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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January 24, 2007
07-04

RECALLS AND FIELD CORRECTIONS: FOOD and COSMETICS -- CLASS I

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PRODUCT
Ocean Delight Frozen Cooked Lobster Meat, Product of Canada. Packed 6 x 2 lb units/case. 12 lb (Product not labeled for retail sale), Recall # F-091-7
CODE
Lot number: 05346
RECALLING FIRM/MANUFACTURER
Recalling Firm: Orion Seafood, Portsmouth, NH, by fax and by mail on November 14, 2006.
Manufacturer: Madelimer, Inc., Quebec, Canada. Firm initiated recall is ongoing.
REASON
Product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
177 cases
DISTRIBUTION
CA, IL and MN

RECALLS AND FIELD CORRECTIONS: FOOD and COSMETICS -- CLASS III

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PRODUCT
World's Finest Chocolate 1 lb Chocolate Fudge. The product is shipped in a lidded tin, 15 tins per case/carton. The product is sold through fund raiser opportunities, Recall # F-092-7
CODE
Lot numbers: 6226, 6228, 6229, 6234, 6235, 6236, 6242, 6244, 6248, 6249, and 6250
RECALLING FIRM/MANUFACTURER
Asher Chocolates, Souderton, PA, by telephone beginning on October 18, 2006. Firm initiated recall is ongoing.
REASON
Fudge contains mold.
VOLUME OF PRODUCT IN COMMERCE
20,842 units
DISTRIBUTION
IA

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PRODUCT
Lubriderm Moisture Mitts, skin moisturizing lotion: a) Lubriderm Moisture Mitts 15 ct. - Case UPC: 50052800489405; Lubriderm Mitt Unit UPC: 052800489400 Promotional Display -Lubriderm Moisture Mitts 15 ct 12 pc PDQ: Case UPC: 00052800928343; Lubriderm Mitt Unit UPC: 0528009489400;
b) Lubriderm Moisture Mitts 15 ct 12 pc PDQ: Case UPC: 00052800929388, Luriderm Mitt Unit UPC: 05200489400 Promotional Display -Lubriderm MX 16 oz w/Lubriderm Mitt 15 ct & IRC x18PDQ display containing: 6 boxes of 15 single use mitts 4 bottles of Lubriderm Nourishing Lotion 16 oz., 4 bottles Lubriderm Advanced Therapy Moisturing Lotion 16 oz., 4 bottles Lubriderm Skin Nourishing Moisturing Lotion with Sea Kelp 16 oz: Case UPC 00052800927810, Lubriderm Mitt Unit UPC: 052800489400;
c) Promotional Display - Lubriderm MX 19.6 oz. & Lubriderm Mitts 15 ct x 24 PDQ Display containing: 6 boxes of 15 single use mitts, 6 bottles Lubriderm Advanced Therapy Moisturing Lotion 19.6 oz., 6 bottles Lubriderm Daily Moisturing Lotion 19.6 oz., 6 bottles of Lubriderm Skin Moisturing Lotion with Sea Kelp 19.6 oz. Case UPC 00052800927902, Lubriderm mitt Unit UPC 052800489400;
d) Lubriderm Moisture MItts UPC 052800489400, each case contains boxes of 12 mitts,
Recall # F-093-7
CODE
a) Case Lot #'s: 00286SD2, 00386SD1, 00386SD2, 00986SD1, 00986SD1A, 01086SD1, 01086SD2, 01186SD1, 01486SD1, 01586SD1, 01686SD1, 0168SD1, 0186SD1;
b) Case lot #'s: 00196SD1, 03086SD1, 03086SD2, 03186SD1, 03186SD2;
c) Case lot #''s 00896SD1, 01196SD1, 01296SD1, 01296SD2, 01396SD1, 01396SD2, 01496SD1, 01496SD2, 01596SD1, 01596SD2, 02196SD1;
d) Lot #'s: 171602, 172602, 173602, 174602, 174601, 175601, 175603, 177603, 177604, 177605, 178605, 181605, 182605, 183605, 186605, 187605, 188605, 189605, 191606,192606, 193606, 194606, 195606, 196606, 198606, 199606, 200606, 200607, 201607, 202607, 203607, 205607, 206607, 207607, 208608, 209608, 210608, 212608, 213608, 215608, 216608, 219608, 220609, 212609, 222609, 227609, 230609, 233609
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer, Inc., Morris Plains, NJ, by mailing notification packages on October 11, 2006.
Manufacturer: Pacon Manufacturing Corp., Somerset, NJ. Firm initiated recall is ongoing.
REASON
Lubriderm Moisture Mitts were tested and found to contain mold - Aspergillus fumigatus, Aspergillus versicolor, and Penicillium sp.
VOLUME OF PRODUCT IN COMMERCE
24,069 cases of 12 mitts each (288,828 mitts)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

