Enforcement Report

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.

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September 3, 2008
08-35

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

___________________________________
PRODUCT
Chef's Review Garbanzo Beans, in 29 oz. can, item number CR4-FB-1225, 12 cans per case. UPC code on can is 041512068775, Recall # F-529-8
CODE
07 080, 07 226, 07 268, 07 316, 07 353, 08 136, 08 172
RECALLING FIRM/MANUFACTURER
Teasdale Quality Foods, Atwater, CA, by telephone and e-mail on July 22, 2008. Firm initiated recall is ongoing.
REASON
Product contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
3,863 cases (12 cans per case)
DISTRIBUTION
CA, AZ, and NV
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PRODUCT
Publix NSA, no sugar added cherry pies, 8 inches in plastic clamshell containers. Publix NSA 8inch Cherry Pie, UPC: 41415-65990; Publix NSA ½ Cherry Pie, UPC: 03000-00225; Publix NSA ¼ Cherry Pie, UPC: 41415-66990, Recall # F-530-8
CODE
Sell-by-date July 8 – July 27
RECALLING FIRM/MANUFACTURER
Publix Super Markets, Lakeland, FL, by press release on July 24, 2008 and e-mail on July 25, 2008. Firm initiated recall is ongoing.
REASON
Cherry pies contain undeclared soy lecithin.
VOLUME OF PRODUCT IN COMMERCE
2,034 pies
DISTRIBUTION
GA, AL, SC, TN and FL

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

__________________________________
PRODUCT
1) BI-MART brand Complete Allergy Liquid Antihistamine, Each 5mL (one teaspoon):
    Diphenhydramine HCl 12.5 mg, 4 fl oz. bottles, Cherry Flavor, Recall # D-296-2008;
2) a) BI-MART brand Children's Non-Aspirin Pain Relief Liquid, Each 5mL (teaspoon):
    Acetaminophen160 mg, Cherry Flavor, 4 FL. OZ. (118mL) bottles, Also labeled as:
    b) Generamed Brand - GM APAP Oral Suspension, USP 160mg/5mL, and
    c) Aurora Pharmacy Children's Pain Relief Suspension Acetaminophen,
    Recall # D-297-2008;
3) MHL brand Tussin DM Cough Suppressant/Expectorant, Dextromethorphan HBr,
    USP 10 mg and Guaifenesin USP 100 mg, 8 fluid ounce bottles: a) MHL, and
    b) BI-MART, Recall # D-298-2008;
4) Aurora Pharmacy Cold & Allergy Elixir, Brompheniramine maleate 1 mg and
    Phenylephrine HCl 2.5 mg, 4 fluid ounce bottles, Grape flavor, Recall # D-299-2008;
5) a) MHL brand Night Time Regular Cold Medicine, New Pseudoephedrine-Free
    Formula, Acetaminophen 500 mg, Dextromethorphan hydrobromide 15 mg,
    Doxylamine succinate 6.25 mg, 6 FL OZ bottles, Also labeled as: b) BI-MART
    brand Night Time Cold Medicine New Pseudoephedrine-Free Formula, 6 & 10
    fluid ounce bottles, distributed by BI-MART, Eugene, and c) Aurora Pharmacy
   brand Nighttime Cold Medicine, 6 & 10 fluid ounce bottles, Recall # D-300-2008;
6) a) MHL brand Night Time Cherry Cold Medicine, New Pseudoephedrine-Free
    Formula, Acetaminophen 500 mg, Dextromethorphan hydrobromide 15 mg,
    Doxylamine succinate 6.25 mg, --- Also labeled as: b) BI-MART Cherry Flavor
    Night Time Cold Medicine New Pseudoephedrine-Free Formula, 6 & 10 fluid
    ounce bottles, c) Aurora Pharmacy Nighttime Cold Medicine Cherry Flavor,
    6 & 10 fluid ounce bottles, Recall # D-301-2008;
7) Aurora Pharmacy Daytime Cold Medicine, Acetaminophen 325 mg and
    Dextromethorphan HBr 15 mg, 6 fluid ounce bottles, Recall # D-302-2008;
8) BI-MART Day Time Cold Medicine, New Pseudoephedrine-Free Formula,
    Acetaminophen 325 mg, Dextromethorphan HBr 10 mg and Phenylephrine
    HCl 5 mg, 6 fluid ounce bottles, Recall # D-303-2008
CODE
1) Lot: 336929, Exp. 07/09 A 6 digit lot number followed by the month/year expiry
    date (example ###### MM/YY) is inked vertically just to the right principal
    display panel on the product label;
2) a) Lot: 335381, Exp. 08/08; Lot: 335734, Exp. 08/08; Lot: 335971, Exp. 02/09;
        Lot: 336682, Exp. 02/09; Lot: 336683, Exp. 02/09; Lot: 336684, Exp. 07/09;
        Lot: 337132, Exp. 02/09; Lot: 337211, Exp. 09/09; and Lot: 337493, Exp. 02/10;
    b) Lot: 337478, Exp. 06/09;
    c) Lot: 336368, Exp. 02/09; and Lot: 336984, Exp. 02/09.
    A 6 digit lot number followed by the month/year expiry date (example ######
    MM/YY) is inked vertically just to the right principal display panel on the product
    label.
3) a) Lot: 335519, Exp. 09/08; and Lot: 336249, Exp. 12/08;
    b) Lot: 335732, Exp. 09/08; Lot: 335979, Exp. 09/08; Lot: 336005, Exp. 12/08;
        Lot: 336176, Exp. 12/08; Lot: 336270, Exp. 12/08; Lot: 336541, Exp. 07/09;
        Lot: 336986, Exp. 09/09; Lot: 337014, Exp. 07/09; Lot: 337059, Exp. 11/09;
        Lot: 337279, Exp. 11/09; and Lot: 337384, Exp. 12/09. A 6 digit lot number
       followed by the month/year expiry date (example ###### MM/YY) is inked
       vertically just to the right principal display panel on the product label.
4) Lot: 336372, Exp. 11/08; Lot: 336705, Exp. 12/08; and Lot: 336967, Exp. 12/08.
    A 6 digit lot number followed by the month/year expiry date (example ######
    MM/YY) is inked vertically just to the right principal display panel on the product
    label.
5) a) Lot: 335791, Exp. 09/08;
    b) Lot: 335605, Exp. 11/08; Lot: 335606, Exp. 11/08; Lot: 336157, Exp. 11/08;
        Lot: 336195, Exp. 11/08; Lot: 336746, Exp. 11/08; Lot: 337009, Exp. 09/09;
        Lot: 337010, Exp. 10/09; and Lot: 337375, Exp. 10/09; Lot: 335646, Exp. 11/08;
        Lot: 335758, Exp. 11/08; Lot: 336006, Exp. 05/09; Lot: 336462, Exp. 11/08;
        Lot: 336463, Exp. 05/09; Lot: 336555, Exp. 07/09; Lot: 336556, Exp. 05/09;
        Lot: 336907, Exp. 07/09; Lot: 337135, Exp. 07/09; and Lot: 337494, Exp. 01/10;
    c) Lot: 336373, Exp. 11/08; Lot: 336707, Exp. 09/09; and 10 fluid ounce bottles:
        Lot: 336374, Exp. 05/09; and Lot: 336708, Exp. 07/09. A 6 digit lot number
       followed by the month/year expiry date (example ###### MM/YY) is inked
       vertically just to the right principal display panel on the product label;
6) a) Lot: 335792, Exp. 11/08;
    b) Lot: 335588, Exp. 07/08; Lot: 335599, Exp. 07/08; Lot: 335601, Exp. 11/08;
        Lot: 335864, Exp. 12/08; Lot: 336775, Exp. 12/08; Lot: 336776, Exp. 04/09;
       Lot: 337136, Exp. 12/08; Lot: 337142, Exp. 04/09; Lot: 337376, Exp. 11/09;
      Lot: 335537, Exp. 09/08; Lot: 335626, Exp. 12/08; Lot: 336509, Exp. 07/09;
       Lot: 336968, Exp. 07/09; Lot: 336969, Exp. 08/09; Lot: 337008, Exp. 11/09;
       Lot: 337318, Exp. 12/09; Lot: 337378, Exp. 11/09; Lot: 337567, Exp. 12/09;
   c) Lot: 336375, Exp. 04/09; Lot: 336706, Exp. 04/09; and 10 fluid ounce bottles:
      Lot: 336376, Exp. 07/09; Lot: 336709, Exp. 08/09. A 6 digit lot number followed
      by the month/year expiry date (example ###### MM/YY) is inked vertically just
      to the right principal display panel on the product label;
7) Lot: 336377, Exp. 06/09; and Lot: 336710, Exp. 09/09. A 6 digit lot number
    followed by the month/year expiry date (example ###### MM/YY) is inked
    vertically just to the right principal display panel on the product label;
8) Lot: 337484, Exp. 01/10; and Lot 337639, Exp. 01/10. A 6 digit lot number followed
    by the month/year expiry date (example ###### MM/YY) is inked vertically just to
    the right principal display panel on the product label
RECALLING FIRM/MANUFACTURER
Magno Humphries Inc., Tigard, OR, by letter on May 30, 2008. Firm initiated recall is ongoing.
REASON
Labeling Illegible; The product warnings, OTC dosage information, and the drug use information is potentially illegible. The peel back labels are tearing and there is a significant amount of ink transferred to the bottle.
VOLUME OF PRODUCT IN COMMERCE
64,581 bottles
DISTRIBUTION
Nationwide and Fiji Island

