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U.S. Department of Health and Human Services

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Enforcement Report for November 30, 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.

November 30, 2005
05-48

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I

______________________________
PRODUCT
Product is 1-ounce glass eye dropper bottles of Eye Food. Product is labeled in part: The Old Path "God's Herbal Blessing Tea Eye Food: God's Blessing to Mankind", Recall # D-026-6
CODE
All codes are being recalled
RECALLING FIRM/MANUFACTURER
The Old Path Natural Herbs, Inc., Pensacola, FL, by letter and press release in June 2005. Firm initiated recall is ongoing.
REASON
Non-Sterility: The product was contaminated with multiple strains of bacteria and could cause eye infections and possible blindness.
VOLUME OF PRODUCT IN COMMERCE
30 1-ounce bottles
DISTRIBUTION
FL, GA, and CA

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Cervical Amino Acid Cream (Urea, Methionine, Inositol, Cystine), Net Wt. 2.75 oz (78 grams), Active Ingredients: Urea 8.34%, Methionine 0.83%, Inositol 0.83%, Cystine 0.35% Buffered to pH of 5.5 in a water-miscible cream base, Rx Only, NDC 0603-7729-86, Recall # D-025-6
CODE
Lot No. 40719, exp. 05/06; Lot No. 40720, exp 05/06; Lot No. 41008, exp. 07/06; Lot No. 50609, exp. 04/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Qualitest Pharmaceuticals, Inc., Huntsville, al, by fax or letter on November 3, 2005.
Manufacturer: Sheffield Laboratories, Div. of Faria Limited LLC, New London, CT. Firm initiated recall is ongoing.
REASON
Method validation deviations for finished product testing.
VOLUME OF PRODUCT IN COMMERCE
25,395 units
DISTRIBUTION
Nationwide and PR

_______________________________
PRODUCT
Papain-Urea-Chorophyllin Ointment, Contains Papain, USP (not less than 521,700 USP units per gram of ointment), Urea, USP 10% and Chlorophyllin Copper Complex Sodium, USP 0.5% in an ointment base, Net Wt. 1.1oz (30g), Rx only,. NDC 60258-031-30, Recall # D-027-6
CODE
Lot no. 30314, exp 02-2006; Lot no. 31216, exp 11-2005, Lot No. 40701, exp 05-2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cypress Pharmaceutical, Inc, Madison, MS, by letter dated November 2, 2005.
Manufacturer: Sheffield Laboratories, New London, CT. Firm initiated recall is ongoing.
REASON
Method validation deviations for finished product testing.
VOLUME OF PRODUCT IN COMMERCE
69,696 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Ciprofloxacin Ophthalmic Solution, USP, 0.3%, ciprofloxacin hydrochloride 3.5 mg equivalent to 3 mg base; Rx only, sterile ophthalmic solution for topical ophthalmic use only in 5 mL plastic dispenser bottle, 10 bottles per shelf pack, NDC 60505-1000-1, Recall # D-028-6
CODE
Lot numbers GP1019, GP2332, GP2334
RECALLING FIRM/MANUFACTURER
Recalling Firm: Apotex Corp., Lincolnshire, IL, by letter dated November 7, 2005.
Manufacturer: Apotex Inc., Ontario, Canada. Firm initiated recall is ongoing.
REASON
Degradation Products: Degradation level exceeds specification requirement of less than 0.2% impurities.
VOLUME OF PRODUCT IN COMMERCE
126,790 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Aspirin tablets, 325 mg in bottles of 300 and 500,
OTC, packaged under the following labels: CVS Pharmacy
brand Dist. by CVS Pharmacy, Inc., Woonsocket, FL;
equaline brand Dist. by Albertsons Inc., Boise, ID
NDC 41163-416-87; equate brand Dist. by Wal-Mart Stores,
Inc., Bentonville, AR NDC 49035-416-87 and 49035-416-90;
Medic brand Dist. by Winn-Dixie Stores, Inc.,
Jacksonville, FL NDC 56039-416-87; Meijer brand Dist.
by Meijer Dist., Inc., Grand Rapids, MI NDC 41250-416-90;
ShopRite brand Dist. by Wakefern Food Corp.,
Elizabethtown, NJ and sunmark brand Dist. by
McKesson, San Francisco, CA, NDC 49348-001-14,
Recall # D-029-6;
b) Ibuprofen tablets, 200 mg in 100 tablet bottles, OTC,
packaged under the following labels: equate brand
Dist. by Wal-Mart Stores, Inc., Bentonville, AR
NDC 49035-604-78; Kroger brand Dist. by The Kroger Co,
Cincinnati, OH NDC 30142-604-78 and Meijer brand Dist.
by Meijer Dist., Inc, Grand Rapids, MI NDC 41250-604-78,
Recall # D-030-6
CODE
a) Lot numbers: 5JE0024 and 5JE0074;
b) Lot number: 5HE0342
RECALLING FIRM/MANUFACTURER
Perrigo Company, Allegan, MI, by letter dated November 7, 2005. Firm initiated recall is ongoing.
REASON
Microbial contamination of a non-sterile product.
VOLUME OF PRODUCT IN COMMERCE
107,182 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
DG Guarantee, Regular Strength, Fast Acting Antacid Liquid, Antigas/Antacid original, 12 fl oz (355mL), OTC, Recall # D-031-6
CODE
Lot Numbers: CAR 019A, exp 05/07; CAR019B, exp 05/07; CAR020C, exp 05/07; CAR021, exp 05/07; CAR023A, exp 05/07;
RECALLING FIRM/MANUFACTURER
ANIP Acquisition Company, Gulfport, MS, by telephone, email and letter dated November 4, 2005. Firm initiated recall is ongoing.
REASON
Mislabeling: The package contained an incorrect rear label which indicates the presence of benzyl alcohol.
VOLUME OF PRODUCT IN COMMERCE
3,444 cases of 12 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Robitussin® Cough & Cold CF Syrup, Cough Suppressant/
Expectorant/Nasal Decongestant, (in each 5 mL tsp)
Dextromethorphan HBr USP 10 mg, Guaifenesin USP
100 mg, and Pseudoephedrine HCl USP 30 mg,
12 FL OZ (355 mL) plastic bottles with tamper-
evident bottle cap and plastic dosage cup per
carton and labeled in part, NDC 0031-8678-30,
Recall # D-032-6;
b) Robitussin® Cough & Congestion Syrup, Cough
Suppressant/Expectorant, (in each 5mL tsp)
Dextromethorphan HBr USP 10 mg and Guaifenesin
USP 200 mg, 4 FL OZ plastic bottles with tamper-
evident bottle cap and plastic dosage cup per carton,
NDC 0031-8662-12, Recall # D-033-6
CODE
a) Lot B07738, EXP 8/2008;
b) Lot B07708, EXP 8/2008
RECALLING FIRM/MANUFACTURER
Richmond Division of Wyeth, Richmond, VA, by letters on October 28, 2005. Firm initiated recall is ongoing.
REASON
Defective Tamper-Evident Closure.
VOLUME OF PRODUCT IN COMMERCE
5,472 bottles
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Bisoprolol Fumarate Tablets 5 mg, 30 and 100 count
bottles, Rx only, NDC 53489-555-07 and
53489-555-01, Recall # D-035-6;
b) Bisoprolol Fumarate Tablets 10 mg, 30 and 100 count
bottles, Rx only, NDC 53489-556-07 and 53489-556-01,
Recall # D-036-6
CODE
a) Lot numbers: 51500 exp. 2/06, 51504 exp. 2/06,
52541 exp.6/06, 52728 exp. 7/06, and 53155 exp. 7/06;
b) Lot numbers: 49731 exp. 10/05, 49732 exp. 10/05,
51248 exp. 2/06, 52542 exp. 6/06, 52729 exp. 7/06,
52730 exp. 9/06, and 53128 exp. 9/06
RECALLING FIRM/MANUFACTURER
Mutual Pharmaceutical Co., Inc., Philadelphia, PA, by letter dated October 20, 2005. Firm initiated recall is ongoing.
REASON
Exceeds impurity specification.
VOLUME OF PRODUCT IN COMMERCE
100,118 bottles
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Transfer set with 150 micron Filter with Distal Slip Lock Patient Adapter (For whole blood, red cell, platelets, and plasma to facilitate apportionment and delivery of small aliquots for neonatal/pediatric transfusion), Catalog Number 0-3-960-57, recall # B-0060-6
CODE
Lot Number: 110220
RECALLING FIRM/MANUFACTURER
Charter Medical Limited, Winston-Salem, NC, by telephone on October 13, 2005, by facsimile dated October 14, 2005, and by personal visit on October 18, 2005. Firm initiated recall is ongoing.
REASON
Transfer Sets, labeled as sterile, but had not been exposed to ethylene oxide sterilization, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 cases (96 units)
DISTRIBUTION
IL

