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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March 21 2007
07-12

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS Il

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PRODUCT
Frozen, blanched green beans in 50 lb. poly lined cardboard boxes, Valley Pakt brand. Label states: 1/50 lb., Recall # F-133-7
CODE
Day code: 121406, Product ID number: 205050004408
RECALLING FIRM/MANUFACTURER
Bybee Foods, LLC, Pasco, WA., by letter and telephone on January 18, 2007. Firm initiated recall is complete.
REASON
The product may be contaminated with puncture vine fruit which can pose a physical hazard due to its sharpness.
VOLUME OF PRODUCT IN COMMERCE
645/50 lb. boxes
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

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PRODUCT
a) Pain Reliever PM, oral caplet, active ingredients: Acetaminophen 500 mg,
Diphenhydramine HCl 25 mg, packaged under two labels: 1) MHL Pain
Reliever PM, 100 caplet bottles, distributed by Magno-Humphries Labs;
2) MEDICAP PHARMACY Pain Reliever PM, 50 caplet bottles,
Recall # D-469-2007;
b) Children's non-aspirin pain and fever reliever, oral liquid, active ingredient:
Acetaminophen 160 mg, cherry flavor, 4 fluid ounce bottles, packaged under
two labels: 1) MHL Children's Non-Aspirin Oral Suspension, distributed by
Magno-Humphries Labs;
2) BI-MART Children's Non-Aspirin Pain Relief Liquid, distributed by BI-MART,
Recall # D-470-2007;
c) Extra strength pain reliever, oral tablet, active ingredients: Acetaminophen 250 mg,
Aspirin 250 mg, Caffeine 65 mg, packed under 2 labels:
MHL Extraprin Pain Reliever/Pain Reliever Aid, Extra Strength, 100 & 200
tablet bottles, distributed by Magno-Humphries Labs, Tigard, OR;
BI-MART Extra Strength Combination Pain Reliever, 250 tablet bottles,
distributed by BI-MART, Recall # D-471-2007;
d) Ibuprofen, oral tablets, 200 mg, packed under 3 labels:
1) MHL Ibuprofen, 50 & 100 tablet bottles, distributed by Magno-Humphries Lab,
2) Aurora Pharmacy Ibuprofen, 100 tablet bottles, distributed by Aurora Pharmacy, Inc.
3) AARP Pharmacy Services Ibuprofen, 100 tablet bottles, distributed by United
HealthCare Products, LLC, Recall # D-472-2007;
e) Cough suppressant/expectorant, oral liquid, 8 fluid ounce bottles, active ingredients:
Dextromethorphan HBr, 10 mg, Guaifenesin, 100 mg, packed under two labels:
MHL Tussin DM Cough Suppressant/Expectorant, distributed by Magno-Humphries Labs,
BI-MART Tussin DM Cough Suppressant/Expectorant, distributed by BI-MART,
Recall # D-473-2007;
f) Night time cold medicine, oral liquid, active ingredients: Acetaminophen 500 mg,
Dextromethorphan hydrobromide 15 mg, Doxylamine succinate 6.25 mg, packed
under 2 labels: 1) MHL Nite Time New Pseudoephedrine-free Formula Regular Cold
Medicine, 6 fluid ounce bottles, distributed by Magno-Humphries Labs;
2) BI-MART Night Time Cold Medicine New Pseudoephedrine-Free Formula,
6 & 10 fluid ounce bottles, Recall # D-474-2007;
g) Night time cold medicine cherry flavored, oral liquid, active ingredients:
Acetaminophen 500 mg, Dextromethorphan hydrobromide 15 mg, Doxylamine
succinate 6.25 mg, packed under 2 labels:
1) MHL Nite Time New Pseudoephedrine-free Formula Cherry Cold Medicine,
6 fluid ounce bottles, distributed by Magno-Humphries Labs;
2) BI-MART Cherry Flavor Night Time Cold Medicine New Pseudoephedrine-Free
Formula, 6 & 10 fluid ounce bottles, distributed by BI-MART, Recall # D-475-2007;
h) BI-MART Day Time Cold Medicine, New Pseudoephedrine-Free Formula, oral liquid,
active ingredients: Acetaminophen 325 mg, Dextromethorphan hydrobromide 15 mg,
6 fluid ounce bottles, Recall # D-476-2007;
i) MHL Sleep-Tabs Nighttime Sleeping Aid, oral tablet, active ingredient: Diphenhydramine
hydrochloride 25 mg, 100 tablet bottles, Recall # D-477-2007;
j) MHL Diphenhydramine hydrochloride Nighttime Sleeping Aid, 50 mg, oral tablet,
50 tablet bottle, Recall # D-478-2007;
k) Medicap Pharmacy Aler-Caps, oral capsule, active ingredient: Diphenhydramine
hydrochloride 25 mg,100 capsule bottles, Recall # D-479-2007
CODE
a) 1. Lots: 334900, exp. 02/08; 335267, exp. 04/08; 2) Lot 333365, exp. 11/07;
b) 1) Lot 334558, exp. 02/08; 2) Lots: 334439, exp. 02/08, 334980, exp. 02/08;
c) 1) Lots: 334735, exp. 05/08; 334890, exp. 5/08;
2) 334888, exp. 05/08; 334994, exp. 05/08, 335121, exp. 05/08;
d) 1) Lots: 334842, exp. 06/08; 335042, exp. 06/08;
2) 334985, exp. 06/08; 335185, exp. 06/08;
3) 334761, exp. 06/08; 335062, exp. 06/08;
e) 1) Lot 334767, exp. 02/08;
2) Lots: 334445, exp. 02/08; 334624, exp. 02/08; 334646, exp. 02/08;
334749, exp. 02/08; 334846, exp. 02/08; 335115, exp. 02/08;
335228, exp. 02/08; 335283, exp. 02/08;
f) 1) Lot 334679, exp. 05/08;
2) Lots: 335347, exp. 09/08; 334417, exp. 01/08; 334625, exp. 05/08;
334721, exp. 05/08; 335020, exp. 05/08; 335347, exp. 09/08;
334418, exp. 01/08; 334656, exp. 01/08; 334720, 01/08;
335005, exp. 01/08; 335348, exp. 01/08;
g) 1) Lot 335074, exp. 07/08;
2) Lots: 334446, exp. 07/08; 335272, exp. 07/08; 334419, exp. 01/08;
334647, exp. 01/08; 335006, exp. 01/08; 335116, exp. 01/08;
h) Lots: 334420, exp. 02/08; 334748, exp. 02/08; 334869, exp. 02/08;
i) Lots: 335208, exp. 06/09; 335304, exp. 06/09;
j) Lots: 334764, exp. 07/08; 335114, exp. 07/08;
k) Lots: 333512, exp. 01/08; 334067, exp. 01/08; 334080, exp. 01/08
RECALLING FIRM/MANUFACTURER
Magno Humphries Inc., Tigard, OR., by letter on February 21, 2007. Firm initiated recall is ongoing.
REASON
Peel-back labels may delaminate so that drug use information may not be readable.
VOLUME OF PRODUCT IN COMMERCE
34,787 bottles
DISTRIBUTION
AZ, IL, ND, NY, NJ, NV, MO, OH, OR, TX, WA, and WI

