• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Enforcement Report for December 7, 2005

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.

December 7, 2005
05-49

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

______________________________
PRODUCT
Minute Maid Fruit Punch, 20 oz, Recall # F-031-6
CODE
DEC1205 GR B
RECALLING FIRM/MANUFACTURER
The Coca-Cola Company (Corporate Offices), Atlanta, GA, by letter on/about September 15, 2005.
Manufacturer: Coca Cola Bottling Co, Hancock, MI. Firm initiated recall is complete.
REASON
The product is contaminated with yeast spoilage organisms.
VOLUME OF PRODUCT IN COMMERCE
5,233 cases
DISTRIBUTION
MI and OH

______________________________
PRODUCT
Canada Dry Club Soda, Recall # F-032-6
CODE
AUG2205DF
RECALLING FIRM/MANUFACTURER
The Coca-Cola Company (Corporate Offices), Atlanta, GA, by letter dated July 25, 2005.
Manufacturer: Coca Cola Bottling Co, Downey, MI. Firm initiated recall is ongoing.
REASON
The product has an off taste due to spoilage.
VOLUME OF PRODUCT IN COMMERCE
6,980 cases
DISTRIBUTION
CA

______________________________
PRODUCT
Lipton Brisk Lemon Iced Tea package in 12 ounce cans, Recall # F-033-6
CODE
Lot number: "FEB 13 06*** TG 080805 AX WVI. The *** indicates the processing hour in military time. Code is located on the bottom of the can.
RECALLING FIRM/MANUFACTURER
Pepsi Cola General Bottlers of Ohio Inc., Twinsburg, OH, by visit on beginning on August 19, 2005. Firm initiated recall is ongoing.
REASON
Canned iced tea contains excessive amounts of sodium.
VOLUME OF PRODUCT IN COMMERCE
6,393/12 can cases
DISTRIBUTION
OH

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

______________________________
PRODUCT
Furosemide Tablets, USP, 20 mg, 1000 tablets (white) bottles, NDC 0172-2908-80, Recall # D-034-6
CODE
Lot 136081 exp 3/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ivax Pharmaceuticals, Inc., Northvale, NJ, by letter on September 19, 2005.
Manufacturer: IVAX Pharmaceuticals, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
Adulterated; presence of foreign tablet (Labetolol Tablet 300 mg)
VOLUME OF PRODUCT IN COMMERCE
11,635 bottles
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Potassium Acetate Injection, USP, Concentrated, 200 mEq (4mEq/mL); 50 mL single dose vials, 25 vials per tray; Rx only, Sterile, For IV Use Only After Dilution, Recall # D-039-6
CODE
Lot 141218, exp. 3/06
RECALLING FIRM/MANUFACTURER
American Pharmaceutical Partners, Inc., Melrose Park, IL, by letters dated October 25, 2005. Firm initiated recall is ongoing.
REASON
Exceeds specification for Aluminum content (12 month stability)
VOLUME OF PRODUCT IN COMMERCE
6, 300 vials
DISTRIBUTION
Nationwide, Canada, and Hong Kong

_______________________________
PRODUCT
Pin-X Liquid, Pyrantel Pamoate (Pyrantel base 50mg/mL), 2 fl oz (60mL) bottles, Pinworm Treatment, Over The Counter, NDC 55806-024-11, Recall # D-041-6
CODE
Lot # 048G04A, exp 07/06
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC, Huntsville, AL, by letter dated October 14, 2005. Firm initiated recall is ongoing.
REASON
USP Antimicrobial Effectiveness Failure (12 month stability).
VOLUME OF PRODUCT IN COMMERCE
4,896 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

_______________________________
PRODUCT
a) Retin-A Cream (tretinoin) 0.05% tube,
45g and 20g. Supplied in aluminum tubes.
OrthoNeutrogena distributes the branded
product and under the Retin-A Brand description
while the non-branded product is distributed
by Clay Park (Perrigo) as Tretinoin Cream,
Rx only, Recall # D-037-6;
b) Retin-A Cream (tretinoin) 0.025% tube,
45g and 20g. Supplied in aluminum tubes.
OrthoNeutrogena distributes the branded
product and under the Retin-A Brand
description while the non-branded product
is distributed by Clay Park (Perrigo)
as Tretinoin Cream, Rx only, Recall # D-038-6
CODE
a) Lot 5HM496, exp. 07/07;
Lot 5HM488, exp. 07/07;
Lot 5HM503, exp. 07/07;
b) Lot 5HM500, exp. 07/07;
Lot 5HM499, exp. 07/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pharmaceutical Sourcing Group, Raritan, NJ, by letter on October 28, 2005.
Manufacturer: Ortho Pharmaceutical, Manati, PR. Firm initiated recall is ongoing.
REASON
Microbial Contamination
VOLUME OF PRODUCT IN COMMERCE
29,624 tubes
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Scalp Ointment with 1% Hydrocortisone in the following sizes: 1 oz. plastic jar (item #FL7301), 16 oz. plastic jar (item #FL7316) and 1 gallon plastic bottle (item #FL73128). Recall # D-040-6
CODE
Lot # 07051149
RECALLING FIRM/MANUFACTURER
Coats Aloe International, Inc., Garland, TX, by telephone on November 15, 2005 and by letters on November 16, 2005. Firm initiated recall is ongoing.
REASON
Misbranding: Labeling is not in compliance with regulations.
VOLUME OF PRODUCT IN COMMERCE
116 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_______________________________
PRODUCT
Source Plasma, Recall # B-0184-6
CODE
Unit numbers: 6270381821, 6270381418, 6270380674, 6270380249, 6270379568, 6270379170, 6270377555, 6270377101, 6270376414, 6270375969, 6270375192, 6270374813, 6270374026, 6270373636, 6270372843, 6270372443, 6270371674, 6270371287, 6270370465, 6270370035, 6270369240, 6270368849, 6270368015, 6270367596, 6270365483, 6270365068, 6270364213, 6270363871, 6270363021, 6270362838, 6270361215, 6270360327, 6270360016, 6270350351, 6270349508, 6270349033, 6270348259, 6270347785, 6270347050, 6270346566, 6270345680, 6270345191, 6270344306, 6270341700, 6270341321, 6270340504, 6270340050, 6270339202, 6270338689, 6270337820, 6270337307, 6270336443, 6270335930, 6870335263, 6270334646, 6270333871, 6270333359, 6270332476, 6270331966, 6270331024, 6270330492, 6270329730, 6270328255, 6270327768, 6270326851, 6270326520
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma Inc., South Salt Lake City, UT, by fax on June 15, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was illiterate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
66 units
DISTRIBUTION
NC

_______________________________
PRODUCT
Source Plasma, Recall # B-0328-6
CODE
Unit GBKMPT
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Oklahoma City, OK, by facsimile on May 19, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-0331-6;
b) Fresh Frozen Plasma, Recall # B-0332-6;
c) Recovered Plasma, Recall # B-0333-6
CODE
a) Unit numbers: 20W15154, 20K30417;
b) Unit number: 20W15154;
c) Unit number: 20K30417
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Lewis and Clark Region, Boise, ID, by telephone, facsimile, or letter on May 3, 2002.
Manufacturing Firm: American National Red Cross, Salt Lake City, UT. Firm initiated recall is ongoing.
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
4 units
DISTRIBUTION
CA and UT

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced,
Recall # B-0334-6;
b) Platelets Pheresis, Leukocytes Reduced,
Irradiated, Recall # B-0335-6
CODE
a) and b) Unit number: 20P23987
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Lewis and Clark Region, Boise, ID, by letter dated December 3, 2004.
Manufacturing Firm: American National Red Cross, Salt Lake City, UT. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom an arm scrub may not have been performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
UT