_______________________________
PRODUCT
Source Plasma, Recall # B-0063-6
CODE
Unit numbers: 04RMIC6068, 04RMIC5876, 04RMIC5307, 04RMIC4064, 04RMIC3698, 04RMIC2864, 04RMIC2670, 04RMIC1112, 04RMIC0815, 04RMIC0463, 04RMIC0188, 04RMIB7533, 04RMIB6716, 04RMIB6565, 04RMIB2553, 03RMIC2076, 03RMIC1876, 03RMIC1154, 03RMIC0961, 03RMIC0599, 03RMIC0420, 03RMIB9936, 03RMIB9465, 03RMIB9160, 03RMIB8869, 03RMIB7265, 03RMIB1649, 03RMIB2076, 03RMIB2397, 03RMIB2635, 03RMIB2989, 03RMIB3300, 03RMIB3560, 03RMIB3823, 03RMIB4135, 03RMIB4414, 03RMIB4753, 03RMIB5646, 03RMIB6247, 03RMIB6531, 03RMIB6876, 03RMIB7463, 03RMIB7882, 03RMIB8050, 04RMIC3913, 04RMIC1228, 03RMIC5183, 03RMIC5067, 03RMIC4516, 03RMIC4155
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Kentwood, MI, by facsimile dated January 17, 2005. Firm initiated recall is complete.
REASON
Source Plasma, collected from ineligible donors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
50 units
DISTRIBUTION
NC and CA

_______________________________
PRODUCT
Source Plasma, Recall # B-0183-6
CODE
Unit numbers: 6270400690, 6270400348, 6270381973,
6270381581, 6270380829, 6270380442, 6270379721,
6270379357, 6270378661, 6270378294, 6270377516,
6270377095, 6270376482, 6270375950, 6270365467,
6270365045, 6270364194, 6270363851, 6270362628,
6270361799, 6270361148, 6270360532, 6270359288,
6270358831, 6270358113, 6270357542, 6270357148,
6270356519, 6270355823, 6270355231, 6270354526,
6270353878, 6270353199, 6270952394, 6270351880,
6270350998, 6270350550, 6270348411, 6270347982,
6270346777, 6270345873, 6270345389, 6270344507,
6270342732, 6270340500, 6270340022, 6270339228
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., South Salt Lake City, UT, by fax on September 7, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had an additional body piercing within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
47 units
DISTRIBUTION
CA

_______________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-0185-6;
b) Recovered Plasma, Recall # B-0186-6
CODE
a) Unit numbers: 9654392 (for transfusion);
b) Unit numbers: 9719125, 9654653(FFP)
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers Inc., Orlando, FL, by fax on August 9, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL and Austria

_______________________________
PRODUCT
a) Red Blood Cells Leukocyte Reduced,
Recall # B-0187-6;
b) Recovered Plasma, Recall # B-0188-6
CODE
a) and b) Unit number: 4839424
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers Inc., Orlando, FL, by telephone on March 17, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL

_______________________________
PRODUCT
Red Blood Cells Leukocyte Reduced, Recall # B-0205-6
CODE
Unit number: 06FM20923
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Pomona, CA, by letters dated May 1 and May 15, 2002. Firm initiated recall is complete.
REASON
Blood product, which was 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
CA

_______________________________
PRODUCT
a) Red Blood Cells Leukocyte Reduced,
Recall # B-0206-6;
b) Platelets Irradiated, Recall # B-0207-6
CODE
a) and b) Unit number: 20S13425
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Salt Lake City, UT, by letter dated December 18, 2000. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
UT

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0208-6
CODE
Unit number: 6851793
RECALLING FIRM/MANUFACTURER
HemaCare Corporation, Sherman Oaks, CA, by letter dated December 18, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was not evaluated for risk factors associated with Chagas Disease, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0209-6
CODE
Unit number: 9901496
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on August 8, 2005. Firm initiated recall is complete.
REASON
Blood product, which did not meet the acceptable product specifications for release, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

_______________________________
PRODUCT
Source Plasma, Recall # B-0214-6
CODE
Unit number: G-34163-129
RECALLING FIRM/MANUFACTURER
Advanced BioServices, L.L.C., dba Trimar Hollywood, Inc., Reseda, CA, by facsimile on May 2, 2002. Firm initiated recall is complete.
REASON
Blood product, with an elevated ALT, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0215-6
CODE
Unit numbers: 318519, 320451, 324324, 320448, and 324531
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter dated February 23, 1998. Firm initiated recall is complete.
REASON
Blood products, which were not manufactured in accordance to the manufacturer's instructions for leukocyte reduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Source Plasma, Recall # B-0220-6
CODE
Unit numbers: NG-0027489, NG-0027678, NG-0027999, NG-0028167, NG-0028631, and NG-0029053
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, Texas, by telephone and facsimile on May 1, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
KY

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
Recall # B-0222-6;
b) Platelets, Recall # B-0223-6
CODE
a) and b) Unit number: 4765542
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone and facsimile on September 17, 2004. Firm initiated recall is ongoing.
REASON
Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and NY