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

___________________________________
PRODUCT
Ricola Lemon Mint Herb Throat Drops, Sugar Free, Active Ingredient: Menthol 1.1 mg, 19 drops per bag, Recall # D-466-2007
CODE
Lots: U064737025J and U064737031J
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ricola Inc, Morris Plains, NJ, by letter on January 31, 2007.
Manufacturer: Ricola Ag, Laufen, Switzerland. Firm initiated recall is ongoing.
REASON
Ricola bags labeled as Sugar Free Lemon Mint Herb Throat Drops may contain Ricola Natural Honey Lemon with Echinacea Cough Suppressant Throat Drops which contain 2.2 g of sugar in each throat drop.
VOLUME OF PRODUCT IN COMMERCE
6,048 bags
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

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PRODUCT
Cryoprecipitated AHF, Recall # B-0801-07
CODE
Unit: J39794
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by telephone on April 24, 2006. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA

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PRODUCT
Platelets, Recall # B-0802-07
CODE
Unit: J70002
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by telephone on April 22, 2006 and by letter dated May 22, 2006. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA

___________________________________
PRODUCT
Source Plasma, Recall # B-0841-07
CODE
Units: 06DTXB4358, 06DTXB4657, 06DTXB5091, 06DTXB5342, 06DTXB6853, 06DTXB7028, 06DTXB7626, 06DTXB7969, 06DTXB8573, 06DTXB8889, 06DTXB9420, 06DTXC0057, 06DTXC0382
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, LP, Denton, TX, by facsimile transmission dated August 11, 2006. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who did not have a complete annual physical exam, was distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
CA