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

___________________________________
PRODUCT
Ventavis (iloprost) Inhalation Solution, 10mcg/1 mL, 30 Single-Use Glass Ampules, NDC 10148-102-30, Recall # D-304-2008
CODE
Lot Numbers: 63227A, 63228A, 63230A, 63231A, 63232A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Actelion Pharmaceuticals U.S., Inc., South San Francisco,
CA, by letters on May 17, 2008.
Manufacturer: Berlimed S.A., Madrid, Spain. Firm initiated recall is ongoing.
REASON
Defective Container; The drug product is being recalled because some glass ampules have been found to be empty or only partly filled.
VOLUME OF PRODUCT IN COMMERCE
390,720 ampules
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT
Red Blood Cells, Recall # B-1751-08
CODE
Units: 1420988; 1451889
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated September 26, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1752-08
CODE
Unit: 1455514
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated September 26, 2006. 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
MN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1811-08
CODE
Unit: 72F809602
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on February 15, 2008. Firm initiated recall is complete.
REASON
Blood product, labeled leukoreduced which did not meet the requirements for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1812-08
CODE
Unit: 72E52904X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on February 14, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1813-08;
b) Fresh Frozen Plasma, Recall # B-1814-08
CODE
a) Units: 72F346662, 72F346674, 72F346686, 72F346729, 72F346742, 72F346754,
72F346809, 72F346810, 72F346822, 72F346883, 72F346895;
b) Unit: 72F346834
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on March 19, 2008. Firm initiated recall is complete.
REASON
Blood products, collected in a way that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1816-08
CODE
Unit: V42014
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by fax on February 12, 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
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1820-08
CODE
Unit: 72C075075
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on August 28, 2007. Firm initiated recall is complete.
REASON
Blood component, processed from Whole Blood more than 8 hours after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1821-08
CODE
Units: 72C859632; 72C859632; 72C859632 (split product)
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on May 13, 2008. Firm initiated recall is complete.
REASON
Blood products, with unacceptably high platelet yields, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1823-08
CODE
Units: 72E345330; 72E345471; 72E345286
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on December 20, 2007. Firm initiated recall is complete.
REASON
Blood products, in transit for more than 48 hours and possibly exposed to unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1843-08
CODE
Unit: X17370
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on September 26, 2007. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1889-08
CODE
Unit: 71S957715
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL, by facsimile on September 5, 2006. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Source Plasma, Recall # B-1944-08
CODE
Unit: TQ005791
RECALLING FIRM/MANUFACTURER
IBBI dba Knoxville Plasma, Corp., Knoxville, TN, by fax on April 17, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose scheduled physical exam was overdue, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1945-08
CODE
Unit: 4805214
RECALLING FIRM/MANUFACTURER
Our Lady Of The Lake Hospital, Inc., Baton Rouge, LA, by fax on June 13, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1947-08;
b) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1948-08
CODE
a) Unit: 041FV68594;
b) Unit: 041FV73144
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone and fax on November 27, 2007 and follow-up letter dated November 28, 2007.
Manufacturer: The American National Red Cross, Mobile, AL. 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
AL, GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1951-08
CODE
Unit: 026FZ16922
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone on December 19, 2007 and by follow-up letter dated December 20, 2007.
Manufacturer: The American National Red Cross, Mobile, AL. 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
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1952-08
CODE
Unit: 2442229
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated February 7, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1979-08
CODE
Unit: 026FJ55517
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone, fax and follow-up letter on August 9, 2007.
Manufacturer: The American National Red Cross, Mobile, AL. 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
FL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1887-06
CODE
Unit: 5765145
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on August 4, 2006. 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
LA
___________________________________
PRODUCT
Source Plasma, Recall # B-1888-08
CODE
Unit: KZ013095
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by facsimile on September 18, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1946-08
CODE
Units: 041FV73144; 041FV68594
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone and fax on November 27, 2007 and follow-up letter dated November 28, 2007.
Manufacturer: The American National Red Cross, Mobile, AL. 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-1949-08
CODE
Unit: 2358140
RECALLING FIRM/MANUFACTURER
Medix, Inc., Knoxville, TN, by telephone on December 27, 2007 and follow-up letter on December 31, 2007. Firm initiated recall is complete.
REASON
Blood product, containing a clot, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1950-08
CODE
Unit: 026FZ16922
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by fax on December 19, 2007.
Manufacturer: The American National Red Cross, Mobile, AL. 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
Source Plasma, Recall # B-1953-08
CODE
Unit: KZ036958
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by fax on February 19, 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
Austria
___________________________________
PRODUCT
Source Plasma, Recall # B-1954-08
CODE
Unit: JQ028973
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Jackson, TN, by fax on February 15, 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
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1955-08
CODE
Unit: 4772183
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on April 7, 2008 and follow-up letter dated May 1, 2008. Firm initiated recall is complete.
REASON
Blood product, labeled as an AS-3 product with no red cell preservative solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MO
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1978-08
CODE
Unit: 026FJ55517
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by e-mail on October 10, 2007.
Manufacturer: The American National Red Cross, Mobile, AL. 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