_______________________________
PRODUCT
Platelets, Recall # B-0226-6
CODE
Unit numbers: 4747401 and 4747402
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on June 17, 2004. Firm initiated recall is complete.
REASON
Blood products, which were made from whole blood units that did not meet appropriate temperatures for platelet manufacture, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0230-6
CODE
Unit number: 01Q75614
RECALLING FIRM/MANUFACTURER
American National Red Cross, West Henrietta, NY, by telephone and letter dated June 15, 2004. Firm initiated recall is complete.
REASON
Blood product, in which the corresponding Platelets were contaminated with Staphylococcus epidermidis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced, Recall # B-0233-6
CODE
Unit number: 30GS44664
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone on July 21, 2005 and by letter dated July 26, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0235-6
CODE
Unit number: E29480
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank, Inc., dba Rock River Valley Blood Center, by telephone on July 7, 2005. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Staphylococcus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

_______________________________
PRODUCT
Source Plasma, Recall # B-0236-6
CODE
Unit number: 02LWIC9336
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Onalaska, WI, by facsimile on August 13, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI

_______________________________
PRODUCT
Source Plasma, Recall # B-0239-6
CODE
Unit numbers: 05CILA9138, 05CILA8240, 05CILA8126, 05CILA7942, 05CILA7835
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc. of Chicago, Chicago, IL, by facsimile on July 1, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Source Plasma, Recall # B-0240-6
CODE
Unit number: 28033888
RECALLING FIRM/MANUFACTURER
Milwaukee Blood Plasma, Inc., Milwaukee, WI, by facsimile on March 27, 2002. Firm initiated recall is complete.
REASON
Source Plasma, which tested positive for human immunodeficiency virus (HIV-1/2), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0241-6
CODE
Unit number: 007FT04020 (part 1)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Arizona Region, Tucson, AZ, by telephone on November 25, 2003, Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Platelets that was implicated in a transfusion reaction and was positive for Escherichia coli, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0242-6
CODE
Unit number: 06GE74831
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by facsimile on April 23, 2002, and August 5, 2002 or by letter dated April 24, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to use of the medication Arava, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Source Plasma, Recall # B-0246-6
CODE
Unit numbers: 04ACOB7418, 04ACOB7807, 04ACOB8443, 04ACOB8852
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Aurora, CO, by facsimile transmission dated December 20, 2004. Firm initiated recall is complete.
REASON
Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0248-6
CODE
Unit numbers: 101993969 (Part 1, 2 &3)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on June 7, 2005. Firm initiated recall is complete.
REASON
Platelets possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AZ

_______________________________
PRODUCT
a) Cryoprecipitated AHF, Recall # B-0249-6;
b) Recovered Plasma, Recall # B-0250-6
CODE
a) and b) Unit number: 4718682
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on February 23, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ and TX

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0251-6
CODE
Unit number: 101972342
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on June 28, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

_______________________________
PRODUCT
Source Plasma, Recall # B-0258-6
CODE
Unit numbers: 0200335610, 0200335145, 0200334941
RECALLING FIRM/MANUFACTURER
ZLB BioPlasma, Inc., Norman, OK, by facsimile on December 5, 2003. Firm initiated recall is complete.
REASON
Blood products, which were not properly quarantined after receiving post donation information concerning high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC

_______________________________
PRODUCT
Source Plasma, Recall # B-0259-6
CODE
Unit numbers: 0480788426, 0480789428, 0480840726, 0480841083, 0480841905, 0480843372, and 0480842282
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Tempe, AZ, by telephone on April 30, 2002 and facsimile on May 5, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received a tattoo within twelve months of the donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
NC

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0260-6
CODE
Unit numbers: 20E11060, 20E11064, 20E11068, 20E11069, 20E11073, 20E11078, 20E11081, 20E11083
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Lewis and Clark Region, Boise, ID, by telephone on November 17, 1998.
Manufacturer: American National Red Cross, Salt Lake City, UT. Firm initiated recall is complete.
REASON
Blood products, which were not tested for Cytomegalovirus (CMV), but were labeled as CMV negative, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
CA and UT

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0261-6
CODE
Unit number: FQ06637
RECALLING FIRM/MANUFACTURER
HemaCare Corporation, Sherman Oaks, CA, by letter dated June 12, 2003. Firm initiated recall is complete.
REASON
Blood product, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but was collected from a donor who was subsequently determined to have previously tested positive for HIV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Source Plasma, Recall # B-0263-6
CODE
Unit numbers: 66305880, 66292388, 66283133, 66272809, 66268345, 66258285, 66254386, 66251910, 52371851, 52369735, 52364648, 52361388, 52352775, 52341496, 52339363
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Tucson, AZ, by letter dated December 11, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had unexplained needle marks, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Source Plasma, Recall # B-0264-6
CODE
Unit numbers: 97913290, 97908685
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Tucson, AZ, by e-mail on December 28, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Recovered Plasma, Recall # B-0265-6
CODE
Unit number: 8858113
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by facsimile on June 23, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0266-6
CODE
Unit number: 7692050
RECALLING FIRM/MANUFACTURER
HemaCare Corporation, Sherman Oaks, CA, by telephone on February 12, 2004 and by letter dated February 17, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Source Plasma, Recall # B-0267-6
CODE
Unit numbers: 7020260275, 7020259863, 7020247607, 7020247081, 7020245349, 7020244998, 7020244366, 7020243970, 7020243142, 7020238010, 7020242758, 7020242156, 7020241601, 7020241132, 7020240049, 7020239687, 7020238984, 7020238621, 7020237298, 7020237038, 7020236362, 7020234805, 7020234477, 7020229115, 7020228629, 7020228226, 7020227729, 7020227251, 7020226762, 7020226103, 7020225455, 7020225065, 7020224693, 7020224359, 7020223901, 7020223544, 7020223107, 7020222723, 7020222203, 7020221742, 7020221341, 7020220940, 7020218833, 7020218503, 7020218086, 7020217857, 7020217344, 7020216327, 7020215473, 7020215177, 7020214485, 7020214187, 7020213416, 7020213115, 7020212430, 7020212282, 7020211598, 7020211457, 7020210614, 7020209473, 7020207943, 7020207358, 7020206821, 7020206556, 7020205940, 7020201944, 7020201138, 7020200326, 7020188393, 7020187732, 7020187427, 7020186836, 7020186290, 7020185697, 7020185189, 7020184545, 7020184143, 7020181883, 7020181403, 7020180774, 7020180387, 7020179639, 7020178569, 7020178402, 7020177670, 7020177364, 7020176715, 7020176384, 7020175303, 7020168954, 7020165438, 7020164052, 7080161983, 7020161651, 7020161283, 7020159691, 7020159379, 7020158834, 7020158487, 7020156522, 7020156292, 7020154804, 7020154318, 7020153427, and 7020153142
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Aurora, CO, by facsimile on December 26, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was deferred for testing positive for an infectious disease at another facility, were distributed.
VOLUME OF PRODUCT IN COMMERCE
105 units
DISTRIBUTION
United Kingdom

