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U.S. Department of Health and Human Services

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Enforcement Report for August 6, 2008

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.

 

August 6, 2008
08-31

 

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________
PRODUCT 
Smoked salmon in clear vacuum sealed bags labeled Santa's Smokehouse Gourmet Smoked Salmon Silver Salmon, Recall # F-509-8
CODE
659
RECALLING FIRM/MANUFACTURER
Interior Alaska Fish Processor, Fairbanks, AK, by telephone, press release and sign posted at their retail stores. Firm initiated recall is complete.
REASON
Listeria monocytogenes was detected in the product by the Alaska Department of Environmental Conservation.
VOLUME OF PRODUCT IN COMMERCE
168 lbs.
DISTRIBUTION
AK, LA, PA, VT, WA

___________________________________
PRODUCT 
Lezza Italian Ice, Blue Raspberry, 1 Pint. 2116. Keep Frozen. Ingredients: Water, Sugar, Corn Syrup, Natural & Artificial Flavors, Citric Acid, Guar Gum, Xanthan Gum, Mono & Diglycerides, Polysorbate 80, Carrgeenan, Salt and Blue Color. Plant #55-472. Recall # F-510-8
CODE
2116
RECALLING FIRM/MANUFACTURER
Cedar Crest Specialties, Inc., Manitowoc, WI, by press release on May 2, and May 5, 2008 and by fax. Firm initiated recall is complete.
REASON
Lezza Blue Raspberry Italian Ice in pint containers with lot code of 2116, is being recalled because it may contain undeclared milk protein. People who have an allergy or severe sensitivity to milk may experience a potentially serious or life-threatening allergic reaction if they consume this product.
VOLUME OF PRODUCT IN COMMERCE
6,156 pint containers
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I

___________________________________
PRODUCT 
a) APS Heparin Sodium Injection 10MU/mL (10000u/mL), 1ml SDV 25UD (bag),
    Recall # D-273-2008;
b) APS Heparin Sodium Injection SDV 10MU/mL (10,000 units/mL),
    25UD (box & rod), Recall # D-274-2008
CODE
a) Lot #074155 Exp Date; 8/31/09; Lot #073712 Exp Date 2/31/08; Lot #073613 Exp Date 12/31/08;
    Lot #073454 Exp Date 12/31/08; Lot #073391 Exp Date 12/31/08; Lot #073089 Exp Date 10/31/08;
    Lot #072907 Exp Date 10/31/08; Lot #070095D Exp Date 5/31/08; Lot #070095A Exp Date 5/31/08;
b) Lot #070095B Exp Date 5/31/08; Lot #070095C Exp Date 5/31/08;
    Lot #068286 Exp Date 4/3008; Lot #067755 Exp Date 4/30/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Packaging, Columbus, OH, by e-mail and letter on March 3, 2008.
Manufacturer: Baxter Healthcare, Corp., Round Lake, IL. Firm initiated recall is ongoing.
REASON
Presence of Foreign Substance; over-sulfated chondroitin sulfate (Baxter).
VOLUME OF PRODUCT IN COMMERCE
1,421 units of 25 unit dose vials each
DISTRIBUTION
GA, CA
___________________________________
PRODUCT 
Heparin Sodium, USP (Porcine Intestines), Caution: For Manufacturing and Processing use only. Federal Law Prohibits dispensing without a Prescription. Preserve in tight containers and store below 40 degrees C. Preferably at room temperature. Activity = mmu (1,000,000 USP units of heparin activity), Recall # D-278-2008
CODE
1035-0814, 1035-0815, 1035-0816, 1035-0817, 1035-0818, 1060-07-0016, 1060-07-0017, 1060-07-0018, 1060-07-0020, 1060-07-0021, 1060-07-0022, 1060-07-0023, 1060-07-0024, 1060-07-0025, 1060-07-0026, 1060-07-0027, 1060-07-0028, 1060-07-0029, 1060-07-0030, 1060-07-0031, 1060-07-0034, 1060-07-0035, 1060-07-0036, 1060-07-0037, 1060-07-0038, 1060-07-0039, 1060-07-0040, 1060-07-0041, 1060-07-0042, 1060-07-0043, 1060-07-0044, 1060-07-0045, 1060-07-0046, 1060-07-0047, 1060-07-0048, 1060-07-0049, 1060-07-0050 EXPANDED: 1035-0772, 1035-0773
RECALLING FIRM/MANUFACTURER
Recalling Firm: Scientific Protein Laboratories, LLC, Waunakee, WI, by telephone and letter on March 6, 2008 and by telephone on March 14, 2008, e-mail on March 18, 2008 and by letter beginning March 20, 2008.
Manufacturer: Changzhou SPL Company, Ltd., Changzhou, China. Firm initiated recall is ongoing.
