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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November 2, 2005
05-44

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS I

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PRODUCT
a) Dole Classic Romaine prepackaged salad in 10 oz.
plastic bag, Recall # F-014-6;
b) Dole American Blend prepackaged salad in 12 oz.
plastic bag, Recall # F-015-6;
c) Dole Greener Selection prepackaged salad in 12 oz.
plastic bag, Recall # F-016-6
CODE
Best if used by date of September 23, 2005, production codes beginning with B250
RECALLING FIRM/MANUFACTURER
Dole Fresh Vegetables, Inc., Soledad, CA, by press release on October 1, 2005 and October 2, 2005. Firm initiated recall is ongoing.
REASON
The products have been associated with an outbreak of E.coli O157:H7 illness.
VOLUME OF PRODUCT IN COMMERCE
22,596 cases
DISTRIBUTION
Nationwide

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PRODUCT
HyTop Blueberry Muffin Mix, packaged in paper pouches, Net Wt 7 oz, UPC 50700 06006, Recall # F-017-6
CODE
Lot codes implicated in labeling error: 510145B 0800, 520145B 0800, 510153B 0800, and 520153B 0800. However, firm has removed all codes from the market
RECALLING FIRM/MANUFACTURER
Morrison Milling Co., Denton, TX, by telephone and letters dated August 15, 2005, by e-mail and press release on August 18, 2005. Firm initiated recall is ongoing.
REASON
Hytop Blueberry Muffin Mix contains undeclared eggs and whey.
VOLUME OF PRODUCT IN COMMERCE
1,561 cases
DISTRIBUTION
TX, NM, LA

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

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PRODUCT
Select Brand Nite Time Cold/Flu Relief, (acetaminophen 1000mg, dextromethorphan HBr 30mg, doxylamine succinate 12.5mg and pseudoephedrine HCl 60mg), 6 fl oz (177mL), Cherry Flavor, over the counter, NDC #15127-880-64, Recall # D-012-6
CODE
Lot #L034A05A, expiry 03/07; Lot #L034A05L, expiry 03/07; Lot #L022E05K, expiry 06/07
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC, Huntsville, AL, by letter on August 31, 2005. Firm initiated recall is ongoing.
REASON
Label fails to declare correct dye colors as FD&C blue #1 and FD&C red #40.
VOLUME OF PRODUCT IN COMMERCE
15,896 bottles
DISTRIBUTION
AR

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0009-6
CODE
Unit numbers: 6834707 and 6831870
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on December 29, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO and VA

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0010-6
CODE
Unit number: 6887152
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on December 22, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0011-6
CODE
Unit number: 6627127
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on May 20, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

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PRODUCT
a) Red Blood Cells, Recall # B-0012-6;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0013-6
CODE
a) Unit number: 6886816;
b) Unit number: 6883699
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 3, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO and PA

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0014-6
CODE
Unit number: 6615745
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on May 20, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

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PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0015-6
CODE
Unit number: 13X04137
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Detroit, MI, by telephone and letter on June 24, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

_______________________________
PRODUCT
a) Enteryx Procedure Kit, Order No: M00572600 --US
and M00572500 --OUS, Recall # Z-0040-06;
b) Enteryx Injector Single Pack Order Number:
M00572650 -US and M00572630 -OUS, Recall # Z-0041-06
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Natick, MA, by letter on September 23, 2005.
Manufacturer: Life Science Outsourcing, Inc., Brea, CA. Firm initiated recall is ongoing.
REASON
Incorrect implantation may cause serious health complications. A transmural injection can result in an injection directly into a vital organ including the aorta and serious patient injury and death could occur.
VOLUME OF PRODUCT IN COMMERCE
12,234 kits
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