_______________________________
PRODUCT
Platelets Pheresis, Recall # B-0338-6
CODE
Unit number: 20P24595
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Lewis and Clark Region, Boise, ID, by letter dated February 16, 2005.
Manufacturing Firm: American National Red Cross, Salt Lake City, UT. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may compromise the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0343-6;
b) Fresh Frozen Plasma, Recall # B-0344-6;
c) Recovered Plasma, Recall # B-0345-6
CODE
a) Unit numbers: 0467592, 0468021, 0453519, 0451508,
0467604, 0468057, 0468045, 0468033, 0451223,
0451520, 0451352, 0451364, 0468977;
b) Unit numbers: 0467604, 0468057, 0468045, 0468033;
c) Unit numbers: 0467592, 0468021, 0468977
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter dated July 30, 1999. Firm initiated recall is complete.
REASON
Blood products, which tested initially reactive for an infectious disease on invalidated test runs, but subsequently tested negative on single repeat runs, were distributed.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
CO

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0346-6;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-0347-6;
c) Red Blood Cells, Leukocytes Reduced,
Irradiated, Recall # B-0348-6;
d) Recovered Plasma, Recall # B-0349-6
CODE
a) Unit numbers: 6119683, 6110223, 6102146, 6084539;
b) Unit number: 7002091;
c) Unit number: 6076841;
d) Unit numbers: 7002091, 6102146, 6076841, 6084539
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter on August 30, 2002. Firm initiated recall is ongoing.
REASON
Blood products, collected from a donor who had a non-confidential health history screening, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
CO, FL, IL, TN, and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0350-6;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-0351-6;
c) Red Blood Cells, Leukocytes Reduced,
Irradiated, Recall # B-0352-6;
d) Cryoprecipitated AHF, Recall # B-0353-6;
e) Fresh Frozen Plasma, Recall # B-0354-6;
f) Recovered Plasma, Recall # B-0355-6
CODE
a) Unit numbers: 6839154, 6329613, 6309409,
6305112, 0434659;
b) Unit numbers: 6323568, 6315026, 6312446,
0497940;
c) Unit number: 6836605;
d) Unit numbers: 6839154, 6836605;
e) Unit numbers: 6312446, 0497940, 0434659;
f) Unit numbers: 6839154, 6836605, 6834573,
6323568, 6315026, 6309409, 6305112
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter beginning on April 22, 2004. Firm initiated recall is ongoing.
REASON
Blood products, collected from a donor who had a non-confidential health history screening, were distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
CO, TN, UT, VA, WI, and Switzerland

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0357-6
CODE
Unit number: 0708448
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter on July 28, 2000. Firm initiated recall is ongoing.
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
CO

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0358-6
CODE
Unit number: 6303163
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter on September 18, 2000. Firm initiated recall is ongoing.
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
CO

_______________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-0361-6
CODE
Unit number: 0622675
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter or fax on December 7, 1999. Firm initiated recall is complete.
REASON
Blood product, which was not refrozen within one hour of preparation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0363-6
CODE
Unit number: 0647775
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter or fax on November 24, 1999. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may compromise the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0371-6
CODE
Unit numbers: 0667145 (Parts A & B)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter or fax on January 17, 2000. Firm initiated recall is complete.
REASON
Blood products, which yielded a platelet count that was below the acceptable limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0372-6
CODE
Unit number: 0595215 (Part B)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter on August 24, 1999. Firm initiated recall is complete.
REASON
Platelets Pheresis, with an elevated platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0379-6
CODE
Unit numbers: 4031304, 9262318
RECALLING FIRM/MANUFACTURER
Blood Bank of Delmarva, Inc., Newark, DE, by letter dated August 22, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Purinethol, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
DE

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

*****CORRECTION*****

ENFORCEMENT REPORT 05-48, November 30, 2005, Recall # B-0228-6, the unit number assigned to the Recovered Plasma unit in this recall is incorrect. The correct unit number is 7324670.

_______________________________
PRODUCT
Procleix HIV-1/HCV Assay, Recall # B-0169-6
CODE
Master Lot Number: 401254
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gen-Probe, Inc., San Diego, CA, by telephone on January 12, 2005, and January 14, 2005,and by letter dated January 17, 2005and January 18, 2005.
Manufacturer: Chiron Corporation, Emeryville, CA. Firm initiated recall is complete.
REASON
Procleix HIV-1/HCV test kits, with an elevated level of copper, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2.4 million kits distributed as 1,000 and 5,000 test kits
DISTRIBUTION
CA

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0323-6;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-0324-6;
c) Red Blood Cells Pheresis, Recall # B-0325-6;
d) Red Blood Cells Pheresis, Leukocytes
Reduced, Recall # B-0326-6;
e) Platelets, Leukocytes Reduced, Recall # B-0327-6
CODE
a) Unit numbers: 13GJ10793, 13GJ10794, 13GJ10795,
13GJ10796, 13GJ10798, 13GJ10799, 13GJ10802;
b) Unit numbers: 13FX26095, 13FX26096, 13FX26097,
13FX26098, 13FX26105, 13GP14889, 13GP14890,
13GP14893, 13GP14894, 13GP85344, 13GP85345,
13GQ85346, 13GQ85347, 13GQ85350, 13GQ85352,
13GQ85353, 13GQ85354, 13GQ85355, 13GQ85358,
13GQ85361, 13GQ85362, 13GQ85363, 13GQ85364,
13GQ85365, 13GQ85367, 13GQ85368, 13GQ85369,
13GQ85370, 13GQ85371, 13GQ85372, 13GQ85373,
13GQ85374, 13GQ85375, 13GQ85379, 13GQ85380,
13GQ85381, 13GQ85385, 13GQ85386, 13GS18331,
13GS18333, 13GS18334, 13GS18335, 13GS18337,
13GT08589, 13GT08590, 13GT08596, 13GT08597,
13GT08600, 13GT08603, 13GT08604, 13GT08605,
13GT08606, 13GT08607, 13GV63771, 13GV63774,
13GV63775, 13GV63776, 13GV63777, 13GV63780,
13GV63783, 13GV63784, 13GV63788, 13GV63789,
13GV63790, 13GV63791, 13GV63792, 13GV63794,
13GW47342, 13GW47343, 13GW47344, 13GW47347,
13GW47348, 13GW47349, 13GW47350, 13GW47351,
13GE32870, 13GE32872, 13GE32874, 13GE32878,
13GE32881, 13GE32885, 13GE32886, 13GE32887,
13GE32890, 13FX26162, 13FX26163, 13FX26165,
13FX26166, 13FX26167, 13FX26169, 13FX26170,
13FX26171, 13FX26177, 13FX26179, 13FX26181,
13FX26183, 13FX26184, 13FX26186, 13GQ85839,
13GQ85397, 13GQ85400, 13GQ85402, 13GQ85406,
13GQ85409, 13GQ85410, 13GQ85411, 13GQ85414,
13GQ85415, 13GQ85416, 13GQ85421, 13GQ85423,
13GQ85425, 13GQ85426, 13GQ85427, 13GX89259,
13GX89260, 13GX89261, 13GX89263, 13GX89264,
13GX89265, 13GX89266, 13GX89268, 13GX89269,
13GX89270, 13GX89271, 13GX89272, 13GX89273,
13GT08679, 13GT08680;
c) Unit numbers: 13GE32877 (split unit);
d) Unit numbers: 13GQ85395 (split unit),
13GQ85396 (split unit), 13GQ85403, 13GQ85412,
13GQ85418, 13GQ85419;
e) Unit numbers: 13GJ10793, 13GJ10794, 13GJ10795,
13GJ10796, 13GJ10797, 13GJ10798, 13GJ10799,
13GJ10802, 13GP14887, 13GP148888, 13GP14889,
13GP14890, 13GP14891, 13GP14892, 13GP14893,
13GP14894, 13GP14895, 13GS18331, 13GS18332,
13GS18333, 13GS18334, 13GS18335, 13GS18337,
13GT08589, 13GT08590, 13GT08592, 13GT08593,
13GT08595, 13GT08596, 13GT08597, 13GT08599,
13GT08600, 13GT08601, 13GT08603, 13GT08604,
13GT08605, 13GT08606, 13GT08607, 13GV63771,
13GV63773, 13GV63774, 13GV63776, 13GV63777,
13GV63778, 13GV63779, 13GV63780, 13GV63781,
13GV63783, 13GV63784, 13GV63785, 13GV63786,
13GV63788, 13GV63789, 13GV63790, 13GV63791,
13GV63792, 13GV63794, 13GW47342, 13GW47343,
13GW47344, 13GW47345, 13GW47347, 13GW47348,
13GW47349, 13GW47350, 13GW47351, 13GW47352,
13GW47353, 13GE32870, 13GE32872, 13GE328734,
13GE32874, 13GE32875, 13GE32876, 13GE32878,
13GE32880, 13GE32881, 13GE32882, 13GE32883,
13GE32884, 13GE32885, 13GE32886, 13GE32887,
13GE32888, 13GE32889, 13GE32890, 13FX26162,
13FX26163, 13FX26164, 13FX26166, 13FX26170,
13FX26173, 13FX26174, 13FX26180, 13FX26181,
13FX26182, 13FX26183, 13FX26184, 13FX26185,
13FX26186, 13GX89259, 13GX89260, 13GX89261,
13GX89262, 13GX89263, 13GX89264, 13GX89265,
13GX89266, 13GX89267, 13GX89268, 13GX89269,
13GX89270, 13GX89271, 13GX89272, 13GX89273
13GT08678
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by facsimile or telephone beginning on April 29, 2005. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
262 units
DISTRIBUTION
MI

