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U.S. Department of Health and Human Services

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Enforcement Report for April 16, 2008

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

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April 16, 2008
08-16

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________

PRODUCT

Sum Cheong Lung brand, Dried Fish, Net Wt. 12 oz., Recall # F-280-8
CODE
No codes on this product.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Summit Import Corporation, Jersey City, NJ, by press release on February 12, 2008 and by letters on February 13, 2008.
Manufacturer: Guangzhou Luoxi Marine Products, Guangzhou, China. Firm initiated recall is complete.
REASON
New York State Department of Agriculture and Markets randomly sampled Sum Cheong Lung brand Dried Fish and found that it had not been eviscerated prior to processing.
VOLUME OF PRODUCT IN COMMERCE
3 cartons
DISTRIBUTION
NY

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III

___________________________________

PRODUCT

R.W. Knudsen brand Just Pomegranate Juice in 32 FL OZ glass bottles with UPC 0 74682 10308 3. Product is packaged 12 bottles per case. Recall # F-263-8

CODE

F 239 005 1424 CT458, Best if used by: Feb-27-2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: JM Smucker Co., Orrville, OH, by telephone on February 20, 2008 and by letter on March 4, 2008.
Manufacturer: Smuckers Quality Beverages, Inc., Havre de Grace, MD.  Firm initiated recall is ongoing.
REASON
Pomegranate Juice was tested by the state of Connecticut State and found to contain 0.011ppm - 0.052ppm of Carbendazim (Benomyl) in the finished product. There is no telerance for this pesticide in pomegranate.
VOLUME OF PRODUCT IN COMMERCE
6746 cases
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________

PRODUCT

Sertraline Hydrochloride Oral Concentrate, 20 mg/mL, 60 mL bottle, RX only, NDC 0054-0082-46, Recall # D-196-2008

CODE

Lots: 657694A, exp. Sep 08; 657695A, exp. Sep 08; 658085A exp. Jan 09
RECALLING FIRM/MANUFACTURER
Boehringer Ingelheim Roxane Incorporated, Columbus, OH, by letters on March 5, 2008. Firm initiated recall is ongoing.
REASON
Product does not meet degradation specifications over shelf life.
VOLUME OF PRODUCT IN COMMERCE
21,822 Units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________

PRODUCT

ACT Restoring Anticavity Fluoride Mouthwash (sodium fluoride 0.05%), Cool Splash Spearmint flavor, 18 fl oz. Recall # D-184-2008
CODE
Lot: RTP0078G, exp. 01/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Chattem Inc., Chattanooga, TN, by e-mail on March 17, 2008.
Manufacturer: Access Business Group Llc, Ada, MI. Firm initiated recall is ongoing.
REASON
Some bottles are mislabeled as mint flavor instead of spearmint flavor and do not declare the presence of color ingredients green 3 and yellow 10.
VOLUME OF PRODUCT IN COMMERCE
26,976 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS I

