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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March 29, 2006
06-13

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS I

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PRODUCT
Medline Alcohol-Free Mouthwash, Reorder numbers: MDS095029 for 2-oz. size and MDS095030 for 4-oz. size. Manufacturer's Code is RA05CRR, UPC Code for 2-oz. product is 0 8019616684 1, UPC Code for 4-oz. product is 0 8019674536 7, Recall # F-092-6
CODE
All products with lot codes beginning with the numbers 0503 through 0508 followed by 3 or 4 additional digits.
RECALLING FIRM/MANUFACTURER
Carrington Laboratories, Inc., Irving, TX, by fax on August 23, 2005 and by letter on August 25, 2005, firm initiated recall is ongoing.
REASON
Alcohol-free mouthwash is contaminated with Burkholderia cepacia and is associated with an illness outbreak.
VOLUME OF PRODUCT IN COMMERCE
21,504-2 oz. bottles and 129,000 4-oz. bottles
DISTRIBUTION
Nationwide

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PRODUCT
Medline Personal Hygiene Hospital Admission Kits; these custom packaged kits are assembled with various items per the customers orders, but all contain either a 2 fl. oz. or 4 fl. oz. bottle of Medline Alcohol-Free Mouthwash; the kits are not individually labeled, and are packaged 12 per case; the cases are labeled Medline. Medline has two suppliers of Alcohol-Free Mouthwash that may have been included in the kits. The mouthwash being recalled by Carrington Labs has reorder numbers MDS095029 for 2-oz size and MDS095030 for 4-oz size, Recall # F-093-6
CODE
All mouthwash with lot codes beginning with the numbers 0503 through 0508 followed by 3 or 4 additional digits stamped on the bottom of the bottle are being recalled. The affected mouthwash may also be identified by the printer's code of RA05CRR located at the bottom right of the label's back panel. The following kits are being recalled by Medline to remove the mouthwash manufactured by Carrington Labs from the kits:
Kit reorder # containing 2 oz. Mouthwash: DYK1000858A, DYK1005385A3, DYK1005386A3, DYK1005386A4, DYK1005395A, DYK1005395A1, DYK1005395A2, DYK1005395A3, DYK1018676A1, DYK1050298P, DYK1066423A, DYKD1000841A, DYKD1000858A, DYKD1001038H, DYKD1005386A1, DYKD1005386A2, DYKD1005457A1, DYKD1005549A, DYKD1009292A1, DYKD1009321A, DYKD100COLP3, DYKD1011857A, DYKD1011891A, DYKD1018563A3, DYKD1019249A, DYKD1019286A, DYKD11077A2, DYKD14109A, DYKD14302D, DYKD14320A, DYKD2003A, DYKD22450AMM, DYKN1005386A, DYKN10055386A, MDS095029H, DYK1004177AX1, DYK1004214A, DYK1004427A, DYK1004980A3, DYK1004980A4, DYK1004980A5, DYKD1001038H, DYKD1004239A, DYKD1004438A, DYKD100COLP3, DYKD100COLP4, DYKD1067381A, DYKD10914T, DYKD11081A, DYKD1175041A, DYKD711091AX, DYK1009291A, DYK1009312C1, DYK1011891A1, DYK1011891M, DYK1012026A1, DYK1012026C, DYK1019498A, DYK1055075A2, DYK1066658A, DYKD1001038H, DYKD1009292A, DYKD1009292A1, DYKD1009312C, DYKD1009321A, DYKD1009326A, DYKD100COLP3, DYKD100COLP4, DYKD1020287A, DYKD1023707A, DYKD1023726A, DYKD1023786A, DYKD1028186A, DYKD1041379A1, DYKD1058363A, DYKD1066705A, DYKD1078899A1, DYKD23149A1, DYKD48003M, DYKD57117M, DYKD57990A, DYK1019573A, DYKD1001038H, DYKD100COLP4, DYKD1023766AE, DYKD56443A, MDS095029H, DYK1014973A, DYK1014973A1, DYK1014973A2, DYK1014973A3, DYK1014973A4, DYK1014973A5, DYK1018520A, DYK1018563A, DYK1018563A4, DYK1018645A, DYK1050298P, DYK1066515A, DYKD1001038H, DYKD100COLP3, DYKD1015016A, DYKD1015045A, DYKD1015385A, DYKD1018513A, DYKD1018562A, DYKD1018563A1, DYKD1018563A2, DYKD1018563A3, DYKD1018578A, DYKD1018578A1, DYKD1018595M, DYKD1018595O, DYKD1018663AK, DYKD1019286A, DYKD1021267M, DYKD1021267M1, DYKD1021311A, DYKD1053945A, DYKD2003A, DYKD44205A, DYKD53043A, DYKD53191A, DYK1009291A, DYK1009292A, DYK1009312C1, DYK1011891A1, DYK1011891M, DYK1012026A1, DYK1012026C, DYK1055075A, DYK1055075A1, DYK1055075A2, DYK1066658A, DYK1082407A1, DYK1082407P, DYKD1009292A1, DYKD1009312A, DYKD1009321A, DYKD100COLP4, DYKD1011857A, DYKD1011891A, DYKD1012480A, MDS095029H, DYK1001429A, DYK1001429A1, DYK1071134A3, DYK1009291A, DYK1011891A1, DYK1011891M, DYK1012026A1, DYK1012026C, DYK1055075A2, DYK1066658A, DYKD1009321A, DYKD100COLP4, DYKD100COLP3, DYKD100COLP4, DYK1009291A, DYK1011891A1, DYK1011891M, DYK1012026A1, DYK1055075A2, DYK1066658A, DYKD1009321A and DYK1012026C;