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PRODUCT
a) Red Blood Cells, Recall # B-0848-07;
b) Red Blood Cells, Irradiated, Recall # B-0849-07;
c) Whole Blood, Recall # B-0850-07
CODE
a) Units: LP10544, LP10545, LP10549, LP10558, LP10560, LP10564, LP10534,
LP10522, LP10542, LP10543, LP10539, LP10541, LP10538, LP10537, LP10536, LP10535,
LP10533, LP10567, LP10561, LP10563, LP10555, LP10554, LP10556, LP10551, LP10557,
LP10548, LP10550, LP10566, LP10565, LP10559, LP10552;
b) Units: LP10514, LP10547, LP10546, LP10515, LP10562, LP10553;
c) Units: LS12736, LS12727, LS12732, LS12730, LS12717, LS12720, LS12718, LS12716,
LS12725, LS12724, LS12721, LS12726, LS12723, LS12719
RECALLING FIRM/MANUFACTURER
Southern California Permanente Medical Group, Woodland Hills, CA, by letter dated September 19, 2002. Firm initiated recall is complete.
REASON
Blood products, which were stored at an unacceptable temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
51 units
DISTRIBUTION
CA

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PRODUCT
Source Plasma, Recall # B-0862-07
CODE
Units: 05RMID9123, 05RMID9292, 05RMIE0017, 05RMIE1072, 05RMIE1469, 06RMIA0084, 06RMIA1864, 06RMIC0541, 06RMID1828
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Kentwood, MI, by facsimile on November 14, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom post donation information was received regarding multiple high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CA and Austria

___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0864-07;
b) Recovered Plasma, Recall # B-0865-07
CODE
a) and b) Unit: 3862647
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone on November 17, 2006 or by facsimile on December 22, 2006 and follow-up letter dated December 22, 2006. Firm initiated recall is complete..
REASON
Blood products, collected from a donor who was previously deferred for a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN and Austria

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PRODUCT
Source Plasma, Recall # B-0866-07
CODE
Units: 91346483, 93216104, 90495328, 90490651
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc. of Wisconsin, Milwaukee, WI, by facsimile on July 25, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0886-07
CODE
Unit: 2084324
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on July 12, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-0887-07
CODE
Units: 99JWIB9391, 99JWIB7846, 99JWIB7973
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Janesville, WI, by facsimile on March 20, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MI and Austria

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0888-07
CODE
Unit: 17KN69421
RECALLING FIRM/MANUFACTURER
American National Red Cross, North Central Region, St. Paul, MN, by letter dated April 29, 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
1 unit
DISTRIBUTION
CA

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PRODUCT
Source Plasma, Recall # B-0889-07
CODE
Units: 03BNDD2327, 03BNDD3468
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Bismarck, ND, by facsimile on July 11, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had received the MMR vaccine within two weeks of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI

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PRODUCT
a) Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0890-07;
b) Fresh Frozen Plasma Pheresis, Recall # B-0891-07
CODE
a) and b) Unit: 17FX67516
RECALLING FIRM/MANUFACTURER
American National Red Cross, North Central Region, St. Paul, MN, by letter dated November 4, 2003. Firm initiated recall is complete.
REASON
Blood products, associated with a unit of platelets that was possibly contaminated with Staphylococcus aureus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0892-07
CODE
Unit: 17FX65572 (Part 2)
RECALLING FIRM/MANUFACTURER
American National Red Cross, North Central Region, St. Paul, MN, by telephone on August 8, 2003. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with coagulase negative Staphylococcus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN

___________________________________
PRODUCT
Recovered Plasma, Recall # B-0893-07
CODE
Unit: W13604
RECALLING FIRM/MANUFACTURER
Blood Center of Northcentral Wisconsin, Inc., Wausau, WI, by facsimile on November 13, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had received a body piercing within twelve months of donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

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PRODUCT
Red Blood Cells, Recall # B-0894-07
CODE
Unit: D144018
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by letter on January 14, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0897-07
CODE
Unit: B323024
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by letter on September 14, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0898-07
CODE
Unit: D151836
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by letter on September 10, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0899-07;
b) Platelets Pooled Irradiated, Recall # B-0900-07
CODE
a) Unit: F159006;
b) Unit: UP15271 (from donation unit # F159006)
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by letter on August 31, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA

___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0901-07
CODE
Unit: F208076
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by letter on March 26, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

___________________________________
PRODUCT
Red Blood Cells, Recall # B-0902-07
CODE
Units: X119492 and X118424
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by letter dated September 17, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had taken the medication Avodart, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA

___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0903-07;
b) Platelets,Pooled, Recall # B-0904-07
CODE
a) Units: B322679, U122123 and B315155;
b) Unit: HP12205 (from donation unit # U122123)
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by letters on September 21, 2004 and October 1, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
WA