REASON
Presence of foreign substance; identification of unexpected, additional signals and peaks. Now identified as over-sulfated chondroitin sulfate.
VOLUME OF PRODUCT IN COMMERCE
1035 ~350kg (60,884 mmu), 1036 ~2240kg (386,391 mmu) EXPANDED 1035: 23,002.72 mmu
DISTRIBUTION
NJ, CA, IL, NJ, NY, PA, Canada, Ireland

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
Mommy’s Bliss Nipple Cream, 2 fl. Oz. tubes, Recall # D-261-2008
CODE
All products with lot codes/expiration dates 1388/05/2009, 1419/05/2009, and 1478/07/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: MOM Enterprises, Inc., San Rafael, CA, by telephone and internet on May 28, 2008.
Manufacturer: LifeTech Resources, Chatsworth, CA. Firm initiated recall is ongoing.
REASON
Unapproved New Drug; product contains chlorphenesin and phenoxyethanol
VOLUME OF PRODUCT IN COMMERCE
5,628 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), lyophilized sterile powder in 5 mL vials, cartons of 20 vials, Rx only, for diagnostic use, NDC No. 11994-001-20, Recall # D-275-2008
CODE
Lot 3955 (3955PU on carton), exp. February 1, 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lantheus Medical Imaging, Inc., North Billerica, MA, by telephone on June 14, 2008 and by letter on June 17, 2008.
Manufacturer: Ben Venue Laboratories, Inc., Bedford, OH. Firm initiated recall is ongoing.
REASON
Sterility of the product is not assured.
VOLUME OF PRODUCT IN COMMERCE
8,460 vials
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
a) Heparin Sodium Powder, USP, Bulk, HE150, 1 Million Units, Potency = 173 U/mg
    CAS 9041-08-1, Recall # D-276-2008;
b) Heparin Sodium Powder, USP, Bulk, HE150, 10,000 Units, Potency = 173 U/mg
    CAS 9041-08-1, Recall # D-277-2008
CODE
 a) and b) Lot: XB0070
RECALLING FIRM/MANUFACTURER
Spectrum Laboratory Products, Inc., Gardena, CA, by telephone on April 2, 2008, and by fax and e-mail on April 18, 2008.
Celsus Laboratories, Inc., Cincinnati, OH. Firm initiated recall is complete.
REASON
Presence of foreign substance; product found to be contaminated with over-sulfated chondroitin sulfate (manufacturer).
VOLUME OF PRODUCT IN COMMERCE
6 bottles
DISTRIBUTION
AZ, GA

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT 
a) Sandoz, Estradiol Valerate Injection, USP, 40 mg per mL, 5 mL Multiple Dose Vial,
    Rx only, Sterile, NDC 0781-3031-75, Recall D-268-2008;
b) Sandoz, Estradiol Valerate Injection, USP, 20 mg per mL, 5 mL Multiple Dose Vial,
    Rx only, Sterile, NDC 00781-3029-75, Recall # D-269-2008;
c) Sandoz, Estradiol Valerate Injection, USP, 10 mg per mL, 5 mL Multiple Dose Vial,
    Rx only, Sterile, NDC 0781-3030-75, Recall # D-270-2008
CODE
a) Lot number 130964;
b) Lot number 138050;
c) Lot number 144500
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz, Inc., Princeton, NJ, by letters on May 16, 2008 and June 6, 2008.
Manufacturer: Sandoz Canada, Inc., Boucherville, Canada. Firm initiated recall is ongoing.
REASON
Drug product exceeded the unknown impurity specification during stability testing.
VOLUME OF PRODUCT IN COMMERCE
7,088/5mL vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Acetaminophen and Codeine Phosphate Oral Solution USP, Each 5mL (one teaspoonful) contains: Acetaminophen 120 mg and Codeine phosphate 12 mg, in 4 fl oz bottles (NDC 0472-1419-04) and 16 fl oz bottles (NDC 0472-1419-16), Rx Only, Recall # D-279-2008
CODE
Lot: Q02055, expiration date 07/2009
RECALLING FIRM/MANUFACTURER
Actavis Mid-Atlantic, LLC, Baltimore, MD, by letter on April 30, 2008. Firm initiated recall is ongoing.
REASON
Degradation; acetaminophen (18 month stability)
VOLUME OF PRODUCT IN COMMERCE
41,975 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # 1030-08
CODE
Unit: 5233296
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on August 18, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported living in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Sunquest Laboratory Blood Bank and Blood Donor Modules v5.2, Distributed with Sunquest Laboratory v5.3 and v5.4. and Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1, v6.0.2 and v6.4.0 (Beta), Distributed with Sunquest Laboratory v6.1, v6.2, v6.3 and v6.3.1 (Beta), Recall # B-1137-08
CODE
Sunquest Laboratory Blood Bank and Blood Donor Modules v5.2, Distributed with Sunquest Laboratory v5.3 and v5.4. and Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1, v6.0.2 and v6.4.0 (Beta), Distributed with Sunquest Laboratory v6.1, v6.2, v6.3 and v6.3.1 (Beta)
RECALLING FIRM/MANUFACTURER
Sunquest Information Systems, Inc., Tucson, AZ, by e-mail on June 5, 2008. Firm initiated recall is ongoing.