Kit reorder # containing 4 oz. Mouthwash: DYK1000844A, DYK1000867P, DYK1004191A, DYK1005388MC1, DYK1005481A1, DYK1005481A2, DYK1005518P, DYK1005518W2, DYK1005679A, DYK1019292A, DYK1065831A1, DYK1067383A, DYK1067383A1, DYK1077038A, DYK1077038A1, DYK1165686P1, DYKD1000909AM, DYKD1000935A, DYKD1000935A1, DYKD1000957A, DYKD1001089A, DYKD1001793A, DYKD1001A, DYKD1002A, DYKD1005388MC, DYKD1005400A, DYKD1005419A, DYKD1005419A1, DYKD1005421H, DYKD1005431A, DYKD1005474A, DYKD1005483A, DYKD1005518P, DYKD1008988A1, DYKD1008993A1, DYKD1009302A, DYKD1009323A, DYKD100COLP1, DYKD1011873A, DYKD1011946A, DYKD1011946A2, DYKD1018497A, DYKD1019268A, DYKD1045425A, DYKD1059698PC, DYKD1065207A, DYKD1065831A, DYKD1066A, DYKD1077047A, DYKD1097615A, DYKD1154308A, DYKD1154308A1, DYKD1165686P, DYKD14135AX, DYKD14152A, DYKD14169A1, DYKD14184A, DYKD14613A1, DYKD14614A1, DYKD494806A, DYKD55235ICU, DYKD731042A, DYKDN1092442P, DYKG1407A, DYKN1000883A, DYKN1005518P, DYKN1005518W1, DYKN1005518WA, DYKN1011935A, DYKN1012025H, MDS095030H, DYK1004191A, DYK1047033A, DYK1057519A, DYK1057519G, DYK1059826A2, DYK1194815A, DYK1194815A1, DYKD1001A, DYKD1002A, DYKD1003972A1, DYKD1003996M1, DYKD1003996M2, DYKD1004031A, DYKD1004206F, DYKD1004206M, DYKD1004212A, DYKD1004458A, DYKD1004468A1, DYKD1004509P, DYKD1004946A, DYKD1005216A, DYKD100COLP1, DYKD1057519A, DYKD1059826A, DYKD1059826A1, DYKD1065455A, DYKD1068455A, DYKD1077750D, DYKD1084144A1, DYKD1157310A, DYKD1157310A1, DYKD11623A, DYKD12311A1, DYKD711311A1, DYKD712608A1, DYKD712608A2, MDS095030H, WHI1004946A, DKY1172636A, DYK1001793A1, DYK1001842A, DYK1009304A, DYK1009305A1, DYK1011878A2, DYK1011946A4, DYK1014053A, DYK1016454A, DYK1020234A, DYK1023735A1, DYK1023735A2, DYK1029682A, DYK1059995A, DYK1059995A1, DYK1066128A, DYK1151343A, DYK1172636A, DYK1172636A1, DYK1172636A2, DYK1172636A3, DYK1196044A, DYK1198321A, DYK1216063A, DYK1216063A1, DYKD1001793A, DYKD1001808A, DYKD1001808A1, DYKD1001A, DYKD1002A, DYKD1009302A, DYKD1009305A, DYKD1009323A, DYKD1009584A, DYKD100CMMAP, DYKD100COLP1, DYKD1014057A, DYKD1016469A, DYKD1016594O, DYKD1016923A, DYKD1020631A, DYKD1023482A, DYKD1023735A, DYKD1023803H, DYKD1023803H1, DYKD1029682A, DYKD1058363A1, DYKD1066577A1, DYKD1158056AF, DYKD151194A, DYKD15278A, DYKD23153A, DYKD23290A, DYKD23467A, DYKD4082M, DYKD4238P2, DYKD48268OHX, DYKN1012025H, DYKN1012052PH, DYKN1040955P, MDS095030H, DYKD1001A, DYKD1002A, DYKD100COLP1, DYKD1023764M, DYKD1023764M1, DYKD1023764M2, DYKD1023797OB, DYKD152249H, MDS095030H, DYK1018503A, DYK1018505A, DYK1018505A1, DYK1018533A1, DYK1018533A2, DYK1021280V, DYK1077257A, DYK1080336A, DYK1080336M, DYK1152785A, DYK1152785A1, DYK1166218A, DYKD1002A, DYKD100COLP1, DYKD1014985A, DYKD1015051A, DYKD1015077A, DYKD1015233A, DYKD1018533A, DYKD1018541A, DYKD1018541A1, DYKD1018542A, DYKD1018568A, DYKD1018585A, DYKD1018660A, DYKD1021267H, DYKD1021268A, DYKD1021268P4, DYKD1021278M, DYKD1021323A, DYKD1021323A1, DYKD1021323A2, DYKD1021323A3, DYKD1021323P, DYKD1021323P1, DYKD1021323P2, DYKD1021323P3, DYKD1021366A, DYKD1021411A, DYKD1021579A, DYKD1022056A, DYKD1022207A1, DYKD1022207M, DYKD1057399C, DYKD1066560D, DYKD44074A, DYKD44302A2, DYKD53139A, DYKD55235ICU, DYKD60197D, DYKD60197TC, DYKD60222P, DYKD744274A, DYKD744954A, DYKN1014971A, MDS095030H, DYK1001793A1, DYK1001842A, DYK1001842A1, DYK1011878A1, DYK1011878A2, DYK1011946A4, DYK1012026A, DYK1029682A, DYK1066128A, DYK1066579K, DYKD1001793A, DYKD1001A, DYKD1002A, DYKD1008993A1, DYKD1009301H, DYKD1009302A, DYKD1009323A, DYKD100COLP1, DYKD1011873A, DYKD1011878A, DYKD1011946A2, DYKD1011946A3, DYKD1012232A, DYKD1058363A1, DYKD1066577A1, DYKD731042A, DYKDN1092442P, DYKN1011935A, DYKN1012025H, DYKN1012052PH, DYKN1040955P, MDS095030H, DYK1014053A, DYK1151343A, DYKD1001769A, DYKD1002A, DYKD100COLP1, MDS095030H, DYK1011878A2, DYK1011946A4, DYKD1001A, DYKD1002A, DYKD1009302A, DYKN1012025H, MDS095030H, DYKD1001A, DYKD1002A, DYKD100COLP1, DYK1011878A2, DYK1011946A4, DYKD1009302A and DYKN1012025H
RECALLING FIRM/MANUFACTURER
Medline Industries, Inc., Mundelein, IL, by letters dated August 26, 2005, firm initiated recall is ongoing.
REASON
The kits contain Medline Alcohol-Free Mouthwash that is being recalled for contamination with Burkholderia cepacia bacteria. The mouthwash is associated with an illness outbreak/
VOLUME OF PRODUCT IN COMMERCE
404,435 kits and 913,215 bottles of mouthwash
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS II

