• 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 March 25, 2009

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.

 

March 25, 2009
09-12

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
ERBITUX (cetuximab), For Intravenous Use, 100 mg (2 mg/mL), single use 50 mL vial, Rx only, NDC 66733-948-23, Recall # D-211-2009
CODE
Lot numbers: 06Q00715, Exp. Jan 2010; 07Q00311A, Exp. Aug 2010, 07Q00311B, Exp. Aug 2010; 07T00312; Exp. Aug 2010; 07T00359A, Exp. Sep 2010; 07T00359C, Exp. Oct 2010; 07T00466A, Exp Nov 2010; 07T00663, Exp Dec 2010; 07T00664, Exp Dec 2010; 07T00677B, Exp. Dec. 2010; 07T00678, Exp Dec 2010; 07T00680, Exp. Dec 2010; 07T00681, Exp Dec 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: ImClone Systems Inc., Branchburg, NJ, by letters on March 5, 2009.
Manufacturer: Hollister Stier Laboratories LLC, Spokane, WA. Firm initiated recall is ongoing.
REASON
Cracks in vial: A product complaint identified leaking from underneath the cap of ERBITUX (cetuximab) 100 mg/50 mL vial, was found to be from undetected split finish cracks in the vial, possibly affecting the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE
224,888 vials
DISTRIBUTION
Nationwide and Canada

___________________________________
PRODUCT 
Dosing Card for Brevibloc Premixed Single Strength Injection 10 mg/mL (2,500 mg/250 mL) Ready-to-use Bags; dosing card for esmolol hydrochloride in sodium chloride injection, 250 mL bags, NDC 10019-055-61, an Rx IV beta-blocker anti-hypertensive; Recall # D-212-2009
CODE
Promotional item 748762
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated August 27, 2008.
Manufacturer: American Slide Chart Corp., Carol Stream, IL. Firm initiated recall is ongoing.
REASON
Misbranded; dosing card contains an incorrect maintenance infusion for patient weight of 55 kg and dose of 100 mcg/min. The infusion rate is shown as 55000 mcg/min, but the correct rate should be 5500 mcg/min.
VOLUME OF PRODUCT IN COMMERCE
37,700 dosing cards
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT 
Actavis, Acetaminophen and Codeine Phosphate, Oral Solution USP, Each 5 mL contains the following: Codeine Phosphate 12 mg, Acetaminophen 120 mg, Alcohol 7 %, 4 fl. oz. (118 mL), plastic bottles, NDC 0472-1419-04, One Pint plastic bottles, NDC 0472-1419-16, Rx Only, Recall # D-209-2009
CODE
4 oz bottles: Lot #R02135, Exp. Date: 11/2009; Lot #R02186, Exp. Date: 04/2010; Lot #R02255, Exp. Date: 05/2010; Lot #R02354, Exp. Date: 08/2010; Lot #R02418, Exp. Date: 09/2010 and Lot #R02439, Exp. Date: 01/2011. 16 oz bottles: Lot #R02135, Exp. Date: 11/2009; Lot #R02186, Exp. Date: 04/2010; Lot #R02226, Exp. Date: 04/2010; Lot #R02255, Exp. Date: 05/2010; Lot #R02298, Exp. Date: 07/2010; Lot #R02323, Exp. Date: 07/2010; Lot #R02354, Exp. Date: 08/2010; Lot #R02398, Exp. Date: 09/2010; Lot #R02418, Exp. Date: 09/2010; Lot #R02487, Exp. Date: 02/2011; Lot #R02488, Exp. Date: 03/2011 and Lot #R02489, Exp. Date: 04/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Actavis Mid Atlantic LLC, Lincolnton, NC, by letter on/about January 27, 2009. 
Manufacturer: Actavis Mid-Atlantic, LLC, Baltimore, MD. Firm initiated recall is ongoing.
REASON
Failed Degradation Specification; p-Aminophenol (18 month stability).
VOLUME OF PRODUCT IN COMMERCE
512,112 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0432-09
CODE
Unit: Y51668
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by letter dated February 8, 2008. Firm initiated recall is complete.
REASON
Blood product collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0506-09
CODE
Unit: 72E906611
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by telephone on February 12, 2008. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0558-09
CODE
Unit: 9910414
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on October 24, 2007. Firm initiated recall is complete.
REASON
Blood product, which failed to meet the minimum product specifications for a 7 day platelet pheresis, was distributed.

VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0559-09
CODE
Units: 9954342 Parts 1, 2, and 3
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on November 13, 2007. Firm initiated recall is complete.
REASON
Blood products, which failed to meet the minimum product specifications for a 7 day platelet pheresis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0560-09
CODE
Units: 9952957 Part 1 and Part 2
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on October 28, 2007. Firm initiated recall is complete.
REASON
Blood products, which failed to meet the minimum product specifications for a 7 day platelet pheresis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0580-09
CODE
Unit: W089808001088 (Part A and B)
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling, VA, by letter dated July 31, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA and DC
___________________________________
PRODUCT 
Red Blood Cells, Recall # B-0581-09
CODE
Unit: KT81284
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling, VA, by letter dated July 25, 2008 and September 12, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0589-09
CODE
Unit: 71X225648
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center – Montgomery Region, Montgomery, AL, by telephone on April 11, 2006. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0592-09
CODE
Unit: 71R431990
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center – Montgomery Region, Montgomery, AL, by facsimile on November 17, 2005. Firm initiated recall is complete.
REASON
Blood product, which was quarantined subsequent to receiving information regarding a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0601-09
CODE
Unit: 53FM97003
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by telephone on November 29, 2007 and follow-up letter dated December 4, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0602-09
CODE
Unit: 9916926
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on December 11, 2007. Firm initiated recall is complete.
REASON
Blood product, which did not meet the platelet pH QC specification, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0603-09
CODE
Units: 9918144; 9918144; 9918144 (split product)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on December 11, 2007. Firm initiated recall is complete.
REASON
Blood products, which did not meet the platelet pH QC specification, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units (split product)
DISTRIBUTION
FL, SC
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0604-09
CODE
Unit: 9732982 (split product)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on February 19, 2008. Firm initiated recall is complete.
REASON
Blood products, which did not meet the platelet pH QC specification, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units (split product)
DISTRIBUTION
FL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0605-09
CODE
Units: 303569824; 301330172; 309085574
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated December 19, 2006.
Manufacturer: Blood Systems, Inc., Bismarck, ND. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AZ, MN, CA
___________________________________
PRODUCT 
Fresh Frozen Plasma (Apheresis), Recall # B-0607-09
CODE
Unit numbers: W085608000848, W084908001328, GY05499, FL32961, FL32808, LQ16296, FL32291, KE88444, KE88374, KE88373, GC08553, LT29480, LT29494, LT27858, LT27731, LN13761, LN13762, LT27356, LT06821, LT08128, LQ03964, LE03038, LQ03330, LQ04622, LT09813, LT10667, LQ05519, LT11607, LE04429, LQ06014, LE04833, LE04340, LE05153, LT14117, LE06289, LQ08004, LE05995, LT09877, LT09875, LE04063, LE04019, LE07500, LE07131, LS03217, LN09104, LT18638, LT18263, LT18067, LN08552, LE06426, LE06389, LT17248, and LQ03301.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by fax on July 11, 2008. Firm initiated recall is complete.
REASON
Blood products, processed without documentation of freezing time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
53 units
DISTRIBUTION
PA

