703 H270843 H180687 H180729 H180771
H180812 H260905 H270321 H270505 H270710 H270844 H180688 H180730 H180772 H180813
H260913 H270322 H270507 H270717 H270846 H180689 H180731 H180773 H180814 H260924
H270323 H270513 H270718 H270848 H180690 H180732 H180774 H180815 H260928 H270327
H270514 H270719 H270852 H180691 H180733 H180775 H180816 H260947 H270338 H270521
H270721 H270855 H180692 H180734 H180776 H180817 H270004 H270345 H270522 H270726
H270857 H180693 H180735 H180777 H180818 H270006 H270347 H270524 H270727 H270861
H180694 H180736 H180778 H180819 H270009 H270349 H270532 H270728 H270862 H180695
H180737 H180779 H180820 H270010 H270359 H270535 H270735 H270863 H180696 H180738
H180780 H180821 H270056 H270362 H270537 H270737 H270868 H180697 H180739 H180781
H180822 H270058 H270369 H270541 H270739 H270875 H180698 H180740 H180782 H180823
H270060 H270370 H270548 H270740 H270880 H180699 H180741 H180783 H180824 H270073
H270378 H270549 H270746 H270882 H180700 H180742 H180784 H180825 H270084 H270379
H270600 H270749 H270883 H180701 H180743 H180785 H180826 H270092 H270386 H270602
H270757 H270884 H180702 H180744 H180786 H180827 H270094 H270391 H270603 H270761
H270888 H180703 H180745 H180787 H180828 H270096 H270392 H270604 H270762 H270890
H180704 H180746 H180788 H180829 H270106 H270393 H270614 H270767 H270894 H180705
H180747 H180789 H180830 H270108 H270396 H270616 H270775 H271000 H180706 H180748
H180790 H180831 H270126 H270399 H270635 H270780 H271002 H180707 H180749 H180791
H180832 H270136 H270401 H270639 H270781 H271005 H180708 H180750 H180792 H180833
H270138 H270407 H270640 H270784 H271006 H180709 H180751 H180793 H180834 H270201
H270408 H270644 H270785 H271007 H180710 H180752 H180794 H180835 H270206 H270416
H270646 H270787 H271011 H180711 H180753 H180795 H180836 H270214 H270421 H270647
H270788 H271016 H180712 H180754 H180795 H180837 H270219 H270430 H270649 H270797
H271017 H180713 H180755 H180796 H180838 H270227 H270431 H270652 H270801 H271018
H180714 H180756 H180797 H180839 H270228 H270437 H270655 H270803 H271021 H180715
H180757 H180798 H180840 H270241 H270438 H270656 H270804 H271023 H271024 H271108
H271151 H271197 H271240 H271282 H271324 H271365 H271409 H271027 H271109 H271152
H271198 H271241 H271283 H271325 H271367 H271410 H271029 H271110 H271153 H271199
H271242 H271284 H271326 H271368 H271411 H271030 H271111 H271154 H271200 H271243
H271285 H271327 H271369 H271412 H271033 H271112 H271155 H271201 H271244 H271286
H271328 H271370 H271413 H271041 H271113 H271157 H271202 H271245 H271287 H271329
H271371 H271414 H271042 H271114 H271158 H271203 H271246 H271288 H271330 H271372
H271415 H271044 H271115 H271159 H271204 H271247 H271289 H271331 H271373 H271416
H271045 H271116 H271160 H271205 H271248 H271290 H271332 H271374 H271417 H271050
H271117 H271161 H271206 H271249 H271291 H271333 H271375 H271418 H271056 H271118
H271162 H271207 H271250 H271292 H271334 H271376 H271419 H271057 H271119 H271163
H271208 H271251 H271293 H271335 H271377 H271420 H271061 H271120 H271164 H271209
H271252 H271294 H271336 H271378 H271421 H271061 H271121 H271165 H271210 H271253
H271295 H271337 H271379 H271422 H271065 H271122 H271166 H271212 H271254 H271296
H271338 H271380 H271423 H271066 H271123 H271167 H271213 H271255 H271297 H271339
H271381 H271424 H271070 H271124 H271168 H271214 H271256 H271298 H271339 H271382
H271425 H271071 H271125 H271169 H271215 H271257 H271299 H271340 H271383 H271426
H271072 H271126 H271170 H271216 H271258 H271300 H271341 H271384 H271427 H271074
H271127 H271171 H271217 H271259 H271301 H271342 H271385 H271428 H271075 H271128
H271172 H271218 H271260 H271302 H271343 H271386 H271429 H271080 H271129 H271173
H271219 H271261 H271303 H271344 H271387 H271430 H271081 H271130 H271174 H271220
H271262 H271304 H271345 H271388 H271431 H271082 H271131 H271175 H271222 H271263
H271305 H271346 H271389 H271432 H271083 H271132 H271176 H271223 H271264 H271306
H271347 H271390 H271433 H271084 H271133 H271177 H271224 H271265 H271307 H271348
H271391 H271434 H271085 H271135 H271178 H271225 H271266 H271308 H271349 H271392
H271435 H271093 H271136 H271179 H271226 H271267 H271309 H271350 H271393 H271436
H271094 H271137 H271182 H271227 H271268 H271310 H271351 H271394 H271437 H271095
H271138 H271183 H271228 H271269 H271311 H271352 H271395 H271438 H271096 H271139
H271184 H271229 H271270 H271312 H271353 H271396 H271439 H271097 H271140 H271185
H271230 H271271 H271313 H271354 H271397 H271440 H271098 H271141 H271186 H271231
H271272 H271314 H271355 H271398 H271441 H271099 H271142 H271188 H271232 H271273
H271315 H271356 H271399 H271442 H271100 H271143 H271189 H271233 H271274 H271316
H271357 H271400 H271443 H271101 H271144 H271190 H271234 H271275 H271317 H271358
H271401 H271444 H271102 H271145 H271191 H271234 H271276 H271318 H271359 H271402
H271445 H271103 H271146 H271192 H271235 H271277 H271319 H271360 H271403 H271446
H271104 H271147 H271193 H271236 H271278 H271320 H271361 H271404 H271447 H271105
H271148 H271194 H271237 H271279 H271321 H271362 H271406 H271448 H271106 H271149
H271195 H271238 H271280 H271322 H271363 H271407 H271449 H271107 H271150 H271196
H271239 H271281 H271323 H271364 H271408 H271450 H271451 H271494 H271535 H271577
H271621 H271664 H271707 H271749 H271791 H271452 H271494 H271536 H271578 H271622
H271665 H271708 H271750 H271792 H271453 H271495 H271537 H271579 H271623 H271666
H271709 H271751 H271793 H271454 H271496 H271538 H271580 H271624 H271667 H271710
H271752 H271794 H271455 H271497 H271539 H271581 H271625 H271668 H271711 H271753
H271795 H271456 H271498 H271540 H271582 H271626 H271669 H271712 H271754 H271796
H271457 H271499 H271541 H271583 H271627 H271670 H271713 H271755 H271797 H271458
H271500 H271542 H271584 H271628 H271671 H271714 H271756 H271798 H271459 H271501
H271543 H271585 H271629 H271672 H271715 H271757 H271799 H271460 H271502 H271544
H271586 H271630 H271673 H271716 H271758 H271800 H271461 H271503 H271545 H271587
H271631 H271674 H271717 H271759 H271801 H271462 H271504 H271546 H271588 H271632
H271675 H271718 H271760 H271802 H271463 H271505 H271547 H271589 H271634 H271676
H271719 H271761 H271803 H271464 H271506 H271548 H271590 H271635 H271677 H271720
H271762 H271804 H271465 H271507 H271549 H271591 H271636 H271678 H271721 H271763
H271805 H271466 H271508 H271550 H271592 H271637 H271679 H271722 H271764 H271806
H271467 H271509 H271551 H271593 H271638 H271680 H271723 H271765 H271807 H271468
H271510 H271552 H271594 H271639 H271681 H271724 H271766 H271808 H271469 H271511
H271553 H271595 H271640 H271682 H271725 H271767 H271809 H271470 H271512 H271554
H271596 H271641 H271683 H271726 H271768 H271810 H271471 H271513 H271555 H271597
H271642 H271684 H271727 H271769 H271811 H271472 H271514 H271556 H271598 H271643
H271685 H271728 H271770 H271812 H271473 H271515 H271557 H271599 H271644 H271686
H271729 H271771 H271813 H271474 H271516 H271558 H271600 H271645 H271687 H271730
H271772 H271814 H271475 H271517 H271559 H271601 H271646 H271688 H271731 H271773
H271815 H271476 H271518 H271560 H271602 H271647 H271689 H271732 H271774 H271816
H271477 H271519 H271561 H271603 H271648 H271690 H271733 H271775 H271817 H271478
H271520 H271562 H271604 H271649 H271691 H271734 H271776 H271818 H271479 H271521
H271563 H271605 H271650 H271692 H271735 H271777 H271819 H271480 H271522 H271564
H271606 H271651 H271693 H271736 H271778 H271820 H271481 H271523 H271565 H271607
H271652 H271694 H271737 H271779 H271821 H271482 H271524 H271566 H271608 H271653
H271695 H271738 H271780 H271822 H271483 H271525 H271567 H271610 H271654 H271697
H271739 H271781 H271823 H271484 H271526 H271568 H271611 H271655 H271698 H271740
H271782 H271824 H271485 H271527 H271569 H271612 H271656 H271699 H271741 H271783
H271825 H271486 H271528 H271570 H271613 H271657 H271700 H271742 H271784 H271826
H271487 H271529 H271571 H271614 H271658 H271701 H271743 H271785 H271827 H271488
H271530 H271572 H271615 H271659 H271702 H271744 H271786 H271828 H271490 H271531
H271573 H271616 H271660 H271703 H271745 H271787 H271829 H271491 H271532 H271574
H271618 H271661 H271704 H271746 H271788 H271830 H271492 H271533 H271575 H271619
H271662 H271705 H271747 H271789 H271831 H271493 H271534 H271576 H271620 H271663
H271706 H271748 H271790 H271832 H271833 H271875 H271917 H271959 H272001 H272044
H272086 H272128 H272170 H271834 H271876 H271918 H271960 H272002 H272045 H272087
H272129 H272171 H271835 H271877 H271919 H271961 H272003 H272046 H272088 H272130
H272172 H271836 H271878 H271920 H271962 H272004 H272047 H272089 H272131 H272173
H271837 H271879 H271921 H271963 H272005 H272048 H272090 H272132 H272174 H271838
H271880 H271922 H271964 H272006 H272049 H272091 H272133 H272175 H271839 H271881
H271923 H271965 H272007 H272050 H272092 H272134 H272176 H271840 H271882 H271924
H271966 H272008 H272051 H272093 H272135 H272177 H271841 H271883 H271925 H271967
H272009 H272052 H272094 H272136 H272178 H271842 H271884 H271926 H271968 H272010
H272053 H272095 H272137 H272179 H271843 H271885 H271927 H271969 H272011 H272054
H272096 H272138 H272180 H271844 H271886 H271928 H271970 H272012 H272055 H272097
H272139 H272181 H271845 H271887 H271929 H271971 H272013 H272056 H272098 H272140
H272182 H271846 H271888 H271930 H271972 H272014 H272057 H272099 H272141 H272183
H271847 H271889 H271931 H271973 H272015 H272058 H272100 H272142 H272184 H271848
H271890 H271932 H271974 H272016 H272059 H272101 H272143 H272185 H271849 H271891
H271933 H271975 H272017 H272060 H272102 H272144 H272186 H271850 H271892 H271934
H271976 H272018 H272061 H272103 H272145 H272187 H271851 H271893 H271935 H271977
H272019 H272062 H272104 H272146 H272188 H271852 H271894 H271936 H271978 H272020
H272063 H272105 H272147 H272189 H271853 H271895 H271937 H271979 H272021 H272064
H272106 H272148 H272190 H271854 H271896 H271938 H271980 H272022 H272065 H272107
H272149 H272191 H271855 H271897 H271939 H271981 H272023 H272066 H272108 H272150
H272192 H271856 H271898 H271940 H271982 H272024 H272067 H272109 H272151 H272193
H271857 H271899 H271941 H271983 H272025 H272068 H272110 H272152 H272194 H271858
H271900 H271942 H271984 H272026 H272069 H272111 H272153 H272195 H271859 H271901
H271943 H271985 H272027 H272070 H272112 H272154 H272196 H271860 H271902 H271944
H271986 H272028 H272071 H272113 H272155 H272197 H271861 H271903 H271945 H271987
H272029 H272072 H272114 H272156 H272198 H271862 H271904 H271946 H271988 H272030
H272073 H272115 H272157 H272199 H271863 H271905 H271947 H271989 H272031 H272074
H272116 H272158 H272200 H271864 H271906 H271948 H271990 H272032 H272075 H272117
H272159 H272201 H271865 H271907 H271949 H271991 H272033 H272076 H272118 H272160
H272202 H271866 H271908 H271950 H271992 H272034 H272077 H272119 H272161 H272203
H271867 H271909 H271951 H271993 H272035 H272078 H272120 H272162 H272204 H271868
H271910 H271952 H271994 H272036 H272079 H272121 H272163 H272205 H271869 H271911
H271953 H271995 H272037 H272080 H272122 H272164 H272206 H271870 H271912 H271954
H271996 H272038 H272081 H272123 H272165 H272207 H271871 H271913 H271955 H271997
H272039 H272082 H272124 H272166 H272208 H271872 H271914 H271956 H271998 H272040
H272083 H272125 H272167 H272209 H271873 H271915 H271957 H271999 H272041 H272084
H272126 H272168 H272210 H271874 H271916 H271958 H272000 H272043 H272085 H272127
H272169 H272211 H272212 H272254 H272296 H272338 H272380 H272422 H272464 H272810
