July 30, 2003
03-31
__________________________
PRODUCT
Pasteurized Liquid Whole Eggs, Net Wt. 30 lbs., in boxes with plastic liners. Recall # F-461-3.
CODE
Lot 1283.
RECALLING FIRM/MANUFACTURER
Echo Lake Farm Prod. Co., Inc., Burlington, WI, by telephone on May 14, 2003. Firm initiated recall is complete.
REASON
The product was contaminated with Salmonella enteritidis.
VOLUME OF PRODUCT IN COMMERCE
128/30 lb. and 89/45 lb.
DISTRIBUTION
IL.
______________________________
PRODUCT
Fresh Express brand Hearts of Romaine lettuce, Net Wt. 10 oz., packed in plastic bags. Recall # F-463-3.
CODE
06 May 03 S111A18B.
RECALLING FIRM/MANUFACTURER
Fresh Express Fresh Foods, Salinas, CA, by telephone and press release on May 20, 2003. FDA initiated recall is complete.
REASON
The product was contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
5,622 cases.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Red Blood Cells. Recall # B-1398-3.
CODE
Unit number 6822793.
RECALLING FIRM/MANUFACTURER
W. E. and Lela I. Stewart Blood Center, Tyler, TX, by telephone on February 19, 2003. Firm initiated recall is complete.
REASON
Blood product, collected in an expired collection bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
______________________________
PRODUCT
a) Portex Uncuffed Nasal Tracheal Tubes, Ivory 5mm x 25cm Reference
Number: 100/105/050. Recall # Z-0991-03;
b) Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised 3mm x 17cm
Reference Number: 100/111/030. Recall # Z-0992-03;
c) Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised 3.5mm x 19cm
Reference Number: 100/111/035. Recall # Z-0993-03;
d) Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised 8mm x 33cm
Reference Number: 100/111/080. Recall # Z-0994-03;
e) Portex Uncuffed Oral Tracheal Tubes, Siliconised 6mm x 19cm
Reference Number: 100/126/060. Recall # Z-0995-03;
f) Portex Uncuffed Oral/Nasal Tracheal Tube, Murphy Eye Clear 3.5mm x
19cm Reference Number: 100/127/035. Recall # Z-0996-03;
g) Portex Uncuffed Oral/Nasal Tracheal Tubes, Murphy Eye Siliconised
5mm x 25cm Reference Number: 100/141/050. Recall # Z-0997-03;
h) Portex Tracheal Tube Profile Soft-Seal Cuff, Ivory Nasal 5mm x 25cm
Reference Number: 100/179/050. Recall # Z-0998-03;
i) Portex Profile Soft-Seal Cuff Oral/Nasal Tracheal Tube, Clear
Murphy Eye 8 mm x 33cm Reference Number: 100/199/080.
Recall # Z-0999-03.
CODE
a) Lot number: 161614;
b) Lot number: 161633;
c) Lot number: 161638;
d) Lot number: 161652;
e) Lot number: 161669;
f) Lot number: 161671;
g) Lot number: 161705;
h) Lot number: 153163;
i) Lot numbers: 153011, 153007;
RECALLING FIRM/MANUFACTURER
Portex Ltd., Hythe, Kent, GB, by telephone on May 16, 2003, and by letter on May 17, 2003. Firm initiated recall is ongoing.
REASON
Tracheal tubes may be non-sterile.
VOLUME OF PRODUCT IN COMMERCE
2,580 units.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Zoll M Series External Defibrillator. Recall # Z-1000-03.
CODE
Serial Numbers: T02137097-T03C45238.
RECALLING FIRM/MANUFACTURER
Zoll Medical Corporation, Burlington, MA, by letter on June 25, 2003 and June 26, 2003. Firm initiated recall is ongoing.
REASON
Defibrillator may fail to charge or hold its charge above energies of 75 joules.
VOLUME OF PRODUCT IN COMMERCE
8,142 units.
DISTRIBUTION
Nationwide, and Internationally.
______________________________
PRODUCT
MagNA Pure LC Instrument; Catalog number 2236931. Recall # Z-1001-03.
CODE
All units with software version 3.0.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics, Corp., Indianapolis, IN, by letter dated May 27, 2003. Firm initiated recall is ongoing.
REASON
Potential for false negative patient results with software version
3.0.