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0268-6;
b) Fresh Frozen Plasma, Recall # B-0269-6
CODE
a) Unit numbers: 20V08263 and 20V08311;
b) Unit numbers: 20V08281 and 20V08291
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Boise, ID, by telephone on August 6, 1999. Firm initiated recall is complete.
REASON
Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
UT

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-0274-6;
b) Fresh Frozen Plasma, Recall # B-0275-6
CODE
a) and b) Unit number: 4017887
RECALLING FIRM/MANUFACTURER
HemaCare Corporation, Sherman Oaks, CA, by telephone and facsimile on November 5, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0277-6
CODE
Unit numbers: 06FT72894 and 06GE84659
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Pomona, CA, by telephone and by letter dated November 5, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0296-6;
b) Recovered Plasma, Recall # B-0297-6
CODE
a) and b) Unit number: 18216-3650
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated February 5, 1999.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. 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
2 units
DISTRIBUTION
NY and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-0299-6;
b) Plasma, Frozen, Recall # B-0300-6
CODE
a) and b) Unit number: 01KX83904
RECALLING FIRM/MANUFACTURER
American National Red Cross, West Henrietta, NY, by telephone on June 15, 2004 and by letter dated June 15, 2004. Firm initiated recall is complete.
REASON
Blood products, in which the corresponding Platelets were contaminated with Staphylococcus epidermidis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY

_______________________________
PRODUCT
Source Plasma, Recall # B-0301-6
CODE
Unit numbers: 0200314394, 0200313274, 0200313015, 0200312560, 0200312321, 0200311879, 0200311641, 0200310943, 0200309128, 0200308403, 0200307937, 0200307245, 0200307105
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Norman, OK, by facsimile on May 29, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
NC

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0302-6
CODE
Unit numbers: 4805767 (3 parts)
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on August 8, 2005 and by letter dated September 8, 2005. Firm initiated recall is complete.
REASON
Platelets Pheresis with elevated platelet counts were distributed
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IN

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0303-6;
b) Recovered Plasma, Recall # B-0304-6
CODE
a) and b) Unit number: 25H49723
RECALLING FIRM/MANUFACTURER
American National Red Cross, West Henrietta, NY, by facsimile on May 20, 2004 or by letter dated May 21, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY and Switzerland

_______________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced, Recall # B-0305-6
CODE
Unit number: 71X12877X
RECALLING FIRM/MANUFACTURER
Life South Community Blood Center, Gainesville, FL, by facsimile on April 20, 2005. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

_______________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced, Recall # B-0307-6
CODE
Unit numbers: 71X142093 (Parts 1 and 3)
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Gainesville, FL, by facsimile on April 26, 2005. Firm initiated recall is complete.
REASON
Platelets with insufficient plasma volume to support the platelet yield, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL and AL

_______________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced, Recall # B-0308-6
CODE
Unit number: 71X126216 part 3
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Gainesville, FL, by facsimile on April 26, 2005. Firm initiated recall is complete.
REASON
Platelets with insufficient plasma volume to support the platelet yield, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Platelet Pheresis Leukoreduced, Recall # B-0117-6
CODE
Unit number: 2627421 (distributed as 2 split products)
RECALLING FIRM/MANUFACTURER
Life Source, Glenview, IL, by telephone on July 24, 2005. Firm initiated recall is complete.
REASON
Blood products, possible contaminated with Staphylococcus epidermidis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL

_______________________________
PRODUCT
Platelet Pheresis, Recall # B-0190-6
CODE
Unit number: 9521546
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers Inc., Orlando, FL, by fax on June 25, 2005. Firm initiated recall is complete.
REASON
Blood product, labeled "Leukocyte Reduced" but which failed to meet the criteria for a leukoreduced unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-0198-6;
b) Platelets, Leukocytes Reduced,
Recall # B-0199-6
CODE
a) and b) Unit number: 17KC38772
RECALLING FIRM/MANUFACTURER
American National Red Cross, North Central Region, St. Paul, MN, by letter dated June 27, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN and WI

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0216-6
CODE
Unit number: 1417764
RECALLING FIRM/MANUFACTURER
Florida's Blood Center, Inc., Orlando, FL, by telephone on March 21, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose temperature was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

_______________________________
PRODUCT
Recovered Plasma, Recall # B-0228-6
CODE
Unit number: 1417764
RECALLING FIRM/MANUFACTURER
Florida's Blood Center, Inc., Orlando, FL, by fax on March 25, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of Crohn's disease, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0238-6
CODE
Unit number: 01LY32827
RECALLING FIRM/MANUFACTURER
American National Red Cross, West Henrietta, NY, by telephone on April 26, 2004 and by letter dated May 7, 2004. Firm initiated recall is complete.
REASON
Blood product, which tested positive by the pooled nucleic acid test (NAT) method, but subsequently tested negative for viral markers, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

_______________________________
PRODUCT
Recovered Plasma, Recall # B-0243-6
CODE
Unit number: 06GE74831
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by facsimile on April 23, 2002, and August 5, 2002 or by letter dated April 24, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to use of the medication Arava, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0244-6
CODE
Unit numbers: 22KX72717, 22KX72719, 22KX72720, 22KX72722, 22KX72723, 22KX72724, 22KX68285, 22KX68286, 22KX72710, 22KX72711, 22KX72712, 22KX72713, 22KX72714, 22KX72715, 22KX72716, 22KX72721
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on April 26, 2005 and by letters dated May 23, 2005 and June 23, 2005. Firm initiated recall is complete.
REASON
Blood products, collected on trip scales that were incorrectly calibrated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
NJ, PA, and TN

_______________________________
PRODUCT
Platelets Pheresis Leukoreduced, Recall # B-0245-6
CODE
Unit number: 4746796
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by fax on April 26, 2004. Firm initiated recall is complete.
REASON
Blood product, possible contaminated with diptheroids, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
Platelets Pheresis Leukoreduced, Recall # B-0252-6
CODE
Unit number: 9322249
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on September 17, 2004. Firm initiated recall is complete.
REASON
Blood product, which was labeled leukoreduced but had an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-0253-6;
b) Platelets Pheresis, Leukocytes Reduced,
Recall # B-0254-6;
c) Platelets Pheresis, Irradiated,
Recall # B-0255-6;
d) Fresh Frozen Plasma, Recall # B-0256-6;
e) Fresh Frozen Plasma (Apheresis),
Recall # B-0257-6
CODE
a) Unit numbers: 4772858, 4850937, 4723971,
4827820, 4850945, 4850565, 4867079, and
4827994; and the following units were
distributed as two split products:
units 4841281 and 4850936;
b) Unit numbers: 4850947, 4827544, 4799486,
and 4827543; and the following units were
distributed as split products: units
4850946, 4850949, 4850944, 4827542
(2 split products), and 4820787 (3 split
products);
c) Unit numbers: 4827542, 4827545, 4827543,
and 4827544;
d) Unit numbers: 4723971, 4827820, 4794573,
and 4867079;
e) Unit number 4827794
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile transmission and telephone on March 30, 2004. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for West Nile Virus (WNV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
36 units
DISTRIBUTION
OK, NY, and AR