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PRODUCT
Betamethasone Acetate/Sodium Phosphate Injectable, 6mg/mL, 10 mL vial, Rx, Recall # D-430-7
CODE
Lots: 11272006@13, exp. 5/26/07; 12042006@9, exp. 6/2/07
RECALLING FIRM/MANUFACTURER
MED South Pharmacy DBA Partners In Care, Pelham, AL, by telephone on December 7, 2006 and by letters on December 23, 2006. Firm initiated recall is ongoing.
REASON
Adverse reactions due to formula change.
VOLUME OF PRODUCT IN COMMERCE
239 vials
DISTRIBUTION
AL, AR, FL, GA, LA, and TN

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I

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PRODUCT
Human Tissue for Transplantation:
a) Achilles Tendon Frozen;
b) Tibialis Anterior Tendon, Frozen, Recall # B-0114-7
CODE
a) 03-0168302
b) 03-0168303, 03-0168304
RECALLING FIRM/MANUFACTURER
DCI Donor Services Tissue Services Division, Nashville, TN, by letters on May 23, 2005. Firm initiated recall is ongoing.
REASON
Human tissue, which was either implicated in a post-transplant bacterial infection, or was processed in the same manner as tissue that was implicated in a post-transplant bacterial infection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 tissue allografts
DISTRIBUTION
New Mexico, TN

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

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PRODUCT
Human Tissue for Transplantation:
a) Achilles Tendon Frozen;
b) Patellar Ligament Hemi, Frozen;
c) Cartilage in Saline Vacuum;
d) Tibialis Anterior Tendon, Frozen
e) Tibialis Tendon Frozen;
f) Tibialis Tendon Posterior Frozen;
g) Fascia Lyo 101-150 sq cm;
h) Pericardium Lyo 26-50 sq cm;
i) ) Semitendonosus / Gracilis Frozen;
j) Patella Ligament Whole Frozen,
Recall # B-0115-7
CODE
a) 03-0178792, 03-0173682, 03-0168103, 03-0168104, 03-0162640,
03-0168841, 03-0181591, 03-0179205, 03-0181592, 03-0042572,
03-0155372, 03-0182234, 03-0032401, 03-0174931, 03-0155371,
03-0161144, 03-0182782, 03-0182623, 03-0181628, 03-0182051,
03-0032400, 03-0168301, 03-0147962, 03-0173822, 03-0182235,
03-0181627, 03-0128130, 03-0162639, 03-0182783, 03-0182624,
03-0161143, 03-0182052, 03-0151503, 03-0147961, 03-0042571,
03-0179206, 03-0172621, 03-0135831, 03-0174932, 03-0173821,
03-0173681, 03-0172251, 03-0178791, 03-0173841, 03-0173842;
b) 03-0168842, 03-0181593, 03-0135832, 03-0181595, 03-0182781,
03-0178796, 03-0182625, 03-0182626, 03-0168844, 03-0173823,
03-0173825, 03-0179203, 03-0173826, 03-0182011, 03-0182049,
03-0179202, 03-0042574, 03-0139081, 03-0151502, 03-0147967,
03-0168102, 03-0162641, 03-0161142, 03-0128132, 03-0042575,
03-0168101, 03-0172618, 03-0181594, 03-0162643, 03-0168843,
03-0181438, 03-0172252, 03-0181596, 03-0178793, 03-0178794,
03-0032405, 03-0139084, 03-0179204, 03-0182047, 03-0181212,
03-0172620, 03-0182048, 03-0172617, 03-0172619, 03-0042573,
03-0042576, 03-0178795, 03-0139082, 03-0162644, 03-0173824,
03-0181213, 03-0172253, 03-0182050, 03-0151501, 03-0179201,
03-0181436, 03-0181437, 03-0032402, 03-00324404, 03-0162642,
03-0128131, 03-0128133, 03-0147968, 03-0181211;
c) 03-0014874, 03-0014871, 03-0014878, 03-0014875, 03-0014876, 03-0014877;
d) 03-0182053, 03-0182054, 03-0181621, 03-0179207, 03-0179208,
03-0181600, 03-0181599, 03-0155375, 03-0173846, 03-0173847, 03-0181622;
e) 03-0042582, 03-0042580, 03-0042581, 03-0178797, 03-0178798,
03-0178799, 03-0147963, 03-0147964, 03-0147965, 03-0147966;
f) 03-0155377, 03-0173845, 03-0182055, 03-0181623, 03-0155376,
03-0181598, 03-0181624, 03-0179209, 03-0181597, 03-0179210;
g) 03-0182237, 03-0182238, 03-0168105;
h) 03-0168845, 03-0173684, 03-168846, 03-0174935, 03-0174936, 03-0173683;
i) 03-0147971;
j) 03-0182232, 03-0182233, 03-0155373, 03-0155374, 03-0179281,
03-0111812, 03-0174933, 03-0161141, 03-0173844, 03-0181625, 03-0173843
RECALLING FIRM/MANUFACTURER
DCI Donor Services Tissue Services Division, Nashville, TN, by letters on May 23, 2005, by email and telephone on May 26, 2005, and by mail on August 25, 2006. Firm initiated recall is ongoing.
REASON
Human tissue, which was either implicated in a post-transplant bacterial infection, or was processed in the same manner as tissue that was implicated in a post-transplant bacterial infection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
167 tissue allografts
DISTRIBUTION
TN, CA, NV, AR and New Mexico