VOLUME OF PRODUCT IN COMMERCE
17.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Drill bits used in ENDOTINE Forehead( 3.5 and 3.0, Catalog Number: CFD-010-4203 and CFD-010-4303. Recall # Z-1002-03.
CODE
Lot numbers: 00085, and 00092.
RECALLING FIRM/MANUFACTURER
Coapt Systems, Inc., Palo Alto, CA., by letters on May 19, 2003. Firm initiated recall is ongoing.
REASON
During use, the device has a potential for unacceptable deep hole in the cranium which can cause patient injury.
VOLUME OF PRODUCT IN COMMERCE
275 units.
DISTRIBUTION
Nationwide and Internationally.
______________________________
PRODUCT
EDI VueCath Endoscopic Spinal System. Catalog Number: S002.
Recall # Z-1006-03.
CODE
Lot/Serial Nos: F10021, F10017, F10012, F10018, F10025, F10019, F10020, F10014, F10023, F10022, F10001, F10000, F10024, F10007, F10008, F00005, F10003, F10016, F10015, F10002, F10027.
RECALLING FIRM/MANUFACTURER
EBI, L.P., Parsippany, NJ, by letter dated June 17, 2003. Firm initiated recall is ongoing.
REASON
Non sterile device is labeled sterile.
VOLUME OF PRODUCT IN COMMERCE
39.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Misys Laboratory System. Recall # Z-1007-03.
CODE
Versions 5.2, 5.23, and 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on June 10, 2003, and on June 13, 2003. Firm initiated recall is ongoing.
REASON
Software anomally. Results with a global flag failure that autofile without review can cause abnormal results being communicated without associated abnormal disignations.
VOLUME OF PRODUCT IN COMMERCE
467.
DISTRIBUTION
Nationwide, and Internationally.
______________________________
PRODUCT
Sanarus Visica( Treatment System (disposable), Model/Product Code: VP-0500 (single). Recall # Z-1008-03.
CODE
Lot # C030404.
RECALLING FIRM/MANUFACTURER
Sanarus Medical, Inc., Pleasanton, CA, by letter on June 16, 2003. Firm initiated recall is ongoing.
REASON
Corrosion in stainless steel device shaft that allows Argon gas to escape from device during a cryoablation procedure.
VOLUME OF PRODUCT IN COMMERCE
41 units.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
a) Pulsar Max II Multiprogrammable Pacemaker, Model 1180.
Recall # Z-1009-03;
b) Pulsar Max II Multiprogrammable Pacemaker, Model 1181.
Recall # Z-1010-03;
c) Discovery II Multiprogrammable Pacemaker, Model 0481.
Recall # Z-1011-03;
d) Discovery II Multiprogrammable Pacemaker, Model 0981.
Recall # Z-1012-03;
e) Discovery II Multiprogrammable Pacemaker, Model 1184.
Recall # Z-1013-03;
f) Discovery II Multiprogrammable Pacemaker, Model 1283.
Recall # Z-1014-03;
g) Discovery II Multiprogrammable Pacemaker, Model 1284.
Recall # Z-1015-03;
h) Discovery II Multiprogrammable Pacemaker, Model 1286.
Recall # Z-1016-03;
i) Discovery II Multiprogrammable Pacemaker, Model 1280.
Recall # Z-1017-03;
CODE
a) Serial numbers 110685, 110687, 110688, 110706, 110708, 110709, 110710,
110711, 110712, 110713, 110714, and 110715;
b) Serial number 811798;
c) Serial number 105497;
d) Serial numbers 206555, 206557, 206558, 206559, 206560, 206561, 206562,
206525, 206526, 206527, 206528, and 206529;
e) Serial numbers 319492, 319493, 319494, 319495, 319496, 319497, 319498,
319499, 319500, 319501, 319502, 319503, 319505, 319506, and 319507;
f) Serial numbers 639293, 639295, and 639296;
g) Serial numbers 721824, 721825, 721826, 721827, 721828, 721829,
721830, 721831, 721832, 721833,721834, 721835, 721836, 721837,
721838, 721839, 721840, 721841, 721843, 721908, 721909, 721910,
721911, 721912, 721913, 721914, 721915, 721916, 721917, 721918,
721919, 721920, 721921, 721922, 721923, 721924, 721926, 721927,
721928, 721929, 721930, 721931, 721932, 721933, 721934, 721935,
721936, 721937, 721938, and 721939;
h) Serial numbers 908813, 908814, 908817, 908819, 908820;
i) Serial numbers 547737, 547738, 547739, 547740, 547741, 547742,
547744, 547745, 547746, 547747, 547748, 547749, 547751, 547753,
547754, and 547964.