REASON
Software, with a glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE
103 clients - Sunquest Blood Bank 5.2; 286 clients - Sunquest Blood Bank 6.0.1 and 6.0.2 and (Beta)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
Fresh Frozen Plasma, Recall # B-1391-08
CODE
Unit: 5252988
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on December 14, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had previously been incarcerated, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1402-08
CODE
Unit: 9879745 (parts 1 and 3)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on February 6, 2007 and by letter on February 9, 2007. Firm initiated recall is complete.
REASON
Platelets, with an unacceptable pH, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-1634-08
CODE
Unit: 7093886
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by email on July 20, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-1640-08
CODE
Unit: 3964221
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by email on January 31, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT 
a) Fresh Frozen Plasma, Recall # B-1641-08;
b) Recovered Plasma, Recall # B-1642-08
CODE
a) Unit: 4962368;
b) Unit: 1920960
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone and fax on September 9, 2006. 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
2 units
DISTRIBUTION
FL, Austria
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1643-08
CODE
Unit: 9948343 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on August 22, 2006 and by letter on August 29, 2006. Firm initiated recall is complete.
REASON
Blood products, with platelet count below the specified minimum requirement, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1645-08
CODE
Unit: 4872985
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on December 9, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
a) Red blood cells, Recall # B-1647-08;
b) Platelets, irradiated, Recall # B-1648-08
CODE
a) and b) Unit: M90891
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saginaw MI, by facsimile on April 4, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
___________________________________
PRODUCT 
Source Plasma, Recall # B-1652-08
CODE
Units: 0070150080, 0070149894, 0070146125, 0070145642, 0070145344, 0070144710, 0070144511, 0070143479, 0070143126, 0070142729, 0070142206, 0070141992, 0070141591, 0070141348, 0070140935, 0070140703, 0070140083, 0070139866, 0070139421, 0070139142, 0070138789, 0070138221, 0070137978, 0070137199, 0070136974, 0070136202
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on October 17, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information regarding multiple high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
26 units
DISTRIBUTION
Barcelona Spain
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-1658-08;
b) Recovered Plasma, Recall # B-1659-08
CODE
a) and b) 3072780
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by letter on March 8, 2006. 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
2 units
DISTRIBUTION
MS, Switzerland
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1664-08
CODE
Unit: S98822
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Center, Springfield, IL, by facsimile on March 14, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-1699-08
CODE
Unit: 5250166
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by electronic mail on July 5, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1705-08
CODE
Unit: 4075715 (Part 1 & 2)
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by fax dated November 15, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had previously tested reactive for Cytomegalovirus (CMV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA
___________________________________
PRODUCT 
Source Plasma, Recall # 1706-08
CODE
Units: 07755194, 05MTNA1548, 04MTNA1948, 04MTNA1498, 04MTNA0467, 20387280, 20385934, 20382599, 20380656, 20375591, 20374099, 20366520, 08717009, 08712301, 08369765, 08366139, 08362414, 07759093, KP086501, 10412220, 07496394, 07490842, KP083074, 04619802, KP82717, KP82315, 04306023, 04302582, KP81945, 03984260, 03881071, 93048866
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by letter on March 11, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
32 units
DISTRIBUTION
CA, NC, PA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1710-08
CODE
Unit: 0375272 (Part 1 and 2)
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by fax on September 20, 2007. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced without the assurance that it met the criteria for a leukoreduced product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1712-08
CODE
Unit: 5726821
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on October 31, 2005. Firm initiated recall is complete.