___________________________________
PRODUCT
a) Canc/Cort (Spierings), Recall # B-0874-08;
b) Flex HD Allogarfts, Recall # B-0875-08;
c) Posterior Tibialis, Recall # B-0876-08;
d) Radius/Ulna Shaft, 4cm, Recall # B-0877-08;
e) Femoral Head >=44mm, Recall # B-0878-08;
f) BTB W/Quad, Hemi, Recall # B-0879-08;
g) Anterior Tibialis Tendon, Recall # B-0880-08;
h) Achilles Tendon w/calc, Recall B-0881-08;
i) Cancellous Cervical Spacer, Recall # B-0882-08
CODE
a) Serial number: 005645311025P, 005645310026P;
b) (4cm x 7cm) 005645311007 (6 pieces); (6cm x 16cm) 005645311001 (1 piece);
    (4cm x 12cm) 005645311006 (3 pieces); (4cm x 16cm) 005645311005 (2 pieces);
    (3cm x 12cm) 005645311008 (1 piece);
c) Serial number: 0056453110021P, 005645311016P;
d) Serial numbers: 0056453110037P, 0056453110036P;
e) Serial numbers: 005645311038P, 005645311039P;
f) Serial number: 005645311018P;
g) Serial numbers: 005645311015P, 005645311020P;
h) Serial numbers: 005645311017P, 005645311022P;
i) Serial number: 005645311042
RECALLING FIRM/MANUFACTURER
Musculoskeleta Transplant Foundation, Edison, NJ, by telephone on November 8, 2007 and letters on November 10, 2007. Firm initiated recall is complete.
REASON
Patient who received graft from MTF developed an infection 12 days post surgery. Sample collected during second surgery grew Clostridium Perfringens.
VOLUME OF PRODUCT IN COMMERCE
28 allografts
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) AlloDerm Regenerative Tissue Matrix Oral Plastic Surgery 1x2cm, .89-1.65 (mm)
    and 1x4cm, .89-1.65 (mm), Recall # B-0909-08;
b) AlloDerm Implantable Abdominal Wall Repair; 6x16 cm,. 79-2.03 (mm); 6x12 cm,
    .79-2.03 (mm); 4x16 cm, .79-2.03 (mm); 5x12cm, .79-2.03 (mm); 4x12 cm, .79-2.03
    (mm), Recall # B-0910-08;
c) AlloDerm Implantable, 4x16cm, 2.06-3.30 (mm) and 2x4cm, .33-.76 (mm),
    Recall # B-0911-08;
d) AlloDerm, Oral Plastic Surgery, 2x4 cm, .8901.65 (mm), Recall # B-0912-08;
e) Graftjacket Regenerative Tissue Matrix 5x5cm, .89-1.52 (mm).Non-meshed.
    Inner package not sterile, Recall # B-0913-08;
f) Repliform Tissue Regeneration Matrix; Aseptically Processed; 4x7 cm,. 9-1.6 (mm)
    35-65 (1/1000 in.); 5x10 cm,. 9-1.6 (mm), 35-65 (1/1000 in.); 6x12 cm,. 9-1.6 (mm)
    35-65 (1/1000 in.), Recall # B-0914-08
CODE
a) Lot B16375, sublots 005, 006, 010, 012, 019, 020, 021, 023, 026, 029.
    Lot 16375, sub lots 033, 034, 035, 036;
b) Lot B16375, sublots 071, 072, 078, 074, 075, 076, 077, 073. Lot B16375, sublots 067,
    070; Lot B16375, sublots 056, 050, 051, 052, 054, 055, 049; Lot B16375, sublots 062,
    063; Lot B16375, sublot 048;
c) Lot B16375, sublot 053 and Lot B16375, sublot 042;
d) Lot B16375, sub lot 040;
e) Lot B16375, sublots 057, 058, 059;
f) Lot B16375, sublots: 043, 046; Lot B16375, Sublots: 060, 061;
    Lot B16375, sublots: 064, 065, 066, 068, 069
RECALLING FIRM/MANUFACTURER
LifeCell Corporation, Somerville, NJ, by telephone and fax on October 9, 2007 and by letters on October 22, 2007. Firm initiated recall is ongoing.
REASON
Human tissues from donors, tested using diagnostic test kits rather than FDA licensed or cleared screening tests for hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core antigen (anti-HBc total), were distributed.
VOLUME OF PRODUCT IN COMMERCE
49 units (1 unit scrapped 6/7/07, 2 units in quarantine)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II