RECALLING FIRM/MANUFACTURER
Guidant Corp-Cpi Division, St Paul, MN, by letter, dated June 23, 2003. Firm initiated recall is ongoing.
REASON
Some of the pacemakers may fail to pace due to an inadequately soldered electrical connection at an integrated circuit.
VOLUME OF PRODUCT IN COMMERCE
115 pacemakers.
DISTRIBUTION
Nationwide, and Internationally.
______________________________
PRODUCT
MSI-EpiDermGlu (Iso-Butyl 2 Cyanoacrylate) tissue adhesive for soft tissue approximation; 0.22 cc plastic squeeze tubes packaged in a Tyvek/PPE pouch with paper label, 10 units per case. Recall # Z-1018-03.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Recall Firm: Elite Medical Group, Bloomington, IL, by letter dated July 2, 2003.
Manufacturer: Medisav Services, Inc., Ontario L3S 1Y7, Canada. FDA initiated recall is ongoing.
REASON
The liquid tissue adhesive was marketed with FDA pre-market clearance.
VOLUME OF PRODUCT IN COMMERCE
129 cases.
DISTRIBUTION
IL, TN, KN, KY, MD, and MO.
______________________________
PRODUCT
a) Vail Enclosed Bed System, model 1000. Recall # Z-1025-03;
b) Vail Enclosed Bed System, model 2000. Recall # Z-1026-03.
CODE
All serial numbers affected.
RECALLING FIRM/MANUFACTURER
Vail Products, Inc., Toledo, OH, by letter in April 2003, and by telephone, fax, and letter on June 30, 2003. Firm initiated recall is ongoing.
REASON
Patients may become entrapped between the bottom side rail and mattress.
VOLUME OF PRODUCT IN COMMERCE
1,899 units.
DISTRIBUTION
Nationwide, Canada, and Saudi Arabia.
______________________________
PRODUCT
a) Hill-Rom Newborn bassinet, model P247. Recall # Z-1027-03;
b) Hill-Rom Newborn bassinet, model P248. Recall # Z-1028-03.
CODE
All units distributed from November 2000 through April 2003.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letters dated June 20, 2003. Firm initiated recall is ongoing.
REASON
The caster/wheel may come off of the bassinet, causing the bassinet to tip.
VOLUME OF PRODUCT IN COMMERCE
2,901.
DISTRIBUTION
Nationwide, and Internationally.
______________________________
PRODUCT
Magic View 1000U, version VE40A. Digital Image Communication System. Recall # Z-1029-03.
CODE
Part number 7502003.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated February 28, 2002. Firm initiated recall is ongoing.
REASON
Software issue. New examinations may not be saved properly and the examination may be lost.
VOLUME OF PRODUCT IN COMMERCE
49 units.
DISTRIBUTION
Nationwide.
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PRODUCT
a) Fibered Platinum Coil, 0.035 Type, 4 mm x 30 mm. Catalog no. 372403.
Recall # Z-1033-03;
b) Fibered Platinum Coil, 0.035 Type, 9 mm x 60 mm. Catalog no. 372906.
Recall # Z-1034-03.
CODE
a) Lot number: 5473831;
b) Lot number: 5472234.
RECALLING FIRM/MANUFACTURER
Boston Scientific Corporation, Natick, MA, by sales representatives' visit beginning on June 23, 2003. Firm initiated recall is ongoing.
REASON
Product's Outer box label may not match pouch label: a 4 mm x 30 mm coil may be labeled as a 9 mm x 60 mm or vice versa.
VOLUME OF PRODUCT IN COMMERCE
60 units.
DISTRIBUTION
Japan, Italy, France, Turkey, Israel, Finland.
______________________________
PRODUCT
9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicrobial Surface Sheath. Catalog numbers AK-07903-AG, SI-07903-AG, JM-07903-AG, and CI-07903-AG. Recall # Z-1035-03.
CODE
Not indicated.