H272854 H272213 H272255 H272297 H272339 H272381 H272423 H272465 H272811 H272855
H272214 H272256 H272298 H272340 H272382 H272424 H272466 H272812 H272856 H272215
H272257 H272299 H272341 H272383 H272425 H272467 H272813 H272857 H272216 H272258
H272300 H272342 H272384 H272426 H272468 H272814 H272858 H272217 H272259 H272301
H272343 H272385 H272427 H272469 H272815 H272859 H272218 H272260 H272302 H272344
H272386 H272428 H272470 H272816 H272860 H272219 H272261 H272303 H272345 H272387
H272429 H272471 H272817 H272861 H272220 H272262 H272304 H272346 H272388 H272430
H272472 H272819 H272862 H272221 H272263 H272305 H272347 H272389 H272431 H272473
H272820 H272863 H272222 H272264 H272306 H272348 H272390 H272432 H272475 H272821
H272864 H272223 H272265 H272307 H272349 H272391 H272433 H272476 H272822 H272865
H272224 H272266 H272308 H272350 H272392 H272434 H272477 H272823 H272866 H272225
H272267 H272309 H272351 H272393 H272435 H272478 H272824 H272867 H272226 H272268
H272310 H272352 H272394 H272436 H272479 H272825 H272868 H272227 H272269 H272311
H272353 H272395 H272437 H272480 H272826 H272869 H272228 H272270 H272312 H272354
H272396 H272438 H272482 H272827 H272870 H272229 H272271 H272313 H272355 H272397
H272439 H272483 H272828 H272871 H272230 H272272 H272314 H272356 H272398 H272440
H272484 H272829 H272872 H272231 H272273 H272315 H272357 H272399 H272441 H272485
H272830 H272873 H272232 H272274 H272316 H272358 H272400 H272442 H272488 H272831
H272875 H272233 H272275 H272317 H272359 H272401 H272443 H272489 H272833 H272876
H272234 H272276 H272318 H272360 H272402 H272444 H272490 H272834 H272877 H272235
H272277 H272319 H272361 H272403 H272445 H272491 H272835 H272878 H272236 H272278
H272320 H272362 H272404 H272446 H272492 H272836 H272879 H272237 H272279 H272321
H272363 H272405 H272447 H272493 H272837 H272880 H272238 H272280 H272322 H272364
H272406 H272448 H272494 H272838 H272881 H272239 H272281 H272323 H272365 H272407
H272449 H272495 H272839 H272882 H272240 H272282 H272324 H272366 H272408 H272450
H272496 H272840 H272883 H272241 H272283 H272325 H272367 H272409 H272451 H272497
H272841 H272884 H272242 H272284 H272326 H272368 H272410 H272452 H272498 H272842
H272885 H272243 H272285 H272327 H272369 H272411 H272453 H272500 H272843 H272886
H272244 H272286 H272328 H272370 H272412 H272454 H272800 H272844 H272887 H272245
H272287 H272329 H272371 H272413 H272455 H272801 H272845 H272888 H272246 H272288
H272330 H272372 H272414 H272456 H272802 H272846 H272889 H272247 H272289 H272331
H272373 H272415 H272457 H272803 H272847 H272890 H272248 H272290 H272332 H272374
H272416 H272458 H272804 H272848 H272891 H272249 H272291 H272333 H272375 H272417
H272459 H272805 H272849 H272892 H272250 H272292 H272334 H272376 H272418 H272460
H272806 H272850 H272893 H272251 H272293 H272335 H272377 H272419 H272461 H272807
H272851 H272894 H272252 H272294 H272336 H272378 H272420 H272462 H272808 H272852
H272895 H272253 H272295 H272337 H272379 H272421 H272463 H272809 H272853 H272896
H272897 H272939 H290142 H290195 H290234 H290274 H290316 H290358 H290399 H272898
H272940 H290145 H290196 H290235 H290275 H290317 H290359 H290400 H272899 H272941
H290147 H290197 H290236 H290276 H290318 H290360 H290401 H272900 H272942 H290148
H290198 H290237 H290277 H290319 H290361 H290402 H272901 H272943 H290153 H290199
H290238 H290278 H290320 H290362 H290403 H272902 H272944 H290154 H290200 H290239
H290279 H290321 H290363 H290404 H272903 H272946 H290155 H290201 H290240 H290280
H290322 H290364 H290405 H272904 H272947 H290156 H290202 H290241 H290281 H290323
H290365 H290406 H272905 H272948 H290157 H290203 H290242 H290282 H290324 H290366
H290407 H272906 H272949 H290161 H290203 H290243 H290283 H290325 H290367 H290408
H272907 H272950 H290163 H290204 H290244 H290284 H290326 H290368 H290409 H272908
H272951 H290164 H290204 H290245 H290285 H290327 H290369 H290410 H272909 H272952
H290165 H290205 H290245 H290286 H290328 H290370 H290411 H272910 H272953 H290165
H290206 H290246 H290287 H290329 H290371 H290412 H272911 H290002 H290166 H290207
H290247 H290288 H290330 H290372 H290413 H272912 H290006 H290167 H290208 H290248
H290289 H290331 H290372 H290414 H272913 H290008 H290168 H290209 H290249 H290290
H290332 H290373 H290415 H272914 H290010 H290169 H290210 H290250 H290291 H290333
H290374 H290416 H272915 H290012 H290170 H290211 H290251 H290292 H290334 H290375
H290417 H272916 H290017 H290171 H290212 H290251 H290293 H290335 H290376 H290422
H272917 H290018 H290172 H290213 H290252 H290294 H290336 H290377 H290423 H272918
H290024 H290173 H290214 H290253 H290295 H290337 H290378 H290424 H272919 H290026
H290175 H290215 H290254 H290296 H290338 H290379 H290425 H272920 H290030 H290176
H290216 H290255 H290297 H290339 H290380 H290426 H272921 H290031 H290177 H290217
H290256 H290298 H290340 H290381 H290427 H272922 H290032 H290178 H290218 H290257
H290299 H290341 H290382 H290500 H272923 H290033 H290179 H290219 H290258 H290300
H290342 H290383 H290501 H272924 H290034 H290180 H290220 H290259 H290301 H290343
H290384 H290502 H272925 H290104 H290181 H290220 H290260 H290302 H290344 H290385
H290503 H272926 H290106 H290182 H290221 H290261 H290303 H290345 H290386 H290504
H272927 H290108 H290183 H290222 H290262 H290304 H290346 H290386 H290505 H272928
H290109 H290185 H290223 H290263 H290305 H290347 H290387 H290506 H272929 H290110
H290186 H290224 H290264 H290306 H290348 H290388 H290507 H272930 H290114 H290187
H290225 H290265 H290307 H290349 H290389 H290508 H272931 H290115 H290188 H290226
H290266 H290308 H290350 H290390 H290509 H272932 H290117 H290189 H290227 H290267
H290309 H290351 H290391 H290510 H272933 H290120 H290190 H290228 H290268 H290310
H290352 H290392 H290511 H272934 H290122 H290191 H290229 H290269 H290311 H290353
H290393 H290512 H272935 H290123 H290192 H290230 H290270 H290312 H290354 H290394
H290513 H272936 H290128 H290193 H290231 H290271 H290313 H290355 H290395 H290514
H272937 H290132 H290194 H290232 H290272 H290314 H290356 H290396 H290515 H272938
H290135 H290194 H290233 H290273 H290315 H290357 H290397 H290516 H290517 H290561
H720425 H720633 H720738 H720784 H720828 H720872 H720916 H290518 H290600 H720429
H720638 H720739 H720785 H720829 H720873 H720918 H290519 H720040 H720432 H720643
H720741 H720786 H720830 H720874 H720919 H290520 H720060 H720434 H720647 H720742
H720787 H720831 H720875 H720920 H290521 H720070 H720435 H720650 H720743 H720788
H720832 H720876 H720921 H290522 H720076 H720445 H720651 H720744 H720789 H720833
H720877 H720922 H290523 H720102 H720453 H720653 H720745 H720790 H720834 H720878
H720923 H290524 H720109 H720455 H720654 H720746 H720791 H720835 H720879 H720924
H290525 H720113 H720461 H720665 H720747 H720792 H720836 H720880 H720925 H290526
H720114 H720463 H720667 H720748 H720793 H720838 H720881 H720926 H290527 H720121
H720473 H720668 H720749 H720794 H720839 H720882 H720927 H290528 H720130 H720474
H720679 H720750 H720795 H720840 H720883 H720928 H290529 H720173 H720475 H720690
H720751 H720796 H720841 H720884 H720929 H290530 H720182 H720481 H720692 H720752
H720797 H720842 H720885 H720930 H290531 H720213 H720492 H720709 H720753 H720798
H720843 H720886 H720931 H290532 H720233 H720499 H720711 H720754 H720799 H720843
H720888 H720932 H290533 H720247 H720500 H720712 H720755 H720801 H720844 H720889
H720933 H290534 H720248 H720502 H720714 H720756 H720802 H720845 H720890 H720934
H290535 H720262 H720513 H720715 H720757 H720803 H720846 H720891 H720935 H290536
H720269 H720514 H720716 H720759 H720804 H720847 H720892 H720936 H290537 H720276
H720515 H720717 H720760 H720805 H720848 H720893 H720937 H290538 H720278 H720521
H720718 H720761 H720806 H720850 H720894 H720938 H290539 H720282 H720535 H720719
H720762 H720807 H720851 H720895 H720939 H290540 H720291 H720536 h720719 H720763
H720808 H720852 H720896 H720940 H290541 H720294 H720541 H720720 H720765 H720809
H720854 H720897 H720941 H290542 H720297 H720542 H720721 H720766 H720810 H720855
H720898 H720942 H290543 H720308 H720548 H720722 H720767 H720811 H720856 H720899
H720943 H290544 H720309 H720551 H720723 H720768 H720812 H720857 H720900 H720944
H290545 H720319 H720556 H720724 H720769 H720813 H720858 H720901 H720945 H290546
H720347 H720559 H720724 H720770 H720814 H720859 H720902 H720946 H290547 H720349
H720562 H720725 H720772 H720815 H720860 H720903 H720947 H290548 H720350 H720566
H720726 H720773 H720816 H720861 H720904 H720948 H290549 H720356 H720568 H720727
H720774 H720817 H720862 H720905 H720949 H290550 H720361 H720571 H720727 H720775
H720818 H720863 H720906 H720950 H290551 H720364 H720578 H720728 H720776 H720819
H720864 H720907 H720951 H290552 H720367 H720581 H720729 H720777 H720820 H720865
H720908 H720952 H290553 H720377 H720596 H720730 H720778 H720822 H720866 H720909
H720953 H290554 H720379 H720602 H720732 H720779 H720823 H720867 H720910 H720954
H290555 H720387 H720613 H720733 H720780 H720824 H720868 H720911 H720955 H290556
H720388 H720617 H720734 H720781 H720825 H720869 H720913 H720956 H290558 H720408
H720621 H720736 H720782 H720826 H720870 H720914 H720957 H290559 H720418 H720632
H720737 H720783 H720827 H720871 H720915 H720958 H720959 H721002 H721045 H770042
H770086 H770129 H770171 H720960 H721003 H721046 H770043 H770087 H770130 H770172
H720961 H721004 H721047 H770045 H770088 H770131 H770173 H720962 H721005 H721048
H770046 H770089 H770132 H770174 H720963 H721006 H770002 H770047 H770090 H770133
H770175 H720964 H721007 H770004 H770048 H770091 H770134 H770176 H720965 H721008
H770005 H770049 H770092 H770135 H770177 H720966 H721009 H770006 H770051 H770093
H770136 H770178 H720967 H721010 H770007 H770052 H770094 H770137 H770179 H720968
H721011 H770009 H770053 H770095 H770138 H770180 H720969 H721012 H770010 H770054
H770096 H770139 H770181 H720970 H721013 H770011 H770055 H770097 H770140 H770182
H720971 H721014 H770012 H770056 H770098 H770141 H770183 H720973 H721015 H770013
H770057 H770099 H770142 H770184 H720974 H721016 H770014 H770058 H770100 H770143
H770185 H720975 H721017 H770015 H770059 H770101 H770144 H770186 H720976 H721018
H770016 H770060 H770102 H770145 H770187 H720977 H721019 H770017 H770061 H770103
H770146 H770188 H720978 H721020 H770018 H770062 H770104 H770147 H770189 H720979
H721022 H770019 H770063 H770105 H770148 H770190 H720980 H721023 H770020 H770064
H770106 H770149 H720981 H721024 H770021 H770065 H770107 H770150 H720982 H721025
H770022 H770066 H770108 H770151 H720983 H721026 H770023 H770067 H770109 H770152
H720984 H721027 H770024 H770068 H770110 H770153 H720985 H721028 H770025 H770069
H770112 H770154 H720986 H721029 H770026 H770070 H770113 H770155 H720987 H721030
H770027 H770071 H770114 H770156 H720988 H721031 H770028 H770072 H770115 H770157
H720989 H721032 H770029 H770073 H770116 H770158 H720990 H721033 H770030 H770074
H770117 H770159 H720991 H721034 H770031 H770075 H770118 H770160 H720992 H721035
H770032 H770076 H770119 H770161 H720993 H721036 H770033 H770077 H770120 H770162
H720994 H721037 H770034 H770078 H770121 H770163 H720995 H721037 H770035 H770079
H770122 H770164 H720996 H721038 H770036 H770080 H770123 H770165 H720997 H721040
H770037 H770081 H770124 H770166 H720998 H721041 H770038 H770082 H770125 H770167
H720999 H721042 H770039 H770083 H770126 H770168 H721000 H721043 H770040 H770084
H770127 H770169 H721001 H721044 H770041 H770085 H770128 and H770170
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letters on August
11, 2008. Firm initiated recall is ongoing.