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PRODUCT
Green's Greatwoods Classics "Under the Stars" flavor ice cream, 56 oz. containers, Recall # F-095-6
CODE
Code: 3015
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kemps, LLC, St. Paul, MN, by letter on February 7, 2006.
Manufacturer: H. P. Hood, Inc., Suffield, CT, firm initiated recall is complete.
REASON
Product containing peanuts may be packaged with incorrect lid.
VOLUME OF PRODUCT IN COMMERCE
794 cases -- 6 per case
DISTRIBUTION
PA, MD, DE, VA, WV, and OH

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS III

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PRODUCT
Home Special brand Chicken Soup Mix, Net Wt. 3 oz. (85g), Serving Size: 30 g, Servings Per Container: 15. The product is packed in a sealed plastic package, UPC barcode # 6 64460 10471 7, Recall # F-100-6
CODE
No coding.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ho's Trading Inc., Brooklyn, NY, by telephone beginning on June 13, 2005.
Manufacturer: Sinojet Development Ltd., Hong Kong, China, firm initiated recall is complete.
REASON
The product contained undeclared sulfites based on sampling and analysis by New York State Department of Agriculture and Markets.
VOLUME OF PRODUCT IN COMMERCE
46 cases (100 packages per case)
DISTRIBUTION
NY, NJ, MA, MD, VA, WV, GA, FL, MI, OH, TX, and CO

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PRODUCT
Helen Grace Chocolates, Chocolate Covered Fudge 6.5 oz. Label on side panel reads in part: "Exclusively For Innisbrook Wraps Premium Products For Fundraising", Recall # F-101-6
CODE
Lots B1206, B1216, B1226, B1236, and B1246
RECALLING FIRM/MANUFACTURER
Helen Grace Chocolates, Inc, Rancho Dominguez, CA, by letter beginning on January 17, 2006, firm initiated recall is ongoing.
REASON
Recent production processes may have resulted in the contamination of the Helen Grace Chocolates, Chocolate Covered Fudge 6.5 oz. box with metal fragments.
VOLUME OF PRODUCT IN COMMERCE
11,528 X6.5 oz.
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I