___________________________________
PRODUCT 
Red Blood Cells, Recall # B-0608-09
CODE
Unit: LW89998
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by letter dated July 13, 2008. Firm initiated recall is complete.
REASON
Blood product collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT 
Granulocytes Pheresis, Recall # B-0611-09
CODE
Unit: LH69577
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by telephone and facsimile on March 6, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT 
a) Platelets Pheresis Leukocytes Reduced, Recall # B-0612-09;
b) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0613-09
CODE
a) Units: 2117134; 2116714; 3673725; 3672856; 3672113 Part 1; 3672113 Part 2;
b) Units: 2116373; 3674439
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter on April 28, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0614-09
CODE
Unit: GR74669
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by electronic notification on August 24, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT 
a) Platelets Pheresis Leukocytes Reduced, Recall # B-0615-09;
b) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0616-09;
CODE
a) and b) Unit: 9912583
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on January 15, 2008. For, initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Propionibacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0632-09
CODE
Unit: 9866768 Part 1 and Part 2
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on October 20, 2007. Firm initiated recall is complete.
REASON
Blood products, which failed to meet the minimum product specifications for a 7 day platelet pheresis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0633-09
CODE
Unit: 9935410 Part 1 and Part 2
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on September 18, 2007. Firm initiated recall is complete.
REASON
Blood products, which failed to meet the minimum product specifications for a 7 day platelet pheresis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0634-09
CODE
Unit: 9955086 Part 1 and Part 2
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on December 20, 2007. Firm initiated recall is complete.
REASON
Blood products, which failed to meet the minimum product specifications for a 7 day platelet pheresis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0484-09
CODE
Units: 22FC40024, 22KY94833
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by letter dated October 22, 2007. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for red blood cell antigens, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0590-09
CODE
Unit: 18GQ19451
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on June 30, 2006 and by letter on July 7, 2006. Firm initiated recall is complete.
REASON
Blood product, which failed to meet the minimum specification for percent red blood cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT 
Fresh Frozen Plasma, Recall # B-0591-09
CODE
Unit: 71R431990
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center – Montgomery Region, Montgomery, AL, by facsimile on November 17, 2005. Firm initiated recall is complete.
REASON
Blood product, which was quarantined subsequent to receiving information regarding a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0593-09
CODE
Unit: 13X15531
RECALLING FIRM/MANUFACTURER
American Red Cross Southeastern Michigan Region, Detroit, MI, by telephone on October 11, 2006. Firm initiated recall is complete.
REASON
Blood product, which was exposed to unacceptable temperature during storage, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0600-09
CODE
Unit: 53FM97003
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by e-mail on November 29, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0606-09
CODE
Unit: 302987378
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Fargo, ND, by letter dated October 30, 2006.
Manufacturer: Blood Systems, Inc., Bismarck, ND. Firm initiated recall is complete.
REASON
Blood product, documented as being out of controlled storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
ND
___________________________________
PRODUCT 
Platelets Leukocytes Reduced, Recall # B-0610-09
CODE
Unit: 13GW59633
RECALLING FIRM/MANUFACTURER
American Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on September 5, 2006 and by letter on September 19, 2006. Firm initiated recall is complete.
REASON
Blood product, which failed to meet collection time specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT 
PROSTIVA RF Model 8929 Hand Piece is the delivery system component of the PROSTIVA RF Therapy System. PROSTIVA RF Therapy Kit 8929, Sterilized using ethylene oxide. Indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 cm3 and 50 cm3, Recall # Z-1060-2009
CODE
All lot numbers are included
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN, by letter on August 6, 2008.
Manufacturer: Medtronic Puerto Rico, Inc., Villalba, PR. Firm initiated recall is ongoing.  
REASON
Reported incidents of needle retraction failure when using the PROSTIVA RF Model 8929 Hand Piece.
VOLUME OF PRODUCT IN COMMERCE
40,168 units
DISTRIBUTION
Nationwide and countries of Australia, New Zealand, China, Austria, Denmark, Finland, France, Germany, Italy, Kuwait, Lebanon, Norway, Qatar, Russian Federation, Spain, Sweden, Switzerland, and United Kingdom
___________________________________
PRODUCT 
OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureStep brand Blood Glucose Meters, Recall # Z-1070-2009
CODE
Lot numbers: 2802961 and 2802962
RECALLING FIRM/MANUFACTURER
LifeScan Inc., Milpitas, CA, by letters dated November 24, 2008. Firm initiated recall is ongoing.
REASON
Deformity in the test strip may result in insufficient blood transfer to reaction area, resulting in inaccurate test results.
VOLUME OF PRODUCT IN COMMERCE
23,288 vials
DISTRIBUTION
Nationwide and the Caribbean
___________________________________
PRODUCT 
a) Magic3 (Intermittent Catheter), Sterile, Uncoated 6 French Pediatric Length REF 52306. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1074-2009;