****CORRECTION****

Enforcement Report on March 19, 2008, Corneal tissue for transplant, Recall # B-0844-08, Manufacturer is Georgia Eye Bank, Atlanta, GA - NOT Emory Clinic, Decatur, GA.
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1081-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1082-08;
c) Fresh Frozen Plasma, Recall # B-1083-08
CODE
a) Units: 04F59264; 04J95500;
b) Units: 04FS96202; 04J95741; 04LQ80645;
c) Units: 04F59264; 04J95500
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by telephone, facsimile and electronic mail on November 1, 2007 and November 26, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from donors in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units   
DISTRIBUTION
CA, CT, MA, and NY
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1087-08
CODE
Unit: 04KM69756
RECALLING FIRM/MANUFACTURER
Recalling Firm: ARC Blood Services, New England Region, Dedham, MA, by electronic mail on November 23, 2007.
Manufacturer: ARC/Manchester, NH. 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
CA
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-1088-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1089-08
CODE
a) and b) Unit: 012FS30908
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC, by telephone on July 19, 2007 and follow-up letter on July 28, 2007. 
Manufacturer: American Red Cross Blood Services, Durham, NC. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1090-08
CODE
Unit: 72C893625
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by facsimile on October 4, 2007. Firm initiated recall is complete.

REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1091-08
CODE
Unit: 030GV32963
RECALLING FIRM/MANUFACTURER
American Red Cross, Northeastern, Ashley, PA, by letter on November 16, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Source Plasma, Recall # B-1092-08
CODE
Units: 05GWIG7642, 05GWIG8334, 05GWIG9440, 05GWIH0121, 05GWIH1171, 05GWIH1847, 05GWIH2969, 05GWIH3675, 05GWIH4747 ,05GWIH5363, 05GWIH6431
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by facsimile on January 17, 2006.
Manufacturer: BioLife Plasma Services, LP, Green Bay, WI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom post donation information was provided regarding multiple high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1095-08
CODE
Unit: 3102000
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on December 11, 2007. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with Corynebacterium species, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT
Platelets Leukocytes Reduced, Recall # B-1103-08
CODE
Unit: M56598
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saginaw, MI, by facsimile on December 24, 2007. Firm initiated recall is complete.
REASON
Blood product, associated with a red cell unit that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1106-08
CODE
Unit: 4766018
RECALLING FIRM/MANUFACTURER
Indian Blood Center, Indianapolis, IN, by telephone on November 30, 2007 and by letter dated December 19, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

___________________________________
PRODUCT
Plasma Cryoprecipitate Reduced, Recall # B-1108-08
CODE
Unit: 71T736572
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone on September 5, 2007. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1110-08
CODE
Unit: 4147235
RECALLING FIRM/MANUFACTURER
Indian Blood Center, Indianapolis, IN, by telephone on September 24, 2007 and by letter dated October 3, 2007. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with Corynebacterium species, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1123-08
CODE
Unit: 0406767
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on June 5, 2007. Firm initiated recall is complete.
REASON
Blood product, leukoreduced after the allowable post collection time limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1124-08
CODE
Units: 0353059; 0407472
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on May 30, 2007 and letter on June 4, 2007. Firm initiated recall is complete.
REASON
Blood products, leukoreduced after the allowable post collection time limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA and MS
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1125-08
CODE
Unit: 0419588
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on June 11, 2007. Firm initiated recall is complete.
REASON
Blood product, labeled leukoreduced which did not meet the requirements for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III

___________________________________
PRODUCT
Red Blood Cells Irradiated, Recall # B-0392-08
CODE
Unit: 0408195
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on April 5, 2007 and by letter dated April 11, 2007. 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
AL
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0393-08
CODE
Unit: 0355173
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on April 5, 2007. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of platelets that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1048-08
CODE
Unit: 123797668
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by facsimile on November 8, 2007.
Manufacturer: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall is complete.
REASON
Blood product, collected under conditions where the sterility of the products may have been compromised, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NM
___________________________________
PRODUCT
Source Plasma, Recall # B-1054-08
CODE
Units: 04PWIF9366, 04PWIF9963, 04PWIG1143
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by facsimile on February 11, 2005.
Manufacturer: Biolife Plasma Services, Stevens Point, WI. Firm initiated recall is complete.
REASON
Blood products, which were not quarantined after the donor provided information concerning a post-donation illness, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA