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced,
Recall # B-0329-6;
b) Platelets Pheresis, Leukocytes Reduced,
Irradiated, Recall # B-0330-6
CODE
a) Unit numbers: 20R11824 (split unit), 20R11818
(split unit), 20R11811 (split unit), 20R11810
(split unit), 20R11807 (split unit), 20R11803,
20R11798;
b) Unit numbers: 20R11814 (split unit), 20R11803,
20R11798
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Lewis and Clark Region, Boise, ID, by letter dated June 8, 2001.
Manufacturing Firm: American National Red Cross, Salt Lake City, UT. Firm initiated recall is complete.
REASON
Blood products, which were labeled leukoreduced, but had an unacceptable white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
ID and UT

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-0336-6;
b) Fresh Frozen Plasma, Recall # B-0337-6
CODE
a) Unit numbers: 020F99102, 020K88325, 020M38931, 020M38932, 020S79914, 020T61934, 020S79918;
b) Unit numbers: 020S79914, 020S79918
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Lewis and Clark Region, Boise, ID, by telephone or facsimile on April 7, 2005.
Manufacturing Firm: American National Red Cross, Salt Lake City, UT. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CA and UT

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0356-6
CODE
Unit number: 6483568
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO by letter or fax on September 4, 2000. Firm initiated recall is complete.
REASON
Unlicensed blood product, labeled with the firm's license number, was distributed in interstate commerce.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

PRODUCT
a) Red Blood Cells, Recall # B-0359-6;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-0360-6
CODE
a) Unit number: 0493608;
b) Unit numbers: 0483640, 0493641
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter or fax on August 3, 1999. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly labeled as to the antigen typing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0362-6
CODE
Unit number: 6030991
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter or fax on September 21, 2000. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving information regarding a post-donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0364-6
CODE
Unit number: 0620264
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter or fax on September 2, 1999. Firm initiated recall is complete.
REASON
Blood product, possibly out of controlled storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0366-6
CODE
Unit number: 6424228
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter or fax on August 14, 2000. Firm initiated recall is complete.
REASON
Blood product, possibly out of controlled storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0367-6
CODE
Unit numbers: 0679172, 0705367, 6001525
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter or fax on March 13, 2000. Firm initiated recall is complete.
REASON
Blood products, possibly out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0368-6
CODE
Unit number: 0617059
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter or fax on August 18, 1999. Firm initiated recall is complete.
REASON
Blood product, possibly out of controlled storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0369-6
CODE
Unit number: 6391749
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter or fax on June 13, 2000. Firm initiated recall is complete.
REASON
Blood product, possibly out of controlled storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0370-6
CODE
Unit numbers: 0669869 (Part B), 0669922 (Parts A & B)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter or fax on January 27, 2000. Firm initiated recall is complete.
REASON
Blood products, which were labeled leukoreduced, but had an unacceptable white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0378-6
CODE
Unit number: 17KY62397
RECALLING FIRM/MANUFACTURER
American National Red Cross, North Central Region, St. Paul, MN, by letter dated March 18, 2003. Firm initiated recall is complete.
REASON
Blood product, which failed to meet the minimun specification for red blood cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