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

___________________________________
PRODUCT
Pacific Consolidated Industries Mobile Oxygen Storage Tank, MOST 20-2B, Part Number: 793080-002, Recall # Z-2201-2008
CODE
Serial numbers: 6947-001 to 6947-546, 6968-001 to 6968-211, 6982-001 to 6982-134, C4340-24, C4340-25, 7224-001 to 7224-011, and 10001 to 10194
RECALLING FIRM/MANUFACTURER
Pacific Consolidated Industries, LLC, Riverside, CA, by letter on September 8, 2007 and July 24, 2008. Firm initiated recall is ongoing.
REASON
The recall was initiated after the firm received two customer complaints of ruptured bourdon tubes that had resulted in bellowed out face gauges.
VOLUME OF PRODUCT IN COMMERCE
1,032 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT
Nautica (GK) Mattress Stretcher. There are no serial numbers on the GK Mattress Stretchers. These mattress stretchers were sold for installation on or as a component of the following patient bath lifts: a) Nautica Bath Lift System, Part number 88004051; b) Nautica Bath Lift System, Part number 88004051.12, Recall # Z-1234-2008
CODE
a) Serial number: NTCA-040;
b) Serial numbers: NTCA-0197, NTCA-0200, NTCA-0201, NTCA-0225, NTCA-0166, NTCA-0198
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL, by letter on January 23, 2007 and January 23, 2008.
Manufacturer: B. H. M. Medical, Inc., Magog, Canada. Firm initiated recall is complete.
REASON
Repeated use of the ratchets that lock the position of the back and leg rest of the stretcher may damage the retention pin that prevents the latch from disengaging from the anchor system. This would allow the backrest to pivot freely down to the floor.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Quickie Rhythm Power Wheelchair with QC (non-expandable) electronics,
    Model number EIPW10, Recall # Z-1531-2008;
b) Quickie Groove Power Wheelchair with QC (non-expandable) electronics,
    Model number EIPW13, Recall # Z-1532-2008
CODE
All wheelchairs with the QC Motor controller units with version 2.0 parameter or *.SUN file software.
RECALLING FIRM/MANUFACTURER
Sunrise Medical, Inc., Fresno, CA, by telephone and letters beginning on January 11, 2008. Firm initiated recall is ongoing.
REASON
Product experiences a longer than expected stopping distance, which may cause injury to the user, objects, or the chair itself.
VOLUME OF PRODUCT IN COMMERCE
205 controller units (affecting 141 wheelchairs)
DISTRIBUTION
Nationwide, Canada and Australia
___________________________________
PRODUCT
a) CareVue Chart Release C ,Versions C.00.00 through C.00.06 Product No. 862246.
    This device is a clinical information system intended for use in data collection, storage,
    and management with independent bedside devices, and other systems that are
    connected either directly or through networks. It is used when there is a need for
    generating patient records and computation of drug dosage, Recall # Z-1540-2008;
b) IntelliVue Clinical Information Portfolio Critical Care Release D, Version D.00.00
    Product Number: 865047. This device is a clinical information system intended for use
  in data collection, storage, and management with independent bedside devices, and
    other systems that are connected either directly or through networks. It is used when
    there is a need for generating patient records and computation of drug dosage,
    Recall # Z-1541-2008
CODE
a) Software Versions: C.00.00 through C.00.06;
b) Software Version D.00.00
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA, by letter dated February 29, 2008. Firm initiated recall is ongoing.
REASON
Medications prescribed for one patient were printed on the record of another patient.
VOLUME OF PRODUCT IN COMMERCE
138 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
24mm Rotating C-Mount Coupler, Model Number 1088-020-121S2. The device is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope, endoscope or arthroscope is indicated for use, Recall # Z-1558-2008
CODE
Lot Numbers: 07L046134, 07L046144, 07L046154, 07L046164, 07L046184, 07L046194, 07L046214, 07L046224, 07L046234, 07L046244, 07L046254, 07L046274, 07L046284, 07L046294, 07L046304, 07L046324, 07L046334, 07L046344, 07L046364, 07L046374, 07L046384, 07L046394, 07L046404, 07L046414, 07L046424, 07L046454, 07L046464, and 07L046474
RECALLING FIRM/MANUFACTURER
Stryker Endoscopy, San Jose, CA, by telephone on March 27, 2008. Firm initiated recall is ongoing.
REASON
The coupler on this device was manufactured without set-screws that are used to hold and center the rear assembly and the endobody. The coupler is part of the camera system and affects the ability to focus.
VOLUME OF PRODUCT IN COMMERCE
28 devices
DISTRIBUTION
IA
___________________________________
PRODUCT
a) GE Healthcare Precision RXi 23A/ 32A Remote X-Ray Imaging R&F System.
    It is a remote analog R&F system consisting of a tilting table with integrated spot
    film device, 65 kW pulsing generator and high heat capacity X-Ray tube. The
    system can be configured to meet a wide variety of exams for various clinical
    applications with ether 23 cm image intensifier with 512x512 Image Chain
    or 32 cm Image intensifier with either 512x512 Image Chain or 1Kx 1K Image
    Chain, Recall # Z-1563-2008;
b) GE Healthcare Precision RXi Digital Remote X-Ray Imaging R&F System. It is a
    remote R&F system consisting of a tilting table with integrated spot film device,
    65 or 89 kW pulsing generator and high heat capacity X-Ray tube. The system can
be configured to meet a wide variety of digital record and fluoroscopy exams for
   various clinical applications with either 32 cm or 40 cm image intensifier,
    Recall # Z-1564-2008;
c) GE Healthcare Precision RXi version e Remote X-Ray Imaging R&F System.
    It is a remote analog R&F system consisting of a tilting table with integrated spot
    film device, and 50KW or 65 kW pulsing generator. The system is configured with
    a 23 cm image intensifier and a 512x512 Image Chain, Recall # Z-1565-2008
CODE
a) Units: 101 103 117 121 128 132 133 135 136 152 156 160 162 164 173 178 182 184
    190 194 196 201 202 209 221 228 232 235 238 240 246 250 251 252 254 259 260
    261 263 264 267 268 273 275 276 281 283 289 295 297 300 302 310 322 330 331
    333 342 343 347 348 351 353 354 365 367;
b) Units: 100 102 104 105 106 107 108 109 110 111 112 113 114 115 116 118 119
    120 122 123 124 125 126 127 129 130 131 134 137 138 139 140 141 142 143 144
    145 146 147 148 149 150 151 153 154 155 157 158 159 161 163 165 166 167 168
    169 170 171 172 174 175 176 177 179 180 181 183 185 186 187 188 189 191 192
    193 195 197 198 199 200 203 204 205 207 208 210 211 212 213 214 215 216 217
    218 219 220 222 223 224 225 226 227 229 230 231 233 234 236 237 239 241 242
    243 244 245 247 248 249 253 255 256 257 258 262 265 266 269 270 271 272 274
    277 278 279 280 282 284 285 286 287 288 290 291 292 293 296 301 303 305 306
    307 308 309 311 312 313 314 315 316 317 318 319 320 321 323 324 325 326 327
    328 329 332 335 336 337 338 339 340 341 344 345 346 349 350 352 355 356 357
    358 359 360 361 368;
c) Units: 10805 10805 10805 10804 10804 10804
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI, by letters dated December 18, 2007 and March 7, 2008.
Manufacturer: General Medical Merate, Seriate, Italy. Firm initiated recall is ongoing.
REASON
GE Healthcare Precision RXi tilt joystick became stuck in the Trendelenburg direction causing the patient to slide off the table. Also recall conducted to investigate the possibility of accidentally activation of the remote console joystick where a fatal accident occurred on a non-GE Remote R&F System.
VOLUME OF PRODUCT IN COMMERCE
265 systems
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
FASTPAK batteries are Nickel-Cadmium (NiCd) battery packs used to provide DC power to LIFEPAK 5, 10, 11, or 12 defibrillator/monitors. The FASTPAK battery has a capacity of 1 amp/hour (1.0AH). The battery can be charged in a Battery Support System, Battery Support System 2, Mobile Battery Service Station, or the LIFEPAK 10, 11 or 12 defibrillator/monitor when the device is powered by an external power adapter. The FASTPAK battery does not have a pushbutton fuel gauge like the LIFEPAK NiCd. The fuel gauge provides a visual indication of battery capacity. Battery part number 9-10424-18, sold with LIFEPAK defibrillators and also sold separately, Recall # Z-1567-2008
CODE
All batteries with lot code 0624
RECALLING FIRM/MANUFACTURER
Recalling Firm: Physio Control, Inc., Redmond, WA, by letter on February 27, 2008.
Manufacturer: Micropower Electronics, Beaverton, OR. Firm initiated recall is ongoing.
REASON
Batteries mislabeled - batteries labeled as 2.4 amp/hour batteries; however they are 1.0 amp/hour batteries.
VOLUME OF PRODUCT IN COMMERCE
811 batteries
DISTRIBUTION
Nationwide, Canada, Netherlands, Asia Pacific and Latin America
___________________________________
PRODUCT
TomoTherapy Hi-Art System with software versions 3.0 and 3.1 - Radiation Therapy System. The device is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy, Recall # Z-1615-2008
CODE
10002 10003 10007 10016 10019 10021 10028 10037 10044 10048 10050 10051 10056 10094 10165 10166 10168 10169 10174 10185 10186 10187 10188 10189 10190 10191 10192 10193 10194 10195 10196 10198
RECALLING FIRM/MANUFACTURER
Tomo Therapy Inc., Madison, WI, by letter dated February 22, 2008. Firm initiated recall is ongoing.
REASON
In certain cases of HI-ART Systems operating with 3.0 or 3.1 SW, the registration adjustment field numbers may appear as nonsense characters or values on printed pages of the Register Tab. These values may appear differently than those shown on the Operator Station (OS) display. For example, the number "8" may appear as the number "0" on the printed page. During the registration process, the HI-ART couch will achieve the accepted and approved registered position automatically. However, if the operator subsequently adjusts the couch position manually based on a printout with the anomaly, the patient may be in the incorrect position during treatment.
VOLUME OF PRODUCT IN COMMERCE
32 systems
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Logix TPN Software Solution, catalog 2M8410, consists of the Logix Order Entry (OE) Installation CD, version 1.0.28 and Logix Compounder Manager (CM) Installation CD, version 3.1.8. The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration, Recall # Z-1640-2008
CODE
Software version 1.0.2 (comprised of Logix OE version 1.0.28 and Logix CM version 3.1.8)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare, Corp., Round Lake, IL, by letter on March 28, 2008.
Manufacturer: Baxter Healthcare Corp., Buffalo Grove, IL. Firm initiated recall is complete.
REASON
Software anomaly results in inaccurate information being printed out on the Delivery Report, even though the compounder performed the compounding correctly.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
AZ, MN, WI, PR and Canada
___________________________________
PRODUCT
CADD-MS"3 Ambulatory Infusion Pumps, Model 7400, Rx only, CE 0473, SN 499000. The device is designed for subcutaneous, intravenous, epidural and intrathecal infusion of medication. Reorder Numbers 21-7401-51/49/00 & 21-7411-51, Recall # Z-1641-2008
CODE
Original Serial Numbers: 440018 440019 440020 440021 440022 440023 440024 440025 440026 440027 440028 440029 440030 440031 440032 440033 440034 440035 440036 440037 440038 440039 440040 440041 440042 440043 440044 440045 440046 440047 440048 440049 440050 440051 440052 440053 440054 440055 440056 440057 440058 440059 440060 440061 440062 440063 440064 440065 440066 440067 440068 440069 440070 440071 440072 440073 440074 440075 440076 440077 440078 440079 440080 440081 440082 440083 440084 440085 440086 440087 440088 440089 440090 440091 440092 440093 440094 440095 440096 440097 440098 440099 440100 440101 440102 440103 440104 440105 440106 440107 440108 440109 440110 440111 440112 440113 440114 440115 440116 440117 440118 440119 440120 440121 440122 440123 440124 440125 440126 440127 440128 440129 440130 440131 440132 440133 440134 440135 440136 440137 440138 440139 440140 440141 440142 440143 440144 440145 440146 440147 440148 440149 440150 440151 440152 440153 440154 440155 440156 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RECALLING FIRM/MANUFACTURER
Smiths Medical MD, Inc., Saint Paul, MN, by letter dated February 22, 2008. Firm initiated recall is ongoing.
REASON
Smiths Medical has received reports that the device powers down without an alarm. Investigation concluded that if the battery cap is not fully tightened, the pump may power down and a brief "chirp" will sound. This may occur if the user has not sufficiently tightened the battery cap or if the battery cap is damaged. If a patient is asleep or does not regularly check their blood glucose, as trained, there is a potential risk of harm to the patient if the Pump's powering down goes unnoticed. When the Pump is powered down, delivery of insulin is interrupted.
VOLUME OF PRODUCT IN COMMERCE
2,303 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Syn go Imaging XS is a picture archiving and communication system intended to display, process, read, report, communicate, distribute, store and archive digital radiological images, including digital mammography images. Model number 7502029, Recall # Z-1643-2008
CODE
Serial numbers: 9288, 9632, 9633, 9640, 9792, 10412, 10625, 11106, 11942, 12029, 12030, 12031, 12032, 12068, 12211, 12216, 12217, 12222, 12229, 12235, 12276, 12283, 12288, 12543, 12577, 12600, 12610, 12660, 12661, 12062, 12063, 12643, 12739, 12773, 12782, 12783, 12789, 13026, 13027, 13090, 13131, 13147, 13155, 13208, 13241, 13280, 13295, 13296, 13297, 13298, 13299, 13300, 13301, 13302, 13303, 13304, 13305, 13306, 13307, 13308, 13310, 13358, 13370, 13371, 13372, 13400, 13401, 13402, 13403, 13404, 13405, 13406, 13407, 13408, 13409, 13410, 13411, 13412, 13413, 13414, 13415, 13416, 13417, 13418, 13419, 13420, 13421, 13427, 13428, 13429, 13432, 13433, 13434, 13435, 13436, 13437, 13438, 13439, 13440, 13441, 13442, 13443, 13444, 13445, 13446, 13447, 13448, 13449, 13450, 13451, 13452, 13453, 13454, 13455, 13456, 13457, 13458, 13459, 13460, 13461, 13462, 13480, 13490, 13491, 13492, 13493, 13494, 13495, 13496, 13501, 13504, 13505, 13510, 13519, 13520, 13574, 13575, 13576, 13591, 13635, 13636, 13637, 13669, 13670, 13671, 13672, 13673, 13674, 13675, 13676, 13679, 13680, 13681, 13682, 13683, 13684, 13685, 13686, 13687, 13688, 13689, 13690, 13691, 13692, 13693, 13694, 13695, 13696, 13697, 13724, 13725, 13732, 13733, 13734, 13735, 13740, 13745, 13749, 13751, 13785, 13791, 13792, 13794, 13811, 13820, 13821, 13822, 13823, 13824, 13825, 13826, 13846, 13847, 13848, 13849, 13850, 13851, 13889, 13890, 13906, 13907, 13908, 13909, 13912, 13913, 13921, 13922, 13933, 13934, 13945, 13959, 13960, 13961, 13968, 13971, 13979, 13980, 13991, 13992, 13996, 13997, 13998, 13999, 14000, 14004, 14005, 14016, 14017, 14043, 14050, 14051, 14052, 14053, 14054, 14059, and 14066