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PRODUCT
a) Cytosol Ophthalmics Balanced Salt
Solution (Sterile Irrigating Solution)
200mL and 500mL glass bottles, 18mL,
250mL and 500mL plastic bottle, NOT
FOR INTRAVENOUS USE, Rx Only, Single
Dose Container Sterile. NDC 23731-8100-5,
Recall # D-210-6;
b) AKORN Balanced Salt Solution, 500mL
glass bottle, NOT FOR INTRAVENOUS USE,
Rx only, Single Dose Container,
Recall # D-211-6
CODE
All Lots
RECALLING FIRM/MANUFACTURER
Cytosol Laboratories, Inc., Braintree, MA, by letter dated February 15, 2006 and by fax on February 16, 2006, firm initiated recall is ongoing.
REASON
Product not manufactured in accordance with cGMPS as finished product positive for endotoxins resulting in serious injury.
VOLUME OF PRODUCT IN COMMERCE
1,094,523 bottles
DISTRIBUTION
Nationwide, Australia, Brazil, Canada, and Germany

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

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PRODUCT
Pulmicort Turbuhaler (budesonide inhalation powder), 200 mcg/dose, 200 metered dose inhalers and 200 metered dose professional samples, Rx only, for oral inhalation, NDC: 0186-0915-42, Recall # D-204-6
CODE
Affected Lots and Expiration Dates: GD2143 10/2006 GI2228 3/2007 GD2144 10/2006 GI2230 3/2007 GD2161 10/2006 GI2241 3/2007 GD2164 10/2006 GI2244 3/2007 GE2170 11/2006 GI2246 3/2007 GE2172 11/2006 GK2247 4/2007 GF2190 12/2006 GK2248 4/2007 GH2196 2//2007 GK2254 4/2007 GH2201 2/2007 GK2255 4/2007 GH2203 2/2007 GK2258 4/2007 GH2207 2/2007 GK2261 4/2007 GH2212 2/2007;
PROFESSIONAL SAMPLES: GD2148 10/2006 GD2150 10/2006 GD2162 10/2006 GH2199 2/2007 GH2211 2/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: AstraZeneca LP, Westborough, MA, by letter on March 6, 2006.
Manufacturer: AstraZeneca, Sodertalje, Sweden, firm initiated recall is ongoing.
REASON
The turbuhaler may not deliver proper metered dose: may dispense a super-potent dose.
VOLUME OF PRODUCT IN COMMERCE
417,605 inhalers
DISTRIBUTION
Nationwide

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PRODUCT
Visine A Antihistamine and Redness Relief Eye Drops, Ophthalmic solution, Pheniramine Mealeate (0.3%) and Naphazoline Hydrochloride (0.05%), 0.5 fluid ounce (15mL) x 2 bottles (promotional bonus pack), Recall # D-205-6
CODE
Case UPC -- Case Lot No: 1007430089860 2: 01725CD04; 01725CM04; 02325CD04. 1007430089736 0: 01125CN04; 01415CN04; 01815CN04; 01215CN04; 01425CD04; 01915CD04; 01225CD04; 01425CN04; 01915CN04; 01225CN04; 01715CD04; 02014CD04; 01315CD04; 01715CN04; 02125CD04; 01315CN04; 01815CD04. 0007430089748 6: 01425CN04; 01525CN04; 02125CN04; 01525CD04; 01625CN04; 02525CD04; 01525CM04; 02125CD04. 0031254789734 1: 00525CD02; 00825CN02; 01125CD02; 00525CN02; 00925CD02; 01125CN02; 00725CD02; 00925CN02; 01725CN12; 00725CN02; 01025CD02; 03035CD01; 00825CD02; 01025CN02. 0007430089737 0: 01125CN04; 01225CN04; 01425CN04; 01225CD04; 01425CD04; 02125CD04. 1007430089792 6: 00125CD04; 01425CN04; 02015CN04; 00125CN04; 01525CD04; 02515CD04; 00225CD04; 01525CM04; 02515CN04; 00725CD04; 01525CN04; 02525CD04; 00725CN04; 01625CN04; 02615CD04; 00825CD04; 02115CD04; 02615CN04; 00825CM04; 02115CN04; 02715CD04; 00825CN04; 02125CD04; 02715CN04; 00925CD04; 02125CN04; 02815CD04; 00925CM04; 02415CD04; 02815CN04; 00925CN04; 02415CD04A. 0007430008158 8: 00225CN04; 00525CM04; 01025CN04; 00325CD04; 00525CN04; 01125CD04; 00325CN04; 00835CD11; 01125CM04; 00425CD04; 00925CN04; 01725CM04; 00425CN04; 01025CD04; 02225CD04; 00525CD04 01025CM04; 02325CD04. 1007430008157 8: 00225CN04; 00515CD04; 00615CN04; 00323CD04; 00515CN04; 00615CD04; 00325CN04; 00516LLD04; 00616LLD04; 00415CD04; 00516LLD04A; 00616LLM04; 00415CN04; 00516LLM04; 00616LLN04; 00416LLN04; 00516LLN04; 00715CD04; 00416LLN04A; 00525CD04; 00715CN04; 00425CD04; 00525CM04; 00835CD11; 00425CN04; 00525CN04; 00916LLD04; 00916LLN04; 01125CD04; 00916LLD10; 00916LLN10; 01125CM04; 02325CD04; 00925CN04; 01225CD04; 027D5LLN10; 01015CD04; 01215CD04A; 028D4CD04; 01015CN04; 01215CN04; 028D4CN04; 01016LLM04; 01725CM04; 028D5LLD10; 01025CD04; 02225CD04; 028D5LLN10; 01025CM04; 023D4CD04; 029D4CD04; 01025CN04; 023D4CD04A; 029D4CN04; 01115CD04; 023D4CN04; 030D4CD04; 01115CN04; 030D4CN04
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer, Inc., Morris Plains, NJ, by letters on January 30, 2006.
Manufacturer: Akorn, Inc., Decatur, IL, firm initiated recall is ongoing.
REASON
Container Leakage: Promotional packager used knives to open boxes containing the plastic bottles of Visine-A in violation of SOP. Bottles were cut and packaged for distribution. Complaints of empty bottles were received.
VOLUME OF PRODUCT IN COMMERCE
532,419 units
DISTRIBUTION
Nationwide