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0451-07;
b) Fresh Frozen Plasma, Recall # B-0452-07
CODE
a) and b) Unit: 032KM30370
RECALLING FIRM/MANUFACTURER
American National Red Cross, Badger-Hawkeye Region, Madison, WI, by letters dated August 15, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that tested negative for antibody to Hepatitis B core antigen (anti-HBcore), but previously tested repeatedly reactive for anti-HBcore on two occasions.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI

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PRODUCT
Red Blood Cells, Recall # B-0519-7
CODE
Unit: 0209555
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on May 2, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0550-7
CODE
Unit: 22GQ15801
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by letter and telephone on July 27, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who donation record was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0570-7
CODE
Units: 5242996, 4982587
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on March 29, 2005. 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

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PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0571-7
CODE
Units: 8309271 (triple-split product)
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers Inc., Orlando, FL, by telephone on May 8, 2002. Firm initiated recall is complete.
REASON
Blood products, with platelet yields below the specified minimum requirement, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL

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PRODUCT
Platelets, Recall # B-0584-7
CODE
Unit: 1334632
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Westbury, NY, by telephone and follow-up letter on December 19, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had taken aspirin, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

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PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0588-7;
b) Recovered Plasma, Recall # B-0589-7
CODE
a) and b) Units: 4723660, 4492802
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on June 12, 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
4 units
DISTRIBUTION
OK, MI, NB, and Switzerland

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PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0592-7;
b) Platelets Leukocytes Reduced, Recall # B-0593-7
CODE
a) and b) Unit: LL35485
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, DBA Rhode Island Blood Center, Providence, RI, by fax on October 2, 2006. 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
RI

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PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0594-7;
b) Platelets Leukocytes Reduced, Recall # B-0595-7
CODE
a) and b) Unit: LL30489
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, DBA Rhode Island Blood Center, Providence, RI, by fax on October 6, 2006. 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
MA, and FL

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PRODUCT
Red Blood Cells, Recall # B-0649-7
CODE
Unit: 0430525
RECALLING FIRM/MANUFACTURER
Community Blood Bank of Erie County, Erie, PA, by letter dated September 13, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

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PRODUCT
Red Blood Cells, Recall # B-0650-7
CODE
Unit: C61443
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by telephone on August 9, 2006 and by letter dated September 22, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an unacceptable hemoglobin/hematocrit result, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0340-7
CODE
Unit: 5889460
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by telephone and facsimile on May 22, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

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PRODUCT
Recovered Plasma, Recall # B-0520-7
CODE
Unit: 0209555
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by fax on May 2, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

