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U.S. Department of Health and Human Services

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Enforcement Report for June 16, 2004

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.


June 16, 2004
04-24

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Vinces Famous Southern Style Potato Salad; a fresh, perishable, refrigerated salad of potatoes in a smooth mayonaise and mustard dressing; 16 oz. (1 lb.) plastic carton, 12 cartons per case, UPC 38259-40011. Recall # F-246-4.
CODE
Sell By April 18 04 WH*1.
RECALLING FIRM/MANUFACTURER
Chef Solutions, Wheeling, IL, by internal store e-mail and press release on March 27, 2004. Tennessee State initiated recall is complete.
REASON
The State of Tennessee Department of Agriculture found the potato salad to be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
53 cases.
DISTRIBUTION
NC, SC, GA, and TN.
_______________________________
PRODUCT
Iyan Ado Pounded Yam, Net Wt. 20 lbs, 4 lbs, and 2 lb bags. Recall # F-247-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Golden Tropics Ltd, Newark, NJ, by press release on April 9, 2004. New York initiated recall is complete.
REASON
The product contains undeclared sulfites (128 ppm).
VOLUME OF PRODUCT IN COMMERCE
45 bags.
DISTRIBUTION
NY.

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
M.T.E.-5 Concentrated, Mixture of Five Trace Elements Additive; (Each mL providing: zinc 5 mg, copper 1 mg, manganese 0.5 mg, chromium 10 mcg, selenium 60 mg), 10 mL multidose vial, Rx only, Must be diluted before IV use; NDC 63323-029-10. Recall # D-181-4.
CODE
Lot 130404, exp. April 2006.
RECALLING FIRM/MANUFACTURER
American Pharmaceutical Partners, Inc., Melrose Park, IL, by letters dated May 7, 2004. Firm initiated recall is ongoing.
REASON
Superpotent; Selenium (12 month stability).
VOLUME OF PRODUCT IN COMMERCE
11,440 vials.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Orasept Antiseptic Mouthwash & Gargle (cetylpyridinium HCl 0.05% w/w), 4 fl. oz. (118 mls.) bottles, over-the-counter. NDC 55422-202-04. Recall # D-182-4.
CODE
Lot 4B45, Expiration Date 01/06.
RECALLING FIRM/MANUFACTURER
Pharmakon Laboratory, Inc., Tampa, FL, by letter on April 19, 2004. Firm initiated recall is ongoing.
REASON
Microbial contamination (yeast and mold).
VOLUME OF PRODUCT IN COMMERCE
9,754 bottles.
DISTRIBUTION
PA, GA, and CT.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Contac Cold + Flu Day & Night Caplets, each yellow Day caplet contains Acetaminophen 650mg, Dextromethorphan hydrobromide 30mg, and Pseudoephedrine hydrochloride 60mg and each blue Night caplet contains Acetaminophen 650mg, Diphenhydramine hydrochloride 50mg and Pseudoephedrine hydrochloride 60mg, in blister packs of 15 count Day caplets and 5 count Night caplets, over-the-counter. Recall # D-180-4.
CODE
Lots: 3G23P exp 06/06; 3H12P exp 07/06; 3H12PA exp 07/06; 4B02P exp 01/07.
RECALLING FIRM/MANUFACTURER
Glaxosmithkline, Parsippany, NJ, by letters on April 23, 2004. Firm initiated recall is ongoing.
REASON
Mislabeled; product carton does not have pseudoephedrine warning statement directed to hypertensives and diabetics.
VOLUME OF PRODUCT IN COMMERCE
449,244 units.
DISTRIBUTION
Nationwide, Bahamas and Bermuda.

_______________________________
PRODUCT
Collagenase Santyl? OINTMENT (derived from Clostridium histolyticum), 250 units per gram, 15 gram tubes, Rx only, Knoll label: NDC 0044-5270-02; Smith & Nephew label: NDC 50484-527-15. Recall # D-183-4.
CODE
Knoll label: Lot 0000059281, EXP 10/04; Smith+Nephew label: Lot 0000093210, EXP 6/05.
RECALLING FIRM/MANUFACTURER
Advance Biofactures Corp., Lynbrook, NY, by letters dated May 26, 2004. Firm initiated recall is ongoing.
REASON
Subpotent: stability.
VOLUME OF PRODUCT IN COMMERCE
54,333 tubes.
DISTRIBUTION
Nationwide and Puerto Rico.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0780-4.
CODE
Unit number 9030179.
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by facsimile on March 31, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0781-4;
b) Platelets. Recall # B-0782-4.
CODE
a) and b) Unit number 4133093.
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letter on March 4, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0875-4.
CODE
Unit KE36183.
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, dba BloodSource Sacramento, Sacramento, CA, by telephone and facsimile on April 29, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.