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PRODUCT
a) Advil Tablets, (Ibuprofen) 200mg,
165 count tablets, Pain Reliever/Fever
Reducer, Recall # D-206-6;
b) ADVIL LIQUI-GELS, (Solubilized
Ibuprofen Capsules), 200mg, 135
count bottle, Pain Reliever/Fever
Reducer, Recall # D-207-6;
c) Advil Caplets (Ibuprofen), 200mg,
165 count bottles, Pain Reliever/Fever
Reducer, Recall # D-208-6;
d) Advil Gel Caplets (Ibuprofen) 200mg,
165 count bottles, Pain Reliever/Fever
Reducer, Recall # D-209-6
CODE
a) A43015, A44820, A47109, A47128,
A49043, A49045, A51281, A51282, A51288,
A53439, A53451, A53475, A54750, A58552,
A58583, A64046, A64090, A66327, A66336,
A66340, A73274, A73280, A73301, A77169,
A77170, A82380, A82397, A82418, A86698,
A86700, A88360, A94538, A94547, and A94548;
b) A20744, A43135, A43136, A75133, A75247,
A76963, A80522, A80523, A80525, A80673,
A81563, A83977, A83981, A87708, A87798,
A87800, A94557, A94558, A99286, and A99287;
c) A44821, A49032, A51265, A53444, A58547,
A59282, A66298, A77177, A8699;
d) A73268, A85252, and A85254
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Rouses Point, NY, by letters on February 21, 2006.
Manufacturer: Wyeth Pharmaceuticals, Guayama, PR, firm initiated recall is ongoing.
REASON
The immediate container (bottle) label does not have warning statement for non-child resistant packaging -- "THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN".
VOLUME OF PRODUCT IN COMMERCE
2,826,666 bottles
DISTRIBUTION
Nationwide and HI

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

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PRODUCT
Achilles Tendon with Bone, Frozen, Irradiated, Recall # B-0610-6
CODE
Tissue 040484-018
RECALLING FIRM/MANUFACTURER
Community Blood Center, dba Community Tissue Services, Portland, OR, by e-mail on September 3, 2005 and by facsimile dated September 12, 2005, firm initiated recall is complete.
REASON
Human tissue, positive for Propionibacterium acnes on final culture after processing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue
DISTRIBUTION
Korea

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0721-6
CODE
Unit number: 20FZ22044
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Lewis and Clark Region, Boise, ID, by telephone on April 21, 2003.
Manufacturer: American National Red Cross, Missoula, MT, firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MT

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PRODUCT
a) Red Blood Cells, Recall # B-0722-6;
b) Cryoprecipitated AHF, Pooled,
Recall # B-0723-6;
c) Recovered Plasma, Recall # B-0724-6
CODE
a), b), and c) Unit number: 0633536
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, Cincinnati, OH, by letter dated January 4, 2005, firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of intravenous drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IN and OH

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PRODUCT
a) Red Blood Cells, Recall # B-0725-6;
b) Platelets, Recall # B-0726-6;
c) Cryoprecipitated AHF, Recall # B-0727-6
CODE
a), b), and c) Unit number: 12H21309
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by letter on July 28, 2000, firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MD, NC, and PR