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PRODUCT
Red Blood Cells (Apheresis) Irradiated, Recall # B-0521-7
CODE
Units: 71Q340990, 71Q340873
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham, AL, by telephone on August 2, 2005. Firm initiated recall is complete.
REASON
Blood products, labeled with extended expiration dates, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL

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PRODUCT
Buffy Coat, Recall # B-0590-7
CODE
Unit: 4492802
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK, by fax on June 12, 2006. 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
OK, MI, NB, and Switzerland

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0606-7
CODE
Unit: 5274880
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on April 14, 2005. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Bacillus sp., was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

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PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0607-7
CODE
Unit: 5274799
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on April 19, 2005. Firm initiated recall is complete.
REASON
Blood product, which was identified as being contaminated by the BacT/ALERT system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI

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PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0608-7
CODE
Unit: 5411212
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by telephone and facsimile dated May 27, 2005. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Bacillus sp., was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

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PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0646-7
CODE
Unit: 5651322
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by telephone and facsimile on June 15, 2006. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with coagulase negative Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

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PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0647-7
CODE
Units 033GC03567 (2 units), 033GQ01653 (2 units)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Connecticut Region, Farmington, CT, by telephone on August 4, 2006 and by letter dated August 8, 2006. Firm initiated recall is complete.
REASON
Blood products, for which documentation of the apheresis procedure was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CT

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PRODUCT
Red Blood Cells, Recall # B-0648-7
CODE
Unit: KJ87643
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on August 2, 2006. Firm initiated recall is complete.
REASON
Blood product, manufactured without the additive solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0651-07
CODE
Units: 030GM30971, 030GM30978, 030GM30983
RECALLING FIRM/MANUFACTURER
American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone on July 21, 2006. Firm initiated recall is complete.
REASON
Blood products, collected on a trip scales for which documentation of the daily quality control testing was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NY

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

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PRODUCT
a) RYM-5000 InVision-Plus® Neutral Displacement I.V. Connector, packaged
200 units per box, 5 boxes per case (1000 units/case); labeled as
Sterile-Nonpyrogenic; assembled in Mexico, Recall # Z-0319-2007;
b) RYM-5000 InVision-Plus® NEUTRAL™ I.V. Connector, packaged 200 units
per box, 5 boxes per case (1000 units/case); labeled as Sterile-Nonpyrogenic;
assembled in Mexico, Recall # Z-0320-2007;
c) RYM-5001 InVision-Plus® Neutral Displacement I.V. Connector,
packaged 100 units per box, 5 boxes per case (500 units/case); labeled as
Sterile-Nonpyrogenic; assembled in Mexico, Recall # Z-0321-2007
CODE
a) Lots #400, 401, and 402;
b) Lot #405;
c) Lots #500, 502, 503, 504 and 505
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rymed Technologies, Inc., Austin TX, by e-mail and/or phone on May 25, 2006.
Manufacturer: Accelent Juarez, Juarez, Mexico. Firm initiated recall is complete.
REASON
Weld failures on IV connector (area of female luer and spike body)
VOLUME OF PRODUCT IN COMMERCE
79,328 units
DISTRIBUTION
Nationwide