REASON
During couch movement, a patient’s fingers may get pinched at certain
points which could result in broken, disengaged or pinched fingers.
VOLUME OF PRODUCT IN COMMERCE
3,296 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
iSite PACS (Picture Archiving and Communication System), software versions
3.6.28.x and 4.1.x. The product is an image management system (software package)
used with general purpose computing hardware to acquire, store, distribute,
process and display images and associated data throughout a clinical environment.
Device is intended for use by trained professionals, Recall # Z-0118-2009
CODE
Software versions 3.6.28.x and 4.1.x
RECALLING FIRM/MANUFACTURER
Philips Healthcare Informatics, Inc., Foster City, CA, by letter dated August
29, 2008. Firm initiated recall is ongoing.
REASON
Two defects have been identified: 1) potential to display a patient on the
canvas page that is different from the patient whose images are displayed on
diagnostic monitors when using Conference Presentation States and when opening
two or more studies from a folder or an exam worklist and 2) potential to miscalculate
measurements when Pixel Spacing and Imager Pixel Spacing DICOM tag values are
both present and different.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
Nationwide, Italy, Germany, Netherlands, Sweden, France, Portugal, Switzerland,
Thailand, Japan and Australia
___________________________________
PRODUCT
Sonesta 6210 Fluoroscopy Procedure Table; a motorized procedure table with
adjustments (via a remote control) for height, tilt, back and seat cushion
position; Model 6210, Recall # Z-0119-2009
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Stille AB, Solna, Sweden, by letter dated August 27, 2008. Firm initiated recall
is ongoing.
REASON
The table contains a battery backup, not mentioned in the User Manual, which
automatically will provide power to the electrical actuators/motions in case
of a power loss from the main power supply. However, if a short circuit occurs,
it can result in an uncontrolled movement of the table which cannot be stopped
by disconnecting the device from the main power supply, as the battery automatically
will supply continuous power to the control box.
VOLUME OF PRODUCT IN COMMERCE
114 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic
or therapeutic devices into the body, Recall # Z-0130-2009
CODE
Lot Numbers: C1-02452, C1-02453, C1-02452, C1-02458, C1-02462
RECALLING FIRM/MANUFACTURER
Oscor, Inc., Palm Harbor, FL, by letter on July 3, 2008. Firm initiated recall
is ongoing.
REASON
Difficulty breaking the sheath hub and subsequently to peel the sheath off for
Introducer Set, Adelante size 7F.
VOLUME OF PRODUCT IN COMMERCE
396 units
DISTRIBUTION
MN
___________________________________
PRODUCT
Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and
Pulmonary Toolkit Oncology Pro, Model #455011203131 and Model #455011203191,
Recall # Z-0132-2009
CODE
All units
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland), Inc., Cleveland, OH, by letters on September
8, 2008. Firm initiated recall is ongoing.
REASON
Images not correlated: A leak between the Tube Interface and the Outlet Tube
of the transducer may result in a failure to produce respiratory correlated images.
VOLUME OF PRODUCT IN COMMERCE
507 units
DISTRIBUTION
Nationwide, Australia, Austria, Bahrain, Belgium, Canada, China, Czech Republic,
Denmark, England, Finland, France, Germany, Israel, Italy, Japan, Jordan, Korea,
Lithuania, Malaysia, Netherlands, Norway, New Zealand, Puerto Rico, South Africa,
Saudi Arabia, Spain, Switzerland, Sweden, and Thailand
___________________________________
PRODUCT
Ray TFC Device with End Caps: Single Patient use; Sterile; Stryker Spine Ray
Cage 7-2021 20 (catalog #) mm diameter x 21 mm long. Ray Cages are indicated
for use with autogenous bone graft in patients with Degenerative Disc Disease
(DDD) at one or two levels for L2 to S1, Recall # Z-0151-2009
CODE
Lot number: 07A259
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Spine, Allendale, NJ, by letters on August 18, 2008.
Manufacturer: Stryker Spine, Cestas, Aquitane, France. Firm initiated recall
is ongoing.
REASON
The label on one side on the Ray TFC Device (Ray Cage) is incorrect. It reads
20 mm x 26 mm instead of 20 mm x 21 mm.
VOLUME OF PRODUCT IN COMMERCE
69 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Indicated for infusion
via intravenous, intra-arterial, epidural or subcutaneous routes of administration,
Recall # Z-0152-2009
CODE
Product code 1M8550 serviced or repaired with part numbers AAS5001530RP, AAS5001531RP
or A069160000RP between 11/1/07 and 7/29/08.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated
September 5, 2008.
Manufacturer: Baxter Healthcare Corp., Singapore. Firm initiated recall is ongoing.
REASON
Non-conforming Electrostatic Discharge (ESD) grounding squares may cause the
pump to be susceptible to shorting-out of circuitry, resulting in a loss of audio,
and/or interruption of therapy.
VOLUME OF PRODUCT IN COMMERCE
509 units
DISTRIBUTION
Nationwide, Canada and Korea
___________________________________
PRODUCT
a) Allez Spine Laguna Pedicle Screw System; Catalog Number: IT-FN1003 Del Mar
Pedicle Screw System; IT-ST1001Vertebrae Rotation Tool; IT-H W1001Hex Wrench;
IT-CB1001Coronal Bender-L; IT-CB1002 Coronal Bender-R; IT-PH1001Power Rod Holder;
IT-BP1001 Thoracic Ball Handle Probe, Curved; IT-BP1002 Thoracic Ball Handle
Probe, Straight; DM-MR0530 Monoaxial Screw Non-Winged, Size 5 x 30; DM-MR0535
Monoaxial Screw Non-Winged, Size 5 x 35; DM-MR0540 Monoaxial Screw Non-Winged,
Size 5 x 40; DM-MR0545 Monoaxial Screw Non-Winged, Size 5 x 45; DM-MW0530 Monoaxial
Screw Winged, Size 5 x 30; DM-MW0535 Monoaxial Screw Winged, SizeS x 35; DM-MW0540
Monoaxial Screw Winged, Size S x 40; DM-MW0545 Monoaxial Screw Winged, Size 5
x 45; DM-MR0630 Monoaxial Screw Non-Winged, Size 6 x 30; DM-MR0635 Monoaxial
Screw Non-Winged, Size 6 x 35; DM-MR0640 Monoaxial Screw Non-Winged, Size 6 x
40; DM-MR0645 Monoaxial Screw Non-Winged, Size 6 x 45; DM-MR0650 Monoaxial Screw
Non-Winged, Size 6 x 50; DM-MW0630 Monoaxial Screw Winged, Size 6 x 30; DM-MW0635
Monoaxial Screw Winged, Size 6 x 35; DM-MW0640 Monoaxial Screw Winged, Size 6
x 40; DM-MW0645 Monoaxial Screw Winged, Size 6 x 45; DM-MR0735 Monoaxial Screw
Non-Winged, Size 7 x 35 DM-MR0740 Monoaxial Screw Non-Winged, Size 7 x 40; DM-MR0745
Monoaxial Screw Non-Winged, Size 7 x 45; RD-ST5541 Straight Rod, 4mm Hex Intended
to help provide correction, immobilization and stabilization of spinal segments
as an adjunct to fusion of the thoracic, lumbar and/or sacral space, Recall #
Z-0153-2009;
b) Allez Spine Del Mar Pedicle Screw System; Catalog Number: IT-FN1001 Laguna
Pedicle Screw System Tray #1; IT-FN 1002 Laguna Pedicle Screw System Tray #2;
lT-CT1001Counter Torque (w/Large Rubber Handle); IT-HP1001 Head Positioner (w/Rubber
Handle); IT-RP1001Rod Pusher; lT-RK1001 Rocker (Goal Post Style Tip); lT-BA1002
Vampire Awl; IT-RG1001 Rod Gripper, Ratcheting (Long Nose); IT-TP1001Tap, 4mm
(Thin Style, Gold Tip); IT-TP1002 Tap, 5mm (Thin Style, Gold Tip) IT-TP1003 Tap,
6mm (Thin Style, Gold Tip); IT-TP1004 Tap, 7mm (Thin Style, Gold Tip); IT-SD
1002 Multiaxial Screwdriver (No Windows); IT-SD1005 Screwdriver Shaft 75 (w/BaIl
Bearing); IT-CT1002 Counter Torque (Short No Windows); IT-SD1006 Multiaxial Screwdriver
(w/Windows); IT-TP1005 Tap, 4mm (Silver Tn-Fluted); IT-TP1006 Tap, 5mm (Silver
Tn-Fluted); IT-TP1007 Tap, 6mm (Silver Tn-Fluted); IT-TP1008 Tap, 7mm (Silver
Tn-Fluted); lT-HP1002 Head Positioner (All Metal Handle); IT-RK1002 Rocker (Horse
Shoe Style Tip); IT-SD1007 Screwdriver Shaft 8.5 (w/Ball Bearing); IT-CT1003
Counter Torque (Short w/Windows); IT-TP1014 Tap, 4mm (Silver Circumferential);
IT-TP1015 Tap, 5mm (Silver Circumferential); IT-TP1016 Tap, 6mm (Silver Circumferential);
IT-TP1017 Tap, 7mm (Silver Circumferential); IT-SD1007 Screwdriver Shaft 8.5
(No Ball Bearing); IT-XR1001 Extension Remover; IT-S01006 Screwdriver_Shaft 10
(No Ball Bearing); IT-FB1001 French Rod Bender; IT-SP1001 Ball Tip Probe; IT-TR1001
Trial Rod; IT-RG 1002 Rod Gripper, Ratcheting (Short Nose); IT-BP1003 Lumbar
Probe, Straight (Long); IT-BP1004 Lumbar Probe, Curved (Long); IT-SP1002 Sounder
(Ball Tip) Probe, Heavy Duty; RD-ST5540 Rod 5,5 x 400mm, Straight; IT-BA1001
Newport Awl; IT-PU 1001 Persuader; IT-RR1001 Retaining Ring; lT-NS1001 In-Situ
Left; IT-N51002 In-Situ Right; IT-BP100S Lumbar Probe, Straight (Short); IT-BP1006
Lumbar Probe, Curved (Short); IT-CP1001 Compressor; IT-DT1001 Distractor; IT-BP1001
Thoracic Ball Handle Probe, Curved; IT-BP1002 Thoracic Ball Handle Probe, Straight;
IT-RH1002 Ratcheting T-Handle; IT-NC1001 Locking Nut Caddy; IT-SG1001 Screw Gauge
Block; IT-RH1002 Ratcheting Handle, Straight; IT-T01002 Preset Torque Wrench
(With Connector); LG-LN1002 Locking Nut, Single Piece; LG-PR0530C Polyaxial Screw,
Non-Winged, 5 X 30; LG-PR0535C Polyaxial Screw, Non-Winged, 5 X 35; LG-PR0540C
Polyaxial Screw, Non-Winged, 5 X 40; LG-PR0545C Polyaxial Screw, Non-Winged,
5 X 45; LG-PR0550C Polyaxial Screw, Non-Winged, 5 X 50; LG-PR0630C Polyaxial
Screw, Non-Winged, 6 X 30; LG-PR0635C Polyaxial Screw, Non-Winged, 6 X 35; LG-PR0640C
Polyaxial Screw, Non-Winged, 6 X 40; LG-PR0645C Polyaxial Screw, Non-Winged,
6 X 45; LG-PR0650C Polyaxial Screw, Non-Winged, 6 X 50; LG-PR0730C Polyaxial
Screw, Non-Winged, 7 X 30; LG-PR0735C Polyaxial Screw, Non-Winged, 7 X 35; LG-PR0740C
Polyaxial Screw, Non-Winged, 7 X 40; LG-PR074SC Polyaxial Screw, Non-Winged,
7 X 45; LG-PR0750C Polyaxial Screw, Non-Winged, 7 X 50; LG-PR0755C Polyaxial
Screw, Non-Winged, 7 X 55; LG-PR083SC Polyaxial Screw, Non-Winged, 8 X 35; LG-PR0840C
Polyaxial Screw, Non-Winged, 8 X 40; LG-PR0845C Polyaxial Screw, Non-Winged,
8 X 45; LG-PR0850C Polyaxial Screw, Non-Winged, 8 X 50; LG-PR0855C Polyaxial
Screw, Non-Winged, 8)( 55; LG-PW0535C Polyaxial Screw, Winged, S X 35; LG-PW0540C
Polyaxial Screw, Winged, 5 X 40; LG-PW0545C Polyaxial Screw, Winged, 5 X 45;
LG-PW0635C Polyaxial Screw, Winged, 6 X 35; LG-PW0640C Polyaxial Screw, Winged,
6 X 40; LG-PW0645C Polyaxial Screw, Winged, 6 X 45; LG-PW0735C Polyaxial Screw,
Winged, 7 X 35; LG-PW0740C Polyaxial Screw, Winged, 7 X 40; LG-PW0745C Polyaxial
Screw, Winged, 7 X 45; RD-PB5504 ROD 5.5 X 40, PRE-BENT; RD-PB5505 ROD 5.5 X
50, PRE-BENT; RD-PB5506 ROD 5.5 X 60, PRE-BENT; RD-PB5507 ROD 5.5 X 70, PRE-BENT;
RD-PB5508 ROD 5.5 X 80, PRE-BENT; RD-PB5509 ROD 5.5 X 90, PRE-BENT; RD-PB5510
ROD 5.5 X 100, PRE-BENT; RD-PB5511 ROD 5.5 X 110, PRE-BENT; RD-PB5512 ROD 5.5
X 120, PRE-BENT; 7319-35 Tapered Pedicle Marker Set; 7783-05 Tapered Pedicle
Marker Set; PS103004-A Black Onion Shaped Handle, Non-Ratcheting; 73-8010-AS
Custom Distractor (Boss); 23000-CS001C Custom Compressor Intended for posterior,
non-cervical fixation for the following conditions: degenerative disc disease;
spondylolisthesis; trauma; spinal stenosis; curvatures; tumor pseudarthrosis;
and/or failed previous fusion, Recall # Z-0154-2009;
c) Allez Spine Cross Connectors; Catalog Number: LG-CC1001Cross Link, Small 30-37mm;
LG-CC1002 Cross Link, Medium 37-50mm; LG-CC1003 Cross Link, Lange 50-80mm; lT-T01003
Cross Link Torque Hex Driver, 2.5mm, Recall # Z-0155-2009
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Allez Spine, LLC, Irvine, CA, by letter beginning August 21, 2008. Firm initiated
recall is ongoing.