REASON
Blood product, with insufficient plasma volume to support the platelet concentration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT 
Source Plasma, Recall # B-1716-08
CODE
Unit: DQ039719
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by fax on August 20, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1717-08
CODE
Units: DQ039714, DQ039465, DQ039176, DQ038484, DQ038001
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by fax on August 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1718-08
CODE
Units: DQ038522, DQ038369
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by fax on August 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1719-08
CODE
Unit: DQ039017
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by fax on August 20, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1720-08
CODE
Units: DQ039574, DQ039431
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by fax on August 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Red Blood Cells, Recall # B-1721-08
CODE
Units: 71T974132, 72C011983
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL, by fax on September 4, 2007. 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
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT 
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1733-08;
Recovered Plasma, Recall # B-1734-08
CODE
a) and b) Unit: 4859648
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by email and letter on June 7, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL, Austria
___________________________________
PRODUCT 
Platelets Leukocytes Reduced, Recall # B-1735-08
CODE
Unit: 5265371
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by facsimile on April 26, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III

___________________________________
PRODUCT 
Source Plasma, Recall # B-0006-08
CODE
Units: 0070135897, 0070135547
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on October 17, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information regarding multiple high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Barcelona Spain
___________________________________
PRODUCT 
Source Plasma, Recall # B-1568-08
CODE
Units: I77004880, I77004486, I77003662, I77000900, I77000806, I77000663, I77000120
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Phenix City, AL, by facsimile on September 1, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
NC

___________________________________
PRODUCT 
Source Plasma, Recall # B-1569-08
CODE
Unit: 159049540
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Lafayette, LA, by facsimile on May 19, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-1644-08
CODE
Unit: 5251180
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by email on December 27, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received a bone graft within one year of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT 
Platelets Leukocytes Reduced, Recall # B-1646-08
CODE
Unit: 4898089
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on January 13, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose body temperature was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1657-08
CODE
Unit: 5323101
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center, Inc., Jackson, TN, by telephone on March 31, 2008. Firm initiated recall is complete.
REASON
Blood product, which was not labeled for an unexpected antibody, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1703-08
CODE
Unit: 4069233
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on November 11, 2005. Firm initiated recall is complete.
REASON
Blood product, which was not labeled for an unexpected antibody, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1704-08
CODE
Units: 5719486; 5719489
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on November 11, 2005. Firm initiated recall is complete.
REASON
Blood product, which was not labeled for an unexpected antibody, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA
___________________________________
PRODUCT 
Source Plasma, Recall # B-1708-08
CODE
Unit: 380060024
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Monroe, LA, by fax on May 16, 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
NC
___________________________________
PRODUCT 
Fresh Frozen Plasma, Recall # B-1709-08
CODE
Unit: 2897961
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on May 7, 2007 and by letter on May 11, 2007. Firm initiated recall is complete.
REASON
Blood product, manufactured from Whole Blood unit that may have had an extended collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________
PRODUCT 
Precision 500D Classical R&F System with control room PC; Image-intensified fluoroscopic x-ray system; Model Number: 5117866-27, Recall # Z-0274-2008
CODE
Code Numbers: 00000003712M37 00000004383M36 00000004912M32 00000004207M37 00000003989M31 00000004669M38 00000004911M34 00000003192M32 00000003711M39 00000004391M39 00000003988M33 00000003101M33 00000003986M37 00000003899M32 00000003916M34 00000003991M37 00000003893M35 00000004385M31 00000003190M36 00000004208M35 00000003716M38 00000003918M30 00000003922M32 00000004577M33 00000004572M34 00000003792M39 00000004392M37 00000004388M35 00000004659M39 00000003407M34 00000004209M33 00000003992M35 00000004575M37 00000004579M39 00000003897M36 00000003913M31 00000004782M39 00000003404M31 00000003915M36 00000004389M33 00000003719M32 00000004660M37 00000004780M33 00000004212M37 00000004384M34 00000003896M38 00000003921M34 00000004386M39 00000003226M38 00000003224M33 00000003412M34 00000003386M30 00000004206M39 00000004215M30 00000003189M38 00000004781M31 00000003892M37 00000003713M35 00000004663M31 00000003715M30 00000003227M36 00000004665M36 00000003409M30 00000004787M38 00000003229M32 00000004416M34 00000003403M33 00000004786M30 00000003191M34 00000004578M31 00000004390M31 00000004785M32 00000003408M32 00000003987M35 00000004661M35 00000003894M33 00000003900M38 00000003383M37 00000004662M33 00000003793M37 00000004664M39 00000004909M38 00000003406M36 00000003901M36 00000003405M38 00000003895M30 00000003710M31 00000003717M36 00000004913M30 00000003898M34 00000004170M37 00000003718M34 00000003411M36 00000003919M38 00000003102M31 00000003225M30 00000003384M35 00000003387M38 00000003794M35 00000003917M32 00000003920M36 00000004213M35 00000004415M36 00000004417M32 00000004581M35 00000004666M34 00000004789M34 00000004916M33 00000004999M39 00000005000M35 00000005063M33 00000005064M31 00001009888WK7 00000003990M39 00000004210M31 00000004214M33 00000003993M33 00000004181M34 00000004414M39 00000004418M30 00000004574M30 00000004667M32 00000004668M30 00000004670M36 00000004784M35 00000004788M36 00000004910M36 00000005001M33 and 00000005070M38.
RECALLING FIRM/MANUFACTURER
GE Healthcare, Waukesha, WI, by letters on July 10, 2007. Firm initiated recall is complete.
REASON
Inaccurate cassette size display reading/ Inaccurate mAs reading: 1. When the device is in PBL mode and a larger film cassette is inserted into the table Bucky (replacing a smaller cassette) after a protocol is selected on the console, the collimator will not adjust to the larger cassette size. The collimator stays at the original smaller cassette size and allows the operator to take an exposure. 2. The light X-ray film may report higher than actual mAs readings, than what was actually exposed to the patient.