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0262-6
CODE
Unit number: FC48648B
RECALLING FIRM/MANUFACTURER
HemaCare Corporation, Sherman Oaks, CA, by telephone on December 26, 2001 and by letter dated February 1, 2002. Firm initiated recall is complete.
REASON
Blood product, associated with units of Platelets that did not meet product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0270-6
CODE
Unit number: 06GH47956
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Pomona, CA, by telephone on November 26, 2003 and by letter dated December 1, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected on a device in which instrument quality control was not performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced,
Recall # B-0272-6;
b) Platelets Pheresis, Leukocytes Reduced,
Irradiated, Recall # B-0273-6
CODE
a) Unit numbers: 06KH08281 (Part 2),
06KH08282, 06KH08284;
b) Unit numbers: 06KH08281 (Part 1),
06KH08283 (Part 1)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by telephone on April 12, 2002 and by letter dated April 22, 2002. Firm initiated recall is complete.
REASON
Blood products, which may have reached an unacceptable temperature during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0298-6
CODE
Unit numbers: 12240-1551 (Split unit)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Albuquerque, NM, by letter dated September 2, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of receiving a tissue transplant, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NM, and NC

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
cardioPAT Cardiovascular Perioperative Autotransfusion System, Model: LN 2050-110-E and Disposables: cardioPAT Replacement RBC Bags, LN 00270 cardioPAT Replacement Waste Bags, LN 00271 cardioPAT Replacement Intraoperative Suction Set, LN 00272 cardioPAT Replacement Postoperative Suction Set, LN 00273 cardioPAT cardiovascular Perioperative Autotransfusion System Disposable Set, LN 00274 cardioPAT Replacement One-Way Valve Assembly LN 00275, Recall # Z-0174-06
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Haemonetics Corporation, Braintree, MA, by letter on July 22, 2005. Firm initiated recall is ongoing.
REASON
Blood clotting of patient post operative while on the cardioPAT Cardiovascular Perioperative Autotransfusion System.
VOLUME OF PRODUCT IN COMMERCE
4 systems and 486 disposables
DISTRIBUTION
CA, MN, NE, and TX

_______________________________
PRODUCT
Lysus® Infusion System - PT-3 Control. The Lysus Infusion System employs high frequency, low power ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature. (This system is also called the UltraFlo and EKOS Peripheral Infusion System in internal documents.) The Lysus® Infusion System consists of three main components, a single use Lysus® Infusion Catheter System which is comprised of a Drug Delivery Catheter (DDC) and removable Ultrasound Core (USC), and a reusable EKOS PT-3 Control System. During use, fluids are delivered through the side-holes of the DDC. The USC is placed through the central lumen of the DDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS PT-3 Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Catheter Interface Cable with Pod connects the EKOS PT-3 Control Unit to the Lysus® Infusion Catheter System, Recall # Z-0175-06
CODE
Serial numbers: PT3-002, PT3-006, PT3-007, PT3-009, PT3-012, PT3-013, PT3-014
RECALLING FIRM/MANUFACTURER
Ekos Corporation, Bothell, WA, by visit beginning on January 19, 2005. Firm initiated recall is complete.
REASON
Potential for a faulty thermal channel offset to be reported to the software causing faulty lower temperature values to be reported which allow a power increase.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
AZ, OH, WA, FL, IL, CA, and Germany

_______________________________
PRODUCT
Bard RespiShield™ * Closed Suction System with InnoValve™ * Endotracheal Start Kit * QTY 1 Unit * 14F/4.7mm * Sterile * Rx Only, Recall # Z-0178-06
CODE
Catalog Number: 220059, Lot Numbers: NGPD0713, NGPD0714, NGPE11, Catalog Number: 220067, Lot Number: NGPD2781, Catalog Number: 220068, Lot Number: NGPD0855, Catalog Number: 220069, Lot Numbers: NGPD0939, NGPD1735, NGPD2015, NGPE0403, NGPE0404, Catalog Number: 220141, Lot Number: NGPE1200, Catalog Number: 220145, Lot Number: NGPD0934, Catalog Number: 220155, Lot Number: NGPD2697, Catalog Number: 220211, Lot Number: NGPE1170
RECALLING FIRM/MANUFACTURER
Recalling Firm: C.R. Bard, Inc., Covington, GA, by letter on/about September 28, 2005.
Manufacturer: Bard Sdn Bhd, Nogales, Mexico. Firm initiated recall is ongoing.
REASON
Varying degrees of difficulty were encountered when opening and closing the InnoValve.
VOLUME OF PRODUCT IN COMMERCE
10,169 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) FHC microTargeting Power Assist System used with
the micro Targeting Drive System, models: 66-DA-ME;
66EL-MC; 66EL-MS; 66EL-MS-02; 66-EL-MS-03; 66-EL-RM;
MT-DS-AM; MT-DS-MD. Recall # Z-0179-06;
b) Medtronic microTargeting Drive Motor Option used with
the micro Targeting Drive System with models: 9033G0711;
9033G0712; 9033G0713; 9033G0811 and FHC 1008-66,
Recall # Z-0180-06
CODE
N/A
RECALLING FIRM/MANUFACTURER
FHC, Inc, Bowdoinham, ME, by letter on October 31, 2005. Firm initiated recall is ongoing.
REASON
Power Assist microTargeting System may advance beyond intended target
VOLUME OF PRODUCT IN COMMERCE
300 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Terumo Sarns brand Soft-Flow Aortic Cannula with flange, angled, wire-reinforced, with Luer, 6 mm (18 Fr) OD with 3/8 inch connector, 14 inches (35 cm) long; catalog number 7080. Recall # Z-0181-06
CODE
All lots (0332197, 0349597, 0360492, 0369078, 0373045, 0382401, 0391806 and 0399838)
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems, Corp., Ann Arbor, MI, by telephone, and letter dated October 19, 2005. Firm initiated recall is ongoing.
REASON
The product is labeled as sterile, but the firm has determined that the suture flange may tear through the front of the package.
VOLUME OF PRODUCT IN COMMERCE
48 units
DISTRIBUTION
CA, IN, MO, Brazil and Germany

_______________________________
PRODUCT
AQuify™ Drops, Long Lasting Comfort Drops * Relieves Dryness * For Soft and RGP Contact Lenses * 1/3 fl. Oz. (10mL) * Sterile, Recall # Z-0182-06
CODE
Lot number: 52246
RECALLING FIRM/MANUFACTURER
Recalling Firm: CIBA Vision Corporation, Duluth, GA, by telephone and letter on November 4, 2005.
Manufacturer: Ciba Vision Sterile Manufacturing, Ontario, Canada. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility at the time of manufacture.
VOLUME OF PRODUCT IN COMMERCE
29592 cases (24 units per case)
DISTRIBUTION
Nationwide, Canada, Germany, Benelux, and the UK