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on March 6, 2008.
Manufacturer: Siemens Medical Solutions Inc., Erlangen, Germany. Firm initiated recall is ongoing.
REASON
The selected patient images on the device may display an additional image from another patient or study.
VOLUME OF PRODUCT IN COMMERCE
236 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Seprafilm Adhesion Barrier (chemically modified sodium
    hyaluronate/carboxymethylcellulose absorbable adhesion barrier);
    Product Number: 4301-02, Recall # Z-1647-2008;
b) Seprafilm Adhesion Barrier (chemically modified sodium
    hyaluronate/carboxymethylcellulose absorbable adhesion barrier).
    Japan Distribution Only. Product Number: 4301-05, Recall # Z-1648-2008
CODE
a) Lot Numbers: 07NP135 Exp Date: April 2010; 07NP177 Exp Date: May 2010;
    07NP199 Exp Date: June 2010; 07NP216 Exp. Date: July 2010;
    07NP311 Exp. Date: May 2010;
b) Lot number: 07NP181 Exp June 2010
RECALLING FIRM/MANUFACTURER
Genzyme Corp., Framingham, MA, by letter dated April 10, 2008. Firm initiated recall is ongoing.
REASON
Sterility may be compromised.
VOLUME OF PRODUCT IN COMMERCE
3,149 (10 packs)
DISTRIBUTION
Nationwide, Korea, Taiwan and Japan
___________________________________
PRODUCT
BCI Non Invasive Blood Pressure Monitor Product/Catalog number 6004, Recall # Z-1649-2008
CODE
AJ07080009 AJ07080010 AJ07080041 AJ07080042 AJ07110027 AJ07110030 AJ07110031 AJ07080040 AJ07080043 AJ07110000 AJ07110001 AJ07110002 AJ07110003 AJ07110004 AJ07110026 AJ07080039 AJ07080004 AJ07080032 AJ07080033 AJ07080034 AJ07080044 AJ07080045 AJ07080056 AJ07080057 AJ07080058 AJ07110010 AJ07110047 AJ07110048 AJ07110049 AJ07080002 AJ07110009 AJ07110011 AJ07080003 AJ07080005 AJ07080011 AJ07080012 AJ07080013 AJ07080014 AJ07080015 AJ07080016 AJ07080017 AJ07080018 AJ07080019 AJ07080020 AJ07080021 AJ07080022 AJ07080023 AJ07080024 AJ07080025 AJ07080026 AJ07080027 AJ07080028 AJ07080029 AJ07080030 AJ07080031 AJ07080046 AJ07080047 AJ07080035 AJ07080059 AJ07100060 AJ07100073 AJ07110046 AJ07110012 AJ08010000 AJ08010001 AJ07110042 AJ07110043 AJ07110044 AJ07110045 AJ07080048 AJ07110018 AJ07110019 AJ07110020 AJ07110021 AJ07110040 AJ07100002 AJ07100004 AJ07100006 AJ07100009 AJ07100010 AJ07100011 AJ07100012 AJ07100013 AJ07100014 AJ07100015 AJ07100016 AJ07100017 AJ07100018 AJ07100020 AJ07100024 AJ07100025 AJ07100026 AJ07100028 AJ07100029 AJ07100030 AJ07100031 AJ07100034 AJ07100035 AJ07100036 AJ07100038 AJ07100039 AJ07100051 AJ07100058 AJ07100064 AJ07100065 AJ07100000 AJ07100001 AJ07100005 AJ07100007 AJ07100008 AJ07100019 AJ07100021 AJ07100022 AJ07100023 AJ07100027 AJ07100033 AJ07100037 AJ07100045 AJ07100046 AJ07100047 AJ07100048 AJ07100049 AJ07100050 AJ07100052 AJ07100053 AJ07100054 AJ07100055 AJ07100056 AJ07100057 AJ07100059 AJ07100061 AJ07100062 AJ07100063 AJ07100066 AJ07100067 AJ07100068 AJ07100071 AJ07100072 AJ07100003 AJ07100032 AJ07110014 AJ07110015 AJ07110038 AJ07080036 AJ07080053 AJ07080054 AJ07080055 AJ07100070 AJ07080006 AJ07080007 AJ08010004 AJ07110016 AJ07110017 AJ07110013 AJ07110039 AJ07110041 AJ07110022 AJ07110023 AJ07080051 AJ07100040 AJ07100041 AJ07100042 AJ07110024 AJ07110005 AJ07110006 AJ07110007 AJ07110008 AJ07080052 AJ07100069 AJ07100074 AJ07080008 AJ07100043 AJ07100044 AJ07110032 AJ07110033 AJ07110034 AJ07110035 AJ07110036 AJ07110037
RECALLING FIRM/MANUFACTURER
Smiths Medical PM, Inc., Waukesha, WI, by Safety Action Bulletin, dated April 1, 2008. Firm initiated recall is ongoing.
REASON
Do to a component that may be installed backwards, the device may turn off or may immediately reset.
VOLUME OF PRODUCT IN COMMERCE
195 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Ambulift, standard basic model manually powered patient lift. The Ambulift is used
    to move and lift patients from their beds, transport them to the bathroom, and lift
    them in and out of the bath. Model AB1102 - Standard basic model Ambulift with
    chair and leg rest. Model AB1552 - Standard basic model Ambulift with chair and
    leg rest and scales, Recall # Z-1650-2008;
b) Ambulift Classic, battery powered patient lift. The Ambulift is used to move and
    lift patients from their beds, transport them to the bathroom, and lift them in and
    out of the bath. Model KDB1890-04US - Ambulift Classic with chair and leg rest.
    Model KDB1895-04US - Ambulift Classic with chair, leg rest and scale, Recall #
    Z-1651-2008
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL, by letters dated May 2, 2008.
Manufacturer: Arjo Med. AB, Gloucester, UK. Firm initiated recall is ongoing.
REASON
The armrests of the lift chair may push up, allowing the patient to slip down and out of the seat. The resultant fall could result in serious or fatal patient injuries.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Smash Balloon Dilatation Catheter- is intended for use in percutaneous dilation of the iliac, femoral, popliteal, tibial, renal, tibioperoneal vessels in whose lumens are obstructed by atherosclerotic plaque, Recall # Z-1652-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Natick, MA, by letter dated April 8, 2008.
Manufacturer: Boston Scientific Ireland, Ltd., Galway, Ireland. Firm initiated recall is ongoing.
REASON
Since July 2007, Boston Scientific has tracked an increasing trend in complaints regarding cracks and damage to the balloon inflation hub. The potential clinical effects related to these types of cracks and damage could include no inflation, difficulty inflating, slow deflation, partial deflation or, in a worst case scenario, no deflation of the balloon.
VOLUME OF PRODUCT IN COMMERCE
17,891 units
DISTRIBUTION
Internationally
___________________________________
PRODUCT
a) Dental Cement-Bisco BISCEM® Dual-Cured Self-Adhesive Resin Cement,
    Translucent; The product is intended to serve as a temporary tooth filling or
    as a base cement to affix a temporary tooth filling, to affix dental devices such
    as crowns or bridges, or to be applied to a tooth to protect the pulp, Item
    numbers D-45011P, D-45001S and G-91700K, Recall # Z-1696-2008;
b) Dental Cement-Bisco BISCEM® Dual-Cured Self-Adhesive Resin Cement,
    Translucent; The product is intended to serve as a temporary tooth filling or
    as a base cement to affix a temporary tooth filling, to affix dental devices
    such as crowns or bridges, or to be applied to a tooth to protect the pulp;
    Item numbers D-45012P and D-45002S, Recall # Z-1697-2008;
CODE
All lots
RECALLING FIRM/MANUFACTURER
Bisco, Inc., Schaumburg, IL, by letters dated April 25, 2008. Firm initiated recall is ongoing.
REASON
During product stability testing, Bisco determined that after 15 months of storage, BISCEM® Self-Adhesive Luting Cement used in self-cure mode only without light-curing may take longer than specified to set, resulting in reduced bond strength. Bisco also determined that product component(s) may thicken slightly over time.
VOLUME OF PRODUCT IN COMMERCE
69,847 syringes
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Opthalmic microsurgical system-AMO WHITESTAR SIGNATURE Phacoemulsification System, Product Number NGP680300. The device is a modular ophthalmic microsurgical system that facilitates both anterior segment (i.e., cataract) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. Product Number: NGP680300, Recall # Z-1702-2008
CODE
Lot Numbers: 200750010, 200750016, 200750017, 200750018, 200750019, 200750020, 200750021, 200750024, 200750025, 200750027, 200750028, 200750031, 200750037, 200750042, 200750045, 200750046, 200750051, 200750052, 200750055, 200750056, 200750058, 200750065, 200750067, 200750068, 200750074, 200750079, 200750080, 200750090, 200750094, 200750100, 200750102, 200750110, 200750113, 200750136, 200750137, 200750138, 200750139, 200750140, 200750154, 200750158, 200750159, 200750160, 200750161, 200750162, 200750164, 200750166, 200750167, 200750194, 200750196, 200750199, 200750205, 200750206, 200750209, 200750215, 200750216, 200750222, 200750224, 200750226, 200750229, 200750235, 200850064, 200850066, 200850069, 200850089, 200850092, 200850108, 200850109, 200850111, 200850112, 200750038, 200750040, 200750043, 200750049, 200750064, 200750066, 200750070, 200750085, 200750087, 200750088, 200750089, 200750091, 200750096, 200750097, 200750105, 200750106, 200750107, 200750112, 200750114, 200750115, 200750117, 200750118, 200750119, 200750122, 200750123, 200750126, 200750127, 200750142, 200750143, 200750144, 200750145, 200750146, 200750148, 200750150, 200750151, 200750152, 200750153, 200750155, 200750163, 200750168, 200750169, 200750170, 200750171, 200750173, 200750175, 200750176, 200750177, 200750178, 200750179, 200750184, 200750185, 200750187, 200750189, 200750190, 200750191, 200750192, 200750195, 200750232, 200750238, 200750239, 200750240, 200750242, 200750243, 200750244, 200850001, 200850002, 200850003, 200850015, 200850017, 200850018, 200850020, 200850021, 200850022, 200850026, 200850027, 200850028, 200850037, 200850040, 200850041, 200850043, 200850044, 200850045, 200850046, 200850047, 200850049, 200850050, 200850051, 200850052, 200850053, 200850055, 200850056, 200850057, 200850058, 200850059, 200850073, 200850074, 200850075, 200850076, 200850078, 200850079, 200850080, 200850081, 200850082, 200850083, 200850084, 200850085, 200850086, 200850098, 200850099, 200850100, 200850102, 200850103, 200850106, 200850114, 200850122, 200750047, 200750073, 200750095, 200750099, 200750156, 200850007, 200850060
RECALLING FIRM/MANUFACTURER
Recalling Firm: Advanced Medical Optics, Inc., Santa Ana, CA, by an Urgent Safety Notice, beginning on April 2, 2008.
Manufacturer: Visx, Incorporated, A Subsidiary of Amo, Inc, Santa Clara, CA. Firm initiated recall is ongoing.
REASON
AMO initiated this field correction event after becoming aware of a trend in complaints associated with AMO Vitrectomy Cutter used in conjunction with the Amo Whitestar Signature Phacoemulsification System. The physician may be unable to make a cut during cataract surgery.
VOLUME OF PRODUCT IN COMMERCE
191 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular
    Mapping Catheter- The catheter is indicated for multiple electrode
    electrophysiological mapping of the cardiac structures of the heart, i.e.,
    recording and stimulation only. The device is designed to obtain electro
    grams in the Atrial regions of the heart, Recall # Z-1703-2008;
b) Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular
    Mapping Catheter- The catheter is indicated for multiple electrode
    electrophysiological mapping of the cardiac structures of the heart, i.e.,
    recording and stimulation only. The device is designed to obtain electrograms
    in the Atrial regions of the heart. 20 Poles, US Catalog Number D7L202515RT,
    EU Catalog Number 35T2515R, Recall # Recall # Z-1704-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioSense Webster Inc., Diamond Bar, CA, by letter dated March 25, 2008.
Manufacturer: BioSense Webster, Inc., Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON
This recall was initiated after the firm received several complaints reporting issues with deflection. The catheter may become caught in the mitral valve, requiring surgical procedures, valve may be torn while trying to dislodge, unable to retract the catheter through the sheath and require surgical intervention to remove, pulling on catheter to remove may lead to large atrial septal tear, and separation of the distal end of the catheter may occur. Also,the firm determined that when the catheter is fully deflected and the variable loop is fully contracted, it is possible that the catheter mechanism can become "locked" in position and cannot return to the un-contracted, un-deflected state. This could lead to damage to the device or limit the ability to withdraw the catheter safely.
VOLUME OF PRODUCT IN COMMERCE
14,295 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable oxygen unit, Recall # Z-1716-2008
CODE
Liberator Base units - CBB300634XXXX - CBB300738XXXX. Includes units produced from week 34-2006 through week 38-2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Caire, Inc., Marietta, GA, by a Technical Service Bulletin on/about October 23, 2007.
Manufacturer: Caire, Inc., Ball Ground, GA. Firm initiated recall is ongoing.
REASON
Moisture ingress into the electronic liquid level indicator may cause inaccurate liquid oxygen level readings. The oxygen could run out without the patient knowledge.
VOLUME OF PRODUCT IN COMMERCE
3,470 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Hall Easy-Fit® Prosthetic Heart Valve - Aortic A7700. The device uses a single
    pyrolytic carbon disc occluder pivoting within a titanium housing. The housing is
    machined into final configuration from a single piece of solid titanium and has no
    welds or introduced bends. It is an open-member design in which all members
  project centrally without distal attachment. A rotatable fabric sewing ring is
    affixed to the valve. The valve is provided on a holder (collect) to facilitate
    insertion and to provide protection during shipping and handling. The valve is
    sterile and non-pyrogenic if seal and package are not opened, damaged, or
    broken, Recall # Z-1774-2008;
b) Hall Easy-Fit® Prosthetic Heart Valve - Mitral M7700. The device uses a single
    pyrolytic carbon disc occluder pivoting within a titanium housing. The housing is
    machined into final configuration from a single piece of solid titanium and has no
    welds or introduced bends. It is an open-membered design in which all members
    project centrally without distal attachment. A rotatable fabric sewing ring is affixed
    to the valve. The valve is provided on a holder (collect) to facilitate insertion and to
    provide protection during shipping and handling. The valve is sterile and non-
    pyrogenic if seal and package are not opened, damaged, or broken, Recall # Z-1775-
    2008;
CODE