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0907-07
CODE
Unit: LC32792
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on September 11, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0908-07
CODE
Unit: FW64296
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on November 6, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI

___________________________________
PRODUCT
Red Blood Cells, Recall # B-0909-07
CODE
Unit: LC35371
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on June 9, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0910-07
CODE
Unit: LP58170
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on July 23, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0817-07
CODE
Unit: J24057
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated December 29, 2005. Firm initiated recall is complete.
REASON
Blood product, for which documentation of the apheresis procedure was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA

___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0830-07
CODE
Unit: S71021
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Center, Springfield, IL, by facsimile and letter dated December 5, 2006. Firm initiated recall is complete.
REASON
Platelets, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

___________________________________
PRODUCT
Source Plasma, Recall # B-0842-07
CODE
Unit: 363004226
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Fort Worth, TX, by facsimile dated June 22, 2006. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

___________________________________
PRODUCT
Source Plasma, Recall # B-0863-07
CODE
Unit: 06HINA6532
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Hammond, IN., by facsimile on October 18, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have complete medical history interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

___________________________________
PRODUCT
a) FRAZIER Surgical Suction Instrument, 3 Fr. with Control Vent and Obturator, REF 0031030.
Assembled in Mexico, Recall # Z-0584-2007;
b) FRAZIER Surgical Suction Instrument, 5 Fr. with Control Vent and Obturator, REF 0031050.
Assembled in Mexico, Recall # Z-0585-2007;
c) FRAZIER Surgical Suction Instrument, 7 Fr. with Control Vent and Obturator, REF 0031070.
Assembled in Mexico, Recall # Z-0586-2007;
d) FRAZIER Atraumatic Soft Tip Surgical Suction Instrument with Control Vent and Obturator,
10 French, REF 0031100. Assembled in Mexico, Recall # Z-0587-2007;
e) FRAZIER Surgical Suction Instrument, 8 Fr. with Control Vent and Obturator, REF 0033080.
Assembled in Mexico, Recall # Z-0588-2007;
f) FRAZIER Surgical Suction Instrument, 10 Fr. with Control Vent and Obturator, REF 0033100.
Assembled in Mexico, Recall # Z-0589-2007;
g) FRAZIER Surgical Suction Instrument, 12 Fr. with Control Vent and Obturator, REF 0033120.
Assembled in Mexico, Recall # Z-0590-2007;
h) FRAZIER Surgical Suction Instrument, 18 Fr. with Obturator, REF 0033180. Assembled in Mexico,
Recall # Z-0591-2007;
i) FRAZIER Olive Tip Suction Instrument, 10 Fr. with Control Vent and Obturator
(Bend with Obturator in Place), REF 0033110. Assembled in Mexico, Recall # Z-0592-2007;
j) POOLE Suction Instrument, REF 0035040. Assembled in Mexico, Recall # Z-0593-2007
CODE
All lots manufactured between 10/04/2001 and 10/04/2006. Lot codes on boxes and packaging contain a 7 digit lot code: For example, lot 0409271: the first 2 digits represent the year manufactured (04 represents 2004), next 2 digits represent the month (09 represents September), the next 2 digits represent the day of the month (27), and the last digit represents the manufacturing shift code (1).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Conmed Corporation, Utica, NY, by letters dated November 10, 2006.
Manufacturer: SEISA, Sarabia Parque Industrial, Aeropuerto Jaurez, Mexico. Firm initiated recall is ongoing.
REASON
Firm was made aware of instances where the sterile barrier of the instruments had been compromised.