VOLUME OF PRODUCT IN COMMERCE
101 systems
DISTRIBUTION
Nationwide and Internationally
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PRODUCT 
Steris C1160 Universal Flexible Processing Tray, for use with STERIS SYSTEM 1 Processor, used for sterilization of flexible endoscopes, Recall # Z-1190-2008
CODE
All codes
RECALLING FIRM/MANUFACTURER
Steris Corp., Mentor, OH, by letter dated February 8, 2008. Firm initiated recall is ongoing.
REASON
Failure to effectively sterilize: Under certain conditions, the design/operation of the C1160 Tray may compromise the ability of the SYSTEM 1 processor to correctly assess the state of the high pressure pump during the Sterile Cycle. The L6 sensor fails to alarm when the high pressure pump is not working properly.
VOLUME OF PRODUCT IN COMMERCE
28,766 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT 
INTEGRA NeuroSensor Probe, REF NS-P, component of Cerebral Blood Flow and Intracranial Pressure Monitoring Kit, Recall # Z-1191-2008
CODE
Lot: 100063, all serial numbers
RECALLING FIRM/MANUFACTURER
Integra Neuro Sciences, San Diego, CA, by letter on January 28, 2008. Firm initiated recall is complete.
REASON
Incorrect pressure reading: Due to a manufacturing error, the ICP reading could be inaccurate to the extent that they exceed label claims. Specifically, the Insertion Error label claim of +/- 3mmHg could be exceeded by up to -3mmHg, that could result in a maximum Insertion Error of +/- 6mmHg.
VOLUME OF PRODUCT IN COMMERCE
43 units
DISTRIBUTION
CA, GA, NM, TX, NE, WA, NY
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PRODUCT 
a) International Technidyne Corp. (ITC) AVOXimeter 1000 Oximeter, Catalog Numbers:
    AVON1000-110 and AVOX-1000-220. Note:w The AVOXimeter 1000 was discontinued in
    1996 by the company which which ITC acquired the product line from (AVOX Systems in Texas).
    Today, only service is offered on this mode, Recall # Z-1237-2008;
b) International Technidyne Corp. (ITC) AVOXimeter 1000E Oximeter, Catalog Numbers:
    AVOX1000E-110 and AVOX1000E-220, Recall # Z-1238-2008;
c) International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers:
    AVOX4000-110 and AVOX4000-220, Recall # Z-1239-2008
CODE
a) Serial Numbers: 1073, 1085, 1197, 1245, 1321, 1383, 1162;
b) Serial Numbers:  1482 1531 1627 1633 1635 1707 1708 1716 1740 1804 1864 1961 1968
    1991 1997 2002 2082 2094 2109 2148 2157 2164 2212 2238 2271 2282 2315 2319 2331
    2384 2388 2394 2395 2449 2585 2596 2598 2633 2657 2669 2686 2689 2775 2776 2777
    2725 2728 2732 2741 2742 2743 2744 2746 2747 2748 2749 2750 2751 2752 2753 2754
    2755 2756 2757 2758 2759 2760 2761 2762 2763 2764 2765 2766 2767 2769 2771 2772
    2773 2774 2778 2779 2780 2794 2806 2807 2808 2810 2812 2813 2814 2815 2816 2817
    2818 2819 2820 2821 2822 2823 2824 2825 2826 2827 2828 2831 2832 2833 2834 2835
    2836 2837 2839 2843 2844 2845 2846 2848 2849 2850 2851 2852 2853 2854 2855 2856     
    2857 2858 2859 2860 2861 2863 2864 2865 2866 2867 2868 2869 2870 2871 2872 2873
    2874 2875 2876 2877 2878 2879 2880 2881 2882 2883 2884 2885 2887 2888 2889 2890
    2891 2892 2894 2895 2896 2898 2899 2900 2901 2902 2903 2904 2905 2906 2907 2908
    2909 2910 2912 2913 2914 2915 2917 2918 2921 2922 2924 2925 2926 2927 2928 2929
    2932 2933 2934 2935 2936 2937 2938 2939 2940 2942 2943 2944 2945 2946 2947 2948 2950;
c) Serial Numbers: 41018 41068 41096 41124 41146 41175 41280 41323 41325 41384 41423
    41430 41453 41480 41484 41489 41505 41506 41532 41533 41555 41560 41566 41570
    41571 41572 41573 41574 41575 41576 41577 41578 41579 41580 41581 41582 41583
    41584 41585 41586 41588 41589 41592 41593 41594 41595 41601 41605 41607 41608
    41609 41610 41611 41612 41613 41614 41615 41616 41617 41618 41619 41620 41632
    41633 41634 41635 41636 41637 41638 41639 Q-1034
RECALLING FIRM/MANUFACTURER
International Technidyne Corp., Edison, NJ, by letters dated February 8, 2008. Firm initiated recall is complete.