USA 19A554013J 19A554110J 19A554192J 19A554193J 19A554196J 19A554287J 19A554292J 19A554298J 21A553685J 21A553921J 21A553982J 21A553985J 21A554133J 21A554959J 21A555003J 21A555206J 21A555473J 21A555711J 21A555821J 21A555906J 21A555914J 23A553480J 23A553533J 23A553611J 23A553837J 23A553987J 23A554034J 23A554663J 23A555403J 23A555772J 23A556211J 23A556271J 25A554669J 25A555417J 25A556058J 25A556107J 27A549092J 27A549340J 27A553554J 27A554155J 27A554159J 27A554224J 27A554225J 27A554232J 27A554236J 27A554436J 27A554507J 27A555286J 27A555289J 27A556046J 27A559810J 27A559811J 27A559812J 27A559918J 29A549102J 29A549192J 29A549193J 29A549242J 29A551836J 29A551988J 29A554151J 29A554156J 29A554158J 29A554226J 29A554231J 29A554435J 29A554438J 29A554439J, and 29A554440J EUROPE 19A554058J 19A554109J 19A554126J 19A554201J 19A554289J 19A554290J 19A554604J 19A554654J 19A554749J 19A554754J 19A560318J 19A560981J 19A560992J 19A561161J 19A561162J 19A561172J 19A561230J 19A561233J 19A561237J 19A561246J 21A553907J 21A554016J 21A555382J 21A555395J 21A555637J 21A555719J 21A555723J 23A553121J 23A553122J 23A553200J 23A553412J 23A553478J 23A553531J 23A553539J 23A553605J 23A553616J 23A553838J 23A554137J 23A554331J 23A554493J 23A554658J 23A554709J 23A554716J 23A554720J 23A554843J 23A554965J 23A554968J 23A555025J 23A555251J 23A555263J 23A555516J 23A555519J 23A555523J 23A555524J 23A555527J 23A555531J 23A555532J 23A555613J 23A555622J 23A555623J 23A555675J 23A555681J 23A555735J 23A555773J 23A555775J 23A555915J 23A555917J 23A555922J 23A555924J 23A555926J 23A555927J 23A555928J 23A555929J 23A556008J 23A556011J 25A554042J 25A554044J 25A554047J 25A554139J 25A554144J 25A554217J 25A554220J 25A554221J 25A554425J 25A554426J 25A554428J 25A554429J 25A554431J 25A554432J 25A554503J 25A554554J 25A554556J 25A554557J 25A554558J 25A554561J 25A554562J 25A556030J 25A556035J 25A556038J 25A556101J 25A556116J 27A549104J 27A549189J 27A549194J 27A549245J 27A549339J 27A549341J 27A551835J 27A551989J 27A553552J 27A553553J 27A554157J 27A554223J 27A554230J 27A554237J 27A554976J 27A555291J, and CANADA 21A554071J 23A555518J 25A554143J 27A551991J, and 27A555283J OTHER 19A553455J 19A553748J 19A553881J 19A553901J 19A553998J 19A554000J 19A554001J 19A554010J 19A554059J 19A554063J 19A554064J 19A554108J 19A554113J 19A554122J 19A554194J 19A554202J 21A553173J 21A553181J 21A553405J 21A553466J 21A553525J 21A553598J 21A553687J 21A553790J 21A553825J 21A553828J 21A553832J 21A553905J 21A553910J 21A553913J 21A553920J 21A553977J 21A553981J 21A553983J 21A553984J 21A554089J 21A554131J 21A554308J 21A554309J 21A554311J 21A554312J 21A554313J 21A554314J 21A554320J 21A554607J 21A554702J 21A554703J 21A554706J 21A554758J 21A554793J 21A554794J 21A554797J 21A554800J 21A554837J 21A554839J 21A554840J 21A554841J 21A554887J 21A554889J 21A554893J 21A554895J 21A554896J 21A554899J 21A554954J 21A554962J 21A555002J 21A555004J 21A555005J 21A555006J 21A555007J 21A555014J 21A555203J 21A555205J 21A555375J 21A555378J 21A555385J 21A555386J 21A555388J 21A555397J 21A555477J 21A555478J 21A555483J 21A555494J 21A555496J 21A555499J 21A555500J 21A555504J 21A555507J 21A555580J 21A555581J 21A555583J 21A555584J 21A555626J 21A555627J 21A555630J 21A555633J 21A555634J 21A555673J 21A555674J 21A555706J 21A555708J 21A555709J 21A555716J 21A555717J 21A555726J 21A555806J 21A555909J 21A555913J 21A555992J 21A555993J 21A555994J 21A555995J 21A555997J 21A556053J 21A556085J 21A556151J 23A553484J 23A554024J 23A554027J 23A554028J 23A554031J 23A554136J 23A554206J 23A554208J 23A554213J 23A554329J 23A554334J 23A554339J 23A554340J 23A554344J 23A554383J 23A554384J 23A554386J 23A554488J 23A554489J 23A554612J 23A554657J 23A554661J 23A554664J 23A554711J 23A554717J 23A555027J 23A555529J 23A555680J 23A555732J 23A555738J 23A555916J 23A555918J 23A555923J 23A555925J 23A556005J 23A556006J 23A556009J 23A556013J 23A556015J 23A556019J 23A556021J 23A556023J 23A556024J 23A556096J 23A556206J 23A556208J 23A556210J 25A554563J 25A554666J 25A555279J 25A555280J 25A555282J 25A555419J 25A555428J 25A555826J 25A555939J 25A555940J 25A556039J 25A556112J 27A549240J 27A554506J 27A554977J, and 29A554434J
USA 23M546512J 23M547083J 23M547084J 23M547626J 23M547629J 23M547631J 23M547896J 23M547905J 25M553329J 25M553855J 25M554621J 27M555072J 27M555079J 27M555083J 27M555646J 27M555654J 27M555789J 27M555842J 29M554274J 29M560938J 29M561157J 29M561320J 29M561328J 29M561456J 31M552397J 31M553444J 31M553650J 31M553713J 31M553762J, and 31M555548J EUROPE 23M546513J 23M547076J 23M547088J 23M547195J 25M553559J 25M553640J 25M553854J 25M553931J 25M553946J 25M554246J 25M554629J 25M554858J 25M554910J 25M555060J 25M553850J 27M553375J 27M553383J 27M553562J 27M553570J 27M553572J 27M554161J 27M554172J 27M554173J 27M554176J 27M554181J 27M554182J 27M554185J 27M554187J 27M554189J 27M554260J 27M554262J 27M554263J 27M554264J 27M554265J 27M554267J 27M554269J 27M554271J 27M554351J 27M554354J 27M554358J 27M554450J 27M554454J 27M554458J 27M554511J 27M554518J 27M554642J 27M554643J 27M554645J 27M554646J 27M554810J 27M554863J 27M554870J 27M554923J 27M554992J 27M554993J 27M555069J 27M555315J 27M555330J 27M555333J 27M555341J 27M555342J 27M555347J 27M555350J 27M555353J 27M555439J 27M555440J 27M555441J 27M555442J 27M555443J 27M555444J 27M555538J 27M555540J 27M555541J 27M555543J 27M555545J 27M555546J 27M555641J 27M555642J 27M555644J 27M555647J 27M555652J 27M555691J 27M555743J 27M555744J 27M555745J 27M555746J 27M555754J 27M555755J 27M555763J 27M555787J 27M555791J 27M555852J 27M555858J 27M559405J 27M559440J 27M559448J 29M550088J 29M550209J 29M551061J 29M552565J 29M552612J 29M552648J 29M552649J 29M552717J 29M552722J 29M552922J 29M552927J 29M552937J 29M553239J 29M553240J 29M553289J 29M553295J 29M553353J 29M553355J 29M553442J 29M553763J 29M553857J 29M553858J 29M554079J 29M554080J 29M554369J 29M554400J 29M554578J 29M554679J 29M554680J 29M554683J 29M554684J 29M554734J 29M554736J 29M554737J 29M554744J 29M554783J 29M554871J 29M554872J 29M554874J 29M554875J 29M554877J 29M554879J 29M554929J 29M554930J 29M554931J 29M554932J 29M554933J 29M554935J 29M554936J 29M554937J 29M554939J 29M554940J 29M554941J 29M555095J 29M555099J 29M555101J 29M555107J 29M555110J 29M555153J 29M555154J 29M555158J 29M555556J 29M555560J 29M555561J 29M555656J 29M555657J 29M555665J 29M555984J 29M553354J 31M550204J 31M550207J 31M551255J 31M551256J 31M552714J 31M553351J 31M553443J 31M553446J 31M553576J 31M553657J 31M553711J 31M554466J 31M554471J 31M554577J 31M554876J 31M554880J 31M554934J 31M555371J 31M555372J 31M555549J 31M555980J, and 31M556181J CANADA 27M555436J 31M553577J, and 31M555160J OTHER 25M553700J 25M553796J 25M553798J 25M553799J 25M553841J 25M553933J 25M553943J 25M553948J 25M554348J 25M554565J 25M554619J 25M554626J 25M554633J 25M554721J 25M554729J 25M554731J 25M554733J 25M554775J 25M554803J 25M554804J 25M554805J 25M554806J 25M554856J 27M553374J 27M554676J 27M554922J 27M554926J 27M554989J 27M555001J 27M555084J 27M555313J 27M555314J 27M555316J 27M555317J 27M555331J 27M555332J 27M555337J 27M555338J 27M555339J 27M555340J 27M555343J 27M555345J 27M555348J 27M555349J 27M555430J 27M555433J 27M555437J 27M555542J 27M555643J 27M555645J 27M555649J 27M555687J 27M555689J 27M555690J 27M555741J 27M555748J 27M555749J 27M555751J 27M555752J 27M555759J 27M555786J 27M555790J 27M555843J 27M555846J 27M555851J 27M555854J 27M555945J 27M559304J 29M553712J 29M554078J 29M554085J 29M554086J 29M554087J 29M554784J 29M554928J 29M555098J 29M555108J 29M555159J 31M553761J 31M554280J 31M554465J 31M554468J 31M554685J 31M554735J 31M555370J 31M555373J 31M555547J 21A555222J 23A555240J 23A555676J 25A554043J 27M555544J 29A554153J 31M549988J, and 31M550134J