_______________________________

****DEVICE RECALL EXTENDED****

__________________________________
PRODUCT
Rusch/MMG Urinary Catheterization System, 14 Fr; the single use sterile kit contains a Rusch/MMG Intermittent Catheter, gauze tissue, povidone iodine swabs, two vinyl gloves and underpad; 100 kits per box; product number RLA-142-3, Recall # Z-1083-05
Originally reported in August 17, 2005 Enforcement Report.
CODE
Lot 002990-6, exp. 2007/03 and lot 002990-7, exp. 2007/02; the recall was expanded on 11/15/05 to include lot numbers 004622-3 and 004622-4
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Bannockburn, IL, by letters dated July 11, 2005.
Manufacturer: Teleflex Medical, Nueva Laredo, Mexico. Firm initiated recall is ongoing.
REASON
There is a lack of assurance of sterility for parts of these lots of product.
VOLUME OF PRODUCT IN COMMERCE
95,800 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Fleixiflo Quantum Enteral Pump, Recall # Z-0145-06
CODE
Serial numbers: 1003276, 1022603, 1025074, 1027378, 1028541, 1049161, 1056343, 1056908, 1057323, 1057967, 1058939, 1059103, 1059366, 1059614, 1059641, 1059857, 1059892, 1059945, 1060026, 1060188, 1061131, 1061355, 1061492.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Columbus, OH, by telephone and letter dated October 7, 2005. Firm initiated recall is ongoing.
REASON
Pumps have the potential to malfunction and result in a significant over-under delivery of enteral formula.
VOLUME OF PRODUCT IN COMMERCE
24 devices
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S, Recall # Z-0197-06
CODE
20220 STERRAO 100 Accessory Kit 1.8 20221 STERRAO 100 Accessory Kit 2.0 20222 STERRAO 100 Accessory Kit 2.0 Same as 20221 except single ply paper 20223 STERRAO 1 DOS Accessory Kit A (For use with Block 1.8 STERRAO 100S) 20224 STERRAO 1 DOS Accessory Kit B (For use with Block 2.0 STERRAO 1 DOS) 20225 STERRAO 100S Accessory Kit C (For use with Block 2.0 STERRAO System & Block 1.8 STERRAO with Printer Up Qrade kit install 03-53045- 1- 001 Vaporizer Plate, Shelf Pac 03-05660- 0- 001
RECALLING FIRM/MANUFACTURER
Advanced Sterilization Products, Irvine, CA, by letter on September 22, 2005. Firm initiated recall is ongoing.
REASON
The STERRAD 100 and the STERRAD 100S vaporizer plates are prone to displacement allowing micro-droplets of H2O2 to contact the load. If the vaporizer plate is dislodged, there is an increased chance for operators to have contact with H2O2 resulting in transient burns during the removal of the load.
VOLUME OF PRODUCT IN COMMERCE
5,365 kits
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
High voltage generator XTP-8100G and XTPG-8100G for the Infinx-I series interventional angiography system. Recall # Z-0198-06
CODE
All
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Med Systems, Inc., Tustin, CA, by letter on September 21, 2005. Firm initiated recall is ongoing.
REASON
Arcing might occur in the transformer of the high voltage generator, XTP-8100G and XTBP-8100G displaying an error message and interrupting fluoroscopy.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Baxter and Baxter Interlink Buretrol Solution Sets, a sterile fluid pathway of various lengths, 60 drops/mL, with 150 mL Burette Ball Valve, 2 injection sites and male luer lock adapter; Recall # Z-0199-06
CODE
All lots of product codes 2C7546(S) and 2C7566(S), as well as A2C7572, A2C9568 and A2C9584 for the Australian market, JC7566 for the Canadian market, and VMC9602P for the European market.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Round Lake, IL, by letters dated March 17, 2005.
Manufacturer: Baxter Healthcare Corporation of Puerto Rico, Aibonito, PR. Firm initiated recall is ongoing.
REASON
The Buretrol solution sets are currently labeled as acceptable for use with the Colleague Volumertric Pump, but there is a potential for a non-detection of an upstream occlusion under certain conditions.
VOLUME OF PRODUCT IN COMMERCE
7,507,494 sets
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Terumo Sarns brand Flexible arterial cannula, 7.5 mm (22 Fr) OD with 3/8 inch connector, suture ring, 9.5 inches (24 cm) long, catalog number 13020, sterile, single use only, Recall # Z-0200-06
CODE
Lot numbers: 0385384 and 0386969
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp, Ann Arbor, MI, by letter dated September 12, 2005 and by email or fax between
September 12, 2005 and September 14, 2005. Firm initiated recall is ongoing.
REASON
There may be a solvent bond failure at the tubing/connector site of the cannula, resulting in the disconnection of the cannula parts.
VOLUME OF PRODUCT IN COMMERCE
2,520
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) PROFlex Transporter, Model numbers 35PST.
Catalog number is PT3565, Recall # Z-0201-06;
b) PROFlex Transporter, Model numbes 35P.
Catalog number is PT3550, Recall # Z-0202-06
CODE
All serial numbers beginning with the letter "L" and followed by a sequence of six numbers
RECALLING FIRM/MANUFACTURER
Ferno-Washington Inc., Wilmington, OH, by letter dated March 28, 2003 and June 24, 2003. Firm initiated recall is ongoing.
REASON
The firm received complaints of the stretchers folding. A fold is when the stretchers lowers on its own to either the next position, or any of the other seven positions of the stretcher.
VOLUME OF PRODUCT IN COMMERCE
2,188 stretchers
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) AD5 table for use with Integris and
Integris Allura x-ray systems,
Recall # Z-0206-06;
b) AD6 table for use with Integris and Integris
Allura x-ray systems. The AD6 is the tilt
version. Recall # Z-0207-06;
c) AD5 table, modified, used with the XPER x-ray
systems. The modification on the table is the
cables used for connecting to the XPER systems.
Recall # Z-0208-06;
d) AD6 table, modified, used with the XPER systems.
The modification on the table is the cables used
for connecting to the XPER systems.
Recall # Z-0209-06
CODE
Site numbers for all tables/units: 68168, X0941, 17508, 76380, 519874, 67597, 37872, 100641, 101610, 41222, 84827, 520582, 13093, 76463, 52479, 52480, 52482, X1036, 44969, X1620, 38936, 44808, X1135, 10105, 6820, 6833, 44976, 44975, 44977, 62834, 80330, X0915, X1237, 44821, 44825, 83663, 83664, 83665, 41128, 250073, 41117, 83019, 17334, 17488, 76378, 537466, 100328, X1438, 62377, 62459, 17470, 17547, 76595, 59675, 73426, 73962, 85633, 85635, 505356, 59418, 62653, 62968, 62968, 86456, 85058, 105961, 531926, 62921, X0103, 103763, X1527, 13891, 13980, 13732, 38186, 533857, 38728, 62770, 41109, 535775, 59390, 506008, 85090, 74011, 38592, 537175, X1222, X1732, X1733, X0187, X1313, X1566, X0408, X1646, 26108, 104565, 534565, 82609, 82612, 85096, 26063, 505453, 59610, 59611, 520949, 86068, 26137, 103957, 17651, 76257, 76323, 10439, 10440, 13117, 44848, 10495, 86289, 10325, 17502, 530658, 101609, 37894, 37937, 100704, 87024, 17633, 103420, X0975, X1496, 101135, 504871, 101040, 25979, 38385, 82635, 82636, 82637, 82638, 82639, 37908, 82640, 25908, 62765, 83840, 13294, X0409, X1067, 35593, 82528, 10329, 76411, 84791, 67580, 41330, 83323, 37880, 37964, 73987, 38949, 41423, 41461, 41221, 3580, 44877, 86427, 50312, 38862, 85678, 67486, 45026, 85126, 85131, 47185, 38932, 