____________________________________
PRODUCT
Recovered Plasma, Recall # B-1080-08
CODE
Units: 04FS96202; 04J95741; 04LQ80645
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by telephone, facsimile and electronic mail on November 1, 2007 and November 25, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from donors in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma, Recall # B-1093-08
CODE
Unit: 364001990, I72034585, 364001842, I72053858, I72036569, 364003764, 364003693, 364004896, 364000177, I72058575, I72056802, I72039771, I72058884, I72050211, and I72055055
RECALLING FIRM/MANUFACTURER
International BioResources, Llc, Fort Worth, TX, by facsimile on June 7, 8, and 9, 2006. 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
15 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma, Recall # B-1094-08
CODE
Unit: 04VMNB3594, 04VMNB5382, 04VMNB5664
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by facsimile dated February 8, 2005 and February 28, 2005,
Manufacturer: BioLife Plasma Services LP, Mounds View, MN. 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
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, B-1104-08
CODE
Unit: 0441414; 0408355; 0359754; 0408387; 0373433; 0359768
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on June 28, 2007. Firm initiated recall is complete.
REASON
Blood products, documented as being out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
LA and AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, B-1105-08
CODE
Units: 0395918; 0406729; 0352085; 0354632; 0352124; 0339355; 0406720; 0353131
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by fax on June 1, 2007. Firm initiated recall is complete.
REASON
Blood products, documented as being out of controlled storage for more than 30 minutes,  were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
LA
___________________________________
PRODUCT
Source Plasma, Recall # B-1111-08
CODE
Unit 377030059
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Anderson, IN, by facsimile on December 1, 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