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PRODUCT
Welch Allyn PIC 50 Portable Intensive Care System, Multi-Parameter Monitor/Defibrillator; a portable 12V internal battery powered defibrillator; Part Numbers-971081, 971082, 971083, 971084, Recall # Z-0343-2007
CODE
Serial numbers 80052, 80141, 80190, 80191, 80425, 80426, 80430, 80431, 80432, 80435, 80436, 80587, 80826, 80915, 80916, 80918, 80920, 80921, 80923, 80924, 80925, 80926, 80927, 80928, 80929, 80930, 80932, 80934, 80960, 80962, 80963, 80967, 80969, 80971, 80972, 80973, 80974, 80975, 80976, 80981, 80983, 80987, 80989, 80990, 80991, 80992, 80993, 81003, 81004, 81005, 81006, 81007, 81008, 81009, 81010, 81011, 81012, 81013, 81014, 81015, 81016, 81017, 81018, 81019, 81020, 81022, 81023, 81024, 81025, 81026, 81027, 81028, 81029, 81030, 81031, 81032, 81033, 81034, 81035, 81036, 81037, 81038, 81044, 81045, 81046, 81047, 81049, 81070, 81094, 81102, 81103, 81104, 81105, 81109, 81110, 81111, 81112, 81113, 81165, 81167, 81178, 81179, 81181, 81184, 81187, 81188, 81192, 81194, 81197, 81258, 81297, 81499, 81627, 81765, 81767, 81769, 81770, 81773, 81803, 81804, 81823, 81827, 81828, 81829, 81832, 81833, 81834, 81835, 81837, 81838, 81839, 81840, 81841, 81842, 81843, 81844, 81845, 81846, 81853, 81855, 81857, 81858, 81860, 81861, 81862, 81863, 81864, 81865, 81866, 81867, 81868, 81869, 81884, 81885, 81886, 81920, 81921, 81922, 81923, 81924, 81925, 81926, 81927, 81928, 81929, 81930, 81931, 81932, 81933, 81934, 81935, 81936, 81937, 81938, 81939, 81940, 81941, 81942, 81943, 81944, 81945, 81946, 81949, 81957, 81983, 81984, 81985, 81986, 81987, 81988, 81989, 81990, 81996, 81997, 81998, 81999, 82000, 82001, 82003, 82004, 82005, 82016, 82017, 82019, 82021, 82022, 82023, 82024, 82025, 82027, 82028, 82034, 82035, 82036, 82037, 82038, 82039, 82043, 82061, 82062, 82063, 82064, 82065, 82066, 82067, 82068, 82069, 82070, 82071, 82072, 82073, 82074, 82075, 82076, 82077, 82078, 82079, 82080, 82098, 82099, 82100, 82101, 82102, 82103, 82104, 82105, 82106, 82107, 82108, 82109, 82111, 82122, 82123, 82124, 82126, 82127, 82128, 82160, 82161, 82162, 82163, 82164, 82165, 82169, 82172, 82173, 82174, 82175, 82176, 82177, 82178, 82179, 82180, 82181, 82182, 82183, 82184, 82185, 82186, 82192, 82193, 82194, 82195, 82196, 82198, 82199, 82200, 82201, 82202, 82204, 82252, 82253, 82254, 82255, 82256, 82257, 82258, 82259, 82260, 82261, 82262, 82263, 82264, 82265, 82266, 82267, 82268, 82270, 82271, 82272, 82273, 82284, 82285, 82286, 82317, 82318, 82319, 82321, 82322, 82323, 82324, 82325, 82326, 82327, 82328, 82329, 82330, 82342, 82343, 82344, 82346, 82347, 82348, 82349, 82408, 82409, 82411, 82412, 82413, 82414, 82415, 82416, 82417, 82418, 82419, 82421, 82424, 82426, 82430, 82461, 82462, 82463, 82464, 82465, 82466, 82467, 82468, 82469, 82470, 82471, 82472, 82473, 82474, 82475, 82517, 82518, 82519, 82520, 82521, 82522, 82528, 82529, 82530, 82531, 82532, 82533, 82536, 82537, 82538, 82550, 82552, 82553, 82555, 82556, 82557, 82559, 82560, 82561, 82562, 82563, 82564, 82565, 82569, 82570, 82612, 82613, 82614, 82615, 82616, 82617, 82618, 82619, 82621, 82623, 82624, 82625, 82626, 82627, 82628, 82629, 82630, 82631, 82655, 82656, 82657, 82658, 82659, 82660, 82661, 82662, 82663, 82664, 82665, 82666, 82667, 82668, 82669, 82670, 82671, 82672, 82689, 82690, 82773, 82774, 82775, 82776, 82777, 82778, 82779, 82780, 82781, 82782, 82783, 82784, 82785, 82786, 82787, 82788, 82789, 82790, 82791, 82792, 82793, 82794, 82795, 82796, 82797, 82798, 82799, 82800, 82801, 82802, 82803, 82804, 82805, 82806, 82807, 82808, 82809, 82810, 82811, 82812, 82813, 82827, 82828, 82829, 82830, 82852, 82857, 82858, 82859, 82962, 82965, 82966, 82967, 82975, 82986, 82989, 82991, 82998, 83010, 83011, 83012, 83013, 83060, 83061, 83062, 83063, 83064, 83065, 83066, 83067, 83084, 83088, 83089, 83090, 83142, 83144, 83145, 83147
RECALLING FIRM/MANUFACTURER
MRL, Inc., A Welch Allyn Co., Buffalo Grove, IL, by letters dated November 8, 2006. Firm initiated recall is ongoing.
REASON