VOLUME OF PRODUCT IN COMMERCE
7,401,479 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and plasma. Product No. 61100KVC 10 test devices containing anti D-dimer monoclonal antibody and sheep anti-mouse antibody 1 x 2.6 mL buffer containing 0.9% sodium chloride and 0.05% sodium azide 10 plastic pipettes, Recall # Z-0594-2007
CODE
Kit lot number: PX018A Test device batch number: 682-024, Expiration date: 3/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Inverness Medical Professional Diagnostics, Princeton NJ, by letters on February 14, 2007
Manufacturer: Agen Biomedical, Ltd., Acacia Ridge, Australia. Firm initiated recall is ongoing.
REASON
Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off.
VOLUME OF PRODUCT IN COMMERCE
377 devices
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
a) Wallstent Endoscopic Biliary Endoprosthesis- 8mm x 40mm, UPN H965430100,
Recall # Z-0604-2007;
b) Wallstent Endoscopic Biliary Endoprosthesis 8mm x 60mm, UPN H965430200,
Recall # Z-0605-2007;
c) Wallstent Endoscopic Biliary Endoprosthesis 8mm x 80mm, UPN H965430300,
Recall # Z-0606-2007;
d) Wallstent Endoscopic Biliary Endoprosthesis 10mm x 40mm, UPN H965430400,
Recall # Z-0607-2007;
e) Wallstent Endoscopic Biliary Endoprosthesis 10mm x 60mm, UPN H965430500;
Recall # Z-0608-2007;
f) Wallstent Endoscopic Biliary Endoprosthesis 10mm x 80mm, UPN H965430600,
Recall # Z-0609-2007
CODE
a) Lot Numbers: 8243354, 8243355, 8243356, 8521620, 8913445;
b) Lot Numbers: 7991049, 8056668, 8263142, 8502337, 8502338, 8521621, 8628863,
8770896, 8829555, 8909937;
c) Lot Numbers: 7892444, 7909244, 7909250, 8326863, 8502339, 8541943, 8652467,
8771022, 8831247, 8956367, 8956369;
d) Lot Numbers: 7928218, 7940824, 7959297, 7979465, 8016999, 8017000, 8041037,
8052775, 8093630, 8113554, 8113555, 8155386, 8155387, 8222854, 8247383,
8247384, 8247385, 8251326, 8251327, 8263403, 8263404, 8268291, 8364159,
8389892, 8423296, 8431392, 8442255, 8449736, 8490449, 8490450, 8502340,
8502341, 8502343, 8502344, 8502345, 8502346, 8503289, 8530084, 8530085,
8547344, 8603144, 8620590, 8624525, 8688101, 8688102, 8724565, 8727811,
8736211, 8797653, 8797654, 8829556, 8829557, 8831248, 8871693, 8871694,
8876235, 8876236, 8909940, 8909941, 8948216, 8948216, 8952271, 8952271,
8952432, 9131974, 9131975, 9131976, 9131977, 9131978, 9131979, 9131980;
e) Lot Numbers: 7889255, 7892445, 7905372, 7905374, 7920200, 7920201, 7920402,
7924984, 7928220, 7928221, 7940540, 7940541, 7944156, 7944157, 7948736, 7959298,
7967031, 7967032, 7974510, 7974511, 7979467, 7987625, 7987626, 7987628, 7991050,
7996574, 7996575, 8002683, 8014023, 8014024, 8037243, 8037244, 8037245, 8037246,
8041303, 8041304, 8052776, 8056276, 8056277, 8071724, 8071725, 8075136, 8075137,
8090847, 8090848, 8090849, 8093631, 8097643, 80097646, 8111219, 8117677, 8129796,
8129797, 8135040, 8150710, 8150711, 8166095, 8166096, 8170748, 8170749, 8187006,
8187007, 8191491, 8191492, 8195575, 8206782, 8211777, 8221857, 8221858, 8226825,
8226826, 8251328, 8268292, 8284683, 8286814, 8286815, 8286816, 8290951, 8290953,
8303330, 8303331, 8306943, 8322847, 8322848, 8326864, 8338442, 8346569, 8346570,
8359761, 8359762, 8359863, 8364161, 8364162, 8381248, 8381249, 8381250, 8401049,
8401050, 8410838, 8410839, 8410840, 8423298, 8423299, 8431393, 8442256, 8442257,
8446291, 8446292, 8449737, 8463164, 8463246, 8470264, 8470590, 8470592, 8482831,
8482832, 8490451, 8502347, 8502348, 8502609, 8502727, 8502728, 8502869, 8502973,
8502974, 8502975, 8502976, 8502977, 8502978, 8502979, 8502980, 8502981, 8502982,
8503290, 8503291, 8503292, 8503293, 8503294, 8503295, 8503296, 8503297, 8507018,
8507019, 8511086, 8511087, 8521622, 8526130, 8541944, 8541945, 8551221, 8563750,
8563751, 8563752, 8567702, 8567703, 8588514, 8588516, 8591865, 8591866, 8603141,
8603142, 8620591, 8620592, 8624527, 8624528, 8645198, 8645199, 8645203, 8652468,
8652469, 8655870, 8662303, 8662304, 8662305, 8666752, 8666753, 8666754, 8671097,