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________
PRODUCT
BD FACS Sample Prep Assistant II, Part Number: 337170, Recall # Z-0526-2008
CODE
Serial Numbers: T0246 to T0290 (except for T0274, T0275, T0277 and T0279)
RECALLING FIRM/MANUFACTURER
BD Biosciences, San Jose, Ca, by letter and on-site visit on October 1, 2007. Firm initiated recall is ongoing.
REASON
Mixing Performance: SPA II devices manufactured with the affected product motor control board may exhibit suboptimal mixing performance.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, Sterile, Made In Israel, Recall # Z-0585-2008
CODE
Lot number: 61280807
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lumenis, Inc., Salt Lake City, UT, by letter on December 18, 2007, 
Manufacturer: Lumenis Limited, Yokneam, Israel. Firm initiated recall is ongoing.
REASON
Incorrect Label: The Units outer pouch is labeled 200 micro fiber however, the inner pouch's label affixed to the product indicated that it is a 365 micron fiber. The micron fiber contained in the inner pouch is 200 micro fiber. The inner product is mislabeled with the wrong size.
VOLUME OF PRODUCT IN COMMERCE
59 units
DISTRIBUTION
MA
___________________________________
PRODUCT
a) Myelotec® Steerable Video Guided Catheter, 2.7mm, (product code: 2000),
    Recall # Z-0586-2008;
b) Myelotec® Steerable Video Guided Catheter, 3.0mm, (Product Code: 2010),
    Recall # Z-0587-2008
CODE
a) Label Inserts: LB0013-1, LB0013-2, and LB0013-3;
b) Label Insert: LB0020-0, LB0020-1, LB0020-2, LB0020-3, and LB0020-4
RECALLING FIRM/MANUFACTURER
Myelotec, Inc., Rosewell, GA, by telephone on December 19, 2007 and by letter on/about December 28, 2007. Firm initiated recall is ongoing.
REASON
Incorrect Labeling information: Product may contain inappropriate information in its label insert that refers to the product's use with energy delivering instrumentation.
VOLUME OF PRODUCT IN COMMERCE
1,252 shipping containers
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Medtronic brand AneuRx AAAdvantage Endovascular Stent Graft with the Xcelerant Delivery System; Model Numbers Affected: All AAAdvantage models including: AEXC202040, IEXC121255, ILXC1212115, ILXC151585, AEXC222240, IEXC131355, ILXC1212135, ILXC1616115, AEXC242440, IEXC141455, ILXC121285, ILXC1616135, AEXC262640, IEXC151555, ILXC1313115, ILXC161685, AEXC282840, IEXC161655, ILXC1313135, ILXC1620115, BFXC2012135, IEXC162085, ILXC131385, ILXC1620135, BFXC2012165, IEXC181855, ILXC1414115, ILXC1818115, BFXC2213135, IEXC182285, ILXC1414135, ILXC1818135, BFXC2213165, IEXC182485, ILXC141485, ILXC181885, BFXC2414135, IEXC202055, ILXC1515115, ILXC1822115, BFXC2414165, ILXC1515135, ILXC1822135, BFXC2615135, ILXC1824115, BFXC2615165, ILXC1824135, BFXC2816135, ILXC2020115, BFXC2816165, ILXC2020135, ILXC202085; Recall # Z-0689-2008
CODE
All codes
RECALLING FIRM/MANUFACTURER
Medtronic CardioVascular, Santa Rosa, CA, by letters on December 7, 2007. Firm initiated recall is ongoing.
REASON
Sterility compromised: Device sterility may be compromised as evidenced by a loss of outer package integrity.
VOLUME OF PRODUCT IN COMMERCE
7,000 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
ConMed Linvatec, Ultrapower Burs, Recall # Z-0711-2008
CODE
Lot Numbers: BBD14805 BBD14542 BBD14804 00949613 BBD08721 BBD11468 BBD14258 BBD15139 BBD16978 BBC91085 BBD08725 BBD11465 BBD13560 BBD14265 BBD14533 BBD17117 BBD18411 BBD08940 BBD11470 BBD13564 BBD14680 BBD14711 BBD18412 BBD08939 BBD15429 BBD15591 BBD16681 BBD14944 BBD17632 BBD17835 BBD08961 BBD17399 BBD08935 BBD14264 BBD15416 BBD17423 BBD14935 BBD17832 BBD08942 BBD14261 BBD17633 BBD08448 BBD13158 BBD16029 BBD08943 BBD13565 BBD16122 BBD17627 BBD08389 BBD14260 BBD15401 BBD16652 BBD11471 BBD14266 BBD14658 BBD17631 BBD17836 BBD08443 BBD13567 BBD14747 BBD08445 BBD13569 BBD17896 BBD08959 BBD17626 00950532 BBD08936 BBD13570 BBD08972 BBD15179 BBD08473 BBD13571 BBD14242 BBD15398 BBD17550 BBD08957 BBD08974 BBD16653 BBD08482 BBD17609 BBD08442 BBD15426 BBD16654 BBD08976 BBD14955 BBD08452 BBD09167 BBD14257 BBD16045 BBD08446 BBD15191 BBD16655 BBD08483 BBD15393 BBD16656 BBD08952 BBD11469 BBD16658 BBD17602 BBC89881 BBD08444 BBD16657 BBD17442 BBD08531 BBD15084 BBD17629 BBD14255 BBD14538 BBC92804 BBD15644 BBD16832