REASON
Incorrect reading: ITC discovered that instruments built or repaired since approximately April 2007 were inadvertently left with the diagnostic mode enabled when shipped to customers.
VOLUME OF PRODUCT IN COMMERCE
273 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT 
Da Vinci S 8mm Instrument Cannula with outlet for use with the Da Vinci Surgical System; Model IS2000, Part Numbers: 400254-01, 400255-01; Used in endoscopic surgery to establish a port of entry for Intuitive Surgical's EndoWrist Instruments, Recall # Z-1348-2008
CODE
Lot Numbers: 13730-01-70807, 13793-71106, 13730-02-70807, WI073202, WI074501, WI073201
RECALLING FIRM/MANUFACTURER
Recalling Firm: Intuitive Surgical, Inc., Sunnyvale, CA, by letters on January 4, 2008.
Manufacturer: Wightman Engineering Services, Santa Clara, CA. Firm initiated recall is ongoing.
REASON
(1) Incorrect dimension on Luer on smoke evacuation cannulae not allowing for secure attachment function. (2) Incorrect labeling. External labeling lot number differs from lot number etched on the cannula.
VOLUME OF PRODUCT IN COMMERCE
39 units
DISTRIBUTION
Nationwide
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PRODUCT 
High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy system; Software Version 7.0; Product Code: H56; Accessory to Medical Linear Accelerator, Recall # Z-1459-2008
CODE
Serial number: 1009
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on January 29, 2008. Firm initiated recall is ongoing.
REASON
Dose Calculation Error: Software anomaly may result in failure of a MLC leaf to reach planned position, potentially resulting in misadministration of dose to a patient.
VOLUME OF PRODUCT IN COMMERCE
3 systems
DISTRIBUTION
Nationwide
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PRODUCT 
Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77, Recall # Z-1460-2008
CODE
Serial Numbers: H770002-H780001, H770012-H780058, H770030-H780034, H770055-H780046, H770068-H780010, H770107-H780050, H770113-H780060, H770119-H780035, H770134-H780026, H770143-H780039, H770159-H780062, H770170-H780056, H770184-H780061, H770212-H780074, H770245-H780086 and H770279-H780105
RECALLING FIRM/MANUFACTURER
Recalling Firm: Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on February 5, 2008.
Manufacturer: Varian Medical Systems U.K. Ltd., Crawley, UK. Firm initiated recall is ongoing.
REASON
Incorrect Image Orientation: The image orientation tag may not be set correctly if the patient has been scanned with an orientation other than Head First Spine. When such images are imported to a treatment planning system, they may appear with either a mirrored or a rotated view.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT 
a) Stryker Peek Intraline Anchor, 5.5 mm, Model number 3910-400-010,
    Used for tissue fixation to bone in certain areas, Recall # Z-1533-2008;
b) Stryker Peek Intraline Anchor, 5.5 mm with Needles, Model number 3910-400-015,
    Used for tissue fixation to bone in certain areas, Recall # Z-1534-2008;
c) Stryker Peek Intraline Anchor, 6.5 mm, Model number 3910-400-020,
    Used for tissue fixation to bone in certain areas, Recall # Z-1535-2008;
d) Stryker Peek Intraline Anchor, 6.5 mm with Needles, Model number 3910-400-025,
    Used for tissue fixation to bone in certain areas, Recall # Z-1536-2008;
e) Stryker Wedge HS Suture Anchor II with Needles, 5.0 mm, Model number 3910-100-135.
    Intended for use in securing soft tissue to bone in certain procedures in specific areas,
    Recall # Z-1537-2008;
f) Stryker Wedge HS Suture Anchor II with Needles, 6.5 mm, Model number 3910-100-145.
    Intended for use in securing soft tissue to bone in certain procedures in specific areas,
    Recall # Z-1538-2008
CODE
a) Lot numbers 07276AE2, 07295AE2, 07296AE2, 07299AE2, 07312AE2;
b) Lot numbers 07277AE2, 07292AE2, 07295AE2, 07337AE2;
c) Lot numbers 07276AE2, 07299AE2, 07311AE2;
d) Lot numbers 07277AE2, 07292AE2;
e) Lot number 07298AE2, 07299AE2;
f) Lot Numbers 07299AE2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Endoscopy, San Jose, CA, by telephone and letters on February 7, 2008.
Manufacturer: Stryker Puerto Rico, Inc., Arroyo, PR. Firm initiated recall is ongoing.
REASON
Product package may crack and cause loss of sterility.