_______________________________
PRODUCT
Source Plasma. Recall # B-1375-4.
CODE
Unit numbers: GR050583, and GR050572.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Grand Rapids, MI, by facsimile on February 24, 2000. Firm initiated recall is complete.
REASON
Blood products, which were untested for viral markers, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
England.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1421-4.
CODE
Unit numbers: 40FH26662, 40GV40046.
RECALLING FIRM/MANUFACTURER
American Red Cross, Heart of America, Peoria, IL, by telephone on February 19, 2004, and by letter, dated March 2, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1437-4.
CODE
Unit number 20GM77591.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Lewis and Clark Region, Boise, ID, by telephone on February 21, 2003, and by letter on March 17, 2003.
Manufacturer: American Red Cross Blood Services, Great Falls, MT. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1438-4;
b) Recovered Plasma. Recall # B-1439-4.
CODE
a) and b) Unit number 20FJ03216.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Lewis and Clark Region, ID, by letter and facsimile on July 12, and 15, 2002. Manufacturer: American Red Cross Blood Services, Lewiston, ID. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of jaundice from mononucleosis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
ID, and Switzerland.

_______________________________
PRODUCT
Whole Blood. Recall # B-1440-4.
CODE
Unit 71J04256-4.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile dated July 9, 2003.
Manufacturer: LifeSouth Community Blood Centers, Inc., Ocala, Florida. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1441-4;
b) Platelets. Recall # B-1442-4.
CODE
a) and b) Unit number 2074783.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letters on February 10, 2004, and March 31, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
KY.

_______________________________
PRODUCT
Platelets, Leukocytes Reduced. Recall # B-1443-4.
CODE
Unit number 042FT45500.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone on March 8, 2004, and by letter on March 12, 2004. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from an unsuitable donor due to the application of a tattoo, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Cryoprecipitated AH. Recall # B-1450-4.
CODE
Unit number: 24KM84198.
RECALLING FIRM/MANUFACTURER
American Red Cross, River Valley Region, Louisville, KY, by telephone on October 20, 2003, and by letter, dated October 23, 2003. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of clotted Red Blood Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1451-4.
CODE
Unit number 33GV38645.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Connecticut Region, Farmington, CT, by telephone on March 17, 2003. Firm initiated recall is complete.
REASON
Blood product, corresponding to red cells that were possibly contaminated with Pseudomonas aeruginosa and implicated in an adverse transfusion reaction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CT.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1453-4.
CODE
Unit 33GT43854.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Connecticut Region, Farmington, CT, by telephone on July 7, 2003. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Platelets that was pooled and was possibly contaminated with Staphylococcus sp. bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CT.

_______________________________
PRODUCT
Source Plasma. Recall # B-1458-4.
CODE
DSKJPQ, DSHYTM, DSHXZR, DSHXCF.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International BioResources, LLC, Scottsdale, AZ, by facsimile on September 26, 2003.
Manufacturing Firm: International BioResources, LLC, Tuscaloosa, AL. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
IL.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

*****CORRECTION*****

ENFORCEMENT REPORT 04-20, MAY 19, 2004, CLASS III ? CORRECTION TO CONCURRENCE WITH RECOMMENDATION FOR FIRM INITIATED RECALL: RECALL # B-1256-4, RED BLOOD CELLS, LEUKOCYTES REDUCED, UNIT NUMBER CORRECTED: UNIT NUMBERS 50LJ71343 and 50LJ71131.

_______________________________
PRODUCT
Source Plasma. Recall # B-1376-4.
CODE
Unit numbers: GR050422, GR050473, GR050469, GR050506, GR050525, GR050541.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Grand Rapids, MI, by facsimile on February 24, 2000. Firm initiated recall is complete.
REASON
Blood products, which were untested for viral markers, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
England.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1422-4;
b) Recovered Plasma. Recall # B-1423-4.
CODE
a) and b) Unit number: 20LF51252.  
RECALLING FIRM/MANUFACTURER
American Red Cross, Lewis and Clark Region, Boise, ID, by facsimile on June 11, 2002, and by letter, dated June 17, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
ID, and Switzerland.