Shock Delay:The monitor-debrillator may display an 'ECG Comm' error message on the display during use,which may prevent or cause an unacceptable delay the delivery of a defibrillation shock. This delay could result in failure to resuscitate the patient.
VOLUME OF PRODUCT IN COMMERCE
510 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
a) ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer –
human serum, plasma and urine tests. The following are the measured
parameters that are within the scope of this 'field correction': Affected assay:
Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline,
Recall # Z-0351-2007;
b) ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer –
human serum, plasma and urine tests. The following are the measured
parameters that are within the scope of this 'field correction': Affected assay:
Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline,
Recall # Z-0352-2007;
c) ADVIA 2400 Chemistry System, Automated Clinical Chemistry Analyzer –
human serum, plasma and urine tests. The following are the measured
parameters that are within the scope of this 'field correction': Affected assay:
Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline,
Recall # Z-0353-2007
CODE
a) All ADVIA 1200 Chemistry Systems are involved as well as all existing assay lots
for Valproic Acid (VPA), Phenytoin (PHNY), Gentamicin (GENT), Digoxin (DIG),
and Theophylline (THEO). ADVIA 1200 Part # 094-A001, VPA Part # B01-4784-01,
PHNY Part # B01-4775-01, DIG Part # B01-4769-01, GENT Part # B01-4787-01,
THEO Part # B01-4772-01;
b) All ADVIA 1650 Chemistry Systems are involved as well as all existing assay lots
for Valproic Acid (VPA), Phenytoin (PHNY), Gentamicin (GENT), Digoxin (DIG), and
Theophylline (THEO). ADVIA 1650 Part # 073-A001, VPA Part # B01-4784-01,
PHNY Part # B01-4775-01, DIG Part # B01-4769-01, GENT Part # B01-4787-01,
THEO Part # B01-4772-01;
c) All ADVIA 2400 Chemistry Systems are involved as well as all existing assay lots
for Valproic Acid (VPA), Phenytoin (PHNY), Gentamicin (GENT), Digoxin (DIG),
and Theophylline (THEO). ADVIA 2400 Part # 073-A010, VPA Part # B01-4784-01,
PHNY Part # B01-4775-01, DIG Part # B01-4769-01, GENT Part # B01-4787-01,
THEO Part # B01-4772-01
RECALLING FIRM/MANUFACTURER
Bayer Healthcare, LLC (Diagnostics Division), Tarrytown, NY, by letters on September 8, 2006. Firm initiated recall is ongoing.
REASON
Bayer received a customer complaint where the Valproic Acid Quality control material recovered lower than target when it was run in a panel of other Therapeutic Drug (TDM) assays. The under recovery observed by the customer was approximately -25%.
VOLUME OF PRODUCT IN COMMERCE
1,184 instruments
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
a) TraXis Fixed Trial in sizes: 7mm, 9mm, 11mm, 13mm and 15mm;
part of TraXis vertebral body replacement system,
Part #2665-1-07 (7mm), 2665-1-09 (9mm), 2665-1-11 (11mm),
2665-1-13 (13mm), 2665-1-15 (15mm), Recall # Z-0354-2007;
b) TraXis Fixed Rasp in sizes: 7mm, 9mm, 11mm, 13mm and 15mm;
for use with TraXis vertebral body replacement system
Part #2664-1-07 (7mm), 2664-1-09 (9mm), 2664-1-11 (11mm),
2664-1-13 (13mm), 2664-1-15 (15mm), Recall # Z-0355-2007
CODE
??????
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Spine, Austin, TX, by telephone on November 7, 2006.
Manufacturer: Phillips Precision, Inc., Elmwood Park, NJ. Firm initiated recall is ongoing.
REASON
Tip of devices may dislodge while in use during surgery.
VOLUME OF PRODUCT IN COMMERCE
142 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vitro diagnostic, Recall # Z-0356-2007
CODE
Lots: 66160001; exp. 12/31/06; 66395101, exp. 2/28/07; 67306401, exp. 1/31/08; 66954901, exp. 5/31/07; 67589901, exp. 4/30/08 and 68049501, exp. 10/31/08.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letters dated December 15, 2006.
Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. Firm initiated recall is ongoing.
REASON
Falsely elevated IGGT results may be reported because the R2 reagent of the Tina-quant Gen.2 albumin assay has a carryover effect on the Immunoglobulin G (turbidimetric) assay when used on the COBAS INTEGRA 700 and 800 analyzers.
VOLUME OF PRODUCT IN COMMERCE
18,905 units
DISTRIBUTION
Nationwide