VOLUME OF PRODUCT IN COMMERCE
927 units
DISTRIBUTION
CA, OH, PA, CO, MA, and NJ
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PRODUCT 
a) Zimmer Dermacarriers II skin graft carriers, 1.5 to 1 dermacarrier, Rx, latex free, sterile,
    REF 00-2195-012-00. Single use device for use during skin grafting procedures,
    Recall # Z-1550-2008;
b) Zimmer Dermacarriers II skin graft carriers, 3 to 1 dermacarrier, Rx, latex free, sterile,
    Qty 1, REF 00-2195-013-00. Single use device for use during skin grafting procedures,
    Recall # Z-1551-2008;
c) Zimmer Dermacarriers II skin graft carriers, 6 to 1 dermacarrier, Rx, latex free, sterile, Qty 1,
    REF 00-2195-014-00. Single use device for use during skin grafting procedures,
    Recall # Z-1552-2008;
d) Zimmer Dermacarriers II skin graft carriers, 9 to 1 dermacarrier, Rx, latex free, sterile, Qty 1;
    REF 00-2195-015-00. Single use device for use during skin grafting procedures,
    Recall # Z-1553-2008;
e) Zimmer Dermacarriers skin graft carriers, S.G. Carrier 8IN length, Rx, latex free, sterile;
    REF 00-7708-000-10. Single use device for use during skin grafting procedures, Z-1554-2008;
f) Zimmer Dermacarriers Skin Graft Carriers, S.G. Carrier 16IN length, Rx, latex free, sterile;
    REF 00-7716-000-10. Single use device for use during skin grafting procedures, Z-1555-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer, Inc., Warsaw, IN, by letter dated April 3, 2008.
Manufacturer: Zimmer Orthopedic Surgical Products, Dover, OH. Firm initiated recall is ongoing.
REASON
Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer’s end.
VOLUME OF PRODUCT IN COMMERCE
99,345 devices
DISTRIBUTION
Nationwide and Internationally
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PRODUCT 
CORDIS S.M.A.R.T.® Control" Nitinol Stent System Model Number(s): C10040SL, Manufactured in Mexico. Indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease, Recall # Z-1556-2008
CODE
10 lots. Lot #s: 13326414*, 13326415*, 13327582, 13329185*, 13332369, 13333077*, 13339105*, 13339106*, 13341244, 13343464. (*These six lots have U.S. distribution.)
RECALLING FIRM/MANUFACTURER
Cordis Corporation, Miami Lakes, FL, by letter dated March 11, 2008. Firm initiated recall is ongoing.
REASON
Data transcription error. The 10 affected lots of Catalog Number C10040SL were manufactured with a prior version of the guidewire lumen material, which is not validated with the current manufacturing process. This condition may result in a separation of the device. If a separation was to occur, and the separated fragment of lumen material was not retrieved on the guidewire, blockage of the vessel could occur. If attempts to capture the fragment are unsuccessful, surgical removal may be required.
VOLUME OF PRODUCT IN COMMERCE
398 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT 
a) Medi-Lifter III Plus Total Lift, Model 7000-2000 and b) Summit Total Lift, Model 4800-2000; patient lifts with mast scale (600 lbs. capacity); Mast scale is Intended to be used for weighing patients while in the lifter, Recall # Z-1557-2008
CODE
a) Serial numbers: 76001/1013, 76003/1015, 76004/1014, 76005/1017, 76027/1019, 76028/1012, 76058/1024, 76128/1034, 76129/1025, 76132/1031, 76133/1039, 76162/1033, 76164/1035, 76221/1069, 76247/1065, 76251/1070, 77091/1079, 77092/1088, 77093/1083, 77126/1084, 77127/1085, 77295/1091, 77342/1096, 77343/1093, 77406/1099, 77407/1098, 77408/1092, 78035/1134, 78036/1132, 78037/1133, 78038/1128, 78039/1103, 78040/1130, 78041/1104;
b) Serial numbers: 4800157/1020, 4800166/1077, 4800173/1086
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL, by letters dated April 1, 2008.
Manufacturer: B.H.M. Medical, Inc., Magog, Canada. Firm initiated recall is complete.
REASON
Scale could break and fall potentially causing injuries to someone who is on it. There is a potential for the mast scale load cell ssembly to fracture and allow the mast/boom to fall. Should a patient be in the lift at the time, the patient could fall and sustain injuries.
VOLUME OF PRODUCT IN COMMERCE
37 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
GE Healthcare Centricity Perinatal (formerly QS) System - PFILS (Patient File Server) software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit, Recall # Z-2037-2008
CODE
All CPN versions up to 6.70.6 P02 with PFILS versions below 2.0
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letters dated July 20, 2007 and June 27, 2008. Firm initiated recall is ongoing.
REASON
Patient information mix-up: When the PFILS application, configured with a backup server has experienced a network interruption, PFILS verify could result in the Centricity Perinatal application recording non-identifiable patient information to the incorrect patient file.