RECALLING FIRM/MANUFACTURER
Medtronic Heart Valve Division, Spring Lake Park, MN, by letter dated March 24, 2008. Firm initiated recall is ongoing.
REASON
The holder of the valve was incorrectly secured to the valve. This could potentially make it difficult to easily disengage the holder from the valve.
VOLUME OF PRODUCT IN COMMERCE
685 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Q-Logic Controller Software used on the following power wheelchairs: Q6000, Q6000XL, Q6000Z, R4000, Q600, Q600XL, Q610, Q1107, Q600E, and Dynamo 1107, Recall # Z-1776-2008
CODE
Serial Numbers: J9602208233020, J5736007315020, J7526107036020, J9629207170020, J7501008030020, J5702908797060, J7529607010020, J9630907149020, J5704608254020, J9603908056020, J9603908056020, J5718007250020, J5723307144020, J5723207301020, J5723407136020, J7227507026020, J5728807092020, J7528907141020, J9629507111020, J7529907223020, J5730907096020, J9632007004020, J9635307146020, J5700308104020, J5726906070020, J5728606106020, J5711407229020, J5711607346020, J5717307078020, J5714307169020, J7219107157020, J5721507327020, J5716207521020, J5716507018020, J5732407100020, J5724107138020, J5725407048020, J5726707458020, J7529907221020, J5732307247020, J5705907063020, J5734507146020, J5735307331020, J5700808254020, J9600908175020, J9602508181020, J9402508170020, J5702508198020, J5702808845020, J5702908207020, J5704608142020, J9601808155020, J7225407065020, J5704208091020, J9622207232020, J9628207076020, J9621407082020, J9626407088020, J9600708204020, J5702508551020, J5710207395020, 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RECALLING FIRM/MANUFACTURER
Pride Mobility Products, Corp., Exeter, PA, by letter on April 11, 2008. Firm initiated recall is ongoing.
REASON
Software - Watch dog timer feature was disabled.
VOLUME OF PRODUCT IN COMMERCE
4,129 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Hill-Rom Century+ Bed Model P1400 HBSW siderail upgrade kits; accessory model numbers: P9964-11, P9964-12, P9964-13, P9964-14, P9964-15, P9964-16, P9964-41 and /or P9964-42, Recall # Z-1777-2008
CODE
All MOD 376 HBSW Siderail Upgraded accessory kits shipped between 9/19/06 and 3/18/07.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letter on April 28, 2008. Firm initiated recall is complete.
REASON
A risk of entrapment will exist between the head and foot rails if installation instructions are followed.
VOLUME OF PRODUCT IN COMMERCE
69 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Xcelerate Patella System Reamer Shaft Assembly; Non-Sterile; Product no. 8001-1702, Recall # Z-1778-2008
CODE
Lots: MCYL30A, MCYL30B
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letter on April 19, 2005. Firm initiated recall is complete.
REASON
The Xcelerate Patella Reamer Shaft Assembly and the Reamer Adapter do not mate properly. This could result in the removal of excessive bone from the patella leading to a thinner patella; a patella that does not have enough bone for adequate engagement with pegs or patella fracture.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
Nationwide, Canada, and UK
___________________________________
PRODUCT
Corometrics® Model 250 Series Maternal/ Fetal Monitor, Models 256 and 259, part number 2024489-002. Intended for monitoring fetal and maternal vital signs: fetal heart rate; optional fetal movement detection, FHR and UA alarms; maternal uterine activity; heart/pulse rate, blood pressure and %SP02, Recall # Z-2154-2008
CODE
Serial Numbers: SBE07014189PA SBE07014184PA SBE07014167PA SBE06524133PA SBE07014196PA SBE07024243PA SBE07034259PA SBE07024238PA SBE07034256PA SBE07024218PA SBE07034268PA SBE07024212PA SBE07054323PA SBE07064333PA SBE07064354PA SBE07034248PA SBE07024229PA SBE07024211PA SBE07024239PA SBE07024237PA SBE07024203PA SBE07064387PA SBE07064335PA SBE07064395PA SBE07014187PA SBE07024225PA SBE07024227PA SBE07014181PA SBE07024204PA SBE07024206PA SBE07034313PA SBE07044317PA SBE07034261PA SBE07024231PA SBE07034276PA SBE07064357PA SBE07024219PA SBE07014194PA SBE07044315PA SBE07024201PA SBE07024215PA SBE07034302PA SBE07034252PA SBE07014179PA SBE07034247PA SBE07034246PA SBE07014152PA SBE07024244PA SBE07014191PA SBE07034298PA SBE07034299PA SBE07024241PA SBE07044322PA SBE07024216PA SBE07044318PA SBE07024213PA SBE07044316PA SBE07034260PA SBE07064375PA SBE07064398PA SBE07064368PA SBE07064377PA SBE07064373PA SBE07064341PA SBE07064384PA SBE07034255PA SBE07064347PA SBE07014185PA SBE07024208PA SBE07024214PA SBE07024205PA SBE07024207PA SBE07064389PA SBE07064330PA SBE07064352PA SBE07034250PA SBE07034257PA SBE07034254PA SBE07044321PA SBE07024242PA SBE07024235PA SBE07034270PA SBE07034264PA SBE07024220PA SBE07024236PA SBE06514069PA SBE06514079PA SBE06514078PA SBE06514081PA SBE06514092PA SBE06514084PA SBE06514090PA SBE07014199PA SBE07064385PA SBE07064390PA SBE07064393PA SBE07064331PA SBE07014200PA SBE07064369PA SBE07024232PA SBE07034296PA SBE07064340PA SBE07034307PA SBE07034309PA SBE07064353PA SBE07034301PA SBE07034310PA SBE07034300PA SBE07034306PA SBE07034308PA SBE07044319PA SBE07034312PA SBE07034304PA SBE07014166PA SBE07034272PA SBE07034281PA SBE07034290PA SBE07034291PA SBE07054324PA SBE07064329PA SBE07034280PA SBE07064334PA SBE07064336PA SBE07024240PA SBE07034251PA SBE07034267PA SBE07034293PA SBE07034279PA SBE07034274PA SBE07034258PA SBE07064345PA SBE07034286PA SBE07034295PA
RECALLING FIRM/MANUFACTURER
Datex Ohmeda, Inc., dba GE Healthcare, Laurel, MD, by letter dated July 1, 2008. Firm initiated recall is ongoing.
REASON
Communication connector within monitor is defective and may cause potential loss of telemetry.
VOLUME OF PRODUCT IN COMMERCE
133 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labeled in part, "Polarus Humeral Fixation System& SIZE: 3.5mm X 32.5mm Cortical Screw... REF HCO3325-S... ". Polarus Humeral Fixation System, 3.5mm X 32.5mm Cortical Screw are packaged in a sterile inner package which are placed into an outer box. The cortical screws are used with the Polarus Locking Humeral Rod (Polarus Huemral Fixation System) for the multi-planar fixation. The screws are sold individually to support the Polarus Locking Humeral Rod systems in the field, Recall # Z-2155-2008
CODE
Lot: W24552; Expiration date: 2010-05
RECALLING FIRM/MANUFACTURER
Acumed LLC, Hillsboro, OR, by fax or e-mail on December 27, 2005. Firm initiated recall is complete.
REASON
Package of 3.5mm X 32.5mm cortical screw may contain 3.5mm X 5mm cortical screw.
VOLUME OF PRODUCT IN COMMERCE
112 screws
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23; Intended for use in Spinal, Cranial, Orthopedic, General Surgical and Plastic Surgery applications for transection, osteotomy, graft harvesting, bone shaping, laminectomy, entry hole, suture hole, and midface advancement, Recall # Z-2156-2008
CODE
Lot numbers: 0000710253, 0000710254, 0000710256, 0000710257, 0000710258, 0000710266, 0000710267, 0000710271, 0000710272, 0000710274, 0000710275, 0000710276, 0000710277, 0000710278, 0000710279, 0000710280, 0000710281, and 0000710288
RECALLING FIRM/MANUFACTURER
Medtronic Powered Surgical Solutions, Fort Worth, TX, by letter on May 30, 2008. Firm initiated recall is ongoing.
REASON
Cutting flute geometry of surgical dissecting tools may be outside of established tolerance. This may lead to reduced cutting performance, inability to perform desired dissection, increased risk of overheating, and potential need for revision surgery.
VOLUME OF PRODUCT IN COMMERCE
1,306 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Stem Trial, Triathlon Revision Instruments; Non-Sterile; 100 mm length Catalog
    numbers: 5565-T-009, 5565-T-010, 5565-T-011, 5565-T-012, 5565-T-013,
    5565-T-014 5565-T-015, 5565-T-016, 5565-T-017, 5565-T-018, 5565-T-019,
    5565-T-020 5565-T-021, 5565-T-022, 5565-T-023, 5565-T-024, 5565-T-025;
    Used in Revision TKA, Recall # Z-2157-2008;
b) Stem Trial, Triathlon Revision Instruments; Non-Sterile; 150 mm length Catalog
    Numbers: 5566-T-009, 5566-T-010, 5566-T-011, 5566-T-012, 5566-T-013,
    5566-T-014 5566-T-015, 5566-T-016, 5566-T-017, 5566-T-018, 5566-T-019,
    5566-T-020 5566-T-021, 5566-T-022, 5566-T-023, 5566-T-024, 5566-T-025;
    Used in Revision TKA, Recall # Z-2158-2008
CODE
All lot codes
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letters on May 14, 2008. Firm initiated recall is ongoing.
REASON
Triathlon TS Stems Trails may crack, potentially causing fragments of the plastic handle to fragment and break off completely.
VOLUME OF PRODUCT IN COMMERCE
5,731 Instruments
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
10% Buffered Formalin Phosphate; Certified For laboratory and manufacturing use only, not for drug, food or household use. Do not Transfer to an unmarked container. Catalog numbers: SF100-4, SF100-20, Recall # Z-2159-2008
CODE
Lot: 075923
RECALLING FIRM/MANUFACTURER
ThermoFisher Scientific Co., LLC, Fair Lawn, NJ, by letters on May 1, 2008. Firm initiated recall is ongoing.
REASON
Assay tests on retention sample of 10% Buffered Formalin Phosphate showed it to be 3.417%, which is below the specification of 4-5%.