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0728-6
CODE
Unit number: 040GN08023
RECALLING FIRM/MANUFACTURER
American National Red Cross, Heart of America, Peoria, IL, by telephone on November 22, 2005, firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0729-6
CODE
Unit number: 9050706
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC, by telephone on November 10, 2005, firm initiated recall is complete.
REASON
Platelets, with a platelet count above the firm's specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0733-6
CODE
Unit number: 36M71122
RECALLING FIRM/MANUFACTURER
American National Red Cross, South Carolina Region, Columbia, SC, by telephone on March 20, 2003, firm initiated recall is complete.
REASON
Blood product, manufactured from an overweight unit of Whole Blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0736-6
CODE
Unit number: 003LY14844
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on November 3, 2004, firm initiated recall is complete.
REASON
Platelets Pheresis, with an elevated platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

_______________________________
PRODUCT
Platelets Pheresis, Recall # B-0737-6
CODE
Unit number: 03KN18640
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on March 25, 2004, firm initiated recall is complete.
REASON
Platelets, inappropriately prepared by splitting the product into two storage bags instead of one, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0738-6
CODE
Unit number: 12W96818 (Part 1)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on October 20, 2004, firm initiated recall is complete.
REASON
Blood product, collected in an apheresis collection kit that exceeded the acceptable time period for use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

_______________________________
PRODUCT
Red Blood Cells, Irradiated, Recall # B-0739-6
CODE
Unit number: 9306695
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on January 10, 2006, firm initiated recall is complete.
REASON
Blood product, for which documentation of irradiation was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0742-6;
b) Red Blood Cells, Leukocytes Reduced,
Irradiated, Recall # B-0743-6;
c) Cryoprecipitated AHF, Recall # B-0744-6;
d) Fresh Frozen Plasma, Recall # B-0745-6;
e) Plasma, Frozen, Recall # B-0746-6;
f) Recovered Plasma, Recall # B-0747-6
CODE
a) Unit numbers: 03GS32813, 03GH28032;
b) Unit number: 03LM79071;
c) Unit number: 03GH28032;
d) Unit number: 03GS32813;
e) Unit number: 03GH28032;
f) Unit number: 03LM79071
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA,
by letter dated August 27, 1999, firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
CA, GA, and Switzerland

_______________________________
PRODUCT
Platelets, Leukocytes Reduced, Recall # B-0748-6
CODE
Unit number: 49GW24633
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southwest Region, Tulsa, OK, by telephone and facsimile on March 8, 2005, firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
a) Red Blood Cells, Washed, Recall # B-0749-6;
b) Recovered Plasma, Recall # B-0750-6
CODE
a) and b) Unit number: KC69321
RECALLING FIRM/MANUFACTURER
HCSC-Blood Center, Bethlehem, Pa, by facsimile on August 23, 2005 or by letter dated August 26, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for a history of intravenous (IV) drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ and PA

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0751-6
CODE
Unit number: 6879943
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by facsimile on December 9, 2004, firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as having been irradiated, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-0752-6;
b) Recovered Plasma, Recall # B-0753-6
CODE
a) Unit numbers: 1411853, 1410232;
b) Unit number: 1410232
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter dated March 21, 2005, firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from a donor with a history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NJ, TN, and TX

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-0755-6;
b) Platelets Pheresis, Leukocytes Reduced,
Recall # B-0756-6;
c) Recovered Plasma, Recall # B-0757-6
CODE
a) Unit numbers: 49LF64408, 49LF65369;
b) Unit numbers: 49LP11951, 49LP12030,
49LP12791;
c) Unit numbers: 49LF64408, 49LF65369
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southwest Region, Tulsa, OK, by letter dated January 4, 2005, firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information regarding multiple high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
CA, OK, TX, and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Irradiated, Recall # B-0758-6;
b) Platelets Pheresis, Leukocytes Reduced,
Irradiated, Recall # B-0759-6
CODE
a) Unit number: 6906034;
b) Unit number: 1410768
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by telephone on January 6, 2005, firm initiated recall is complete.
REASON
Blood products, for which documentation of irradiation was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0760-6
CODE
Unit numbers: 3026275, 5502066
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview, IL, by telephone on August 11, 2005.
Manufacturing Firm: LifeSource Hyde Park Donor Center, Chicago, IL, firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0785-6
CODE
Unit number: 027LW50207
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on September 6, 2005 and by letter on September 16, 2005, firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer one of the medical history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY

_______________________________
PRODUCT
Platelet Pheresis, Leukocytes Reduced, Recall # B-0800-6
CODE
Unit number: 6697433
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Sarasota, FL, by fax on October 12, 2004, firm initiated recall is complete.
REASON
Blood product, possibly contaminated with several skin contaminants, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0801-6
CODE
Unit number: 04710
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by letter dated November 29, 2005.
Manufacturer: Blood Systems Inc., Albuquerque, NM, 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
NM

_______________________________
PRODUCT
Plasma, Recall # B-0808-6
CODE
Unit number: 4705440
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on June 8, 2004, firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