_______________________________
PRODUCT
Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System). Recall # Z-0183-06
CODE
The Torque handles contain serial #1 through serial #76 and are part number 10-40-0122 contained in the Coral Lumbar System, Lot W1902 and W1558.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Theken Spine LLC, Akron, OH, by letter, dated April 4, 2005.
Manufacturer: Holmed Corporation, South Easton, MA. Firm initiated recall is ongoing.
REASON
The torque value of the device may increase over time. The increase could exceed the tolerance specification.
VOLUME OF PRODUCT IN COMMERCE
71 or 75 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Lap Top Ventilator (LTV) Series continuous ventilator,
model LTV-1000. The LTV1000 ventilator is intended to
provide continuous or intermittent ventilatory support
for the care of individuals who require mechanical
ventilation. The LTV-1000 is a prescription medical
device suitable for use in institutional, home and
transport settings. Recall # Z-0184-06;
b) Lap Top Ventilator (LTV) Series continuous ventilator,
model LTV-950. The LTV-950 ventilator is intended to
provide continuous or intermittent ventilatory support
for the care of individuals who require mechanical
ventilation. The LTV-950 is a prescription medical
device suitable for use in institutional, home and
transport settings. Recall # Z-0185-06;
c) Lap Top Ventilator (LTV) Series continuous ventilator,
model LTV-900. The LTV-900 ventilator is intended
to provide continuous or intermittent ventilatory
support for the care of individuals who require
mechanical ventilation. The LTV-900 is a prescription
medical device suitable for use in institutional,
home and transport settings. Recall # Z-0186-06
CODE
a) A01916, A01961, A02196, A02656, A02985, A03667,
A03696, A03741, A03774, A03809, A04262, A05454,
A06194, A06585-A06598, A06600-A06613, A06615,
A06616, A06618-A06620, A06622-A06624, A06626-A06630,
A06633, A06635-A06637, A06639-A06654, A06656-A06659,
A06661-A06670, A06672-A06684, A06686-A06696,
A06698-A06700, A06702-A06707, A06709, A06710,
A06712-A06716, A06734, A06746-A06748, A06750,
A06755-A06758, A06760-A06763, A06765-A06766,
A06769, A06771, A06779-A06780, A06783-A06785
and A07226;
b) C01063, C01112, C01605, C02231, C02247, C02488,
C03055, C03096, C03123, C03137, C03437, C03492,
C03828, C03861, C03884, C04056, C04580, C05336,
C06640, C07105-C07107, C07109-C07113, C07115,
C07116, C07118, C07122-C07126, C07130, C07141,
C07145, C07152, C07154, C07157-C07160, C07162,
C07168, C07170, C07173, C07188, C07194 and C07195;
c) B01117, B01236, B01483, B01637, B01640, B01655,
B01802, B01816, B01954, B01974, B01997,
B03500-B03524, B03526-B03536
RECALLING FIRM/MANUFACTURER
Pulmonetic Systems, Inc., Minneapolis, MN, by letter dated November 9, 2005. Firm initiated recall is ongoing.
REASON
Pulmonetic Systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.g. Vent INOP, HW Fault, Xducer Fault) and possibly resulting in failure of the ventilator to breathe for the patient. This malfunction may occur without an accompanying audible alarm.
VOLUME OF PRODUCT IN COMMERCE
249 devices and 20 printed circuit boards
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) Guidant INSIGNIA I Entra family of pacemakers includes
the following: SSI (model numbers 0484 and 0485);
DDD (models 0985, 0986); SR (models 1195, 1198);
and DR (models1294, 1295, 1296). Intermedics NEXUS
Entra family of pacemakers includes the following:
SSI (model 1326); DDD (model 1426); SR (model 1398)
and DR (model 1494). The INSIGNIA I Entra pacemakers
are multiprogrammable pacemakers from Guidant.
The NEXUS I Entra pacemakers are multiprogrammable
pacemakers from Intermedics. The family consists of
both dual-chamber and single-chamber models, offering
adaptive-rate therapy and providing various levels of
therapeutic and diagnostic functionality.
The INSIGNIA and NEXUS I Entra adaptive-rate models
have an accelerometer, which is a motion sensor that
responds to patient activity. Sterilized with gaseous
ethylene oxide. Recall # Z-0187-06;
b) Guidant INSIGNIA I Ultra family of pacemakers includes
the following: SR (models1190); and DR (models1290,
1291). Intermedics NEXUS I Ultra family of pacemakers
includes the following: SR (model 1390) and DR
(model 1490, 1491). The INSIGNIA I Ultra pacemakers are
multiprogrammable pacemakers from Guidant. The NEXUS I
Ultra pacemakers are multiprogrammable pacemakers from
Intermedics. The family consists of both dual-chamber
and single-chamber models, offering adaptive-rate
therapy and providing various levels of therapeutic
and diagnostic functionality. These pacemakers include
ventricular Automatic Capture which automatically
measures the ventricular pacing threshold and adjusts
the pacing output to 0.5 V above the measured threshold.
Two sensors are available: these adapt the pacing rate
to the patient's changing metabolic demand. Minute
ventilation responds to changes in respiration, and
the accelerometer responds to patient activity
(motion). INSIGNIA and NEXUS I Ultra models can use
either the accelerometer or minute ventilation sensor,
or a blend of both accelerometer and minute ventilation.
Sterilized with gaseous ethylene oxide, Recall # Z-0188-06;
c) Guidant INSIGNIA I Plus family of pacemakers includes
the following: SR (models1194); and DR (models 1297,
1298). Intermedics NEXUS I Plus family of pacemakers
includes the following: SR (model 1394) and DR (model
1467, 1468).
The INSIGNIA I Plus pacemakers are multiprogrammable
pacemakers from Guidant. The NEXUS I Plus pacemakers
are multiprogrammable pacemakers from Intermedics.
The family consists of both dual-chamber and
single-chamber models, offering adaptive-rate therapy
and providing various levels of therapeutic and
diagnostic functionality. Two sensors are available:
these adapt the pacing rate to the patient's
changing metabolic demand. Minute ventilation responds
to changes in respiration, and the accelerometer
responds to patient activity (motion). INSIGNIA and
NEXUS I Plus models can use either the accelerometer or
Minute ventilation sensor, or a blend of both
Accelerometer and minute ventilation. Sterilized with
gaseous ethylene oxide. Recall # Z-0189-06;
d) Guidant INSIGNIA I AVT family of pacemakers includes
the following: SSI (model 482), VDD (model 882),
DDD (model 982), SR (model 1192 and DR (model 1292).
Intermedics NEXUS I AVT family of pacemakers includes
the following: SR (model 1392). The INSIGNIA I AVT
pacemakers are multiprogrammable pacemakers from
Guidant. The NEXUS I AVT pacemakers are
multiprogrammable pacemakers from Intermedics.
The family consists of both dual-chamber and
single-chamber models, offering adaptive-rate therapy
and providing various levels of therapeutic and
diagnostic functionality. These pacemakers include
ventricular Automatic Capture which automatically
measures the ventricular pacing threshold and adjusts
the pacing output to 0.5 V above the measured threshold.
The INSIGNIA and NEXUS I Plus adaptive-rate models have
an accelerometer, which is a motion sensor that responds
to patient activity. Sterilized with gaseous ethylene
oxide. Recall # Z-0190-06
CODE
a) Affected devices may be found in the following
serial number ranges. INSIGNIA Entra SSI (model 0484)
serial no. 100879 - 115237; (model 0485)