VOLUME OF PRODUCT IN COMMERCE
1,052 x 4 liters; 564 x 20 liters
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
General X-Ray System types with Digital Spot Imaging (DSI) software. Software version: rel 6, Recall # Z-2160-2008
CODE
Serial numbers: 8, 18, 31, 40, 41, 45, 51, 52, 62, 63, 67, 71, 78, 79, 83, 84, 87, 88, 99, 100, 102, 104, 105, 106, 112, 116, 117, 118, 119, 127, 131, 132, 134, 136, 143, 146, 149, 153, 157, 163, and 164
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter on May 20, 2008.
Manufacturer: Philips Medical System, The Netherlands. Firm initiated recall is ongoing.
REASON
X-ray images may be stored in the wrong patient file or corrupted; images from two different patients may be combined in one patient's folder or may be combined on one image (corrupted).
VOLUME OF PRODUCT IN COMMERCE
41 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) ENDOPATH®ETS-Flex Endoscopic Linear Cutter, ATW35 Utilized during
    general, gynecologic, urologic, and thoracic surgery for transection, resection,
    and/or creation of anastomoses, Recall # Z-2161-2008;
b) ENDOPATH®ETS Endoscopic Linear Cutter, TSW35. Utilized during general,
    gynecologic, urologic, and thoracic surgery for transection, resection, and/or
    creation of anastomoses, Recall # Z-2162-2008;
c) ENDOPATH®ETS and ETS-Flex Endoscopic Linear Cutter Reload; TR35W.
    Utilized during general, gynecologic, urologic, and thoracic surgery for transection,
    resection, and/or creation of anastomoses, Recall # Z-2163-2008;
d) FlexTray"Procedure Delivery System ENDOPATH®; FBW67XL, FD064, FDB15,
    TGL45XL, XBB02B, XBB58S, XBB59S, XLB01B, XLB50S, XPD51S. Utilized
    during general, gynecologic, urologic, and thoracic surgery for transection,
    resection, and/or creation of anastomoses, Recall # Z-2164-2008
CODE
a) Batch #’s: D4G751, D4G753, D4G80W, D4G84U, D4G85N, D4G983, D4GA5T,
    D4GA5U, D4GD6D, D4GE7U, D4GE7V, D4GH0X, D4GH8E, D4GK3M,
    D4GL0U, D4GN0F, D4GN0G, D4GN1C, D4GN85, D4GN86, D4GP7U,
    D4GP7V, D4GT3X, D4GT3Y, D4GW1U, D4GW1V, D4GW2H, D4GW3G,
    D4GW8H, D4H037, D4H038, D4H07L, D4H07M, D4H213, D4H214, D4H546,
    D4H55J, D4H61E, D4H61F, D4H66D, D4H66E, D4H804, D4H806, D4H80W,
    D4H80X, D4H82E, D4H86F, D4H91Z, D4H97U, D4H98J, D4H98K, D4HA2X,
    D4HA54, D4HC1X, D4HC1Y, D4HC93, D4HC94, D4HD95, D4HD96, D4HE2D,
    D4HE2E, D4HF2F, D4HF2G, D4HG65, D4HG66, D4HJ0A, D4HJ8R, D4HJ9K,
    D4HK2G, D4HK4G, D4HL5M, D4HL6K, D4HM2L, D4HM2N, D4HM7W,
    D4HN1Y, D4HN1Z, D4HN5E, D4HR1L, D4HR1M, D4HT53, D4HT5K,
    D4HU3W, D4HU3X, D4HU79, D4HV1P, D4HV3C, D4HV3D, D4HW0G,
    D4HW1A, D4HY9R, D4HZ86, D4J14K, D4J198, D4J199, D4J91, D4JC0, and
    D4JC9P;
b) Batch #s: D4G80V, D4G97P, D4G97R, D4GA09, D4GC96, D4GC97, D4GF6G,
    D4GH13, D4GH5J, D4GJ58, D4GK8C, D4GL2R, D4GN4E, D4GN99, D4GR13,
    D4GT54, D4GT6V, D4GT93, D4GT9Z, D4GV02, D4GV03, D4H03D, D4H03F,
    D4H042, D4H052, D4H053, D4H090, D4H091, D4H092, D4H441, D4H442,
    D4H50M, D4H58Z, D4H68R, D4H68T, D4H69Z, D4H99F, D4H99G, D4HC0R,
    D4HC1C, D4HE3E, D4HF3M, D4HG1D, D4HG1E, D4HH26, D4HJ3W, D4HJ3X,
    D4HK4P, D4HL73, D4HM13, D4HM15, D4HP2L, D4HP2M, D4HP6G, D4HP6J,
    D4HR98, D4HR9A, D4HV3A, D4HW7Y, D4HX1D, D4HY6J, D4HY98,
    D4HZ1M, D4HZ1N, D4J09J, D4J17L;
c) Batch #s: D4G80E, D4G85W, D4G903, D4G94L, D4GA32, D4GD36, D4GE66,
   D4GH0T, D4GJ2K, D4GK3Y, D4GK9L, D4GM52, D4GM7U, D4GN6E,
    D4GP0J, D4GP4R, D4GP72, D4GR0X, D4GT2T, D4GV6T, D4GV87,
    D4GW38, D4GW9W, D4H070, D4H18C, D4H22G, D4H44D, D4H46J,
    D4H48L, D4H49L, D4H51F, D4H60R, D4H70P, D4H72W, D4H77M,
    D4H86J, D4H903, D4H930, D4HA5E, D4HC0M, D4HC72, D4HE2N,
    D4HG0T, D4HG35, D4HG6F, D4HG9G, D4HH5V, D4HH9D, D4HJ8K,
    D4HL4G, D4HM5L, D4HN53, D4HP27, D4HP58, D4HP9X, D4HR68,
    D4HT58, D4HU52, D4HW1L, D4HW24, D4HW7N, D4HX45, D4HX8P,
    D4HY1D, D4HY6U, D4HZ5K, D4J03R, D4J08F, D4J13C, D4J187, D4G51J,
    D4G56F, D4G69L, D4G725;
d) Batch #: D4GR6F, D4GR6P, D4GT7G, D4H14H; Product Code: FD064,
    Batch # D4G520; Product Code: FDB15, Batch # D4GD04;
    Product Code: TGL45XL, Batch # D4J493; Product Code: XBB02B,
    Batch # D4GK74, D4GU1T, D4HL3X, D4HL7C, D4HM4P, D4HM9D,
    D4JE0R; Product Code: XBB58S, Batch # D4G94G, D4GK69, D4GP93,
    D4GW31, D4HG6V, D4J204; Product Code: XBB59S, Batch # D4GA1K,
    D4GC1G, D4GD9U, D4GD7C, D4GX8R, D4HD17, D4HD6X, D4HE54,
    D4HM6G; Product Code: XLB01B, Batch # D4GD0R, D4GF8J, D4H593,
    D4HR87; Product Code: XLB50S, Batch # D4GK4X, D4GP94, D4GT3K,
    D4HF0V, D4J47E, D4JE8P; Product Code: XPD51S, Batch # D4GT7T,
    D4HF7M , D4J32T
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon Endo-Surgery Inc., Cincinnati, OH, by letter on May 5, 2008.
Manufacturer: Ethicon Inc., Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON
The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
VOLUME OF PRODUCT IN COMMERCE
42,434 pieces
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Boston Scientific Scimed Maverick 2 Monorail" PTCA Catheter, 3.0 mm 15 mm REF 38928-1530 Lot 9565194, Use before 2010-04 Indicated for balloon dilation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, Recall # Z-2165-2008
CODE
Lot 9565194, Exp April 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Natick, MA, by letter dated May 11, 2007.
Manufacturer: Boston Scientific Ireland, Ltd., Galway, Ireland. Firm initiated recall is complete.
REASON
The units within this lot may not meet thickness specifications surrounding the wire exit port wall, which may result in an air embolization if the Port Septum Wall burts.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
Internationally
___________________________________
PRODUCT
Boston Scientific Scimed Maverick 2 Monorail 12mm Balloon Catheter, 2.5 mm x 12 mm; REF 38928-1225 Use before 2007-01 UPN H7493892812250 Sterilized with ethylene oxide gas Boston Scientific Scimed Maverick 2 Monorail 20mm Balloon Catheter, 3.5 mm x 20mm Made in Ireland, REF 38928-2035; Use before 2007-01 UPN H7493892820350 Sterilized with ethylene oxide gas Indicated for dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, Recall # Z-2166-2008
CODE
Lots: 6240888, Exp January 2007; 6240363, Exp January 2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Natick, MA, by letter dated November 7, 2005.
Manufacturer: Boston Scientific Ireland, Ltd., Galway, Ireland. Firm initiated recall is complete.
REASON
Two lots may not be correctly labeled. Specifically, a 2.5 mm x 12 mm unit was incorrectly labeled as a 3.5 x 20 mm unit on the box and tyvek label.
VOLUME OF PRODUCT IN COMMERCE
67 units
DISTRIBUTION
Internationally
___________________________________
PRODUCT
Ev3 Protege GPS Biliary Stent Systems 6 mm, 60 mm, 120cm, .35, 6Fr, OTW Ev3 4600, Ref SERB65-06-60-120; Use before 2009-01-01, Sterile EO Intended as a palliative treatment of malignant neoplasms in the biliary tree, Recall # Z-2169-2008
CODE
Lot: 2675311
RECALLING FIRM/MANUFACTURER
Ev3, Inc., Plymouth, MN, by visit on April 24, 2008. Firm initiated recall is ongoing.
REASON
A Protege PS Biliary Stent System was mislabeled. The mislabeling resulted in a 9 mm diameter, 60 mm length stent being labeled as a 6 mm x 60 mm stent.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Ev3 Primus GPS Biliary Stent Systems 8 mm, 37 mm, B7, 40 mm, 5Fr, REF BXB35-08-37-75; Use before 2009-02, Sterile EO Intended as a palliative treatment of malignant neoplasms in the biliary tree, Recall # Z-2170-2008
CODE
Lot: 2092998
RECALLING FIRM/MANUFACTURER
Ev3, Inc., Plymouth, MN, by visit on April 24, 2008. Firm initiated recall is ongoing.
REASON
A Primus GPS Biliary Stent System was mislabeled. The mislabeling resulted in a 8 mm diameter, 27 mm length stent being labeled as a 8 mm x 37 mm stent.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Medtronic 8578 Sutureless Pump Connector Revision Kit. A part of the Synchro
    Med II Infusion system, which is designed to restore and provide intrathecal
    administration of drug therapy, Recall # Z-2171-2008;
b) Model 8596SC Intrathecal Catheter Pump Segment Revision Kit. A part of the
    SynchroMed II Infusion system, which is designed to restore and provide
    intrathecal administration of drug therapy, Recall # Z-2172-2008;
c) Model 8709SC Indura 1P One-Piece Intrathecal Catheter. A part of the
    SynchroMed II Infusion system, which is designed to restore and provide
    intrathecal administration of drug therapy., Recall # Z-2173-2008;
d) Model 8731SC Intrathecal Catheter. A part of the SynchroMed II Infusion
    system, which is designed to restore and provide intrathecal administration of
    drug therapy, Recall # Z-2174-2008
CODE
All lots numbers
RECALLING FIRM/MANUFACTURER
Medtronic Neuromodulation, Minneapolis, MN, by letter on April 3, 2008. Firm initiated recall is complete.
REASON
The SC catheters cannot completely engage with the Model 700-04M portal connector. The result of this condition is a possible leakage or disconnect of the SC catheter from the portal during the continuous therapy trial period.
VOLUME OF PRODUCT IN COMMERCE
232 pumps
DISTRIBUTION
Belgium