8683742, 8683743, 8692107, 8692108, 8705449, 8705846, 8714060, 8714427, 8714428,
8732163, 8732165, 8736497, 8748514, 8748520, 8748521, 8752576, 8752577, 8771059,
8775285, 8789042, 8789044, 8793117, 8793118, 8819197, 8819198, 8831249, 8833912,
8833913, 8834149, 8867179, 8867180, 8871566, 8889077, 8889079, 8889080, 8893395,
8893396, 8898056, 8898057, 8913684, 8913687, 8917868, 8917869, 8931675, 8931676,
8931677, 8947925, 8968803, 8968804, 8968805, 8972725, 8972726, 9132193, 9132194,
9132195, 9132196, 9132197, 9132198, 9132199, 9132200, 9132201, 9132206, 9132207,
9132208, 9132209, 9132210, 9132211, 9132292, 9132293, 9132294, 9132295;
f) Lot Numbers: 7889257, 7892749, 7924670, 7924672, 7944542, 7948443, 7948444, 7959299,
7959300, 7975078, 7975079, 7979468, 7979469, 7991051, 7991054, 7998758, 7998759,
7998760, 8002684, 8002685, 8014025, 8041040, 8041041, 8041222, 8052772, 8052774,
8060259, 8071855, 8071856, 8075138, 8080170, 8093632, 8109650, 8109651, 8114689,
8117678, 8131078, 8151476, 8155398, 8166781, 8170747, 8174687, 8174689, 8187008,
8191493, 8206779, 8206780, 8211778, 8211779, 8214766, 8226828, 8230827, 8230830,
8231159, 8268293, 8272150, 8272151, 8284684, 8284685, 8290955, 8306944, 8319230,
8319231, 8339003, 8339005, 8343275, 8343279, 8347008, 8367859, 8367860, 8367861,
8385775, 8385776, 8385777, 8389894, 8389895, 8401051, 8406650, 8406651, 8406652,
8427648, 8427649, 8431394, 8449739, 84623248, 8466568, 8466569, 8466570, 8474529,
8474530, 8474531, 8482833, 8486629, 8486630, 8486631, 8503298, 8503299, 8503300,
8505352, 8505353, 8505354, 8505355, 8505356, 8505357, 8505358, 8505359, 8505360,
8505361, 8505362, 8505363, 8505364, 8507020, 8511088, 8526132, 8526135, 8547345,
8547346, 8551223, 8551224, 8567704, 8571917, 8571918, 8571919, 8583897, 8583898,
8583899, 8591867, 8611580, 8611581, 8614222, 8648847, 8648849, 8648850, 8655868,
8655869, 8683744, 8688103, 8692109, 8706158, 8709576, 8709923, 8709975, 8724559,
8724560, 8727932, 8727933, 8752575, 8766341, 8766342, 8775286, 8775287, 8810553,
8810554, 8810570, 8814730, 8815105, 8844670, 8844671, 8844872, 8849235, 8849236,
8849237, 8853318, 8853319, 8867181, 8893397, 8898058, 8902082, 8902083, 8913833,
8935976, 8935977, 8935978, 8948215, 8976949, 9132297, 9132373, 9132374, 9132375,
9132376, 9132377, 9132378, 9132379, 9132380, 9132381, 9132382, 9132383, 9132384,
9132385, 9132386, 9132387, 9132388, 9132389
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Natick, MA, by letter on December 20, 2006.
Manufacturer: Boston Scientific Ireland, Ltd., Galway, Ireland. Firm initiated recall is ongoing.
REASON
Guidewire restriction during use (excessive adhesive in the guidewire lumen).
VOLUME OF PRODUCT IN COMMERCE
8,511 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
a) Guidant Acrobat Vacuum Stabilizer, Model Number OM-9000, Recall # Z-0611-2007;
b) Guidant Acrobat Vacuum Stabilizer, Model number-OM-9100, Recall # Z-0612-2007
CODE
a) All products with expiry dates of June 2008, lot codes ranging from 4120181 to 6100281.
See below. 5042281 5071983 5041981 5090881 5102481 5120581 6020881 6050281
6061581 6080581 6091281 4120181 5042581 5072181 5051881 5091281 5102482
5120681 6021081 6050381 6061981 6080781 6091381 4120381 5042981 5072281
5051981 5091381 5102581 5120781 6021381 6050681 6062081 6080881 6091382
4120681 5050281 5072681 5052181 5091481 5102681 5120881 6021581 6050881
6062181 6080882 6091481 4120781 5050381 5072781 5053181 5091981 5102682
5120981 6021681 6051081 6062281 6080981 6092081 4120881 5050481 5072782
5060281 5091982 5102781 5121481 6022281 6051181 6062381 6080982 6092181
4121081 5051081 5080381 5060381 5092081 5102881 5121981 6022781 6051281
6062382 6081081 6092681 4121381 5051181 5080382 5060681 5092082 5102882
5121982 6022782 6051381 6062681 6081082 6092781 4121481 5051281 5080481
5060781 5092181 5103181 5122081 6022881 6051681 6062781 6081281 6092881
4121881 5051381 5080482 5062181 5092182 5110781 6010381 6030181 6051682
6062881 6081481 6092981 4122081 5051681 5080581 5062281 5100181 5110881