b) Magic3 (Intermittent Catheter), Sterile, Uncoated 8 French Pediatric Length REF 52308. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1075-2009;

c) Magic3 (Intermittent Catheter), Sterile, Uncoated 10 French Pediatric Length REF 52310. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1076-2009;

d) Magic3 (Intermittent Catheter), Sterile. Hydrophilic 6 French Pediatric Length REF 52606. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1077-2009;

e) Magic3 (Intermittent Catheter), Sterile. Uncoated 10 French Male Length REF 53310. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1078-2009;

f) Magic3 (Intermittent Catheter), Sterile. Hydrophilic 8 French Pediatric Length REF 52608. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1079-2009;

g) Magic3 (Intermittent Catheter), Sterile. Hydrophilic 10 French Pediatric Length REF 52610. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1080-2009;

h) Magic3 (Intermittent Catheter), Sterile. Hydrophilic 12 French Male Length REF 53612. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1081-2009;

i)  Magic3 (Intermittent Catheter), Sterile. Hydrophilic 14 French Male Length REF 53614. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1082-2009;

j) Magic3 (Intermittent Catheter), Sterile. Hydrophilic 16 French Male Length REF 53616. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1083-2009;

k) HydroSil (Intermittent Urethral Catheter), Hydrophilic 12 French Male Length Sample Packs REF#63612SPL, Sterile R. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1084-2009;

l) HydroSil (Intermittent Catheter), Hydrophilic 14 French Male Length Sample Packs REF#63614SPL, Sterile R. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1085-2009;

m) HydroSil (Intermittent Catheter), Hydrophilic 12 French Male Length REF#63612. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1086-2009;