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PRODUCT
Medrad Overhead Counterpoise System II. Support Arm. Mount Injector Head. Catalog numbers 3010544, 3010545, 3010546, 3010547, 3010548, 3010549, 3010550, 3010551, 3010552, and 3010553, Recall # Z-0089-06
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Medrad, Inc., Indianola, PA, by an Urgent Medical Device Field Correction notice dated October 7, 2005 and October 13, 2005. Firm initiated recall is ongoing.
REASON
Overhead system can fall due to the failure of a retaining ring.
VOLUME OF PRODUCT IN COMMERCE
2,080 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Premicath 28G PICC Catheter, Recall # Z-0090-06
CODE
Lot numbers: 014434 and 012615
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vygon Corporation, Norristown, PA, by letter on June 27, 2005.
Manufacturer: Vygon GmbH & Co., Aachen, Germany. Firm initiated recall is complete.
REASON
Guidewire protruding from tip of the catheter.
VOLUME OF PRODUCT IN COMMERCE
243 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Zimmer brand Sirus Intramedullary femur nail system step reamer 0 mm, 6.5/4.5 mm cannulated, for cervical screws, item number 02.00020.039, Recall # Z-0091-06
CODE
Lots 480103, 480104 and 487665
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN, by letter dated September 30, 2005. Firm initiated recall is ongoing.
REASON
The calibrations on the reamers may lead to inaccurate reaming depth when used in accordance with the published surgical technique.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Sienet Cosmos. Radiological Image Processing. Model number 10018971, Recall # Z-0092-06
CODE
Version VB15C
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by Customer Safety Advisory dated September 22, 2005.
Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.
REASON
Reference lines appear above actual position.
VOLUME OF PRODUCT IN COMMERCE
64 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Tecnis Monofocal Silicone Posterior Chamber IOLs
(Models: Z9000 and Z9001), Recall # Z-0093-06;
b) Tecnis Multifocal Silicone Posterior Chamber IOLs
(Model: ZM900), Recall # Z-0094-06;
c) CeeOn EDGE Silicone Posterior Chamber IOLs
(Models 911A and 913A), Recall # Z-0095-06;
d) CeeOn Heparin Surface Modified (HSM) PMMA One-Piece
Posterior Chamber- IOLs (Models:722C, 722Y, 811C,
812C and 812CU), Recall # Z-0096-06;
e) CeeOn Heparin SurfaceModifie (HSM) PMMA One-Piece
Anterior Chamber IOLs (Model: HSM65),Recall Z-0097-06
CODE
Tecnis® Silicone Z9000, 94 lenses
Tecnis Mono 12mm Z9000+11,5 8160800508
Tecnis Mono 12mm Z9000+23,0 8014050508
Tecnis Mono 12mm Z9000+12,0 8110100508 8014060508
8110110508 8014070508
Tecnis Mono 12mm Z9000+20,5 8095430509 8014090508
Tecnis Mono 12mm Z9000+21,0 8062320509 8014100508
Tecnis Mono 12mm Z9000+22,0 8094140509 8014110508
8094150509 8014120508
Tecnis Mono 12mm Z9000+22,5 8080300509 8014130508
8080310509 8014140508 8117480508 8014150508
Tecnis Mono 12mm Z9000+23,0 8012330508 8014160508
8012340508 8014190508 8012360508
Tecnis Mono 12mm Z9000+23,5 8160360508 8012370508
Tecnis Mono 12mm Z9000+24,0 8166940508 8012380508
8166960508 8012400508 8166970508 8012410508 8012430508
8012440508 8012450508 8012460508 8012470508 8012480508
8012510508 8012530508 8012540508 8013910508 8013920508
8013930508 8013940508 8013950508 8013960508 8013970508
8013980508 8013990508 8014000508 8014010508 8014020508
8014030508 8014040508
Tecnis Mono 12mm Z9000+24,5 8037770508 8037780508
8037790508 8037800508 8037810508 8037820508 8037830508
8037840508 8037850508 8037860508 8037870508 8037880508
8037890508 8037900508 8037910508 8037920508 8037930508
8037940508 8037950508 8037960508 8037970508 8037980508
8037990508 8163880508 8163890508 8163900508 8163910508
8163920508 8163930508 8163940508 8163950508 8163960508
8163970508 8163980508 8163990508 8164000508 8164010508
8164020508
Tecnis® Silicone Z9001, 13 lenses
Tecnis Mono 13mm Z9001+22.5 8030920508 8030930508
8031100508 8031110508 8031130508 8031140508 8031150508
Tecnis Mono 13mm Z9001+25,5 8111960508 8111970508
8111980508 8111990508 8112000508 8112020508;
b) Tecnis® Silicone ZM900, 7 lenses Tecnis Multi 12mm
ZM900+23,0 8027950508 8027960508 8027990508
Tecnis Multi 12mm ZM900+24,0 8026240508 8026260508
8026280508 8026310508;
c) CeeOn® EDGE Silicone 911A, 189 lenses SLMP 911A +10,0
8131520508 SLMP 911A +11,5 8116020508 8116050508
8116060508 SLMP 911A +13,0 8189380508 SLMP 911A +13,5
8108000508 SLMP 911A +14,0 8033720508 8090160508