REASON
This action is being taken voluntarily as a result of a Warning Letter issued
to AlIez Spine LLC by the Food & Drug Administration. The Company decided
it could better address the FDA's concerns regarding Current Good Manufacturing
Practice requirements of the Quality System without any product in the market
so it could focus all of its efforts on responding to the FDA.
VOLUME OF PRODUCT IN COMMERCE
6,472 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Weck Hemoclip Traditional Ligating Clips, Rx Only; The use of the reusable
Teleflex Medical metal ligating clips is transient, invasive and intended for
the application of hemostatic clips during general open surgery. Ligation clips
are non-absorbable to thermostatically restrict flow of fluids within vessels.
Clips are removed from the cartridge and applied in such a manner as to engulf
vessels. Teleflex Medical metal ligating clips are intended for use in procedures
involving vessels or anatomic structures for which the surgeon determines ligating
clips are the best choice. Surgeons should select the size type, and material
of the clip based upon their experience, judgment and needs:
1) HEMOCLIP MEDIUM 250/BOX, Product Code: 523100;
2) HEMOCLIPS SMALL 300/BOX, Product Code: 523135;
3) HEMOCLIP MED-LGE 200/BOX, Product Code: 523160;
4) HEMOCLIP LARGE 150/BOX, Product Code: 523170;
5) HEMOCLIP TEN PAK MEDIUM 200/BOX, Product Code: 523300;
6) HEMOCLIP TEN PAK SMALL 240/BOX, Product Code: 523335;
7) HEMOCLIP TEN PAK MED-LG 160/BX, Product Code: 523360;
8) HEMOCLIP TEN PAK LG 120/BOX, Product Code: 523370;
9) HEMOCLIP S/S MEDIUM 250/BOX, Product Code: 523400;
10) HEMOCLIP S/S SMALL 300/BOX, Product Code; 523435;
11) HEMOCLIP S/S MED/LG 200/BOX, Product Code: 523460;
12) HEMOCLIP S/S LARGE 150/BOX, Product Code: 523470;
13) HEMOCLIP S/S MEDIUM 200/BOX, Product Code: 523600;
14) HEMOCLIP S/S SMALL 240/BOX, Product Code: 523635;
15) HEMOCLIP S/S MEDIUM-LARGE 160/BOX, Product Code: 523660;
16) HEMOCLIP S/S LARGE 120/BOX, Product Code: 523670;
17) HEMOCLIP TITANIUM MEDIUM 250/BOX, Product Code: 523700;
18) HEMOCLIP TITANIUM SMALL 300/BOX, Product Code: 523735;
19) HEMOCLIP TITANIUM MEDIUM-LARGE 200/BOX, Product Code: 523760;
20) HEMOCLIP TITANIUM LARGE 150/BOX, Product Code: 523770;
21) HEMOCLIP TITANIUM MEDIUM 200/BOX, Product Code: 523800;
22) HEMOCLIP TITANIUM SMALL 240/BOX, Product Code: 523835;
23) HEMOCLIP TITANIUM MEDIUM-LARGE 160/BOX, Product Code: 523860;
24) HEMOCLIP TITANIUM LARGE 120/BOX, Product Code: 523870;
Recall # Z-0156-2009;
b) Weck Hemoclip Plus® Ligating Clips, Rx Only, Sterile. The use of the reusable
Teleflex Medical metal ligating clips is transient, invasive and intended for
the application of hemostatic clips during general open surgery. Ligation clips
are non-absorbable to thermostatically restrict flow of fluids within vessels.
Clips are removed from the cartridge and applied in such a manner as to engulf
vessels. Teleflex Medical metal ligating clips are intended for use in procedures
involving vessels or anatomic structures for which the surgeon determines ligating
clips are the best choice. Surgeons should select the size type, and material
of the clip based upon their experience, judgment and needs:
1) HEMO PLUS TITANIUM MEDIUM 25CLIP/10CART, Product Code: 533700;
2) HEMO PLUS TI 25/CART 250BOX NO TAPE, Product Code: 533702;
3) HEMO PLUS TITANIUM SMALL 25CLIP/12CART, Product Code: 533735;
4) HEMO PLUS TI 25/CART 300BOX NO TAPE, Product Code: 533737;
5) HEMO PLUS TITANIUM MEDIUM 10 CLIP/18CART, Product Code: 533800;
6) HEMO PLUS TI M10/18CART NO TAPE, Product Code: 533802;
7) HEMO PLUS TITANIUM SMALL 10 CLIP/18 CART, Product Code: 533835;
8) HEMO PLUS TI S10/18CART NO TAPE, Product Code: 533837;
9) HEMO PLUS TITANIUM MED-LGE 10CLIP/12CART, Product Code: 533860;
10) HEMO PLUS TI ML10/12CART NO TAPE, Product Code: 533862;
11) HEMO PLUS TITANIUM LARGE 10CLIP/12CART, Product Code: 533870;
12) HEMO PLUS TI L10/12CART NO TAPE, Product Code: 533872;
13) HEMO PLUS STRGPT TI SM25/CART, Product Code: 534735, 300/BX;
14) HEMO PLUS STRONGPOINT SM NOTAPE 300 25, Product Code: 534737;
15) HEMO PLUS STRGPT TI SM10/CART 180BX, Product Code: 534835;
16) HEMO PLUS STRONGPOINT SM NO TAPE 180 10, Product Code: 534837,
Recall # Z-0157-2009;
c)Weck , Horizon Titanium Clips, Rx Only, Sterile. The use of the reusable
Teleflex Medical metal ligating clips is transient, invasive and intended for
the application of hemostatic clips during general open surgery. Ligation clips
are non-absorbable to thermostatically restrict flow of fluids within vessels.
Clips are removed from the cartridge and applied in such a manner as to engulf
vessels. Teleflex Medical metal ligating clips are intended for use in procedures
involving vessels or anatomic structures for which the surgeon determines ligating
clips are the best choice. Surgeons should select the size type, and material
of the clip based upon their experience, judgment and needs:
1) HORIZON SMALL TI 6 CLIP, Product Code, 001200;
2) HORIZON SMALL RED TI 6 CLIP WIDE SLOT, Product Code: 001201;
3) HORIZON MED TI CLIP, Product Code: 002200;
4) HORIZON MED/LRG TI 6 CLIP, Produce Code: 003200;
5) HORIZON LARGE TI 6 CLIP, Product Code: 004200;
6) HORIZON MICRO TI 6 CLIP/CART 30 CART/BX, Product Code; 005200;
Recall # Z-0158-2009;
d) WECK Hem-o-lok® Non-absorbable Polymer Ligation Clips, Rx Only,
Sterile. The use of the reusable Teleflex Medical metal ligating clips is transient,
invasive and intended for the application of hemostatic clips during general
open surgery. Ligation clips are non-absorbable to thermostatically restrict
flow of fluids within vessels. Clips are removed from the cartridge and applied
in such a manner as to engulf vessels. Teleflex Medical metal ligating clips
are intended for use in procedures involving vessels or anatomic structures
for which the surgeon determines ligating clips are the best choice. Surgeons
should select the size type, and material of the clip based upon their experience,
judgment and needs:
1) HOL SMALL CLIPS 1 PACK, Product Code: 544210;
2) HOL SMALL CLIPS 4 PACK, Product Code: 544214;
3) HOL SMX CLIPS, Product Code: 544220;
4) HOL ML CLIPS, Product Code: 544230;
5) HOL L CLIPS, Product Code: 544240;
6) HOL XL CLIPS (EXTRA LARGE), Product Code: 544250;
Recall # Z-0159-2009;
e) WECK HemoClip Auto, Rx Only, Sterile. The use of the reusable Teleflex Medical
metal ligating clips is transient, invasive and intended for the application
of hemostatic clips during general open surgery. Ligation clips are non-absorbable
to thermostatically restrict flow of fluids within vessels. Clips are removed
from the cartridge and applied in such a manner as to engulf vessels. Teleflex
Medical metal ligating clips are intended for use in procedures involving vessels
or anatomic structures for which the surgeon determines ligating clips are
the best choice. Surgeons should select the size type, and material of the
clip based upon their experience, judgment and needs:
1) HemoClip Auto S/S Medium 200/Box, Product Code: 527100;
2) HemoClip Auto Titanium Medium 200/Box, Product Code: 527200;
3) HemoClip Auto Titanium Medium 100/Box, Product Code: 527203,
Recall # Z-0160-2009
CODE
a) Product manufactured from January 2006 through July 2008;
1) Lot number: 01C0800066, 01D0800156, 01D0800324, 01E0800203, 01E0800410,
01K0700113, 01K0700198, 01K0700298, 01L0700009, 01M0700131, T1202225, T1202961,
T1209529, T1211719, T1213975, T1220115, T1226528, T1228532, T1229942, T1233481,
T1235583, T1236588, T1239523, T1242799, T1248517, T1249582, T1250496, T1252394,
T1255378, T1256389, T1258311, T1261008, T1262892, T1264925, T1270366, T1272027,
T1273754, T1275784, T1277275, and T1280263;
2) Lot number: 01A0800221, 01B0800284, 01E0800020, 01E0800051, 01E0800205,
01K0700299, 01L0700097, 01M0700054, T1202223, T1207485, T1210251, T1218339,
T1224895, T1229939, T1231420, T1235581, T1239179, T1241604, T1243428, T1247446,
T1248346, T1256385, T1258309, T1260080, T1261781, T1270990, T1272023, and T1276617;
3) Lot number: 01K0700199, 01L0700098, T1201401, T1202195, T1210839, T1213979,
T1229935, T1237417, T1240028, T1242797, T1260076, and T1271937;
4) Lot number: 01A0800325, 01D0800157, 01E0800018, 01L0700340, T1198153, T1201448,
T1203611, T1210220, T1214463, T1218859, T1228527, T1237522, T1238441, T1242798,
T1246173, T1248344, T1253536, T1254318, T1255373, T1258761, T1262886, T1264105,
T1276611, and T1280177;
5) Lot number: 01B0800289, 01D0800158, 01F0800071, 01K0700200, 01K0700300,
01L0700010, 01M0700055, T1195698, T1203615, T1208575, T1213976, T1216526, T1227714,
T1228534, T1231501, T1233521, T1234311, T1252395, T1254402, T1260323, T1262893,
T1266943, T1270995 and T1276883;
6) Lot number: 01A0800327, 01C0800296, 01D0800159, T1203612, T1213977, T1221073,
T1225877, T1230388, T1237120, T1239180, T1241605, T1251449, T1253540, T1260321,
T1261792, T1273752, and T1277291;
7) Lot number: 01A0800328, 01C0800244, T1195769, T1196987, T1199780, T1208571,
T1218337, T1229936, T1237418, T1247368, T1255369, T1264918, T1271938, and T1273748;
8) Lot number: 01C0800245, T1202199, T1209526, T1211715, T1227696, T1234309,
T1238442, T1239176, T1243426, T1245243, T1248508, T1250484, T1254319, T1267799,
T1268809, T1275639, T1276612, T1278104, and T1279053;
9) Lot number: 01A0800329, 01D0800086, 01E0800409, T1226527, T1226762, T1229941,
T1232352, T1237527, T1238445, T1248515, T1249520, T1250494, T1251452, T1261740,
T1262890, T1264923, T1266142, T1270993, T1272025, T1275783, T1278107, and T1279058;
10) Lot number: 01E0800144, 01L0700182, 01M0700132, T1200641, T1232348, T1239177,
T1247445, T1255376, T1257214, T1262887, and T1276616;
11) Lot number: 01B0800076, 01D0800234, 01L0700258, T1201481, T1203609, T1206790,
T1212659, T1219274, T1224891, T1234306, T1239175, T1245241, T1252391, T1255370,
T1271939, and T1277285;
12) Lot number: 01B0800163, 01C0800064, 01L0700171, 01M0700133, T1214678, T1226761,
T1229937, T1237523, T1240293, T1255374, T1257213, T1260078, T1267800, T1276613,
T1277287, and T1280178;
13) Lot number: 01B0800389, 01D0800160, 01E0800021, 01L0700099, 01M0700134,
T1211718, T1216521, T1227711, T1230389, T1238446, T1242668, T1247371, T1251453,
T1256388, T1262891, T1264924, T1266942, T1270994, T1272879, T1277274, and T1280262;