_______________________________
PRODUCT
Platelets, Recall # B-0660-6
CODE
Unit number: GP80277
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by fax on October 15, 2005, firm initiated recall is complete.
REASON
Blood product, inadvertently contaminated with Optisol (AS-5), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0720-6
CODE
Unit numbers: G47666, G47671, J06012, J06070, L53552, L53567, S37262, S37337, S37397
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Center, Springfield, IL, by facsimile and letter on September 16, 2005, firm initiated recall is complete.
REASON
Blood products, mislabeled as leukocytes reduced, were distributed
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
IL

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0730-6;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-0731-6
CODE
a) Unit numbers: J02977, J03004, J02984,
J02991;
b) Unit number: J02997
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Center, Springfield, IL, by facsimile on September 28, 2005, firm initiated recall is complete.
REASON
Blood products, collected on a trip scale that was incorrectly calibrated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
IL

_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0732-6
CODE
Unit numbers: L53131, L53142, S35408
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Center, Springfield, IL, by facsimile on September 29, 2005, firm initiated recall is complete.
REASON
Blood products, which lacked assurance of proper shipping temperatures due to inaccurate documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IL

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-0734-6;
b) Recovered Plasma, Recall # B-0735-6
CODE
a) and b) Unit number: 36LP23987
RECALLING FIRM/MANUFACTURER
American National Red Cross, South Carolina Region, Columbia, SC, by telephone on November 12, 2003 and letter dated November 14, 2003, firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to receipt of the hepatitis B vaccination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and SC

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0740-6
CODE
Unit number: 6443076
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on December 8, 2005, firm initiated recall is complete.
REASON
Blood product, manufactured without the entire quantity of additive solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0741-6
CODE
Unit number: LH33536
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., Dba Rhode Island Blood Center, Providence, RI, by telephone on December 27, 2005, firm initiated recall is complete.
REASON
Blood product, manufactured without the entire quantity of additive solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0761-6
CODE
Unit number: FH24943
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by telephone on December 15, 2005.
Manufacturing Firm: Heartland Blood Centers Dekalb, Dekalb, IL, firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to the use of an antibiotic, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

_______________________________
PRODUCT
a) Platelets Pheresis Leukocytes Reduced,
Recall # B-0779-6;
b) Platelets Pheresis Leukocytes Reduced
Irradiated, Recall # B-0780-6
CODE
a) and b) Unit number: 38FX01910
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone on August 20, 2005 and by letter on August 22, 2005, firm initiated recall is complete.
REASON
Blood products, possible contaminated with coagulase-negative staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI

______________________________
PRODUCT
Platelets, Leukocytes Reduced, Recall # B-0791-6
CODE
Unit number: H18610, H18611, H18617, H18619, C67297
RECALLING FIRM/MANUFACTURER
South Bend Medical Foundation, South Bend, IN, by letter dated October 22, 2005, firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for the antibody to the human T-lymphotropic virus (anti-HTLV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
IN

_______________________________
PRODUCT
Source Plasma, Recall # B-0803-6
CODE
Unit number: SH047021
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Harrisburg, PA, by fax on November 1, 2005, firm initiated recall is complete.
REASON
Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
France

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
a) Powerlink System for Abdominal Aortic
Aneurysm (Endoluminal Bifurcated
Prosthesis with Delivery System)
Model No. 25-16-140BL, Recall #
Z-0589-06;
b) Powerlink System for Abdominal Aortic
Aneurysm (Endoluminal Bifurcated
Prosthesis with Delivery System)
Model No. 25-16-155BL, Recall #
Z-0590-06;
c) Powerlink System for Abdominal Aortic
Aneurysm (Endoluminal Bifurcated
Prosthesis with Delivery System)
Model No. 25-16-135BL, Recall #
Z-0591-06;
d) Powerlink System for Abdominal Aortic
Aneurysm (Endoluminal Bifurcated
Prosthesis with Delivery System)
Model No. 25-16-140BL, Recall #
Z-0592-06;
e) Powerlink System for Abdominal Aortic
Aneurysm (Endoluminal Bifurcated
Prosthesis with Delivery System)
Model No. 25-16-155BL, Recall #
Z-0593-06;
f) Powerlink System for Abdominal Aortic
Aneurysm (Endoluminal Bifurcated
Prosthesis with Delivery System)
Model No. 28-16-135BL, Recall #
Z-0594-06;
g) Powerlink System for Abdominal Aortic
Aneurysm (Endoluminal Bifurcated
Prosthesis with Delivery System)
Model No. 28-16-140BL, Recall #
Z-0595-06;
h) Powerlink System for Abdominal Aortic
Aneurysm (Endoluminal Bifurcated
Prosthesis with Delivery System)
Model No. 28-16-155BL, Recall #
Z-0596-06;
CODE
a) Lot # W05-0884;
b) Lot # W05-0909 and W05-0686;
c) Lot # W05-0511;
d) Lot # W05-0514 and W05-0969;
e) Lot # W05-0764;
f) Lot # W05-0512 and W05-0912;
g) Lot # 05-0513 and W05-883;
h) Lot # W05-0765
RECALLING FIRM/MANUFACTURER
Endologix, Inc., Irvine, CA, by telephone and letters on December 14, and 19-22, 2005, firm initiated recall is ongoing.
REASON
The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.
VOLUME OF PRODUCT IN COMMERCE
145 units
DISTRIBUTION
AZ, DE, KS, PA, and TN