VOLUME OF PRODUCT IN COMMERCE
1,031 CD-ROMs
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
GEM 2753 Microvascular Anastomotic Coupler, 2.5 mm, REF GEM2753/I, P/N 5111-00250-010, Rx only, Irradiation Sterilized This is a microsurgical coupler used in the anastomosis of veins and arteries normally encountered in microsurgical vascular reconstructive procedures, Recall # Z-2138-2008
CODE
Lot numbers: 1808, 1894, 1907, 1923, 1953, 1954, 7139, 7211, 7354, 8998, 8999, 11591, 12364, 15244, 15280, 15281, 18824, 18912, 19294, 19413, 19954, 20263, 20689, 21345, 21515, 21560, 21977, 22556, and 23047
RECALLING FIRM/MANUFACTURER
Recalling Firm: Synovis Micro Companies Alliance Inc., Birmingham, AL, by letters on May 15, 2008 and July 21, 2008.
Manufacturer: Midwest Plastics, Saint Paul, MN. Firm initiated recall is ongoing.
REASON
Coupler rings may slip out of the delivery tool caused by jaws larger than specification.
VOLUME OF PRODUCT IN COMMERCE
19,663 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III

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PRODUCT 
Lumax Cardiac Resyncronization Therapy Defibrillator (CRT-D); Implantable, dual-chamber defibrillator; Model Number: HF-T; Catalog Number 355263; Software Version 603.U; Catalog Model Number 359251; ICS 3000 units are composed of three Catalog/Model Numbers: 349527, 349530, and 355547. The model 349530 is the component which is loaded/updated with software, Recall # Z-1373-2008
CODE
Software version 603.U
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biotronik, Inc., Lake Oswego, OR, by letter on January 10, 2007.
Manufacturer: Biotronik Gmbh & Co, Berlin, Germany. Firm initiated recall is complete.
REASON
Timing Feature Error: An implementation error allows the usage of the V-V timing feature, which is not approved for use in the U.S.
VOLUME OF PRODUCT IN COMMERCE
53 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Medex MX821L 72 inch (182.9cm) Administration Sets, Standard Drip, Sterile Single Use, Latex Free device packaged 25 units per case. Used to administer fluids, Recall # Z-1549-2008
CODE
Lot # 1217947
RECALLING FIRM/MANUFACTURER
Smiths Medical Asd, Inc, Dublin, OH, by letters on March 24, 2008. Firm initiated recall is ongoing.
REASON
Misbranded/mispackaged device was distributed. Product labeled to contain 72 inch Standard Drip ( IV) Administration Sets, actually contained 60 inch (IV) administration sets with a' Y' site.
VOLUME OF PRODUCT IN COMMERCE
350 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
a) Architect Free T4 MasterCheck; a single (specified) analyte control (assayed and unassayed);
    list 6C50-05. Intended for use in the verification of sensitivity, calibration linearity, and
    reportable range on the Abbott ARCHITECT i System, Recall # Z-1569-2008;
b) Architect Total T4 MasterCheck; a single (specified) analyte control (assayed and unassayed);
    list 6C49-05 Intended for use in the verification of sensitivity, calibration linearity, and reportable
    range on the Abbott ARCHITECT i System, Recall # Z-1570-2008
CODE
a) Lots: 82130M, Exp 06/30/2008; 82140M, Exp 10/31/2008; and 82150M, Exp 12/31/2008;
b) Lots: 84110M, Exp 06/30/2008; 84120M, Exp 11/30/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Abbott Park, IL, by letter dated February 27, 2008.
Manufacturer: Bio-Rad Diagnostics Group, Irvin, CA. Firm initiated recall is ongoing.
REASON
Testing material becomes unstable at the recommended storage temperature. Some of the Architect Free T4 MasterCheck and Total T4 MasterCheck lots are not stable at the recommended storage condition of 2 to 8 degrees Celsius through expiration dating. These lots may exceed the suggested tolerance limits listed in the Reportable Range/Calibration Verification section in Appendix B of the Architect i Systems Operations Manual.
VOLUME OF PRODUCT IN COMMERCE
325 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
Flat Drain -10mm, Chariker-Jeter Dressing Kits (Large and Small) -Product numbers 6680217 and 6680221 - Wound Management Product. Indicated for patients who would benefit from a suction device particularly as the device may promote wound healing, Recall # Z-1620-2008
CODE
Lot numbers: 517141, 517269, 517143, and 517108
RECALLING FIRM/MANUFACTURER
Smith And Nephew, Inc. Wound Management Division, Largo, FL, by letter on March 31, 2008. Firm initiated recall is ongoing.
REASON
Incorrect labeling. Kit labels may incorrectly state that a flat drain is contained as a kit component while some kits may contain a round drain.
VOLUME OF PRODUCT IN COMMERCE
4,796 kits
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR AUGUST 6, 2008

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