14) Lot number: 01A0800050, 01A0800169, 01C0800143, 01C0800246, 01C0800295,
01D0800236, T1201422, T1202222, T1206018, T1209527, T1211716, T1213978, T1221290,
T1224894, T1227708, T1230387, T1233478, T1237119, T1239178, T1240295, T1253538,
T1259106, T1262888, T1266119, T1268812, T1270989, T1273751, T1278105, and T1279054;
15) Lot number: 01A0800037, T1202196, T1256382, T1262885, and T1271940;
16) Lot number: 01A0800051, 01C0800065, T1228528, T1237524, T1245245, T1248345,
T1266118, and T1277288;
17) Lot number: 01A0800052, 01A0800170, 01A0800331, 01A0800426, 01A0800427,
01B0800390, 01D0800087, 01D0800088, 01D0800283, 01D0800325, 01E0800412, 01K0700286,
01L0700100, 01L0700342, T1202226, T1203616, T1214464, T1222328, T1223063, T1224897,
T1226763, T1230390, T1231505, T1232353, T1233482, T1234312, T1235584, T1236584,
T1238447, T1244668, T1248519, T1249585, T1252396, T1253543, T1255379, T1255380,
T1257215, T1258314, T1259111, T1260324, T1261794, T1262894, T1264108, T1266144,
T1266944, T1268384, T1270368, T1270996, T1272028, T1272029, T1273755, T1275785,
and T1279059;
18) Lot number: 01B0800315, 01C0800145, 01C0800297, 01D0800395, 01E0800146,
01E0800204, T1192807, T1195697, T1202224, T1216520, T1221291, T1222327, T1223064,
T1226526, T1228531, T1229940, T1232349, T1236587, T1237526, T1239521, T1241480,
T1243837, T1245247, T1249518, T1251450, T1252393, T1253541, T1258215, T1259108,
T1261004, T1262889, T1266941, T1268815, T1270364, T1270991, T1272877, T1273753,
T1275781, T1276620, T1278106, and T1279056;
19) Lot number: 01A0800222, 01B0800077, 01D0800008, 01D0800164, 01E0800143,
T1202197, T1208572, T1210838, T1234307, T1237419, T1247369, T1252392, T1256383,
T1257719, T1258560, T1259103, T1261790, T1266799, T1272021, T1273749, and T1277286;
20) Lot number: 01A0800054, 01D0800235, 01D0800322, 01L0700011, 01L0700260,
T1202200, T1215225, T1220112, T1224663, T1227699, T1228529, T1237525, T1238443,
T1244223, T1247370 , T1248510 , T1250486 , T1254320, T1259104, T1264919, T1272875,
T1276614, and T1280179;
21) Lot number 1A0800223, 01A0800428, 01B0800165, 01C0800247, 01C0800299, 01D0800089,
01D0800288, 01D0800337, 01E0800023, 01K0700301, 01L0700012, 01L0700178, 01L0700261,
01L0700343, 01M0700136, T1192808, T1202227, T1206021, T1207491, T1213973, T1222336,
T1223062, T1224085, T1226764, T1228535, T1229944, T1231510, T1232354, T1233483,
T1234314, T1235585, T1238448, T1239525, T1241011, T1241602, T1242669, T1243437,
T1244224, T1244667, T1247447, T1248348, T1249587, T1250498, T1252397, T1252398,
T1253544, T1254404, T1256391, T1258216, T1259112, T1260326, T1260617, T1261795,
T1261796 T1264109, T1264926, T1266145, T1266946, T1268385, T1270369, T1270997,
T1272880, T1273756, T1275787, T1276885, T1278109, and T1279060;
22) Lot number: 01A0800171, 01A0800224, 01C0800146, 01C0800248, 01C0800298,
01D0800146, 01D0800161, 01D0800323, 01E0800290, 01F0800084, 01K0700114, 01K0700202,
01K0700302, 01L0700161, 01L0700262, 01L0700344, 01M0700137, T1195699, T1208574,
T1213974, T1217528, T1224083, T1227710, T1232350, T1233479, T1235582, T1241601,
T1246175, T1248347, T1249519, T1251451, T1256386, T1258310, T1260322, T1261006,
T1264107, T1264922, T1266141, T1268381, T1268816, T1270365, T1270992, T1272878,
T1275782, T1276881, and T1277293;
23) Lot number: 01K0700203, 01L0700013, 01L0700183, 01M0700138, T1195700, T1201399,
T1202198, T1202860, T1203610, T1206016, T1213980, T1218338, T1226600, T1227690,
T1230384, T1234308, T1235439, T1237521, T1238396, T1240292, T1244666, T1245242,
T1248343, T1253535 , T1255372, T1256384, T1260077, T1261791, T1262882, T1264104,
T1266117, T1266800, T1272022, T1273750, T1278103, and T1279050;
24) Lot number: 01A0800055, 01B0800388, 01C0800294, 01D0800165, 01E0800019,
01E0800206, 01K0700303, 01L0700014, 01L0700184, T1192809, T1202221, T1212660,
T1220113, T1225876, T1227701, T1230386, T1236585, T1238444, T1244676, T1246174,
T1248512, T1253537, T1254401, T1255375, T1258762, T1260079, T1261782, T1264920,
T1268810, T1272876, T1276615, and T1280180;
b) Product manufactured from January 2006 through July 2008;
1) Lot number: 01B0800080, 01C0800069, 01E0800024, 01K0700109, 01K0700306,
01L0700104, 01M0700058, T1195792, T1202229, T1202963, T1206022, T1206785,
T1210254, T1214002, T1224089, T1228537, T1232357, T1234317, T1240300, T1247376,
and T1254408;
2) Lot number: 01B0800290, 01E0800025, 01E0800293, 01M0700139, T1199967, T1203683,
T1221295, T1225871, T1232358, T1234318, T1251457, T1257218, T1258316, T1259116,
T1268818, T1270999, T1278115, and T1279064;
3) Lot number: 01A0800010, 01C0800109, T1201389, T1206042, T1206786,
T1207492, T1208578, T1214465, T1224086, T1228536, T1231515, T1234316, T1238449,
T1239526, T1246179, T1250500 T1254405, T1262895, and T1272030;
4) Lot number: 01E0800055, 01E0800056, 01M0700059, T1192804, T1194951, T1196289,
T1202185, T1203619, T1210837, T1214003, T1215227, T1217531, T1221292, T1225870,
T1229945, T1232356, T1233484, T1235586, T1240297, T1247375, T1251454, T1257216,
T1260327, T1266947, T1268387, and T1278110;
5) Lot number: 01A0800013, 01A0800185, 01A0800186, 01A0800229, 01A0800230,
01A0800314, 01A0800336, 01A0800392, 01A0800433, 01D0800084, 01D0800328, 01E0800149,
01F0800074, 01K0700003, 01K0700116, 01K0700204, 01L0700018, 01L0700188, 01L0700265,
01M0700060, T1201390, T1203684, T1208580, T1212802, T1217533, T1218343, T1221294,
T1222331, T1222960, T1224090, T1224964, T1226766, T1232359, T1233485, T1234319,
T1235590, T1236583, T1240321, T1242824, T1243562, T1244226, T1245248, T1246361,
T1247377, T1252441, T1252442, T1254409, T1256392, T1257219, T1258317, T1259117,
T1260329, T1261011, T1262820, T1264112, T1264113, T1264928, T1266149, T1268391,
T1268819, T1275790, T1276887, T1277326, T1278116, and T1280265;
6) Lot number: 01A0800187, 01A0800337, 01B0800081, 01B0800291, 01D0800009,
01K0700004, T1195762, T1198822, T1205309, T1209534, T1225872, T1229947, T1237528,
T1239527, T1242825, T1246362, T1255383, T1257220, T1259118, T1260330, T1264114,
T1268392, T1268820, T1271000, T1273222, T1275791, T1278117, and T1279066;
7) Lot number: 01A0800011, 01A0800059, 01D0800081, 01D0800082, 01D0800326,
01E0800148, 01K0700205, 01K0700307, 01L0700105, 01L0700349, 01M0700140, T1195763,
T1202228, T1203681, T1205302, T1208579, T1218922, T1222329, T1222959, T1224962,
T1236590, T1238450, T1241603, T1244677, T1246180, T1249588, T1250501, T1251455,
T1254407, T1259115, T1261009, T1262896, T1264110, T1266147, T1266948, T1268388,
T1268817, T1275788, T1276886, and T1277323;
8) Lot number: 01A0800060, 01A0800338, 01D0800083, 01D0800327, 01K0700117,
01L0700106, T1192805, T1196288, T1202962, T1209531, T1224087, T1227715, T1230391,
T1235587, T1242821, T1243440, T1244225, T1247503, T1251456, T1261797, T1264111,
T1270370, T1273757, and T1280264;
9) Lot number: 01A0800101, 01A0800174, 01A0800339, 01B0800169, 01D0800085,
01E0800199, 01F0800075, 01K0700308, 01L0700019, 01L0700266, 01M0700061, T1201391,
T1208601, T1215228, T1219118, T1220119, T1222330, T1223061, T1224966, T1225873,
T1233486, T1234320, T1236337, T1245249, T1249589, T1251458, T1252443, T1264929,
T1266949, T1269021, T1276888, and T1277328;
10) Lot number: 01A0800340, T1195764, T1205306, T1225874, T1227718, T1231520,
T1233487, T1242826, T1246363, T1248465, T1250503, T1251459, T1257301, T1261012,
T1266950, T1271001, and T1280266;
11) Lot number: 01A0800231, 01D0800295, 01F0800014, 01F0800076, 01L0700020,
01L0700189, 01M0700141, T1199779, T1203685, T1206784, T1210835, T1211782, T1216524,
and T1221072;
12) Lot number: 01B0800393, 01F0800077, 01L0700267, T1199778, T1220120, T1234381,
T1244678, T1252444, T1254410, and T1270372;
13) Lot number: 01C0800067, T1196287, T1199966, T1205303, T1218342, T1220117,
T1230392, T1238451, T1242822, T1273221, T1278111, and T1279061;
14) Lot number: 01D0800162, T1201388, T1209532, T1210253, T1217532, T1224088,
T1227717, T1235588, T1240298, T1260328, T1268389, T1278112, and T1279062;
15) Lot number: 01A0800012, 01A0800434, 01B0800392, 01E0800292, 01E0800415,
01K0700206, 01M0700062, T1195765, T1203682, T1205304, T1209533, T1221293, T1225308,
T1226765, T1229946, T1231519, T1238452, T1240299, T1242823, T1250502, T1252400,
T1257217, T1258315, T1264927, T1268390, T1275789, T1277325, and T1278113;
16) Lot number: T1220118, T1235589, T1261010, T1266148, T1278114, and T1279063;
c) Product manufactured from January 2006 through July 2008;
1) Lot Number: 01A0800045, 01A0800319, 01A0800417, 01B0800210, 01B0800307,
01B0800318, 01B0800381, 01C0800054, 01C0800235, 01C0800308, 01D0800032, 01D0800149,
01D0800263, 01E0800030, 01E0800138, 01E0800139, 01K0700193, 01K0700292, 01L0700001,
01L0700089, 01L0700179, 01L0700250, 01L0700332, 01M0700045, 01M0700124, T1196255,
T1201496, T1202233, T1202969, T1211681, T1212807, T1214012, T1214145, T1214803,
T1215232, T1216179, T1217538, T1219268, T1219949, T1221287, T1222337, T1222951,
T1223070, T1223894, T1224976, T1225863, T1226772, T1227726, T1229961, T1233420,
T1234210, T1240153, T1240325, T1242673, T1243571, T1244228, T1244723, T1245254,
T1246551, T1250514, T1251540, T1252517, T1253551, T1254473, T1266156, T1266961,
T1269027, T1272020, T1275128, T1275797, T1277337, T1278125, and T1279073;
2) Lot Number: 01A0800043, 01A0800165, 01A0800217, 01A0800311, 01A0800418,
01A0890013, 01B0800068, 01B0800151, 01B0800159, 01B0800247, 01C0800055, 01C0800151,
01C0800236, 01C0800309, 01D0800106, 01D0800150, 01D0800264, 01E0800031, 01K0700110,
01K0700194, 01K0700195, 01K0700293, 01L0700002, 01L0700090, 01L0700180, 01L0700251,
01L0700333, 01M0700046, 01M0700125, T1202970, T1203693, T1209125, T1209540,
T1210249, T1211682, T1212302, T1212808, T1214013, T1214804, T1215233, T1216180,
T1217539, T1218205, T1219269, T1219948, T1221078, T1221286, T1222338, T1222339,
T1223892, T1224977, T1225864, T1226773, T1227727, T1228570, T1228610, T1229962,
T1230586, T1231598, T1232375, T1233421, T1234211, T1234998, T1236595, T1238043,
T1238498, T1239532, T1244229, T1244724, T1245255, T1246344, T1247434, T1248472,
T1250515, T1251359, T1252518, T1253552, T1254474, T1255175, T1255389, T1256398,
T1256399, T1257313, T1257314, T1258302, T1258344, T1259129, T1259130, T1260339,
T1260340, T1261021, T1261809, T1263003, T1264939, T1266157, T1266158, T1266959,
T1266960, T1268397, T1268398, T1268855, T1269028, T1269784, T1272061, T1272062,