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PRODUCT
Fibrin Analysis Catheter Testing System includes the component BD Vacutainer Luer-Lok Access Device; Catalogue #364902 as a finished sterile device, Non Pyrogenic in unopened undamaged package, Disposable/ Single use/ Do Not Reuse; for use with multi lumen; (4 Venous Catheter sizes) 20 cm. 12 fr. Central; 16 cm. 7-7.5-8 fr. Central; 20 cm 7.7.5-8 fr Central; 16cm 12 fr. Central, Recall # Z-0357-2007
CODE
6071115, 607054, 607123, 607055, 607124, 607116, 607053
RECALLING FIRM/MANUFACTURER
Continental Medical Labs,Inc., Waterford, WI, by letter on October 19, 2006. Firm initiated recall is ongoing.
REASON
Fibrin Analysis Catheter Testing System contains the ''Luer Lok Access Device'' that fails to lock securely to certain catheter devices because the male luer taper surface is not within the specification of the taper.
VOLUME OF PRODUCT IN COMMERCE
840 kits
DISTRIBUTION
WI

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PRODUCT
I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Recall # Z-0358-2007
CODE
Lot numbers: 662449 & 662742
RECALLING FIRM/MANUFACTURER
I-Flow Corp., Lake Forest, CA, by faxed letter on November 29, 2006. Firm initiated recall is ongoing.
REASON
The pump flow rate labeling may not match the package labeling. The label on filter may not match the label on the top of the pump or the package labeling.
VOLUME OF PRODUCT IN COMMERCE
3,475 units
DISTRIBUTION
Nationwide

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PRODUCT
HiZel, Trayless-sterile hydrogel wound dressing. Sizes 2.4 x 2.4', 2.4 x 4.7', & 4.7 x 4.7'. Product is a transparent, flexible sheet. Packaged in a peelable pouch, Recall # Z-0455-2007
CODE
All product from shipment dated March 28, 2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Embeem, Inc., N. Brunswick, NJ, by letters November 9, 2006.
Manufacturer: ABS Medicare Pvt. Ltd, Gujarat, India. Firm initiated recall is ongoing.
REASON
Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material
VOLUME OF PRODUCT IN COMMERCE
1,258 pieces
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

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PRODUCT
DRLock Volar Plate Screw System, Model #DVR-900. The product is a kit contained in an aluminum tray case that contains the following: IMPLANTS: 6 stainless steel plates (2-lefts, 2-rights, and 1-right long and 1-right left), 48 distal locking-screws (ranging from 10-24mm), 32 distal locking pegs, 36 proximal locking screws, 24 proximal non-locking screws. INSTRUMENTS: 2 Bending Pliers*, 1 Bone Reduction Forcep*, 2 Hohmann Retractors *, 1 Ratchet Handle*, 1 Periosteal Elevator*, 1 Dingman Elevator *, 1 K & K Elevator *, four Driver tips *, five drill guides*, 2-1.6 Drill Bits *, 2-2.3 Drill Bits *, 1 Plate Holder Verbruge *, 2 Depth Gages *, 6 K wires, Recall # Z-0349-2007
CODE
Tray kit (case) set number: 'BAA', 'BAB', 'BAC', 'BAD', 'BAE', 'BAF', 'BAH', and 'BAJ'. (The distal locking-screws contained in the kit are identified with lot numbers S104 and S200)
RECALLING FIRM/MANUFACTURER
Recalling Firm: OrthoHelix Surgical Designs, Inc., Akron, OH, by telephone on August 3, 2006.
Manufacturer: Specialized Medical Devices, Lancaster, PA. Firm initiated recall is ongoing.
REASON
The 48 distal locking-screws (ranging from 10-24mm) contained in the kit are not within established specifications, specifically the minor diameter of the screws are undersized.
VOLUME OF PRODUCT IN COMMERCE
180 units
DISTRIBUTION
SC, TX, CO, and OH

END OF ENFORCEMENT REPORT FOR JANUARY 24, 2007

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