8224980508 SLMP 911A +15,0 8105650508 8105660508
8105680508 8105690508 8105730508 8105740508 8105760508
8105770508 8105790508 SLMP 911A +15,5 8064660508
8064800508 8186100508 8186110508 SLMP 911A +16,5
8063190508 8063270508 8063280508 8063290508 8063300508
8063310508 SLMP 911A +17,0 8062880508 8062920508
8062960508 8062970508 8062980508 8063000508 8236490508
SLMP 911A +17,5 8047590508 8047830508
SLMP 911A +18,0 8058440508 8058450508 8058460508
8058470508 8058490508 8058500508 8058520508
SLMP 911A +18,5 8058030508 8058110508 8058350508
8058360508 8139110508 8139150508
SLMP 911A +19,5 8047170508 8047180508 8047200508
8047210508 8047220508 8047250508 8047340508 8047360508
SLMP 911A +21,5 8082640508 8082660508 8082670508
8082680508 8082740508 8082750508 8082760508 8082770508
8082780508 8082920508 8084420508 8084670508
SLMP 911A +22,0 8056570509 8056590509 8164620508
SLMP 911A +22,5 8081650508 8081710508 8081770508
8081790508 8081820508 8081830508 8081840508 8081850508
8081860508 8081870508 8108460508 8108470508 8108500508
8108510508 8108520508 8108560508 8108650508 8165340508
8165350508 8165360508 8165370508 8165380508 8165390508
8165400508 8165410508 8165420508 8165430508
SLMP 911A +23,0 8085040508 8085050508 8085060508
8085080508 8085090508 8085100508 8085120508 8085130508
8085140508 8085150508 8085160508 8085170508 8085180508
8085190508 8085220508 8085230508 8086900508 8086910508
8086920508 8086930508 8086940508 8087040508 8087050508
8087060508 8087070508 8087080508 8176340508
SLMP 911A +24,0 8089850508 8089910508 8175230508
8175260508 8194110508 8194120508 8194130508 8194140508
8194160508 8194180508 8194820508 8194910508 8194950508
8195360508 8195370508 8195410508 8195470508 8195520508
SLMP 911A +24,5 8084090508 8084100508 8084200508
8089000508 8168060508 SLMP 911A +25,0 8067040508
8067300508 SLMP 911A +25,5 8084740508 8084770508
8084780508 8084790508 8084940508 8084950508 8092820508
SLMP 911A +26,5 8100530508 8100540508 8100560508
8100640508 8100660508
SLMP 911A +27,0 8099340508 8099380508
SLMP 911A +28,0 8085670508 8085950508 8085960508
SLMP 911A +28,5 8077790508 8077860508 8102970508
8103030508 8103040508 8103080508 8103090508 8103100508
8103120508 8103130508 8103140508
SLMP 911A +29,0 8096860508 8096900508
SLMP 911A +29,5 8095320508 8095330508
SLMP 911A +30,0 8106430508 8106440508 8106450508
8106460508 8106470508 CeeOn® EDGE Silicone 913A,
103 lenses SLMP 913A +11,0 8184650508
SLMP 913A +15,5 8171590508 SLMP 913A +18,5 8177910508
8177920508 8177960508 8177970508 8178040508
SLMP 913A +19,0 8053490508 8053520508 8053530508
8181070508 SLMP 913A +19,5 8052440508 8052460508
8052470508 8052480508 8052680508
SLMP 913A +20,0 8053300508
SLMP 913A +20,5 8245300508 8245310508 8245320508
8245330508 8245340508 8245350508 8245370508 8245420508
8245430508 8245440508 8245450508 8245460508 8245470508
8245540508 8245570508
SLMP 913A +21,0 8179350508 8179360508 8179370508
8179380508 8179390508 8179400508 8179450508 8179460508
8183440508 8183520508 8183540508 8183550508 8183560508
8183570508 8183580508 SLMP 913A +22,0 8035910509
8070510508 8180690508 8180700508 8180710508 8180720508
8180730508 8180740508 8180750508 8180760508 8180770508
SLMP 913A +22,5 8227980508 8227990508 8228000508
8228010508 8228020508 8228050508 8228200508 8228210508
8228220508 SLMP 913A +23,0 8227170508 8227210508
8227220508 8227240508 8227250508 8227260508 8227270508
SLMP 913A +23,5 8077180508 8077230508 8077240508
8077280508 8180250508 8180260508
SLMP 913A +24,0 8176510508 8176520508 8176530508
8176540508 8176550508 8176560508 8176570508 8176580508
8176590508 8176600508 8176610508 8176620508 8181330508
8181380508 8181390508 8181400508
SLMP 913A +24,5 8078360508 8178480508 8178680508
8178690508 SLMP 913A +25,0 8182890508 8182900508
8182930508;
e) CeeOn® One-Piece PMMA HSM65, 2 lenses PMMA HSM HSM65+22,0
8054720508 8054730508
RECALLING FIRM/MANUFACTURER
Recalling Firm: Advanced Medical Optics, Inc., Santa Ana, CA, by letter beginning on October 5, 2005.
Manufacturer: Amo Groningen, Groningen, CA. Firm initiated recall is ongoing.
REASON
A small opening (channel or tunnel) in the seal of the outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the potentially compromised outer Tyvek pouch may not be sterile and may potentially contaminate an otherwise sterile field during surgery.
VOLUME OF PRODUCT IN COMMERCE
453 units
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR NOVEMBER 2, 2005

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