85415, 73903, 44714, 62376, 86580, 505380, 50419, 83949, 62977, 87324, 13118, 13539, 13644, 100485, 62544, 62668, X1474, 83016, 82665, 74061, 82692, 87055, 86087, 103282, 103283, 103380, 86322, 76198, 504468, 6738, 6814, 530660, 101589, 86135, 17313, 84715, 84716, 35500, 52470, 522136, 102715, 104382, 102870, 103002, X0377, 62306, 83823, 103214, X0886, X1324, X0078, X1695, 87339, 26095, X1557, 86598, 10464, 76327, 76328, 76343, 76445, 86936, 102746, 104403, 86429, 100685, 86431, X0042, 40917, 538194, X1547, 6777, X1724, 83311, 83327, 86196, 44752, 104383, 104384, 17382, 62530, 40929, 10482, 102348, 38373, 17492, 17599, 534155, 76465, 46879, 76360, 76360, 76511, 76512, 68211, 87012, 35473, 38356, 76872, 13631, 102179, 13631, 13035, 82706, 50129, 102664, 103445, 104416, X1358, 13289, 41425, 102650, 59423, 38681, 506509, 38181, 38182, 62891, 84467, 13731, 38925, 38926, 83833, 47127, 13577, 17625, 84790, X1158, X1159, 44774, 50152, 73917, 82526, 62787, 83605, 101938, 13719, 100823, 86367, 45060, 532241, 505886, 82633, 82642, 86585, 86599, 17497, 82915, 38352, 83040, 44766, 83313, 100841, 68044, 68159, 531939, 38879, 38882, 38903, 38904, 38905, 38906, 38907, 41458, 87317, 87318, 38935, 67428, 68231, 82576, 38788, 38795, 59377, 41478, 41480, 102676, X1643, X1687, 506060, 250581, 505520, 50197, 504636, 504638, 13702, 13511, 13512, 85498, 86603, 14026, 14029, 26179, 82615, 59302, 38642, 59380, 59421, 59422, 59710, 520701, 86450, 85120, 38358, 38359, 47138, 76335, 68254, 68255, 40905, 500041, 50184, 31023, 35303, 35617, 41288, 52465, 52472, 86061, 530656, 102855, 85042, 76217, 17596, 76459, 6783, 6784, 6785, 86253, 537181, 100701, 86144, 536639, 10478, 533541, 82950, 37959, 85501, 59548, 38637, 85676, 101239, 62798, 101238, 519673, 10390, 38919, 85020, 102863, 86914, 86934, 534879, 41293, 41294, 86398, 103212, 103213, 6660, 67433, 76999, 87023, 102629, X0626, X1738, X1736, 505611, 86935, 6739, 76830, 100262, 101606, 101607, 86066, 100261, 85488, 41154, 41155, 86022, 100657, 37924, 62792, 86434, 83015, 17380, 35356, 17500, 76486, 535173, 83996, 85179, 534252, 41153, 47187, 17519, 13109, 76575, 76594, 85095, 86981, 17458, 17457, 17327, 83855, 38933, 76962, 83607, 86572, 26286, 45051, 100811, 76931, 76932, 76933, 82691, 35319, 35434, 83310, 59659, 104201, 86149, 41019, 47042, 17578, 82643, X1327, 250334, 102707, 38386, 38387, 13617, 13670, 14101, 519212, 76831, 519767, 534268, 534270, 86577, X0969, X0973, X0974, 44779, 50222, 50223, 50224, 83807, 86126, 50335, 100432, 13997, 13107, 102908, X0434, X0902, 100612, 83399, 83399, 505270, 76546, 76545, 59709, X0036, 13065, 83659, X0939, 102808, 102810, X1186, X0384, X0043, X1064, X1065, 519676, 101612, 59552, 38868, 38934, 38941, 68157, 74016, 41163, 41164, 84436, 47190, 10391, 35308, 101873, 26295, 59296, 41328, 41329, 84843, 521918, 62669, 87070, 76813, 13452, 76986, 86136, 76558, 76559, 76560, 102809, 85692, 47139, 62435, 62436, 62804, 101583, 62299, 62524, 83632, 101952, 82664, 102193, 100658, 83821, 86575, 506541, 50142, 82676, 530396, 44857, 82814, 83054, 50389, 50392, 38290, 86319, 40224, 45045, 40406, 41026, 105073, 101036, 101434, 38329, 85195, 505077, X0913, 102868, X0146, 41018, 84443, 82823, 504646, 82645, 10104, 82917, 101465, X1558, 532152, 10277, 62390, 62519, 62892, 100948, 38017, 505064, 13688, 14010, 83841, 85092, 87603, 85689, 74046, 82543, 100949, 100950, 500052, 534159, 87530, X1066, X1339, 82522, 50083, 25993, 85106, 35447, 100839, 59551, 59698, 59699, 38339, 47141, 47188, 86321, 38297, 38297, 35281, 100606, 100607, 83667, 86989, 17474, 17475, 76528, 13044, 83994, 537644, 86057, 62940, 45077, 532383, 37910, 35463, 86129, 86992, 13615, 100881, 62976, 13863, 14021, 102161, 505135, 100945, 82711, 38416, 38109, 38110, 84378, 73885, 83882, 44712, 85055, 10454, 10463, 10465, 85098, 6837, 41269, 85416, 38986, 519199, 80325, 45058, 45059, 103022, 506026, 17453, 76557, 85497, 26060, 101566, 67430, 38948, 102612, 76500, 62636, 62638, 62639, 86502, 86502, 13462, 531649, 38554, 59360, 534756, X1223, 68151, 13441, X1483, 102677, 250338, X0436, X1546, 102871, X1511, X0351, 13461, 535202, 13937, 13634, 52485, 38928, 505803, 505807, 44767, 44768, 50202, 82591, 13883, 100840, 41455, 41475, 13589, 13590, 13716, 13743, 13982, 85129, 26117, 85634, 86145, 62833, 13664, 13502, 13683, 40217, 102949, 103327, 6643, 76917, 86063, 84789, X0041, X0202, X0338, X1168, 102673, 532653, 13629, 13756, 6995, 6996, 6818, 50147, 534874, 25952, 17472, 17472, 41139, 504664, 6867, 86290, 41017, 86189, 17504, 17505, 76514, 519536, 535387, 533290, X0134, X0151, 6602, 83926, 38261, 85015, 100316, 6951, X0179, 521525, 76148, 100611, X1227, 86424, 74044, 17598, 13710, 62335, 85016, 86341, 6652, 6654, 38146, X1232, 103144, 86494, 83670, 86488, 13530, 84826, 25999, 84447, 25965, 25973, 26064, 100865, 68002, 82575, 26268, 101567, 59490, 73927, 101949, 101216, 76992, 38937, 38937, 68154, 68156, 76992, 506009, X0079, 250300, 250674, 17628, 26159, 26160, 26161, 52466, 82822, 41145, 101615, 101928, 74080, 41207, 52488, 521313, 84852, 62557, 41355, 533397, 44820, 504655, 38918, 84734, 85008, 536471, 535250, X0063, X0066, 25992, 25935, 25948, 25989, 25992, 38376, 38377, 38378, 38406, 86169, 86170, 86171, 26204, 101110, 25895, 26218, 102243, 83309, 522224, 82539, 50180, 505252, 62483, 59434, 85639, 10313, 85010, 85011, 6946, 85018, 534786, 62528, 100496, 87315, 519136, 13259, 38757, 26048, 520623, X0104, X1389, 87334, 102096, 38916, 76987, X1341, 13043, 62559, 62871, 87300, 520688, 86576, 35441, 521562, 86420, 86420, 85107, 38789, X0683, 13046, 13699, 13992, 13993, 76214, 76460, 76462, 83924, 86495, 76489, 76490, 62648, 102032, 59364, 14147, 76527, 62955, 82709, X1584, 522456, 62320, 13482, 102158, 59557, 82517, 82592, 82523, 73912, X1269, X0712, 62238, 44791, 44966, 17291, 86295, 62975, 86537, 87316, 532148, 82699, 84752, X0978, X1164, 59501, 59383, 83842, 83875, 45066, 83024, 76365, 76324, 84489, 41460, 67628, 82572, 534380, X1699, 76520, 505250, 44854, 50125, 50388, 534108, 68214, 35410, 35411, 62920, 83081, 47269, 83013, 83028, 62649, 62651, 62967, 82909, 38964, 68171, 85409, 520964, 50203, 102523, 44327, 38355, 101617, 101618, 86982, 85197, 100812, 83993, 41079, 84821, 50310, 82593, 52464, 101564, 62340, 85499, 62835, 86540, 44946, 101160, 6849, 101205, 76497, 67587, 76955, 82537, 82577, 105908, 37923, 38028, 38062, 38204, 38205, 82661, 506121, 86433, 13990, 13106, 13108, 17529, 76454, 76547, 76574, 76576, 76577, 85087, 101945, 35489, 100470, X0044, 26006, 26007, 26094, 533848, 104325, X1484, X1498, 87528, 41116, X1185, 6571, 62424, 86435, 13734, X1494, 506655, 85137, 85190, X0051, 59396, 83863, 520189, 101037, 41114, 41115, 83023, 101619, 10441, 38733, 100645, 87081, 82824, 85640, X1637, X1315, X1316, X1688, 86505, 101575, 86422, 41406, 52451, 41374, 31001, 41191, 532218, 86088, 505804, 41103, 41104, X1335, X1499, 519678, 41150, 41242, 100783, 52476, 52477, 59275, 83861, 83862, 38573, X0069, X1665, 83322, 83324, 44689, 50371, 50373, 50405, 102572, X1146, 102098, 13113, 84714, 50231, 87004, 101430, 86994, 52463, X0040, 104480, 14068, 103034, 25998, 26076, 62999, 59703, 87337, X1486, X1491, X1493, 38754, 102714, 102790, 505680, 59520, 505008, 13570, 14168, 100585, 102418, 82945, 100869, 