n) HydroSil (Intermittent Catheter) Hydrophilic 14 French Male Length REF#63614. Intended for use for bladder management including urine drainage, collection and measurement, Recall # Z-1087-2009  
CODE
a) Lot number: 53606938; 
b) Lot number: 53606939;   
c) Lot number: 53606940;    
d) Lot number: 53606896;    
e) Lot number: 53606945;    
f) Lot number: 53606897;    
g) Lot number: 53606898;    
h) Lot number: 53606907;    
i)  Lot number: 53606906;     
j)  Lot number: 53606910;   
k) Lot number: 53607048;     
l)  Lot number: 53607105; 
m) Lot number: 53606961;    
n)  Lot number: 53606963   
RECALLING FIRM/MANUFACTURER
Rochester Medical Corp., Stewartville, MN, by telephone, in-person visit, e-mail or letter dated January 14, 2009. Firm initiated recall is ongoing.
REASON
Catheter packages in which the  catheter was caught in the package seal during the packaging process.
VOLUME OF PRODUCT IN COMMERCE
1,960 units
DISTRIBUTION
Nationwide and countries of United Kingdom
___________________________________
PRODUCT 
Triage Drugs of Abuse Panel, Model Number: 95000. Is an immunoassay test kit used for the qualitative determination of the presence of the major metabolites of drugs of abuse in urine, Recall # Z-1088-2009
CODE
Lot/Unit Code: 186625
RECALLING FIRM/MANUFACTURER
Biosite, Inc., San Diego, CA, by letters dated November 5, 2008. Firm initiated recall is ongoing.
REASON
The recall was initiated after the firm's investigations confirmed that, while lot #186625 passed all internal specifications and quality requirements, the incidence of false positive PCP results has exceeded their post market surveillance thresholds for customer complaints in the field. In addition, the firm has been able to reproduce false positive results reported by customers and as a result we are conducting this voluntary recall.
VOLUME OF PRODUCT IN COMMERCE
2,634 kits
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
BD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 799-14000-00R; Catalog Number: 05CR000021, 05CR000021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 7914000-00R. PrepStain is a liquid-based thin layer cell preparation device for preparation and staining of Prep smear slides from cervical specimens in a liquid based format (gyn use) and of cytology examination slides from non-cervical specimens such as urine and lung lavage, Recall # Z-1090-2009
CODE
GYN software version 1.2, Non-GYN version 2.80; GYN software version 1.3.0.1, Non-GYN software version 2.80
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bd Diagnostic Systems Tripath, Durham, NC, by telephone on September 26, 2008 and by letter on September 29, 2008.
Manufacturer: Bd Diagnostics, Burlington, NC. Firm initiated recall is ongoing.
REASON
Software Error in the non-gyn program of some devices may cause non-gyn samples to be incorrectly transferred from centrifuge tubes to slides potentially resulting in mismatched patient results.
VOLUME OF PRODUCT IN COMMERCE
662 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT 
Medtronic COMPLETE SE Self Expanding Biliary Stent System, Model number SC760L, includes a pre-loaded self-expanding Nickel-Titanium (Nitinol) stent with 8 tantalum radiopaque markers, 4 on each end, and an over the wire retractable sheath delivery system, Recall # Z-0642-2009
CODE
Lot number: 0000767722
RECALLING FIRM/MANUFACTURER
Medtronic Cardiovascular, Santa Rosa, CA, by letter on November 21, 2008. Firm initiated recall is ongoing.
REASON
Mislabeled: Product may contain wrong instructions for use – may contain International IFU instead of the correct US (for Biliary indication use only)
VOLUME OF PRODUCT IN COMMERCE
23 units
DISTRIBUTION
NY, TX, CA, IA, AZ, PA, IN, and KS
___________________________________
PRODUCT 
Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Latex slide agglutination test for the differentiation of Staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccharides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties. Recall # Z-1008-2009
CODE
Lot number: J054710, Exp. 2010.04.30
RECALLING FIRM/MANUFACTURER
Recalling Firm: Remel, Inc., Lenexa, KS, by letters dated October 7, 2008.
Manufacturer: Oxoid, Ltd., Basingstoke, UK. Firm initiated recall is complete.
REASON
Control and test wells are reversed on some of the reaction cards.
VOLUME OF PRODUCT IN COMMERCE
33 kits
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II
___________________________________
PRODUCT 
a) Factrel (gonadorelin injectable) for the treatment of cystic ovaries in cattle. Each milliliter sterile aqueous solution contains 50 micrograms of gonadorelin (as hydrochloride). NADA 139-237. 20 mL vial; NDC 0856-4311-02. Recall # V-136-2009;

b) Torbugesic (butorphanol tartrate injection) for use in horses as an opioid analgesic. Each milliliter of aqueous solution contains 10 milligrams of butorphanol (as butorphanol tartrate). NADA 135-780, 50 mL vial; NDC 0856-2033-20. Recall # V-137-2009
CODE
a) Lot numbers: 431413 and 431414, Exp. Dec 2011;
b) Lot number: 454473, Exp. Dec. 2011
RECALLING FIRM/MANUFACTURER
Fort Dodge Laboratories, Inc., Fort Dodge, IA, by letters on February 6, 2009. Firm initiated recall is ongoing.
REASON
The manufacturing site encountered an equipment malfunction which could have affected the sterility assurance of the glass vial of the drug product.
VOLUME OF PRODUCT IN COMMERCE
a) 32,596 vials;
b) 6,602 vials
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR March 25, 2009

###

RSS Feed for FDA Enforcement Report [what is RSS?]