T1273232, , T1273235, T1275142, T1275146, T1275798, T1276895, T1277338, T1278126,
T1278127, T1279074, and T1279915;
3) Lot number: 01A0800047, 01A0800093, 01A0800167, 01A0800215, 01A0800276,
01A0800277, 01A0800313, 01A0800421, 01B0800071, 01B0800161, 01B0800296, 01B0800382,
01C0800056, 01C0800139, 01C0800239, 01C0800310, 01D0800023, 01D0800112, 01D0800233,
01E0800080, 01E0800140, 01E0800302, 01F0800081, 01F0800379, 01L0700004, 01L0700173,
01L0700181, 01L0700252, 01L0700334, 01M0700222, T1205292, T1206699, T1207473,
T1208607, T1209126, T1209541, T1210250, T1211683, T1212809, T1213972, T1214009,
T1214809, T1215180, T1216202, T1217540, T1219270, T1219944, T1220367, T1221276,
T1222225, T1222801, T1223071, T1223895, T1224978, T1225865, T1226774, T1227728,
T1228611, T1229615, T1230587, T1230588, T1231599, T1232376, T1233422, T1234212,
T1234999, T1236596, T1238499, T1239533, T1241009, T1241609, T1243104, T1243105,
T1243572, T1244230, T1244511, T1244725, T1246548, T1247435, T1248473, T1249599,
T1250516, T1251541, T1252519, T1253553, T1256400, T1256401, T1257315, T1258345,
T1259832, T1260421, T1261022, T1261810, T1264227, T1264826, T1264940, T1266341,
T1266343, T1268399, T1269029, T1269030, T1270230, T1270231, T1271007, T1271008,
T1272063, T1272064, T1273237, T1275155, T1275799, T1277428, T1277429, T1278128,
T1279075, and T1279916;
4) Lot number: 01A0800048, 01A0800194, 01A0800346, 01A0890012, 01B0800073,
01B0800162, 01B0800248, 01B0800297, 01B0800383, 01C0800057, 01C0800241, 01C0800311,
01D0800033, 01D0800154, 01D0800280, 01D0800335, 01D0800369, 01E0800141, 01E0800422,
01F0800036, 01F0800082, 01F0800169, 01K0700296, 01L0700006, 01L0700094, 01L0700174,
01L0700254, 01L0700330, 01L0700335, 01M0700049, 01M0700122, 01M0700123, T1196254,
T1201499, T1202234, T1202235, T1202971, T1203694, T1206023, T1206700, T1207474,
T1208563, T1209378, T1214014, T1214468, T1216782, T1218206, T1219271, T1219945,
T1220365, T1221272, T1222958, T1223896, T1224979, T1226775, T1228342, T1229963,
T1230589, T1231600, T1232377, T1233424, T1234213, T1235000, T1236554, T1236935,
T1238503, T1239534, T1240141, T1241017, T1243128, T1244670, T1245256, T1246549,
T1247342, T1247436, T1251542, T1252520, T1253554, T1254475, T1256402, T1257316,
T1258346, T1259131, T1260422, T1261023, T1261811, T1263004, T1264228, T1264941,
T1266344, T1266962, T1268400, T1269031, T1270232, T1271009, T1271010, T1272065,
T1272066, T1273239, T1275168, T1275800, T1276896, T1277339, T1278129, T1279076,
and T1279917;
5) Lot number: 01A0800014, 01A0800136, 01A0800220, 01A0800322, 01A0800424,
01B0800074, 01B0800384, 01C0800058, 01C0800242, 01D0800034, 01D0800155, 01E0800192,
01E0800304, 01E0800423, 01K0700009, 01K0700112, 01K0700297, 01L0700095, 01L0700175,
01L0700255, 01L0700337, 01M0700190, T1196253, T1206015, T1206781, T1207475,
T1208564, T1209377, T1210120, T1210813, T1212330, T1214015, T1217541, T1219273,
T1221273, T1223072, T1223897, T1225866, T1227729, T1228612, T1230590, T1231601,
T1232378, T1233428, T1234214, T1235421, T1236194, T1237537, T1238505, T1239535,
T1243129, T1245257, T1246550, T1247397, T1248462, T1249600, T1251220, T1252521,
T1253555, T1254476, T1255390, T1256403, T1257318, T1257328, T1258347, T1259132,
T1260423, T1261024, T1261812, T1262821, T1264229, T1264942, T1266346, T1266963,
T1273809, T1275119, T1275430, T1275841, T1276897, T1277340, T1279077, and T1279918;
6) Lot number: 01A0800044, 01B0800305, 01B0800385, 01D0800035, 01E0800193,
01E0800214, 01F0800083, 01L0700256, 01L0700338, 01M0700051, T1199816, T1203695,
T1208608, T1212811, T1214016, T1219272, T1221288, T1227730, T1228613, T1238191,
T1244726, T1247398, T1251543, T1253556, T1257319, T1262053, T1263005, T1275842,
and T1278131;
d) Product manufactured from January 2006 through July 2008;
1) Lot number: 01C0800150, and T1278089;
2) Lot number: T1278090, and T1278091;
3) Lot number: 01D0800096, 01D0800274, 01M0700186, T1199965, T1203687, T1217534,
T1228540, T1238491, T1240322, T1250508, T1254468, T1260331, T1261800, T1264120,
T1264930, T1266953, T1271002, T1275103, and T1279909;
4) Lot number: 01A0800008, 01A0800061, 01A0800062, 01A0800177, 01A0800233,
01A0800344, 01A0800435, 01B0800174, 01B0800293, 01B0800374, 01C0800060, 01C0800149,
01C0800302, 01D0800094, 01D0800136, 01D0800275, 01E0800079, 01E0800112, 01E0800159,
01E0800249, 01E0800334, 01F0800022, 01F0800117, 01K0700006, 01K0700119, 01M0700014,
01M0700147, T1202230, T1202965, T1203688, T1213241, T1214808, T1218508, T1220366,
T1222324, T1225867, T1226767, T1228410, T1228561, T1229915, T1230518, T1231590,
T1232367, T1233411 , T1234215, T1235422, T1237016, T1238490, T1239528, T1244679,
T1246346, T1246459, T1247429, T1249597, T1252218, T1252509, T1253546, T1254469,
T1256202, T1256393, T1257303, T1258318, T1259122, T1261014, T1261801, T1262898,
T1264221, T1264931, T1266150, T1266151, T1266954, T1268393, T1272013, T1272014,
T1273718, T1276889, T1276890, T1277330, T1278118, T1279067, and T1279910;
5) Lot number: 01A0800007, 01A0800094, 01A0800139, 01A0800188, 01A0800234,
01A0800318, 01A0800382, 01A0800383, 01B0800040, 01B0800047, 01B0800048, 01B0800116,
01B0800130, 01B0800205, 01B0800206, 01B0800331, 01C0800007, 01C0800008, 01C0800076,
01C0800107, 01C0800184, 01C0800254, 01D0800001, 01D0800002, 01D0800111, 01D0800198,
01D0800199, 01D0800277, 01D0800329, 01E0800009, 01E0800057, 01E0800058, 01E0800160,
01E0800161, 01E0800250, 01E0800251, 01E0800296, 01E0800353, 01E0800416, 01E0800417,
01F0800037, 01K0700008, 01K0700120, 01K0700272, 01L0700021, 01L0700107, 01L0700190,
01L0700271, 01M0700098, 01M0700126, and 01M0700148;
6) Lot number: 01A0800436, 01B0800082, 01B0800175, 01B0800294, 01B0800375,
01C0800255, 01C0800304, 01D0800141, 01E0800252, 01E0800352, 01K0700209, 01K0700310,
01L0700022, 01L0700191, 01L0700268, T1195768, T1202966, T1203690, T1208603,
T1210246, T1211617, T1216058, T1221102, T1223849, T1226768, T1227722, T1228562,
T1229917, T1230520, T1231592, T1232369, T1233413, T1234217, T1235424, T1236592,
T1237531, T1238493, T1240323, T1244680, T1246541, T1247431, T1249598, T1250510,
T1251534, T1252511, T1253547, T1256395, T1257305, T1258320, T1259124, T1261803,
T1262822, T1262900, T1266956, T1268394, T1269024, T1270229, T1271005, T1273225,
T1273797, T1275793, T1276892, T1277331, T1278121, and T1279068;
e) Product manufactured from January 2006 through July 2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Inc., Durham, NC, by letters on/about August
22, 2008.
Manufacturer: Teleflex Medical, Inc., Tecate, B.C., Mexico. Firm initiated
recall is ongoing.
REASON
A hole in the sterile unit blister pack was detected that would compromise
sterility.
VOLUME OF PRODUCT IN COMMERCE
786,036 pieces
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Accessory Head Rest for Alphastar Operating Tables. USA part number: 1130.67FO,
Recall # Z-0161-2009
CODE
No serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Maquet Inc., Bridgewater, NJ, by letters beginning September
26, 2008.
Manufacturer: Maquet Aktiengesellschaft, Rastatt, Germany. Firm initiated recall
is ongoing.
REASON
During installation or cleaning there is a risk of crushing the finger by handling
the head rest in the area of the gas strut while simultaneously actuating the
release lever.
VOLUME OF PRODUCT IN COMMERCE
88 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
GlobTek, Inc. Power Supply for Medical Use Part No: TR9CE4000LCP-Y-MED Model:
GTM21097-5012, Made in China. Indicated for patients who would benefit from a
suction device particularly as the device may promote wound healing, including
patients who would benefit from vacuum assisted drainage and removal of infectious
materials or other fluid from wounds under the influence of continuous pressure,
Recall # Z-0162-2009
CODE
SSN: RoHS02492601 Last 4 digits of SSN identifies affected products: 05/08; 06/08;
07/08; 08/08; 09/08; 10/08; 11/08; 12/08; 13/08; 14/08 and 15/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith And Nephew, Inc. Wound Management Division, Largo, FL,
by letter dated August 7, 2008.
Manufacturer: Atmos Medizintechnik Gmbh & Co. KG, Lenzkirch, Germany. Firm
initiated recall is ongoing.
REASON
External battery chargers used with the Version 29 VISTA Negative Pressure Wound
Therapy pumps are failing to properly charge the pump's battery.
VOLUME OF PRODUCT IN COMMERCE
2,550 units
DISTRIBUTION
Nationwide, United Kingdom, New Zealand, Germany, Canada and Australia
___________________________________
PRODUCT
Axiom Aristos FX Multipurpose Radiography System, stationary X-Ray Ssystem, Model
number: 7414803, Recall # Z-0163-2009
CODE
Serial numbers: 1059, 1078, 1083, 1088, 1093, 1109, and 1135
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solution USA, Inc., Malvern, PA, by letter in
August 2008.
Manufacturer: Siemens Medical Solutions, Inc., Erlangen, Germany. Firm initiated
recall is complete.
REASON
Tube support arm or the detecting mounting hardware may become loose at the joint
with the telescope.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Varian RV Software Varian Treatment for Non-Varian Linacs Version 6.6.5042 and
6.6.5043; Model Number: H46; Designed to assist the operator of a radiation therapy
device in providing accurate treatment setups for each patient by monitoring
set up parameters and preventing the radiation therapy from commencing irradiation
while any parameter is out of conformance with the treatment plan, Recall # Z-0164-2009
CODE
H462082, H463052, H462031, H463016, H462001, H462075, H462079, H462005, H462006,
H462016, H462017, H462021, H462022, H462023, H462024, H463024, H463377, H463017
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on June 2,
2008. Firm initiated recall is ongoing.
REASON
A malfunction within the Varis software might result in a misadministration (under
dose). The software does not correctly interpret the number, causing field parameters
having decimal values to be incorrect.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
Nationwide, Canada, Austria, France, Germany, South Korea, Sweden, and the UK
___________________________________
PRODUCT
Roche/Hitachi Modular E Module immunoassay analyzer, GMMI Nos. 04998642001 and
03617505001, Recalling Firm: Z-0165-2009
CODE
All units with software version 08-02
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated June
24, 2008.