76525, X0374, X1684, 47089, 531758, 102094, 76953, 105866, X1528, 83822, 82696, 84445, 38276, 102180, X1794, 101077, X1228, 100475, 14044, 84721, 26062, 38425, 38426, 102817, 85128, 38718, 38719, 536173, 85641, 13114, 13685, 84487, 26069, 26073, 84481, 100486, 100487, X0017, 103447, 38702, 38703, 38704, 38705, 62998, 17369, 37883, 37884, X1476, 59311, 83834, 86421, 26217, 62942, 62948, 85004, 13628, 13720, 85013, 100630, 13240, 13595, 13596, 103005, 76521, 76522, 44697, 50433, 62625, 62806, 86419, 14145, 102842, 101078, 105422, 13484, 76397, 76398, 530464, 530668, 505650, 10166, 13242, 13485, 13914, 13915, 41027, 13463, 13878, 10431, 13627, 13689, 13633, 13639, 102160, 102162, 13890, X1235, 103255, 38336, 520840, X0893, 82916, 76133, 40344, 520526, 38531, 38532, 38533, 59391, 82542, 76832, 76873, 6778, 6949, 532240, 100521, 44860, 25964, 26072, 519730, 84823, 84845, 504908, 38203, 38206, 37988, 38201, 40389, 40390, 10430, 13296, 13599, 80310, 80315, 100656, 76442, 86971, 86972, 62627, 62628, 44791, 13292, 102166, 84998, 87084, X1717, X1718, X0016, X0767, X1246, 13483, 13941, 13592, 85057, 50030, 86360, 6917, 6547, 6770, 6875, 6876, 6911, 76870, 44896, 50187, 85150, 85169, 25835, 13562, 13954, 13994, 50305, 50306, 40938, X1716, 10442, 76443, 76342, 102001, 85041, 91650, 6733, 86975, 76325, 100696, 102000, 506693, 76918, 519868, 10288, 100862, 100861, 100864, X1492, X0093, 37970, 26061, 38389, 87319, 17612, 76505, 50438, 82520, 82521, 82719, 82514, 84713, 38199, 44973, 76572, 506069, 76580, 44971, 44972, 59300, 62773, 25950, 59400, 26293, 101073, 85135, 45104, 41129, 47006, 86332, 62460, 62969, 44763, 73988, 85643, 44719, 40132, 41028, 101620, 82825, 10100, 47110, 532234, 103182, 100610, 82589, 62339, 104410, X1035, 38080, 59366, 86991, 86993, 102869, 85638, 45072, 100961, 86252, 519118, 38437, 505706, 6821, 35427, 35485, 80305, 44978, 50145, 50339, 83904, 500004, 13519, 13557, 86536, 86542, 6753, 84828, 84829, 102823, 10414, 76867, 44844, 44842, 44845, 44850, 505068, 82812, 25849, 41224, 76883, 76884, 76885, 76886, 102083, 102995, X0731, 80320, 80322, 80323, X1685, X1686, 102037, 6607, 6869, 6962, 102038, 59527, 73950, 74012, 74013, 50185, 50186, 534545, 13534, 87366, X1224, 100719, 103015, 40307, 50332, 17626, 17627, 76084, 38755, 62637, 62786, 62803, 59271, 59310, 59373, 62655, 87068, 87069, 41141, 530466, 76395, 76471, 521154, 13230, 104341, 102632, 13290, 76941, 76503, 76504, 62805, 62606, 102874, 104345, 41479, 62493, 62531, 45047, 45048, 41176, 41268, 100683, 47106, 100327, 100875, 105684, 44740, 50374, 50375, 101208, 86506, 59379, 44698, 44886, 44809, 26158, 59368, 6957, 76510, 17514, 76455, 10403, 13503, 62521, 6967, 50311, 50345, 102558, 86065, 76387, 250333, X1342, 41050, 38790, 38792, 531799, 103211, 85196, 62521, 506369, 519196, 521310, 47168, 47169, 47046, 47140, 87013, X1596, 86581, 62386, 101966, 13910, 26109, 6803, 6839, 85070, 76389, 35488, 519981, 41020, 41021, 85130, 40131, 100788, 76555, 41430, 76995, 102778, 520756, 506469, 85133, 35450, 41405, 41409, 41411, 35318, 41151, 41266, 80327, 100613, 35354, 35448, 41178, 41267, 41336, 41340, 41341, 41385, 103147, 86539, 86538, 83026, 38298, 6944, 76880, 76882, 6788, 86953, 41272, 59346, 535777, 10455, 10462, 13575, 13605, 504868, 6671, 59301, 82815, 86578, 86583, 86584, 83927, 73908, 26288, 26289, 62772, 44784, 83838, X1525, X0889, 76346, 17528, 62508, 62774, 62775, 62776, 62779, 62671, 86437, 87364, 506048, 62670, 62941, 86415, 100714, 35436, 35505, 41335, 76184, 74053, 73963, 82608, 41424, 86172, 533394, 534131, 86272, 87179, 101973, 505363, X0609, X0610, X1268, 83326, 25974, 26144, 26264, 504344, 101309, 83375
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co, Phillips, Bothell, WA, by letter on October 10, 2005.
Manufacturer: Philips Medical Systems, Netherlands. Firm initiated recall is ongoing.
REASON
Potential for high voltage exposure involving the injector interface connector of patient support tables.
VOLUME OF PRODUCT IN COMMERCE
1,793 devices
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) CryoValve, Alt Aortic Valve & Conduit,
Donor #30436, Model #AV05, Donor #30676,
Model #AV05, Recall # Z-0210-06;
b) CryoValve, Alt Pulmonary Valve, Donor
#29892, Model #PV15, Recall # Z-0211-06;
c) CryoValve, Alt Pulmonary Valve & Conduit,
Donor #28776, Model #PV05, Donor #29275,
Model #PV05, Donor #30815, Model #PV05,
Recall # Z-0212-06;
d) CryoValve, Aortic Valve, Donor #28956,
Model #AV10, Recall # Z-0213-06;
e) CryoValve, Aortic Valve & Conduit, Donor #29051,
Model #AV00, Donor #67609, Model #AV00,
Donor #68422, Model #AV00, Donor #69368,
Model #AV00, Donor #69826, Model #AV00,
Donor #69934, Model #AV00, Donor #30373,
Model #AV00, Recall # Z-0214-06;
f) CryoValve, Aortic Valve & Conduit SG,
Donor #66126, Model #SGAV00, Donor #66858,
Model #SGAV00, Donor #67001, Model #SGAV00,
Donor #67404, Model #SGAV00,
Recall # Z-0215-06;
g) CryoValve, Pulmonary Valve, Donor #29558,
Model #PV10, Recall # Z-0216-06;
h) CryoValve, Pulmonary Valve & Conduit,
Donor #68206, Model #PV00, Donor #68241,
Model #PV00, Donor #68422, Model #PV00,
Donor #69368, Model #PV00, Donor #69826,
Model #PV00, Donor #69934, Model #PV00,
Donor #67086, Model #PV00, Donor #30309,
Model #PV00, Recall # Z-0217-06;
i) CryoValve, Pulmonary Valve & Conduit SG,
Donor #65569, Model #SGPV00, Donor #66126,
Model #SGPV00, Donor #67001, Model #SGPV00,
Donor #67404, Model #SGPV00, Donor #61482,
Model #SGPV00, Donor #66320, Model #SGPV00,
Donor #66035, Model #SGPV00, Recall # Z-0218-06
CODE
a) Serial #6230415, Serial #6231586;
b) Serial #6202748,
c) Serial #6162886, Serial #6180566, Serial #6235387;
d) Serial #6169392;
e) Serial #6170536, Serial #7966771, Serial #8047328,
Serial #8022381, Serial #8071460, Serial #8059698,
Serial #6216684;
f) Serial #8111039, Serial #7988012, Serial #7996690,
Serial #7972081;
g) Serial #6190065;
h) Serial #7960244, Serial #7971710, Serial #8047344,
Serial #8022398, Serial #8047344, Serial #8022398,
Serial #8071361, Serial #8059703, Serial #7993957,
Serial #6218156;
i) Serial #7949899, Serial #8111048, Serial #7996682,
Serial #7972091, Serial #7692521, Serial #8099887,
Serial #8103460
RECALLING FIRM/MANUFACTURER
Cryolife Inc, Kennesaw, GA, by letter starting November 17, 2003. Firm initiated recall is ongoing.
REASON
Previously released tissues no longer meet CryoLife's enhanced suitability release criteria because donors possessed a positive post processing microbiological culture of "potentially pathogenic" organisms.
VOLUME OF PRODUCT IN COMMERCE
34 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part: "***LeMaitre VASCULAR** FL 33713***Pruitt Aortic Occlusion Catheter***REF 2101-12***STERILE***", Recall # Z-0219-06
CODE
Lot No: 1010505-07, 1010505-08, 1030404-09, 104104-05, 1041404-06, 1042204-12, 1042704-01, 1042704-03, 1052204-01, 1061404-04, 1061404-05, 1070204-03, 1080204-08, 1082304-06, l100604-01, l100704-01, l120104-02, l121604-04
RECALLING FIRM/MANUFACTURER
LaMaitre Vascular, Inc., St Petersburg, FL, by letter on May 17, 2005. Firm initiated recall is ongoing.
REASON
LeMaitre Vascular is recalling certain lots of its Pruitt Aortic Occlusion Catheters due to a packaging defect which could compromise product sterility.