_______________________________
PRODUCT
Source Plasma. Recall # B-1454-4.
CODE
Unit number DSNTCZ.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International BioResources, LLC, Scottsdale, AZ, by facsimile on October 22, 2003.
Manufacturer: International BioResources, LLC, Tuscaloosa, AL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Source Plasma. Recall # B-1455-4.
CODE
Unit number DSNZVC.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International BioResources, LLC, Scottsdale, AZ, by facsimile on October 23, 2003.
Manufacturer: International BioResources, LLC, Tuscaloosa, AL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Source Plasma. Recall # B-1456-4.
CODE
Unit number DSHYRF.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International BioResources, LLC, Scottsdale, AZ, by facsimile on November 26, 2003.
Manufacturer: International BioResources, LLC, Tuscaloosa, AL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Source Plasma. Recall # B-1457-4.
CODE
Unit number DSJQRQ.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International BioResources, LLC, Scottsdale, AZ, by facsimile on September 10, 2003.
Manufacturer: International BioResources, LLC, Tuscaloosa, AL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Source Plasma. Recall # B-1462-4.
CODE
Unit number DSMBTN.
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Tuscaloosa, AL, by facsimile on September 18, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which there was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Source Plasma. Recall # B-1469-4.
CODE
Unit number DSKZDP.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International BioResources, LLC, Scottsdale, AZ, by facsimile on September 23, 2003.
Manufacturer: International BioResources, LLC, Tuscaloosa, AL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer the medical history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Source Plasma. Recall # B-1470-4.
CODE
Unit number DSNJVT.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International BioResources, LLC, Scottsdale, AZ, by facsimile on October 16, 2003.
Manufacturer: International BioResources, LLC, Tuscaloosa, AL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer the medical history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Source Plasma. Recall # B-1471-4.
CODE
Unit number DSPLBT.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International BioResources, LLC, Scottsdale, AZ, by facsimile on October 17, 2003.
Manufacturer: International BioResources, LLC, Tuscaloosa, AL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer the medical history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
LuMend brand percutaneous catheter .35" R in plastic sealed bag, sterilized with ethylene oxide gas. Recall # Z-0995-04.
CODE
Model number OTB 1235, Dates of manufacture 11-2003, 03-2004 and 04-2004. Model number OTB 1245, Dates of manufacture 11-2003. 510(k) K032298.
RECALLING FIRM/MANUFACTURER
Lumend Inc, Redwood City, CA, by telephone on May 18, 2004. Firm initiated recall is complete.
REASON
Recall initiated after Lumend received a report of a malfunction of an Outback Catheter in Ohio.
VOLUME OF PRODUCT IN COMMERCE
117 catheters.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System. Recall # Z-1002-04.
CODE
Lot # 0584B.
RECALLING FIRM/MANUFACTURER
Acist Medical Systems, Eden Prairie, MN, by telephone on May 19, 2004. Firm initiated recall is ongoing.
REASON
Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile.
VOLUME OF PRODUCT IN COMMERCE
3590 kits.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM Service Pack 1 and EZU-FC5W. Recall # Z-1005-04.
CODE
Serial Numbers: SE15704205, SE16773210, and SE16935305.
RECALLING FIRM/MANUFACTURER
Hitachi Medical Systems America Inc, Twinsburg, OH, by letter on May 7, 2004 and May 25, 2004. Firm initiated recall is ongoing.
REASON
Due to a software anomaly, various patient images may be intermixed within a single patient folder, which may result in misdiagnosis and delay in treatment.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OH, PA, and WI.

_______________________________
PRODUCT
Quickcable Autoclaveable Cable Electrode Cable. Recall # Z-1006-04.
CODE
Lot 005955.
RECALLING FIRM/MANUFACTURER
Biosense Webster, Inc., Irwindale, CA, by letter on May 21, 2004. Firm initiated recall is ongoing.
REASON
Mislabeling.
VOLUME OF PRODUCT IN COMMERCE
212.
DISTRIBUTION
Nationwide, Australia, Korea, Chile, Brazil.