Manufacturer: Division, Hitachi Ltd., Hitachinaka-Ibaraki, Japan. Firm initiated
recall is ongoing.
REASON
A software bug may result in pipetting from an incorrect reagent pack and/or
assigning calibration curve parameters incorrectly.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Flexiguide Needle, Series-15, 25CM, with Female Luer Adaptor, Sharp and Stylet
with Male Luer Aaaptor (HDR); 10/PKG Quantity: 10/PKG L-NFV0001-004. The FlexiGuide
is a flexible needle designed to provide an enclosed pathway for localized radiation
therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate
(LDR) method. Product No: NFV0001-004, Recall # Z-0166-2009;
b) Flexiguide Needle, Series-15, 20CM, with Female Luer Adaptor, Sharp and Stylet
with Male Luer Adaptor (HDR); 10/PKG Quantity: 10/PKG L-NFV0003-003. Product
No: NFV0003-003. The FlexiGuide is a flexible needle designed to provide an enclosed
pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader
or manual Low Dose Rate (LDR) method, Recall # Z-0167-2009;
c) Custom Flexiguide Needle, Series 15, with Female Luer and Stylet with Male
Luer 28CM, Set of 100 Quantity: 1/PKG Lot No: K00136 L-SPECIAL- NFV. The FlexiGuide
is a flexible needle designed to provide an enclosed pathway for localized radiation
therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate
(LDR) method. Product No: SPECIAL-NFV, Recall # Z-0168-2009;
d) Flexiguide Needle, Series-15, 20 CM without Female Luer Adaptor, Sharp and
Stylet With 90-Degree Bend, 10/PKG Quantity: 10/PKG L-NFW0001-009. Product No:
FW0001-009. The FlexiGuide is a flexible needle designed to provide an enclosed
pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader
or manual Low Dose Rate (LDR) method, Recall # Z-0169-2009;
e) Flexiguide Needle, Series-15, 25 CM without Female Luer Adaptor, Sharp and
Stylet with 90-Degree Bend, 10/PKG Quantity: 10/PKG L-NFW0001-010. Product No:
FW0001-010. The FlexiGuide is a flexible needle designed to provide an enclosed
pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader
or manual Low Dose Rate (LDR) method, Recall # Z-0170-2009
CODE
a) Lots: F02586, and F02617;
b) Lots: F02562, F02569, and F02611;
c) Lot: K00136;
d) Lots: F02422, F02486, and F02665;
e) Lots: F02497, and F02574
RECALLING FIRM/MANUFACTURER
Alpha Omega Services Inc., Bellflower, CA, by letters beginning November
15, 2007 and November 27,2007. Firm initiated recall is complete.
REASON
There is a possibility that the Flexiguide Needle tip is defective. There is
the potential for the needles tip to leak, thereby breaking the sterile boundary
and possibly contaminating other devices with body fluids.
VOLUME OF PRODUCT IN COMMERCE
198 packages
DISTRIBUTION
NV, AZ, CA, MI, UT, MO, CO, and OH
___________________________________
PRODUCT
a) Liquid AST (SGOT) Reagent Set, in 150 ml (Product no. A7561-150) and 450 ml
(Product no A7561-450). For the quantitative determination of aspartate amoinotransferase
in human serum, Recall # Z-0171-2009;
b) AST R1 Reagent, 120 ml.; Catalog no. 8-A7561-R1-120. For the quantitative
determination of aspartate amoinotransferase in human serum, Recall # Z-0172-2009
CODE
a) Lots: 728504-046 and 728504-094; Lot: 728504-063. Exp. 4/09;
b) Lot 728504-079; Exp. 4/09
RECALLING FIRM/MANUFACTURER
Pointe Scientific, Inc., Canton, MI, by letter dated August 22, 2008. Firm
initiated recall is ongoing.
REASON
The R1 component may be contaminated with Serratia liquefaciens, resulting decreased
absorbance and failure of the reagent to produce test results.
VOLUME OF PRODUCT IN COMMERCE
109 kits and 25 vials
DISTRIBUTION
Nationwide, Bolivia, Ecuador, Greece, Indonesia, Mexico, Nepal, Philippines,
Romania and Serbia
___________________________________
PRODUCT
Premier Value Lancing Device. UPC Code: 840986016707, The Package Includes: 1
Lancing Device, 1 Clear Cap and 5 Premier Value Ultra Thin Lancets. Lancing Device
intended to be used by diabetes patients that require a drop of capillary blood
for testing, Recalling # Z-0174-2009
CODE
Lot Numbers: M057030, and M057022; Unit numbers: L339011, L339011, L339011, and
L339011
RECALLING FIRM/MANUFACTURER
Facet Technologies, McDonough, GA, by letter on/about July 18, 2008. Firm initiated
recall is ongoing.
REASON
The Alternate Site Cap was not included in the package as indicated on the labeling.
VOLUME OF PRODUCT IN COMMERCE
2,976 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) STANDARD, Uterine
Manipulator, REF 60-6085-000. Made in USA. The ConMed VCARE® Retractor/Elevator
is indicated for manipulation of the uterus and injection of fluids or gases
during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy
(LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion,
or diagnostic laparoscopy and also maintains pneumoperitoneum by sealing the
vagina once colpotomy is performed, Recall # Z-0175-2009;
b) VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) SMALL, Uterine Manipulator,
REF 60-6085-001. Made in USA. The ConMed VCARE® Retractor/Elevator is indicated
for manipulation of the uterus and injection of fluids or gases during laparoscopic
procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic
Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy
and also maintains pneumoperitoneum by sealing the vagina once colpotomy is performed,
Recall # Z-0176-2009;
c) VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) LARGE, Uterine Manipulator,
REF 60-6085-002. Made in USA. The ConMed VCARE® Retractor/Elevator is indicated
for manipulation of the uterus and injection of fluids or gases during laparoscopic
procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic
Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy
and also maintains pneumoperitoneum by sealing the vagina once colpotomy is performed,
Recall # Z-0177-2009;
d) VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) STANDARD, Uterine
Manipulator, REF 60-6085-100. Made in USA. The ConMed VCARE® Retractor/Elevator
is indicated for manipulation of the uterus and injection of fluids or gases
during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy
(LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion,
or diagnostic laparoscopy and also maintains pneumoperitoneum by sealing the
vagina once colpotomy is performed, Recall # Z-0178-2009;
e) VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) SMALL, Uterine Manipulator,
REF 60-6085-101. Made in USA, Recall # Z-0179-2009;
f) VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) LARGE, Uterine Manipulator,
REF 60-6085-102. Made in USA. The ConMed VCARE® Retractor/Elevator is indicated
for manipulation of the uterus and injection of fluids or gases during laparoscopic
procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic
Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy
and also maintains pneumoperitoneum by sealing the vagina once colpotomy is performed,
Recall # Z-0180-2009
CODE
Lots 0710121x through and including 0804111x [yymmddx where x = shift code 1,2,
or 3] . All lots of the recalled devices were manufactured between and including
October 12, 2007 and April 11, 2008
RECALLING FIRM/MANUFACTURER
ConMed, Corp., Utica, NY, by letters on September 8, 2008. Firm initiated recall
is ongoing.
REASON
The firm received several complaints sighting detachment of the balloon at the
distal end of the shaft. It was also noted that the incidence of the forward
cup slipping off the shaft and being retained in the vaginal canal had increased.
VOLUME OF PRODUCT IN COMMERCE
32,453 devices
DISTRIBUTION
Nationwide, Australia, Belgium, Brazil, Chile, Ecuador, France, and Switzerland
___________________________________
PRODUCT
Biomet brand Modular Microplasty Cup Inserter, 3/8" thread, Model 31-400600.
Non-powered, hand-held instrument intended for use as an impactor during orthopedic
surgery, Recall # Z-0181-2009
CODE
Lot numbers: 097525, 097526, 532370 and 532810
RECALLING FIRM/MANUFACTURER
Biomet Orthopedics, Inc., Warsaw, IN, by letter dated July 28, 2008. Firm initiated
recall is ongoing.
REASON
The pin and clip may fracture during use.
VOLUME OF PRODUCT IN COMMERCE
85 Units
DISTRIBUTION
Nationwide, Australia, Belgium, Canada, Denmark, New Zealand and Sweden
___________________________________
PRODUCT
Circlip component of the Stryker Flat Panel and Navigation Arm System. Stryker
Flat Panel and Navigation Arm System are intended for use as a ceiling-mounted
device to support a medical grade flat panel monitor or camera in the patient
area. The Circlip within the flat panel and navigation arms is part of the mechanical
stop designed to prevent the arm from rotating infinitely. It also prevents the
cables routed through the arm from becoming twisted during routine movement and
rotation of the arm.
Part numbers: 0682-000-005 (A-O), 0682-000-200, 0682-000-270, 0682-000-280, 0682-000-281,
0682-000-850, and 0682-000-851, Recall # Z-0182-2009
CODE
All units distributed between December 23, 2003 and September 30, 2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Communications Corp., Flower Mound, TX, by letter on
September 5, 2008.
Manufacturer: Ondal Indust Gmbh, Hunfeld, Germany. Firm initiated recall is ongoing.
REASON
Circlip component used to suspend flat panel and navigation arm system may become
dislodged.
VOLUME OF PRODUCT IN COMMERCE
705 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Medtronic DBS" 3387S-40 Lead Kit for Deep Brain Stimulation , length:
40 cm. Contents of the inner packages are Sterile and Non-Pyrogenic. Method of
Sterilization: Ethylene Oxide, Rx Only, Activa Therapy, Model 3387 Lead Kit,
STIMLOC Burr Hole Kit; Implant manual: DBS Leads: Proximal 40 mm, Distal 12.0
mm, Medtronic, Inc. Medtronic Active Therapy includes Activa Parkinson's Control
Therapy and Activa Tremor Control Therapy. Parkinson's Control Therapy: Bilateral
stimulation of the internal globus pallidus (GP) or the subthalamic nucleus (STN)
using Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive
therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's
disease that are not adequately controlled with medication. Tremor Control Therapy:
Unilateral thalamic stimulation by the Medtronic Activa Tremor control system
is indicated for the suppression of tremor in the upper extremity. The system
is intended for using patients who are diagnosed with Essential Tremor or Parkinsonian
tremor not adequately controlled by medications and where the tremor constitutes
a significant functional disability., Recall # Z-0184-2009;
b) Medtronic DBS" 3389S-40 Lead Kit for Deep Brain Stimulation , length:
40 cm. Contents of the inner packages are Sterile and Non-Pyrogenic. Method of
Sterilization: Ethylene Ox ide, Rx Only, Activa Therapy, Model 3387 Lead Kit
Manufactured at : Medtronic, Inc., Villalba, Puerto Rico, STIMLOC Burr Hole Kit:
Manufacturer: Medtronic Image-Guided Neurologics, Melbourne, FL 32935-3145 Implant
manual: DBS" Leads: Proximal 40 mm, Distal 9.0 mm, Medtronic, Inc. Medtronic
Active Therapy includes Activa Parkinson's Control Therapy and Activa Tremor
Control Therapy. Parkinson's Control Therapy: Bilateral stimulation of the internal
globus pallidus (GP) or the subthalamic nucleus (STN) using Medtronic Activa
Parkinson's Control Therapy is indicated for adjunctive therapy in reducing some
of the symptoms of advanced, levodopa-responsive Parkinson's disease that are
not adequately controlled with medication. Tremor Control Therapy: Unilateral
thalamic stimulation by the Medtronic Activa Tremor control system is indicated
for the suppression of tremor in the upper extremity. The system is intended
for using patients who are diagnosed with Essential Tremor or Parkinsonian tremor
not adequately controlled by medications and where the tremor constitutes a significant
functional disability, Recall # Z-0185-2009;
c) Medtronic DBS" 3387 Lead Kit for Deep brain stimulation, DBS Leads: Proximal
40 mm, Distal 12.0 mm, Medtronic, Inc. Medtronic Active Therapy includes Activa
Parkinson's Control Therapy and Activa Tremor Control Therapy. Parkinson's Control
Therapy: Bilateral stimulation of the internal globus pallidus (GP) or the subthalamic
nucleus (STN) using Medtronic Activa Parkinson's Control Therapy is indicated
for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive
Parkinson's disease that are not adequately controlled with medication. Tremor
Control Therapy: Unilateral thalamic stimulation by the Medtronic Activa Tremor
control system is indicated for the suppression of tremor in the upper extremity.
The system is intended for using patients who are diagnosed with Essential Tremor
or Parkinsonian tremor not adequately controlled by medications and where the
tremor constitutes a significant functional disability, Recall # Z-0186-2009;
d) Medtronic DBS" 3389 Lead Kit for Deep brain stimulation, DBS Leads: Proximal
40 mm, Distal 9.0 mm, Medtronic, Inc. Medtronic Active Therapy includes Activa
Parkinson's Control Therapy and Activa Tremor Control Therapy. Parkinson's Control
Therapy: Bilateral stimulation of the internal globus pallidus (GP) or the subthalamic
nucleus (STN) using Medtronic Activa Parkinson's Control Therapy is indicated
for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive
Parkinson's disease that are not adequately controlled with medication. Tremor
Control Therapy: Unilateral thalamic stimulation by the Medtronic Activa Tremor
control system is indicated for the suppression of tremor in the upper extremity.