RECALLING FIRM/MANUFACTURER
Linvatec, Corp., Largo, FL, by letters on August 9, 2007. Firm initiated recall is ongoing.
REASON
Compromised sterility: ConMed Linvatec medical devices packaged within a certain Peel Pouch Sterile Package may have compromised sterility due to an improper seal.
VOLUME OF PRODUCT IN COMMERCE
1,181 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
CES Ultra, Cranial Electrotherapy Stimulator, Recall # Z-0712-2008
CODE
Serial Numbers: 1000 through 3999
RECALLING FIRM/MANUFACTURER
Recalling Firm: Neuro-Fitness LLC, Fall City, WA, by letter on October 29, 2007.
Manufacturer: Arco Electronics Limited, Hong Kong, Hong Kong SAR. Firm initiated recall is ongoing.
REASON
No FDA clearance for the .35Hz/.45Hz frequency option on device.
VOLUME OF PRODUCT IN COMMERCE
2,020 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Nonin Model 2500 PalmSAT handheld pluse Oximeter, Recall # Z-0843-2008
CODE
Lot #’s: 500222509 500207705 500222537 500222539 500222540 500222541 500222542 500222546 500222547 500222548 500222552 500222554 500222572 500222592 500222594 500222595 500207668 500207669 500207684 500222521 500222525 500218324 500218325 500218331 500218332 500218333 500218335 500218337 500218338 500218340 500218346 500222496 500222507 500218319 500218320 500207666 500218365 500218334 500218339 500218368 500218377 500218378 500222497 500222502 500222506 500222511 500222513 500207691 500207698 500207703 500207667 500222522 500222523 500207675 500207678 500207679 500207685 200207689 50207693 500207704 500222492 500222498 500222501 500222504 500222508 500222512 500222518 500222527 500222538 500222544 500222545 500222549 500222550 500222551 500222556 500222558 500222559 500222560 500222561 500222562 500222576 500222579 500222580 500222591 500222592 500222593 500207663 500207670 500207673 500207674 500207676 500207682 500207683 500207686 500207687 500207688 500218321 500218322 500218323 500218326 500218327 500218328 500218329 500218330 500218341 500222510 500207695 500207696 500207697 500207707 500207708 500222500 500222543 500222553 500222555 500222564 500222578 500222524 500222526 500218362 500218363 500218364 500218366 500218369 500218370 500218373 500218376 500222493 500222494 500222528 500222529 500222530 500222534 500222491 500222499 500222516 500222517 500207649 500207651 500207652 500207653 500207654 500207655 500207656 500207657 500207658 500207659 500207660 500207661 500207662 500207663 500207664 500207665 500207071 500207672 500207680 500207681 500218349 500218350 500218351 500218354 500218355 500218356 500218358 500218359 500218360 500218361 500218367 500218374 500222477 500222478 500222479 500222480 500222481 500222482 500222483 500222484 500222485 500222486 500222487 500222488 500222489 500222490 500222495 500222503 500222505 500222514 500222515 500222519 500222520 500222531 500222532 500222533 500222535 500222536 500222574 500222577 500222582 500222583 500222584 500222585 500222586 500222587 500222588 500222589 500222590 500222596 500207677 500207692 500207694 500207699 500207700 500207701 500207690 500207702 500218336 500218342 500218343 500218344 500218345 500218347 500218348 500218352 500218353 500218357 500218370 500218372 500218375 500222557 500222563 500222565 500222566 500222567 500222568 500222569 500222570 500222571 500222573 500222575 500222581
RECALLING FIRM/MANUFACTURER
Nonin Medical, Inc., Plymouth, MN, by letters on October 11, 2007. Firm initiated recall is ongoing.
REASON