_______________________________
PRODUCT
a) Ultraview Universal Clinical Workstation Model 90385.
Recall # Z-1007-04;
b) Ultraview 1700 Monitor Model 90387. Recall # Z-1008-04.
CODE
a) Serial numbers 385-3xxxxx or higher;
b) Serial numbers 387-1xxxxx or higher.
RECALLING FIRM/MANUFACTURER
Spacelabs Medical, Issaquah, WA, by letters on May 7, 2004, and May 14, 2004. Firm initiated recall is ongoing.
REASON
Potential for telemetry channels to drop off display.
VOLUME OF PRODUCT IN COMMERCE
1,792 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt. Catalog # 027770201. Recall # Z-1009-04.
CODE
Lot # 0406800015.
RECALLING FIRM/MANUFACTURER
Cobe Cardiovascular, Inc , Arvada, CO, by telephone on May 25, 2004 and by letter on June 3, 2004. Firm initiated recall is ongoing.
REASON
Some Cardioplegia Delivery Sets, 4:1 w/shunt, were misassembled with 1:1 tubing sub-assemblies. This would provide 2 1/2x the desired cardioplegia.
VOLUME OF PRODUCT IN COMMERCE
216 sets.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
a) HomeChoice and Yume Automated Peritoneal Dialysis
Systems; catalog numbers 5C4471, 5C4471R, 5C4474,
5C4474R, T5C4441, T5C4441R. Recall # Z-1012-04;
b) HomeChoice PRO and Yume PlusAutomated Peritoneal
Dialysis Systems; catalog numbers 5C8310, 5C8310R,
R5C8320, R5C8320R, T5C8300, T5C8300R. Recall # Z-1013-
04.
CODE
a) and b) All HomeChoice Systems with software versions 8.5 and higher.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Renal Div, Mc Gaw Park, IL, by letters dated May 24, 2004. Firm initiated recall is ongoing.
REASON
A software defect could result in a patient experiencing an overfill with software versions 8.5 and higher. The possibility of an overfill can occur when the Initial Drain Alarm Volume is set to OFF and a change to the volume is made at the Verify I-DRAIN:XXXXML prompt.
VOLUME OF PRODUCT IN COMMERCE
17,026 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Dinalink brand Communication Cable which is an accessory to a medical device Dinalike which is an isolated protocol converter used to convert the serial data from a DINAMAP Monitor to that of the APEXPRO telemetry transmitter. Recall # Z-1015-04.
CODE
No serial numbers but the Dinalink protocol converter and cable has the product identifier of "LC1931".
RECALLING FIRM/MANUFACTURER
GE Medical Systems Information Technologies, Tampa, FL, by letter on January 27, 2004. Firm initiated recall is complete.
REASON
The potential exists for external electrical noise to be processed as irregular pacing thereby masking potential asystole events.
VOLUME OF PRODUCT IN COMMERCE
36.
DISTRIBUTION
PA, SC, GA, FL, WI, SD AND WY. _______________________________
PRODUCT
a) Portex Inner Cannula for Tracheostomy Tube Size 7.0 mm,
REF Code 566070. Recall # Z-1016-04;
b) Portex Inner Cannula for Tracheostomy Tube size 8.0 mm,
REF Code 566080. Recall # Z-1017-04.
CODE
All lot numbers.
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc, Keene, NH, by letter, dated May 21, 2004. Firm initiated recall is ongoing.
REASON
Incompatible products may cause potential trachea trauma.
VOLUME OF PRODUCT IN COMMERCE
85,800.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Nasal Jejunal Feeding Tube, Tube Diameter: 10 FR. Tube Length: 240CM., Disposable ? Single Use Only, Rx Only. Recall # Z-1003-04.
CODE
Reorder/Catalog Number: NJFT-1-ML, Lot #1803299, Expiration Date: 09-2008.
RECALLING FIRM/MANUFACTURER
Wilson-Cook Medical Inc, Winston Salem, SC, by letters on May 26, 2004. Firm initiated recall is ongoing.
REASON
The nasal transfer tube may be missing from the package of the affected lot.
VOLUME OF PRODUCT IN COMMERCE
20 units.
DISTRIBUTION
NC, Ireland & Poland.

_______________________________
PRODUCT
M/DN Intramedullary Fixation Humeral Nail. Catalog no. 00-2254-195-09. Recall # Z-1004-04.
CODE
Lot # 20118000.
RECALLING FIRM/MANUFACTURER
Zimmer Inc. Warsaw, IN, by letters dated March 16, 2004. Firm initiated recall is ongoing.
REASON
One and possibly more units in the lot have the proximal angled hole oriented 180 degrees reversed from the required orientation.
VOLUME OF PRODUCT IN COMMERCE
33 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Foundation Knee System, Tibia-Nonporous, Size 6, Right,
sterile. Catalog number 324-01-106. Recall # Z-1010-04;
b) 3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6,
Right, sterile. Catalog number 333-02-106; Recall # Z-
1011-04.
CODE
a) Lot number 991151;
b) Lot numbers 991141 and 991131.
RECALLING FIRM/MANUFACTURER
Encore Medical, LP, Austin, TX, by letters on May 10, 2004. Firm initiated recall is ongoing.
REASON
Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE.
VOLUME OF PRODUCT IN COMMERCE
31.
DISTRIBUTION
IA, MA, OK, TX, FL, CA, and SD and Germany.

END OF ENFORCEMENT REPORT FOR JUNE 16, 2004

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