VOLUME OF PRODUCT IN COMMERCE
1,919 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) Advisor Vital Signs Monitor (model 9200),
catalog number 920634235, with Impedance
Respiration board (optional circuit board,
P/N: 80004B1) installed manufactured with
Rev 10 Main boards (P/N: 80002B1)with 3-lead
60 Hz ECG, standard SPO2 option, printer
and battery, Recall # Z-0220-06;
b) Advisor Vital Signs Monitor (model 9200),
catalog number 920654230, with Impedance
Respiration board (optional circuit board,
P/N: 80004B1) installed manufactured with
Rev 10 Main boards (P/N: 80002B1) with 3-lead
60 Hz ECG, standard SPO2 option, and printer;
Recall # Z-0221-06;
c) Advisor Vital Signs Monitor (model 9200),
Catalog number 920654235, with Impedance
Respiration board (optional circuit board,
P/N: 80004B1) installed manufactured with
Rev 10 Main boards (P/N: 80002B1) with 3-lead
60 Hz ECG, standard SPO2 option, printer and
battery, Recall # Z-0222-06;
d) Advisor Vital Signs Monitor (model 9200),
catalog number 920654335, with Impedance
Respiration board (optional circuit board,
P/N: 80004B1) installed manufactured with
Rev 10 Main boards (P/N: 80002B1)3-lead 60
Hz ECG, standarn SPO2, Invasive pressure/
temperature option, printer and battery,
Recall # Z-0223-06;
e) Advisor Vital Signs Monitor (model 9200),
catalog number 920655235, with Impedance
Respiration board (optional circuit board,
P/N: 80004B1) installed manufactured with
Rev 10 Main boards (P/N: 80002B1) 3-lead
60 Hz ECG, Nellcor SPO2 option, printer
and battery, Recall # Z-0224-06;
f) Advisor Vital Signs Monitor (model 9200),
catalog number 920754235, with Impedance
Respiration board (optional circuit board,
P/N: 80004B1) installed manufactured with
Rev 10 Main boards (P/N: 80002B1) 5-lead
60 Hz ECG, standard SPO2 option, printer
and battery, Recall # Z-0225-06;
g) Advisor Vital Signs Monitor (model 9200),
catalog number 925454220, with Impedance
Respiration board (optional circuit board,
P/N: 80004B1) installed manufactured with
Rev 10 Main boards (P/N: 80002B1) CE/MDD
marking, 3-lead 50 Hz ECG and standard SPO2
option, Recall # Z-0226-06;
h) Advisor Vital Signs Monitor (model 9200),
catalog number 925454225, with Impedance
Respiration board (optional circuit board,
P/N: 80004B1) installed manufactured with
Rev 10 Main boards (P/N: 80002B1) CE/MDD
marking, 3-lead 50 Hz ECG, Standard SPO2
option and battery, Recall # Z-0227-06;
i) Advisor Vital Signs Monitor (model 9200),
catalog number 925454325, with Impedance
Respiration board (optional circuit board,
P/N: 80004B1) installed manufactured with
Rev 10 Main boards (P/N: 80002B1) CE/MMD
marking, 3-lead 50 Hz ECG, standard SPO2
option, Invasive Pressure/Temp option and
battery, Recall # Z-0228-06;
j) Advisor Vital Signs Monitor (model 9200),
catalog number 925454335, with Impedance
Respiration board (optional circuit board,
P/N: 80004B1) installed manufactured with
Rev 10 Main boards (P/N: 80002B1) EC/MDD
marking, 3-lead 50Hz ECG, standard SPO2
option, Invasive Pressure/Temperature
option, printer and battery,
Recall # Z-0229-06;
k) Advisor Vital Signs Monitor (model 9200),
catalog number 925474335, with Impedance
Respiration board (optional circuit board,
P/N: 80004B1) installed manufactured with
Rev 10 Main boards (P/N: 80002B1) CE/MDD
marking, 3-lead 50 Hz ECG, standard SPO2
option, Invasive Pressure/Temperature
option, printer and battery,
Recall # Z-0230-06;
l) Advisor Vital Signs Monitor (model 9200),
catalog number 925534325, with Impedance
Respiration board (optional circuit board,
P/N: 80004B1) installed manufactured with
Rev 10 Main boards (P/N: 80002B1) CE/MDD
marking, 5-lead 50 Hz ECG, standard SPO2
option, Invasive Pressure/Temperature and
battery, Recall # Z-0231-06;
m) Advisor Vital Signs Monitor (model 9200),
catalog number 925654320, with Impedance
Respiration board (optional circuit board,
P/N: 80004B1) installed manufactured with
Rev 10 Main boards (P/N: 80002B1) CE/MDD
marking, 3-lead 60 Hz ECG, standard SPO2
option and Invasive Pressure/Temperature
option, Recall # Z-0232-06;
n) Advisor Vital Signs Monitor (model 9200),
catalog number 925654335, with Impedance
Respiration board (optional circuit board,
P/N: 80004B1) installed manufactured with
Rev 10 Main boards (P/N: 80002B1) CE/MDD
marking, 3-lead 60 Hz ECG, standard SPO2
option, Invasive Pressure/Temperature
option, printer and battery,
Recall # Z-0233-06;
o) Advisor Vital Signs Monitor (model 9200),
catalog number 925674325, with Impedance
Respiration board (optional circuit board,
P/N: 80004B1) installed manufactured with
Rev 10 Main boards (P/N: 80002B1) CE/MDD
marking, 3-lead 60 Hz ECG, standard SPO3
option, Invasive Pressure/Temperature and
battery, Recall # Z-0234-06;
p) Advisor Vital Signs Monitor (model 9200),
catalog number 925754220, with Impedance
Respiration board (optional circuit board,
P/N: 80004B1) installed manufactured with
Rev 10 Main boards (P/N: 80002B1) CE/MDD
marking, 5-lead 60 Hz ECG and standard
SPO2 option, Recall # Z-0235-06;
q) Advisor Vital Signs Monitor (model 9200),
catalog number 925754225, with Impedance
Respiration board (optional circuit board,
P/N: 80004B1) installed manufactured with
Rev 10 Main boards (P/N: 80002B1) CE/MDD
marking, 5-lead 60 Hz ECG, standard SPO2
and battery, Recall # Z-0236-06;
r) Advisor Vital Signs Monitor (model 9200),
catalog number 925754325, with Impedance
Respiration board (optional circuit board,
P/N: 80004B1) installed manufactured with
Rev 10 Main boards (P/N: 80002B1) CE/MDD
marking, 5-lead 60 Hz ECG, standard SPO2
option, Invasive Pressure/Temperture option,
printer and battery, Recall # Z-0237-06;
s) Advisor Vital Signs Monitor (model 9200),
catalog number 92D654335, with Impedance
Respiration board (optional circuit board,
P/N: 80004B1) installed manufactured with
Rev 10 Main boards (P/N: 80002B1) 3-lead
60 Hz ECG, standard SPO2 option, Invasive
Pressure/Temperature, printer and battery,
Recall # Z-0238-06;
t) Advisor Vital Signs Monitor (model 9200),
catalog number 92D754335, with Impedance
Respiration board (optional circuit board,
P/N: 80004B1) installed manufactured with
Rev 10 Main boards (P/N: 80002B1) 5-lead
60 Hz ECG, standard SPO2 option, invasive
Pressure/Temperature, printer and battery,
Recall # Z-0239-06;
u) Advisor Vital Signs Monitor (model 9200),
catalog number 92E654335, with Impedance
Respiration board (optional circuit board,
P/N: 80004B1) installed manufactured with
Rev 10 Main boards (P/N: 80002B1) 3-lead
60 Hz ECG, standard SPO2 option, invasive
Pressure/Temperature option, printer and
battery, Recall # Z-0240-06
CODE
a) AM05070149, AM05070150, AM05070151;
b) Serial number: AM05070100, AM05070101,
AM05070102, AM05070103, AM05070104, AM05070105,
AM05070106, AM05070107, AM05070108, AM05070109,
AM05070110, AM05070111 and AM05070112;
c) Serial number: AM05070166;
d) Serial number: AM05070144;
e) Serial numbers: AM05070146; AM05070147,
AM05070148; AM0580001, AM0580002, AM0580003,
AM0580004, AM0580005, AM0580006 and
AM0580007;
f) Serial numbers AM05070167 and AM05070168;
g) Serial number: AM05070061;
h) Serial number: AM05070145;
i) Serial numbers: AM05070083, AM05070084,
AM05070085, AM05070086, AM05070087
and AM05070089;
j) Serial numbers: AM05080012 and AM05080013;