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

___________________________________
PRODUCT
HOUVA III Phototherapy System with DermaSense Technology comes on one skid within 10 cardboard boxes. A therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders, Recall # Z-1309-2008
CODE
Serial #'s: 10134, 10145, 10147, 10148, 10105, 10151, 10112, 10113, 10114, 10101, 10150, 10140, 10103, 10123, 10135, 10135, 10138, 10137, 10122
RECALLING FIRM/MANUFACTURER
National Biological Corp., Beachwood, OH, by letters dated February 11, 2008. Firm initiated recall is ongoing.
REASON
Software allows operator to override “low line voltage” error warning and store light intensity value.
VOLUME OF PRODUCT IN COMMERCE
48 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, “Acu-Loc Distal Radius Plate, Standard, Left… PL-DR50L W48003, Recall # Z-2153-2008
CODE
Lot: W4800; Expiration date: 2012-02
RECALLING FIRM/MANUFACTURER
Recalling Firm: Acumed LLC, Hillsboro, OR, by letter on June 29, 2007.
Manufacturer: Specialized Medical Devices, Lancaster, PA. Firm initiated recall is complete.
REASON
Plates are incorrectly laser marked. The PL-DR50L plates are incorrectly laser marked with PL-DR70L.
VOLUME OF PRODUCT IN COMMERCE
51 plates
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Radiation Protective Eyewear (only involving multifocals. FTC 28 Progress X-Ray Protective Eyewear Protective Eyewear is not sent with any package inserts or labeling. It is sent in plain envelope, bag or box. FT28 product numbers: PX-PROG, PX-FT28, FB-103-RXB, FB-500-RXB, FB-100-SRXB, FB-100-BRXB, FB-100-CRXB, FB-108-SRXB, FB-108-BRXB, RGS-97RX-BI, SFFT X-RAY, RGS-53-BI, LT-53-RXP, RG-500-SRG1.5, RG-500-SRG2.0, Recall # Z-2167-2008
CODE
All radiation protective bifocals
RECALLING FIRM/MANUFACTURER
Phillips Safety Products, Middlesex, NJ, by telephone and letter dated June 3, 2008. Firm initiated recall is ongoing.
REASON
Radiation Protective Eyewear does not meet the radiation protection levels stated on the labeling.
VOLUME OF PRODUCT IN COMMERCE
845 pairs
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR SEPTEMBER 3, 2008

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