serial no. 100088 - 100104; NEXUS Entra SSI (model 1326)
serial no. 100122 - 100175. INSIGNIA Entra DDD
(model 0985) serial no. 100059 - 100089; (model 0986)
serial no. 100600 - 104439; NEXUS Entra DDD (model 1426)
serial no. 100032 - 100091. INSIGNIA Entra SR (model
1195) serial no. 100739 - 101623;
(model 1198) serial no. 102498 - 117468;
NEXUS Entra SR (model 1398) serial no. 100067 - 100120.
INSIGNIA Entra DR (model 1294) serial no. 101132 --
107445 & 292190;
(model 1295) serial no. 100503 - 102668; (model 1296)
serial no. 101519 - 153064; NEXUS Entra DR (model 1494)
serial no. 100028 & 100029;
b) INSIGNIA Ultra SR (model 1190) serial no. 889963 --
891468; NEXUS Ultra SR (model 1390) serial no. 100007 --
100034. INSIGNIA Ultra DR (model 1290) serial no.
105229; (model 1291) serial no. 100279 - 100913;
NEXUS Ultra DR (model 1490) serial no. 100007,
100008, 100009, 100013, 100014, 100015, 100016,
100017, 100018; (model 1491) serial no. 100007,
100008, 100009, 100010, 100013, 100015, 100016,
100017, 100018;
c) INSIGNIA Plus SR (model 1194) serial no. 107477 --
123441; NEXUS Plus SR (model 1394) serial no.
100072 -- 100130. INSIGNIA Plus DR (model 1297)
serial no. 282034 - 294735; (model 1298)
serial no. 128040 - 889944; NEXUS Plus DR (model 1467)
serial no. 100011 - 100060; (model 1468)
serial no. 100090 - 100276.
d) INSIGNIA AVT SSI (model 482) serial no. 100005 - 100324;
INSIGNIA AVT VDD (model 882) serial no. 100006 - 100410;
INSIGNIA DDD (model 982) serial no. 100007 - 100473;
INSIGNIA AVT SR (model 1192) serial no. 100008 --
100473; NEXUS AVT SR (model 1392) serial no.
100016 and 100020; INSIGNIA AVT DR (model 1292)
serial no. 100007 - 100798
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guidant Corporation, St. Paul, MN, by press release and letter dated September 22, 2005.
Manufacturer: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing.
REASON
A failure mode occurring at a low rate, has been identified within the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include: Intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.
VOLUME OF PRODUCT IN COMMERCE
52,079 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) Guidant INSIGNIA I Entra family of pacemakers includes
the following: SSI (model numbers 0484 and 0485);
DDD (models 0985, 0986); SR (models 1195, 1198);
and DR (models1294, 1295, 1296). Intermedics NEXUS
Entra family of pacemakers includes the following:
SSI (model 1326); DDD (model 1426); SR (model 1398) and
DR (model 1494). The INSIGNIA I Entra pacemakers are
multiprogrammable pacemakers from Guidant. The NEXUS
I Entra pacemakers are multiprogrammable pacemakers
from Intermedics. The family consists of both dual-
chamber and single-chamber models, offering adaptive-
rate therapy and providing various levels of therapeutic
and diagnostic functionality. The INSIGNIA and NEXUS I
Entra adaptive-rate models have an accelerometer,
which is a motion sensor that responds to patient
activity. Sterilized with gaseous ethylene oxide,
Recall # Z-0191-06;
b) Guidant INSIGNIA I Ultra family of pacemakers includes
the following: SR (models1190); and DR (models 1290,
1291). Intermedics NEXUS I Ultra family of pacemakers
includes the following: SR (model 1390) and DR
(model 1490, 1491). The INSIGNIA I Ultra pacemakers
are multiprogrammable pacemakers from Guidant.
The NEXUS I Ultra pacemakers are multiprogrammable
pacemakers from Intermedics. The family consists of
both dual-chamber and single-chamber models, offering
adaptive-rate therapy and providing various levels of
therapeutic and diagnostic functionality.
These pacemakers include ventricular Automatic
Capture which automatically measures the ventricular
pacing threshold and adjusts the pacing output to
0.5 V above the measured threshold. Two sensors are
available: these adapt the pacing rate to the
patient's changing metabolic demand. Minute
ventilation responds to changes in respiration,
and the accelerometer responds to patient activity
(motion). INSIGNIA and NEXUS I Ultra models can use
either the accelerometer or minute ventilation sensor,
or a blend of both accelerometer and minute ventilation.
Sterilized with gaseous ethylene oxide.
Recall # Z-0192-06;
c) Guidant INSIGNIA I Plus family of pacemakers includes
the following: SR (model 1194); and DR (models 1297,
1298).
Intermedics NEXUS I Plus family of pacemakers includes
the following: SR (model 1394) and DR (model 1467,
1468).
The INSIGNIA I Plus pacemakers are multiprogrammable
pacemakers from Guidant. The NEXUS I Plus pacemakers are
multiprogrammable pacemakers from Intermedics.
The family consists of both dual-chamber and single-
chamber models, offering adaptive-rate therapy and
providing various levels of therapeutic and diagnostic
functionality.
Two sensors are available: these adapt the pacing rate
to the patient's changing metabolic demand. Minute
ventilation responds to changes in respiration,
and the accelerometer responds to patient activity
(motion). INSIGNIA and NEXUS I Plus models can use
either the accelerometer or minute ventilation sensor,
or a blend of both accelerometer and minute ventilation.
Sterilized with gaseous ethylene oxide,
Recall # Z-0193-06;
d) Guidant INSIGNIA I AVT family of pacemakers includes
the following: SSI (model 482), VDD (model 882),
DDD (model 982), SR (model 1192 and DR (model 1292).
Intermedics NEXUS I AVT family of pacemakers includes
the following: SR (model 1392). The INSIGNIA I AVT
pacemakers are multiprogrammable pacemakers from
Guidant.
The NEXUS I AVT pacemakers are multiprogrammable
pacemakers from Intermedics. The family consists of
both dual-chamber and single-chamber models, offering
adaptive-rate therapy and providing various levels of
therapeutic and diagnostic functionality. These
pacemakers include ventricular Automatic Capture
which automatically measures the ventricular pacing
threshold and adjusts the pacing output to 0.5 V above
the measured threshold. The INSIGNIA and NEXUS I Plus
adaptive-rate models have an accelerometer, which is
a motion sensor that responds to patient activity.
Sterilized with gaseous ethylene oxide,
Recall # Z-0194-05
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guidant Corporation, St. Paul, MN, by press release and letter dated September 22, 2005.
Manufacturer: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing.
REASON
Another failure mode, which occurs at a low rate, has been identified with the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include; intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.
VOLUME OF PRODUCT IN COMMERCE
341,00 (an estimated 145,000 active in the US)
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
LifeShield Latex-Free HEMA Blood PlumSet, Nonvented, 110 Inch with 210 Micron Filter, Prepierced Injection Site and OPTION-LOK, Dual Channel, Capped Secondary Port; a sterile Rx blood administration set for use with the Plum Series Infuser; list number 11235-03, Recall # Z-0195-06
CODE
Lot 25-086-5H
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira, Inc., Lake Forest, IL, by letters dated May 6, 2005.
Manufacturer: Abbott Laboratories de Costa Rica S.A., La Aurora de Heredia, Costa Rica. Firm initiated recall is complete.
REASON
Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.
VOLUME OF PRODUCT IN COMMERCE
17,184 units
DISTRIBUTION
Nationwide, PR, Mexico and Australia