_______________________________
PRODUCT
Baxter Auto Syringe AS50 Infusion Pump, product
code 1 M8550, Recall # Z-0612-06
CODE
Serial numbers 15060001AB, 15060002AB, 15060004AB/15060013AB, 15060015AB/15060021AB, 15060023AB/15060073AB, 15060075AB, 15060077AB/15060116AB, 15060116AB, 15060118AB/15060126AB, 15060128AB/15060130AB, 15060132AB/15060172AB, 15060174AB/15060209AB, 15070003AB/15070006AB, 15070008AB/15070018AB, 15070021AB, 15070023AB, 15070026AB/15070034AB, 15070037AB15070041AB, 15070044AB/15070047AB, 15070049AB/15070052AB, 15070056AB/15070059AB, 15070066AB, 15070069AB, 15070071AB, 15070072AB, 15070076AB, 15070077AB, 15070079AB, 15070081AB, 15070082AB, 15070084AB, 15070086AB, 15070087AB, 15070092AB, 15070094AB/15070096AB, 15070099AB, 15070101AB, 15070109AB, 15070111AB/15070115AB, 15070117AB, 15070119AB, 15070121AB, 15070122AB, 15070124AB, 15070126AB/15070128AB, 15070130AB/15070132AB, 15070138AB/15070140AB, 15070144AB
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated February 7, 2006.
Manufacturer: Baxter Healthcare Corp., Singapore, firm initiated recall is ongoing.
REASON
A non-conforming gasket was used in manufacturing of the specific pumps, causing the pumps to be more susceptible to electro-static discharge, which could increase the potential for the pump to fail during use and alarm.
VOLUME OF PRODUCT IN COMMERCE
282 pumps
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Large-Volume IV Administration Sets
for use with Deltec 3000 and Deltec
Micro 3100 Large Volume Infusion Pumps.
Model Number CC1301 (Reorder No.
21-0334-01)Primary Checkvalve set for
Secondary (piggyback) Administration.
Sterile, non-pyrogenic. Length 115
inch/292 cm, 27 ml priming volume,
20 drops/ml and 3 SureSite Prepierced
Injection sites, Recall # Z-0658-06;
b) Large-Volume IV Administration Sets
for use with Deltec 3000 and Deltec
Micro 3100 Large Volume Infusion Pumps.
Model Number RC4106 (Reorder No.
21-0402-25) Primary Administration Set.
Sterile, non-pyrogenic. Length 105
inch/267 cm, 25 ml priming volume,
20 drops/ml and 1 needless injection site,
Recall # Z-0659-06;
c) Large-Volume IV Administration Sets
for use with Deltec 3000 and Deltec
Micro 3100 Large Volume Infusion Pumps.
Model Number 8C290 (Reorder No.
21-0304-01) Speciality Administration Set.
Sterile, non-pyrogenic. Length 105
inch/267 cm, 25 ml priming volume,
20 drops/ml and 0 Injection sites,
PVC cassette, non-PVC lined tubing,
non-PVC drip chamber, Recall # Z-0660-06
CODE
a) Lot number: MAR04T22;
b) Lot number: FEB04T15;
c) Lot number: FEB04T06
RECALLING FIRM/MANUFACTURER
Smiths Medical MD, Inc., Saint Paul, MN, by telephone on December 8, 2005, firm initiated recall is complete.
REASON
Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely.
VOLUME OF PRODUCT IN COMMERCE
13 boxes for a total of 450 individual Administration Sets
DISTRIBUTION
SC, Australia, Canada and PR

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
a) Groshong nXt ClearVue 4 Fr
Single-Lumen PICC, Product
code 7617405, Recall # Z-0541-06;
b) Groshong nXt ClearVue 4 Fr.
Single-Lumen PICC, Product
Code 7617408, Recall # Z-0542-06;
c) Groshong nXt 5 Fr. Dual-Lumen
Reverse Taper PICC, Product
Code 7827508, Recall # Z-0543-06;
d) Groshong nXt 5 Fr. Dual-Lumen
Reverse Taper PICC, Product
Code 7927508, Recall # Z-0544-06
CODE
a) Lot # REPI0344;
b) Lot # REPI0738;
c) Lot # REPI0650;
d) Lot # REPI10649, REPI0911
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bard Access Systems, Inc, Salt Lake City, UT, by letter on December 20, 2005.
Manufacturer: Bard Reynosa S.A. De C.V., Reynosa, Mexico, firm initiated recall is ongoing.
REASON
Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions, possible complications, and insertion instructions.
VOLUME OF PRODUCT IN COMMERCE
1,848 units
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR MARCH 29 2006

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