6010382 6030381 6051981 6062981 6081482 6100281 4122181 5051781 5080881
5062282 5100381 5110981 6010481 6030881 6052282 6070681 6081581 4122881
5020781 5080882 5062381 5100481 5111081 6010981 6030981 6052381 6070781
6081781 4122981 5020981 5080981 5062382 5100681 5111082 6011181 6031081
6052382 6070782 6082181 4123081 5021081 5081081 5062881 5100682 5111181
6011281 6031381 6052581 6071081 6082281 4123082 5021681 5081181 5071881
5101081 5111182 6011381 6031481 6052681 6071082 6082282 5010481 5021781
5082281 5071981 5101082 5111281 6011382 6032481 6053081 6071181 6082381
5010581 5022181 5082282 5071982 5101181 5111481 6011781 6032482 6053082
6071281 6082481 5010682 5022481 5032881 5082381 5101182 5111581 6011881
6032781 6053181 6071381 6082581 5011081 5022581 5033081 5082481 5101281
5111582 6012381 6032981 6060281 6071382 6082681 5011181 5022881 5033181
5082482 5101282 5111681 6012382 6040681 6060282 6071781 6082881 5011381
5030181 5040481 5082681 5101381 5111781 6012481 6041081 6060381 6071881
6082882 5011481 5030281 5040581 5082981 5101382 5112181 6012581 6041181
6060581 6071981 6082981 5011881 5030481 5040881 5083081 5101481 5112281
6012681 6041281 6060681 6072082 6083081 5011981 5030781 5041181 5090181
5101581 5112282 6012781 6041381 6060682 6072281 6090582 5012181 5031481
5041281 5090281 5101781 5112881 6013081 6041781 6060781 6072481 6090681
5012781 5031581 5041381 5090681 5101782 5112981 6020281 6041881 6060881
6072482 6090781 5020181 5031782 5041481 5090682 5101783 5112982 6020681
6042082 6060981 6072681 6090881 5020281 5031881 5041581 5090683 5101881
5113081 6020781 6042481 6061281 6072781 6091181;
b) All products with expiry dates of June 2008, lot codes ranging from 4120281 to 6102381.
See Below: 4120281 5020781 5051381 5062181 5091481 5110182 6013181 6040581
6062481 6091881 6101881 4120681 5021481 5052381 5072881 5092781 5110381
6020681 6050181 6070581 6091981 6101882 4121581 5031681 5052382 5081081
5092782 5110481 6020682 6050681 6081781 6092581 6102381 5010681 5032181
5061581 5081681 5101881 5120181 6022181 6051881 6081782 6092582 5011881
5040681 5061681 5081781 5101981 5120281 6030681 6052081 6081881 6101181
5012881 5041881 5061781 5081782 5101982 6010481 6030781 6060981 6083081
6101681 5020381 5050281 5062081 5081881 5110181 6011981 6040481 6061981
6083181 6101682
RECALLING FIRM/MANUFACTURER
Guidant Cardiac Surgery, Santa Clara, CA, by teleconference on December 1, 2006 and by letters on December 4, 2006. Firm initiated recall is ongoing.
REASON
Vacuum Tubing Failure. Vacuum tubing fails before the labeled two year shelf life. This may result in partial or complete vacuum loss during surgery.
VOLUME OF PRODUCT IN COMMERCE
57,691 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
a) Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number:
TRU5-32, Recall # Z-0613-2007;
b) Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm-Reference Number:
006689-901, Recall # Z-0614-2007;
c) Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm w/rotation-Reference Number:
006689-903, Recall Z-0615-2007
CODE
a) Lot Numbers: 6236019, 6236020, 6236021, 6258015, 6297001, 6300013, 6306015,
6320041, 6326021, 6326097, 6335042, 6342008, 6349001, 6349002, 6355029, 7011002,
7011003, 7019012;
b) Lot Numbers: 6258014, 6303028, 6306017, 6312602, 6314021, 6320034, 6326096,
6335040, 6342010, 6362025, 7004015, 7009015;
c) Lot Numbers: 6236022, 6236023, 6236024
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gyrus ACMI Corp., by letters on February 19, 2007.
Manufacturer: Gyrus Medical, Inc., Maple Grove, MN. Firm initiated recall is ongoing.
REASON
Product sterility may be compromised due to failure of the tray seal packaging.
VOLUME OF PRODUCT IN COMMERCE
922 boxes (5 units to a box)
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
The iSight PACS (picture archiving and communications system) a software package used with general purpose computer hardware to acquire, store, distribute, process, and display images/associated data throughout a clinical environment, Recall # Z-0616-2007