Incorrect Label: The label on the back of the device may show Model 2500A rather than Model 2500.
VOLUME OF PRODUCT IN COMMERCE
240 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Recall # Z-0916-2008
CODE
Lot # 2792584
RECALLING FIRM/MANUFACTURER
Ormco Corporation, Glendora, CA, by letters on October 31, 2007. Firm initiated recall is complete.
REASON
Mislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of 2009/07.
VOLUME OF PRODUCT IN COMMERCE
4 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog
    Number/REF: 00-2550-001-10, 400 ml INF. Control Kit w/ 3/32" drain, 2.4 mm,
    7Fr, PVC, 107 cm, small, sterile, latex free, Rx only; Sold in packages of 10,
    which contain packages of 1 and 5, Recall # Z-1448-2008;
b) Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/
    REF 00-2550-002-10, 400 ml-INF. Control Kit w/ 1/8" drain, 3.2 mm, 10Fr, PVC, 107
    cm, medium, sterile, latex free, Rx only; Sold in packages of 10, which contain
    packages of 1 and 5; Recall # Z-1449-2008;
c) Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog
    Number/REF 00-2550-003-10; 400 ml INF. Control Kit w/ 3/16" drain, 4.8 mm, 15Fr,
    PVC, 107 cm, soft, sterile, latex free, Rx only; Sold in packages of 10, which contain
    packages of 1 and 5; Recall # Z-1450-2008;
d) Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog
    Number/REF 00-2550-004-10; 400 ml INF. Control Kit w/ 1/4" drain, 6.4 mm, 19Fr,
    PVC, 107 cm, large, sterile, latex free, Rx only; Sold in packages of 10, which
    contain packages of 1 and 5; Recall # Z-1451-2008;
e) Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/
    REF 00-2550-050-10; 400 ml Infection Control Comp. Kit, sterile, latex free, Rx
    only; Sold in packages of 10, which contain packages of 1 and 5;
    Recall # Z-1452-2008;
f) Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/
    REF 00-2550-702-10; 400 ml INF. Control Kit w/ 1/8" Drain Spec., 3.2mm, 10Fr.,
    PVC, 107cm, medium, sterile, latex free, Rx only; Sold in packages of 10, which
    contain packages of 1 and 5; Recall # Z-1453-2008;
g) Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog
    Number/REF 00-2550-703-10; 400 ml INF. Control Kit w/ 3/16" Drain Spec.,
    4.8mm, 15Fr., PVC, 107cm, soft, sterile, latex free, Rx only; Sold in packages
    of 10, which contain packages of 1 and 5; Recall # Z-1454-2008;
h) Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog
    Number/REF 00-2550-704-10; 400 ml INF. Control Kit w/ 1/4" Drain Spec.,
    6.4mm., 19Fr., PVC, 107cm, large, sterile, latex free, Rx only; Sold in packages
    of 10, which contain packages of 1 and 5; Recall Z-1455-2008;
i)  Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number;
    47-2550-002-10, 400 ml evacuators and 450 ml collection bags, 1/8 in. (10 FR.)
    O.D. middle perforated PVC drains with trocars, evaluator tubing and connectors,
    medium, contains 10, non-sterile, latex free, Recall # Z-1456-2008;
j) Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number;
    47-2550-003-10; 400 ml evacuators and 450 ml collection bags, 3/16 in. (15 FR.)
    O.D. middle perforated PVC drains with trocars, evaluator tubing and connectors,
    soft, contains 10, non-sterile, latex free, Recall # Z-1457-2008;
k) Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number:
    47-2550-050-10; 400 ml evacuators and 450 ml collection bags, evaluator tubing
    and universal Y connectors, adapters for silicone drains, contains 10, non-sterile,
    latex-free, Recall # Z-1458-2008
CODE
a) Lots Numbers: 60009294, 60075254, 60101562, 60156041, 60215686, 60271994,
    60314032, 60389073, 60440024, 60506573 and 60590575;
b) Lots Numbers: 33440800, 60006818, 60015773, 60025362, 60033385, 60047775,