The system is intended for using patients who are diagnosed with Essential Tremor
or Parkinsonian tremor not adequately controlled by medications and where the
tremor constitutes a significant functional disability, Recall # Z-0187-2009
CODE
a) PIN # 3387S0000V;
b) PIN # 3389S0000V;
c) PIN # 3387028103, 3387040103, and 338704004V;
d) PIN 3389028103, 33890400103, and 338904004V
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN, by letter on August
20, 2008.
Manufacturer: Medtronic Puerto Rico Operations, Co., Villalba, PR. Firm initiated
recall is ongoing.
REASON
Medtronic has received reports of DBS" leads being damaged at the proximal
connector end of the lead when the lead cap is used in the implant procedure.
The lead damage is the result of excessive torsion and / or tensile lading of
the proximal connector end of the lead. Data also suggest that excessive torque
while tightening or loosening the setscrews may twist the setscrew connector
block and damage the proximal connector end of the lead. Depending on the extent
of lead damage and the need to use the affected lead contact(s) and/or conductor(S),
lead replacement may be required, exposing the patient to the risks of a second
lead implant procedure. To date, there have been no reports of permanent patient
impairment, life-threatening injury, or death as a result of this issue.
VOLUME OF PRODUCT IN COMMERCE
26,313 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Symbia T6 System; a dual-detector variable angle gamma camera with a six slice
CT scanner; Siemens Medical Solutions USA, Inc., Molecular imaging, Hoffman Estates,
IL 60192. The system is used to perform CT scans and nuclear imaging studies
with the same instrument, obtaining attenuation corrected images and providing
registration of anatomical and physiological images within the patient's anatomy.
The Symbia T6 System is used for advanced oncology, neurology and cardiology
applications. System part number 10275009; CT Subassembly 10165632, Recall #
Z-0189-2009;
b) Symbia T16 System; a dual-detector variable angle gamma camera with a sixteen
slice CT scanner; The system is used to perform CT scans and nuclear imaging
studies with the same instrument, obtaining attenuation corrected images and
providing registration of anatomical and physiological images within the patient's
anatomy. The Symbia T6 System is used for advanced oncology, neurology and cardiology
applications. System part number 10275010; CT Subassembly 10165633, Recall #
Z-0190-2009
CODE
a) Serial numbers 1019, 1020, 1021, 1024, 1026, 1030, 1031, 1034, 1038, 1040,
and 1041; Serial numbers 68501 through 68514;
b) Serial numbers 1001, 1002, 1003, 1004, 1005, 1006, 1007, 1008, 1009, and
1010; Serial numbers 69003 through 69012
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, by letters dated
September 29, 2008. Firm initiated recall is ongoing.
REASON
The protective plastic cap over the CT gantry power switch on the Line Connection
Box may come loose, exposing the energized electrical contacts within the switch,
thereby causing an electric hazard.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
DC, FL, GA, IL, IN, MO, OH, TX, Australia, Brazil, Canada, Great Britain, India,
Italy, Japan, Norway and Switzerland
___________________________________
PRODUCT
Stryker Osteosynthesis Reduction Spoon; 1 single unit to a package; non-sterile.
Reduction spoons are sold separately or as part of a kit. The Universal Rod
with Reduction Spoon may be used as a fracture reduction tool to facilitate
Guide Wire insertion. Product Code 1806-0125, Recall # Z-0191-2009
CODE
All product made before design change in 2003.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, letters
on August 14, 2008.
Manufacturer: Stryker Trauma GmbH, Schonkirchen, Germany. Firm initiated recall
is ongoing.
REASON
The potential for breakage of the Reduction Spoon designed prior to 2003.
VOLUME OF PRODUCT IN COMMERCE
1,070 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Smallbore T-Port Extension Set with Female Luer Lock Connector and Male Luer
Lock T-Port with Ultrasite Injection Site 5 in. The product is shipped 100
units per carton. Item number 474515, Recall # Z-0199-2009
CODE
Lot number: 0061014615 exp 6/30/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by letter dated September
17, 2008.
Manufacturer: B Braun Medical Inc., Santo Domingo, Dominican Republic. Firm
initiated recall is ongoing.
REASON
Product was assembled incorrectly and connected to the wrong part.
VOLUME OF PRODUCT IN COMMERCE
3,900 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Monitor suspensions used with Advantx Legacy, RFX Classical, SFX-90, Model
# 46-240838G2, manufactured after March 8, 1985 for Advantx Legacy, RFX and
SFX systems. General-purpose radiographic system component used to suspend
the system's image monitor, Recall # Z-0200-2009
CODE
Serial numbers: 00000486566WK3, 00000486586WK1, 00000486555WK6, 00000486573WK9,
00000486581WK2, 00000478555WK6, 00000486579WK6, 00000486588WK7, 00000486557WK2,
00000486560WK6, 00000486550WK7, 00000486556WK4, 00000486547WK3, 00000056366VP8,
00000486544WK0, 00000486541WK6, 00000486543WK2, 00000471291WK5, 00000486568WK9,
and 00000486559WK8
RECALLING FIRM/MANUFACTURER
GE Healthcare, Waukesha, WI, by letter dated September 13, 2007. Firm initiated
recall is complete.
REASON
GE Healthcare has recently become aware of a potential risk of monitor dropping
associated with the monitor suspension of the Advantx system that may impact
patient safety. It has been reported that suspensions manufactured after March
8, 1995 did not have the required thread locking agent applied to the setscrew,
allowing the setscrew to back out over time, which can lead to the monitor
dropping.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
AZ, CA, FL, GA, IA, MD, MO, NC, NY, OH, OK, TN, TX,WI, and LA, and Slovak Republic
___________________________________
PRODUCT
Oxylog 3000 Emergency and Transport Ventilator Continuous Respirator with software
version 1.10 pre-installed; Catalog number 2M86300, Recall # Z-0202-2009
CODE
Serial numbers: SRZA-0182 and higher tahn 0182, SRZB-xxxx, SRZC-xxxx, SRZD-xxxx,
SRZE-xxxx, SRZF-xxxx, SRZH-xxxx, and SRZJ-xxxx. Note that xxxx stands for numbers
0001 through 9999
RECALLING FIRM/MANUFACTURER
Recalling Firm: Draeger Medical, Inc., Telford, Pa, by letter dated September
2008.
Manufacturer: Draeger Medical B.V., Best, Netherlands. Firm initiated recall
is ongoing.
REASON
May experience an interruption of ventilation for approximately 5 seconds.
VOLUME OF PRODUCT IN COMMERCE
50 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Platinum Plus" LT, REF 46-601, UPN M001466010, LT/0.018/180, Sterilized
with ethylene oxide gas, Rx only. The Platinum Plus" Guidewire facilitates
placement of a catheter during diagnostic or interventional intravascular procedures.
The wire can be torqued to facilitate navigation through tortuous arteries
and/or avoid unwanted side branches, Recall # Z-0030-2009;
b) Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized
with ethylene oxide gas, Rx only. The Platinum Plus" Guidewire facilitates
placement of a catheter during diagnostic or interventional intravascular procedures.
The wire can be torqued to facilitate navigation through tortuous arteries
and/or avoid unwanted side branches, Recall # Z-0031-2009
CODE
a) Lot # 11574626;
b) Lot # 11574628
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Maple Grove, MN,
by letter dated August 25, 2008.
Manufacturer: Boston Scientific Corp., Miami, FL. Firm initiated recall
is ongoing.
REASON
Boston Scientific is initiating a voluntary recall of the Platinum Plus" Guidewire
(peripheral). BSC has received reports that product may be labeled as a 260
CM long guidewire when the actual packaged device is a 180 CM long guidewire
and the product may be labeled as a 180 CM long guidewire when the actual packaged
device is a 260 CM long guidewire. There is no expected potential for injury
to either the patient or user resulting from this product issue. The most serious
adverse effect that is reasonably expected would be a slight prolongation of
the procedure due to product exchange. To date, Boston Scientific has received
two complaints in association to this product issue. No adverse event have
been reported to Boston Scientific.
VOLUME OF PRODUCT IN COMMERCE
82 units
DISTRIBUTION
Nationwide, France, Germany, Great Britain, Italy, and the Netherlands
___________________________________
PRODUCT
3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product
intended for use in general soft tissue approximation and/or ligation including
use in ophthalmic procedures, Recall # Z-0034-2009
CODE
Lot number: M335870
RECALLING FIRM/MANUFACTURER
Surgical Specialties Corp., Reading, PA, by letter dated September 9, 2008.
Firm initiated recall is ongoing.
REASON
Mislabeled product - labeled as 3-0 black mono nylon contains 4-0 black braided
silk suture.
VOLUME OF PRODUCT IN COMMERCE
495 boxes
DISTRIBUTION
Nationwide, Australia, Canada, and Fiji Islands
___________________________________
PRODUCT
IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative determination
of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma.
Ref: AC-57F1; Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin
D and other hydroxylated metabolites in serum or plasma, Recall # Z-0173-2009
CODE
Lot number: 60897, Exp 2009-08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Immunodiagnostics Systems Inc., Fountain Hills, AZ, by letter
dated August 2, 2008 and August 8, 2008.
Manufacturer: Immunodiagnostics Systems Ltd., Boldon Colliery, UK. Firm initiated
recall is ongoing.
REASON
A small number of customers have experienced low absorbance values when using
kits from this batch.
VOLUME OF PRODUCT IN COMMERCE
691 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Bard Vacora Biopsy Vacuum Assisted Biopsy Probe; Catalog numbers VB10118 and
VB10140, Recall # Z-0183-2009
CODE
Lot numbers: 431PI148, 43IPI013 and 43IPI014 with expiry date September 2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bard Peripheral Vascular Inc., Tempe, AZ, by letter dated
September 11, 2008
Manufacturer: Bard Shannon Limited, Humacao, PR. Firm initiated recall is
ongoing.
REASON
Some of the Vacora Biopsy Vacuum Assisted Biopsy Probe thumb wheels from these
lots may fracture when fired using the prime/pierce option.
VOLUME OF PRODUCT IN COMMERCE
125 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
26" Vision Elect HDTV Surgical Viewing Monitor, model number 0240030960,
Manufactured by Stryker Endoscopy San Jose Intended to be used as a visualization
device for events occurring in the sterile field for endoscopic surgical procedures,
Recall # Z-0196-2009
CODE
PER numbers: 98131, 99085,101141,105591,101235,101212, 109617, 110104, 110852,110974,111006,111048,111081,111105,
111181, 111199, 111202, 111303, 111492, 111562, 111595, 111868, 111912, and 111935
RECALLING FIRM/MANUFACTURER
Stryker Endoscopy, San Jose, CA, by letters dated September 22, 2008. Firm
initiated recall is ongoing.
REASON
Knob parts stick together, resulting in poor functionality of the knob.
VOLUME OF PRODUCT IN COMMERCE
2,265 units
DISTRIBUTION
Nationwide, Australia, Canada, China, England, France, Germany, Greece, Iberia,
India, Israel, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Scandinavia,
Singapore, South Africa, Switzerland, and Taiwan
___________________________________
PRODUCT
a) PEDIGREE® Complete Nutrition Small Crunchy Bites in 20 lb, UPC Code:
23100 14719, Recall # V-001-2009;
b) PEDIGREE® Complete Nutrition Small Crunchy Bites, 52 pound bags, Costco
Item: 387022, UPC Code: 23100 05110, Recall # V-002-2009
CODE
a) Lot Code: 830BFCAT02 Best Buy Date: 07/2009;
b) Lot codes: 831BFCAT02 and 830DFCAT02, Best Buy date 07/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: MARS Petcare US, Inc., Franklin, TN, by telephone on August
6/7, 2008 and by follow-up e-mails and press release.
Manufacturer: Mars Inc., Tracy CA. Firm initiated recall
is ongoing.
REASON
Product may be contaminated with salmonella.
VOLUME OF PRODUCT IN COMMERCE
2000 lbs of 20 lb bag, 259350 lbs of 52 lb bag size
DISTRIBUTION
CA, NV
___________________________________
PRODUCT
Fort Dodge Aureomycin Sulmet, Chlortetracycline Bisulfate Sulfamethazine Bisulfate,
Soluble Powder, Antibacterial, For Oral Veterinary Use in Swine Only, each
pound contains chlortetracycline bisulfate equivalent to 102.4 grams chlortetracycline
hydrochloride activity and sulfamethazine bisulfate equivalent to 102.4 grams
sulfamethazine, packaged in 4-oz. pouches, 40 pouches per pail, NADA 055-012,
Recall # V-003-2009
CODE
060979, Exp. Aug 09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fort Dodge Laboratories, Inc., Fort Dodge, IA, by letters dated
October 1, 2008.
Manufacturer: Virbac Bridgeton, Bridgeton, MO. Firm initiated recall is ongoing.
REASON
Out of specification results observed at the 24-mongh stability.
VOLUME OF PRODUCT IN COMMERCE
276/640-pouch pails
DISTRIBUTION
IA and NC
END OF ENFORCEMENT REPORT FOR NOVEMBER 5, 2008
###
RSS Feed for FDA Enforcement Report [what is RSS?]