k) Serial numbers: AM05080008, AM05080009,
AM05080010 and AM05080011;
l) Serial numbers: AM05070039, AM05070043,
AM05070044, AM05070045, AM05070046,
AM05070047, AM05070048, AM05070049,
AM05070050, AM05070051 and AM05070052;
m) Serial numbers: AM05070196, AM05070197,
AM05070198, AM05070199, AM05070200,
AM05070201, AM05070202, AM05070203,
AM05070204, AM05070205 and AM05080023;
n) Serial numbers: AM05070171, AM05070172,
AM05070173, AM05070174 and AM05070175;
o) Serial numbers: AM05070113, AM05070114,
AM05070115, AM05070116, AM05070117,
AM05070118, AM05070119, AM05070120,
AM05070121 and AM05070122;
p) Serial number: AM05070123;
q) Serial number: AM05070169 and AM05070170;
r) Serial numbers: AM05070124, AM05070125,
AM05070126, AM05070127, AM05070130,
AM05070131, AM05070132, AM05070133,
AM05070134, AM05070135, AM05070221,
AM05070222, AM05070224, AM05070225,
AM05070226, AM05070227, AM05070228,
AM05070229, AM05070230 and AM05070231;
s) Serial number: AM05070136;
t) Serial number: AM05070143;
u) Serial number: AM05080016
RECALLING FIRM/MANUFACTURER
Smiths Medical PM, Inc., Waukesha, WI, by email or telephone beginning September 1, 2005. Firm initiated recall is ongoing.
REASON
Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor.
VOLUME OF PRODUCT IN COMMERCE
107 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right, Catalog 3220-0320S and 125 degree catalog number 3225-0360S, Recall # Z-0241-06.
CODE
Lot code K949396, Lot code K949408
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter on November 22, 2004.
Manufacturer: Stryker Trauma, Kiel, Germany. Firm initiated recall is complete.
REASON
The Gamma Nail manufactured with an incorrect lag screw hole angulation. Catalog number 3220-0320S, Lot code K949396 was manufactured with a lag screw hole angulation of 120 degrees instead of 125 degrees. Catalog number 3225-0360S, Lot code K949408 was manufactured with a lag screw hole angulation of 125 degrees instead of 120 degrees.
VOLUME OF PRODUCT IN COMMERCE
19 kits
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Portex 4902 Glass L.O.R. Syringe,
Recall # Z-0242-06;
b) Portex 4903 Glass L.O.R. Syringe,
Recall # Z-0243-06;
c) Portex 4904 Glass L.O.R. Syringe,
Recall # Z-0244-06;
d) 4950-16 Portex Epidural Mini-pack,
Recall # Z-0245-06;
e) 4950-17 Portex Epidural Mini-pack,
Recall # Z-0246-06;
f) 4950-18 Portex Epidural Mini-pack,
Recall # Z-0247-06;
g) 4954-16 Portex Epidural Mini-pack,
Recall # Z-0248-06;
h) 4954-17 Portex Epidural Mini-pack,
Recall # Z-0249-06;
i) A1272-17 Portex Epidural Mini-pack,
Recall # Z-0250-06;
j) A1378-18 Portex Epidural Mini-pack,
Recall # Z-0251-06;
k) A1967-18 Portex Epidural Mini-pack,
Recall # Z-0252-06;
l) A1991-18 Portex Epidural Mini-pack,
Recall # Z-0253-06;
m) A2549-22 Spinal Needle, Recall # Z-0254-06;
n) A3176-18 Portex Epidural Mini-pack,
Recall # Z-0255-06;
CODE
a) Lot Numbers; 102151, 103108, 103218,
K132627, K148054, K156266, K163449,
K176543, K197127, K211492, K535999,
K555552, K586403, K626840, K667012,
K678478, K705482;
b) Lot Numbers: 102517, K154089, K211495,
K222113, K512485, K522220, K538711,
K559480, K573554, K618300, K643592,
K669735, K686834, K700785;
c) Lot Numbers: 102518, K163468, K176555,
K510385, K520203, K529939, K532723, K533729,
K586882, K633942, K675421, K676747, K681955,
K682698;
d) Lot Numbers: 101219, 103102, 105025, 106337,
109045, 110699, 111198, K110057, K110924,
K124484, K128817, K132629, K141382,
K144904, K147200, K148053, K157883,
K160686, K163440, K189808, K211510,
K221874, K511628 4950-17;
e) Lot Numbers: 101146, 101452, 105024,
107076, 109224, 111199, K110058,
K121072, K124485, K128818, K132630,
K141613, K143220, K147085, K151519,
K163451, K180107, K189821, K211507,
K223552, K527934, K541698, K558498,
K598204, K632932, K638749, K642968,
K656458, K699000;
f) Lot Numbers: 101609, 102516, 103474,
104171, 107437, K128819, K148055,
K156254, K542470;
g) Lot Numbers: K171983, K189454, K204089,
K221871, K504917, K508494, K515834,
K519834, K522275, K525643, K529958,
K547910, K549185, K629253, K632933,
K636834, K643593, K645615, K655989,
K656463;
h) Lot Numbers: K167341, K184428,
K197145, K209523, K222123, K502514,
K512986, K517133, K523565, K525700,
K529957, K554390, K558495, K573614,
K630925, K633623, K656459, K673351,
K688226, K704809;
i) Lot Numbers: 104084, 106642, 109225,
110490, 111564, K114323, K122390,
K139141, K140940, K144881, K149138,
K153136, K159840, K165909, K169546,
K177950, K189450, K195968, K209079,
K216388, K223346, K501076, K504897,
K507099, K510126, K513437, K521324,
K523542, K525641, K535225, K537099,
K544240, K554384, K582148, K620716,
K631306, K632931, K634625, K646389,
K646391, K656284, K674392, K683683,
K696769, K699269, K704805;
j) Lot Numbers: 012383, 101306, 106641,
111202, K128822, K141918, K147447,
K171974, K207397, K511073, K558479,
K658947;
k) Lot Numbers: K143207, K620710, K696763;
l) Lot Numbers: 101610, 103217, K510133;
m) Lot Number: 109345;
n) Lot Numbers: K534360, K547115, K671715,
K687779;
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Keene, NH, by letter on November 17, 2005. Firm initiated recall is ongoing.
REASON
Tray may contain holes compromising the sterility of the device.
VOLUME OF PRODUCT IN COMMERCE
84,651 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Long Length Dyax Nail, Catalog No. 1594-4430S, Recall # Z-0256-06
CODE
Lot number: K559623
RECALLING FIRM/MANUFACTURER
Recalling Firm: Styker Howmedica Osteonics Corp, Mahwah, NJ, by letters on September 7, 2004.
Manufacturer: Stryker Trauma, Kiel, Germany. Firm initiated recall is complete.
REASON
Device was manufactured with a lag screw hole angulation of 135 degrees rather than 130 degrees.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) TLC Self -Retaining Retractor System-Single
Product Code: 820-175, Recall # Z-0257-06;
b) TLC Self -Retaining Retractor System-5/box
Product Number:820-176, Recall # Z-0258-06;
c) TLC Retractor and Single Step Pelvic Drape
(contains 1 Product Code 820-175) Product
Code: 820-177, Recall # Z-0259-06;
d) Precision Twist Transvaginal Sling Kit
with Non-Absorbable, Polybutester Monofilament
Suture (contains 1 Product Code 820-175)
Product Code: 820-172, Recall # Z-0260-06;
e) Precision Tack Transvaginal Sling Kit with
Non-Absorbable, Braided Polyester Suture
(contains 1 Product Code 820-175) Product
Code: 820-171, Recall # Z-0261-06;
f) Capio CL Kit Transvaginal Suture Capturing
Device (1TLC Retractor box) Product Code:
831-130, Recall # Z-0262-06;
g) Precision Tack Transvaginal Sling Kit
with Non-Absorbable, Polybustester
Monofilament Suture (contains 1 Product
Code 820-175) Product Code: 820-124,
Recall # Z-0263-06;
h) Precision Tack Transvaginal Sling Kit with
Non-Absorbable, Braided Polyester Suture
(contains 1 Product Code 820-175) Product
Code: 820-123, Recall # Z-0264-06
CODE
All lots codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Natick, MA, by letter on October 25, 2005.
Manufacturer: Applied Medical Technology, Inc., Cleveland, OH. Firm initiated recall is ongoing.
REASON
Sterility of device compromised due to breach in packaging.
VOLUME OF PRODUCT IN COMMERCE
13,499 singles
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR DECEMBER 7, 2005

###