60051617, 60060757, 60067687, 60072831, 60082265, 60090133, 60096160, 60102772, 60108662, 60118934, 60129193, 60139016, 60147493, 60154829, 60163266, 60171588, 60181669, 60190630, 60196964, 60203044, 60212869, 60223951, 60233568, 60245183, 60252225, 60266735, 60278451, 60288208, 60305457, 60317372, 60323772, 60331175, 60339076, 60346591, 60359577, 60372899, 60382573, 60391905, 60401085, 60409371, 60419370, 60430869, 60444464, 60463237, 60475741, 60488170, 60496915, 60511108, 60530243, 60546074, 60565010, 60578962, 60594499, 60607928, 60622522, 60626621 and 60640519;
c) Lot Numbers: 60006897, 60030744, 60051038, 60067688, 60075523, 60099441,
    60113095, 60134967, 60152075, 60168775, 60184523, 60200854, 60227354,
    60240752, 60275128, 60299770, 60329438, 60339077, 60367783, 60385889,
    60402652, 60437089, 60493507, 60525201, 60554806, 60581694, 60617399 and
    60629984;
d) Lot Numbers: 60006898, 60056511, 60075876, 60107088, 60149880, 60187185,
    60238068, 60284223, 60356873, 60406390, 60537533 and 60606313;
e) Lot Numbers: 60006819, 60015774, 60033386, 60045263, 60057329, 60067689,
    60084095, 60094656, 60106763, 60116383, 60126841, 60145039, 60158789,
    60171589, 60184524, 60200855, 60215687, 60230182, 60240753, 60262574,
    60278454, 60294877, 60321541, 60333502, 60342988, 60354480, 60371375,
    60385890, 60402653, 60412505, 60437090, 60471395, 60506574, 60520507,
    60551036, 60570976, 60590576, 60612123 and 60626622;
f) Lot Numbers; 60004885, 60018681, 60030745, 60045264, 60056512, 60090134,
    60101563, 60124258, 60152076, 60189147, 60192877, 60198414, 60217797,
    60236478, 60255679, 60281660, 60314033, 60377257, 60402970, 60406391,
    60419371, 60444465, 60463238, 60479892, 60511109, 60554807, 60575194,
    60586769, 60607929 and 60621372;
g) Lot Numbers: 60045265, 60101564, 60154830, 60196965, 60333503, 60412506,
    60453016 and 60633939;
h) Lot Numbers: 60015775, 60033388, 60145040, 60154831, 60198415, 60215688,
    60243446, 60377258, 60409373, 60440025, 60471398 and 60640520;
i)  Lot Numbers: 32237200, 32285400, 32326900, 32349300, 32380000, 32413600,
    32444100, 32471900, 32503500, 32538000, 32552400, 32580700, 32928800,
    32980300, 33043400, 33121100, 33166500, 33222900, 33300500, 33328900,
    33387100, 33432000, 60057314, 60075861, 60094646, 60113078, 60117514,
    60134951, 60156026, 60176003, 60203020, 60227311, 60249134, 60278438,
    60356862, 60389058, 60617386 and 60621549;
j) Lot Numbers; 32331100, 32531400, 32944300, 33078800, 33208400, 33342100,
    60006805, 60045252, 60088425, 60118920, 60174047, 60215672, 60269221,
    60321524, 60385874, 60540737, 60564969, 60607918 and 60629972;
k) Lot Number: 32256400, 32380100, 33143800, 33234000, 33348300, 33423400,
    60047748, 60066632, 60084083, 60116363, 60212361, 60220450, 60266724,
    60329424, 60398330, 60456738, 60475725, 60575171, 60581678 and 60612083
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer, Inc., Warsaw, IN, by letter dated January 31, 2008.
Manufacturer: Zimmer Orthopedic Surgical Products, Dover, OH. Firm initiated recall is ongoing.
REASON
Leakage: The kits may disassemble at the fluid collection port, which would present a risk of exposure to blood borne pathogens to health care providers should it occur during use.
VOLUME OF PRODUCT IN COMMERCE
Approximately 34,354 kits
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III

___________________________________
PRODUCT
LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Download) Blood Glucose Meters), Recall # Z-1317-2008
CODE
Part Number only.
RECALLING FIRM/MANUFACTURER
LifeScan, INC., Milpitas, CA, by letter on December 18, 2007. Firm initiated recall is ongoing.
REASON
Meter Temporarily Freezes-- A software compatibility issue may cause the blood glucose meter to cease operations and freeze temporarily.
VOLUME OF PRODUCT IN COMMERCE
260 customers to date have the recalled software drivers.
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR APRIL 16, 2008

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