_______________________________
PRODUCT
Analogic SyneRad Multi Digital Radiology System, Model AN6150, Recall # Z-0196-06
CODE
Serial Numbers: 3604-M0120; 5004-M0125; 3204-M0118; 5004-M0126; 4404-M0124; 3204-M0119; 3005-M0131; 2404-M0115; 2404-M0117; 0205-M0130; 3604-M0121; 3904-M0122; 5004-M0127; 3805-M0132; 2705-M0128; 3904-M0123; 0205-M0129
RECALLING FIRM/MANUFACTURER
Analogic Corporation, Peabody, MA, by e-mail on October 14, 2005 and by letter on October 17, 2005. Firm initiated recall is complete.
REASON
Potential weld defect in the Overhead Tube Support assembly which connects to the telescoping arm. This could cause the tube assembly to fall, leading to possible injury of the user or patient.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
AZ, CA, FL, MA, OH, PA, TN, and TX

_______________________________
PRODUCT
a) Damon 3 Bracket Upper Right lateral .022 slot
This device is a fixed attachment on a tooth which
Holds an archwire during orthodontic treatment.
Part Number 491-4210, Recall # Z-0203-06;
b) Damon 3 Bracket Upper Right lateral .022 slot
Part Number 491-4211, Recall # Z-0204-06
CODE
a) Lot Number100512025 and 100512020;
b) Lot Number 100514071 and 100512012
RECALLING FIRM/MANUFACTURER
Ormco Corporation, Glendora, CA, by telephone and letters on November 3, 2005. Firm initiated recall is ongoing.
REASON
Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.
VOLUME OF PRODUCT IN COMMERCE
2980 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Self Contained Biological Indicator, product code SCRE-06, Recall # Z-0205-06
CODE
Lot codes 643, exp. date 4/05 and lot 674, exp. 10/05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Namsa, Northwood, OH, by telephone on or about March 18, 2005 and by letter on or about March 31, 2005.
Manufacturer: Raven Biological Labs, Inc., Ralston, NB. Firm initiated recall is ongoing.
REASON
The certified Ethylene Oxide D-values of the lots cannot be confirmed to be within specification.
VOLUME OF PRODUCT IN COMMERCE
Lot 643: 10/50 kit boxes; lot 674: 39 boxes
DISTRIBUTION
CA, OH, NH, WA, NJ, and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
a) Spectrum Patient Monitor, Physiological, Patient
with arrhythmia detection or alarms. Monitor can
monitor, display, trend and print a patient's
physiological parameters. The device has a 12.1 inch
color display and has a standard configuration of a
3 or 5 lead ECG, Masimo SET SpO2, non-invasive blood
pressure, respiration, continuous temperature and
IV Drug Calculations. Optional digital displays are
provided for invasive blood pressure (up to four)
anesthetic agents, O2 and NO2, ST, and CO2,
Recall # Z-0176-06;
b) Passport 2 with View 12 ECG Analysis Module.
It is a transportable, multi-parameter physiological
monitor designed to monitor and display the following
physiological parameters: ECG, Heart Rate derived from
selected sources (Sp)2, ECG, IBP and NIBP), SpO2 level,
ST Segment, Arrhythmia, Blood pressure (both invasive
and non-invasive), Respiration rate (dirived from ECG
or CO2), inspired or expired CO2, temperature, and gases
(i.e. five anesthetsia gases, O2, N2O, and CO2),
Recall # Z-0177-06
CODE
a) All Spectrum Monitors that have the following Software
Versions: A.19, A.20, B.23, B.24, B.25, B.27, C.18,
D.07, E.07, F.09, F.16, F.17, F.26;
b) Passport 2 Monitors with software versions: S.10, T.15,
T.31, V.07, W.09, W.13, W.14
RECALLING FIRM/MANUFACTURER
Datascope Corp, Mahwah, NJ, by letter on September 7, 2005. Firm initiated recall is ongoing.
REASON
Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-Lead ECG data.
VOLUME OF PRODUCT IN COMMERCE
1507 monitors
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS I

_______________________________
PRODUCT
Baytril (enrofloxacin) 3.23% Concentrate Antimicrobial Solution, For Use in Chicken and Turkey Drinking Water Only, Each mL contains 32.3 mg enrofloxacin, packaged in 1-gal. bottles (4 per case), RX, NADA 140-828. Recall # V-011-6
CODE
All product, which would include the following batches that are currently within their expiry: 540016P, Exp. 09/2005; 54001WP, Exp. 11/2005; 540022J, Exp. 12/2005; 54002J6, Exp. 02/2006; 5400323, Exp. 03/2006; 5400452, Exp. 06/2006; 54004WX, Exp. 08/2006; 54005K2, Exp. 09/2006; 540067V, Exp. 11/2006; 540076H, Exp. 01/2007; 54007VP, Exp. 03/2007; 540097R, Exp. 05/2007; 5400C2L, Exp. 07/2007; 5400CP7, Exp. 08/2007; KP02G06, Exp. 08/2006; 5400GJC, Exp. 10/2007; KP034DW, Exp. 10/2007; 5400HKL, Exp. 12/2007; KP03567, Exp. 11/2007; 5400HNJ, Exp. 01/2008; 5400HT1, Exp. 03/2008; 5400J9V, Exp. 04/2008; 5400K64, Exp. 04/2008; 5400K9K, Exp. 05/2008.
RECALLING FIRM/MANUFACTURER
Bayer Health Care Llc, Shawnee, KS, by e-mail and letters on September 6, 2005, by letters on September 9, 2005 and by telephone on October 3, 2005. Firm initiated recall is ongoing.
REASON
Product approval withdrawn by FDA.
VOLUME OF PRODUCT IN COMMERCE
51,515 gallons
DISTRIBUTION
NC, TX, MN, GA, IA, and Canada

END OF ENFORCEMENT REPORT FOR NOVEMBER 30, 2005

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Weekly report by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.