RECALLING FIRM/MANUFACTURER
Arrow International, Inc., Reading, PA, by letters dated July 9, 2003. Firm initiated recall is ongoing.
REASON
Separation of sheath.
VOLUME OF PRODUCT IN COMMERCE
13,442 units.
DISTRIBUTION
Nationwide, and Internationally.
______________________________
PRODUCT
AMO PhacoFlex II Model SI40NB, Intraocular Lenses. Recall # Z-1036-03.
CODE
1011620109 1303290109 1011680109 1309920109 1038960109 1330610110 1039310109 1391120107 1077970111 1391590107 1077990111 1391930107 1104820203 1414530107 1123300203 1430530112 1149800001 1441910105 1162800105 1454360107 1167400105 1454380107 1168730109 1459930105 1189090109 1484520108 1191330109 1484570112 1191500109 1484650108 1192830105 1486950107 1192940105 1501090108 1207160105 1690550106 1213960109 1690810106 1214020109 1780720106 1215950109 1780740106 1216120109 1781220106 1224570111 1781340106 1227610105 1785280202 1232610109 1846620106 1232680109 1896320106 1232760109 1896330106 1237660109 1896420106 1237880109 1974109910 1276430109 9909772334 1010640212 1012010212 1012040212 1286460208 1299700208 1299760208 1299770208 1324100211 1324110211 1324530211 1384980211 1392500211 1408400211 1419200208 1445720211 1663700211 1670870211 1670890211 1672080211 1703760211 1721900211 1797030210 1956470211 1963580210 1990660211 1991080211 1993620211 1993660211 2121580206 2121690206
Known Implanted Lenses 1704120211 1990690211.
RECALLING FIRM/MANUFACTURER
Allergan Medical Optics Inc., Santa Ana, CA, by letters on July 2, 3, and 8, 2003. Firm initiated recall is ongoing.
REASON
Post operative complaints of cloudiness in the intraocular lenses.
VOLUME OF PRODUCT IN COMMERCE
98.
DISTRIBUTION
Brazil.
______________________________
PRODUCT
Roche/Hitachi Tina-quant RF II; catalog # 3004902. Recall # Z-1030-03.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by a reagent bulletin dated September 30, 2002. Firm initiated recall is complete.
REASON
Test results may exhibit a positive bias when plasma samples are used for the assay.
VOLUME OF PRODUCT IN COMMERCE
480.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Rheumatoid Factor ELISA Test Kit. Labeled under the following names:
a) Sigma Diagnostics, Inc, Saint Louis, MO. Product Number 507-B;
b) Zeus Scientific, Inc., Branchburg, NJ. Product Number 2Z921M.
Recall # Z-1031-03.
CODE
a) Lot Number: 090K6499 Expiration Date: 5-31-2002;
b) Lot Number: 00010446 Expiration Date: 06-09-2002.
RECALLING FIRM/MANUFACTURER
Zeus Scientific Inc., Branchburg, NJ, by DHL on November 9, 2001. Firm initiated recall is complete.
REASON
Calibrator C not meeting its optical density specification.
VOLUME OF PRODUCT IN COMMERCE
505.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Cathcor/LX/Desktop, System, X-Ray, Angiographic. Recall # Z-1032-03.
CODE
Serial Numbers: 01029, 01033, 01034, 01062, 01108, 01110, 01121, 01125, 02048.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., by letter on October 30, 2002. Firm initiated recall is complete.
REASON
Incorrect CTR values are found when used with ODBC interface, and may result in misdiagnosis.
VOLUME OF PRODUCT IN COMMERCE
9.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Profile Dr. Evans' Alpaca Supplement, packaged in 50 lb. bags, under the brand name of Profile Nutrition. Recall # V-178-3.
CODE
The correct code is "3FEB28MAS". However, due to printer misprints, the code may also read either: "FEB28MAS" or "3FEB28MA".
RECALLING FIRM/MANUFACTURER
Land O Lakes Farmland Feeds LLC, Massillon, OH, by telephone, fax and letter on March 19, 2003. Firm initiated recall is complete.
REASON
Toxicology indicates possible salinomycin contamination of the feed supplement.
VOLUME OF PRODUCT IN COMMERCE
238 - 50 lb. bags.
DISTRIBUTION
OH.
END OF ENFORCEMENT REPORT FOR JULY 30, 2003
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