CODE
Version 3.5
RECALLING FIRM/MANUFACTURER
Stentor Inc., A Phillips Medical Systems Co., Foster City, CA, by letter on February 14, 2007. Firm initiated recall is ongoing.
REASON
A defect may cause patient image orientation markers to be incorrectly labeled on Multi-Planar Reformation (MPR) images. Left and Right Anatomical orientation markers may be reversed.
VOLUME OF PRODUCT IN COMMERCE
54 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268, Recall # Z-0617-2007
CODE
Serial numbers 0001 through 2696
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems, Corp., Ann Arbor, MI, by letter dated December 12, 2006. Firm initiated recall is ongoing.
REASON
Internal friction may cause the centrifugal manual drive to be inoperable when a disposable pump is attached.
VOLUME OF PRODUCT IN COMMERCE
2,696 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
a) Baxter Clearlink System Vented Paclitaxel Set; a sterile fluid pathway with
polyethylene lined tubing, non-DEHP 12 inch pump segment, 0.22 micron
downstream high pressure filter, Luer activated valve, male Luer lock adapter;
for use with rigid nonvented solution containers on Colleague and Flo-Gard 6201
and 6301 series pumps; Baxter Healthcare, Deerfield, IL 60015; product code 2C8857,
Recall # Z-0618-2007;
b) Baxter Interlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene
lined tubing, non-DEHP pump segment, 0.22 micron downstream high pressure filter,
injection site, male Luer lock adapter; for use with rigid nonvented solution containers on
Colleague and Flo-Gard 6201 and 6301 series pumps; product code 2C7557,
Recall # Z-0619-2007;
c) Baxter Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing,
non-DEHP pump segment, 0.22 micron downstream high pressure filter, injection site,
male Luer lock adapter; for use with rigid nonvented solution containers on Colleague
and Flo-Gard 6201 and 6301 series pumps; product code 2C7553, Recall # Z-0620-2007
CODE
a) Lots R06F05158, R06F22013, R06F22112;
b) Lots R06I12067, R06J07025, R06J19079, R06J20044;
c) Lots R06E13105, R06E17114, R06E25042, R06F15058, R06G11030,
R06I13107, R06K03071
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letter on February 16, 2007.
Manufacturer: Baxter Productos Medicos Ltda., Cartago, Costa Rica. Firm initiated recall is ongoing.
REASON
Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets.
VOLUME OF PRODUCT IN COMMERCE
215,886 sets
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box, Recall # Z-0621-2007
CODE
Lot 506069, Exp. 2007/30/20
RECALLING FIRM/MANUFACTURER
Remel, Inc., Lenexa, KS., by letters dated February 19, 2007. Firm initiated recall is ongoing.
REASON
Some of the units exhibited false negative results for sorbitol fermenting bacteria such as E. Coli 0157.
VOLUME OF PRODUCT IN COMMERCE
694/10-pack boxes
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
a) StayFix Fixation Device for Percutaneous catheters, REF 680ME, (small) 5F - 14F,
Recall # Z-0627-2007;
b) StayFix Fixation Device for Percutaneous catheters, REF 685ME, (large) 12F - 22F,
Recall # Z-0628-2007;
c) EpiFix Fixation Device for Epidural Catheters, REF 670M, Recall # Z-0629-2007
CODE
a) Lot numbers: 551268, 551537, 551615, 551616, 551702, 551703, 551704, 553104,
553360, 553361, 553362, 553363, 554362, 554367, 554368, 554483, 554497, 554504,
554505, 554506, 554723, 554764, 554765, 554766, 555638, 555639, 555655, 555656,
555657, 555658, 556406, 556407, 556408, 556409, 556410, 556411, 556842, 556843,
556844, 556845, 556846, 556847, 556871, 556872, 556873, 556874, 556875, 562518,
562748, 562874, 563254, 563255, 563388, 563389, 566538, 566899, 566900, 566901,
566902, 566903, 566904, 567248, 567515, 567596, 567599, 567600, 567601, 567767, 567835;
b) Lot Numbers: 547745, 551172, 554699, 555705, 555706, 556394, 556395, 556396,
556876, 556877, 558988, 560767, 560768, 560781, 561127, 561144, 562749, 562750,
563256, 563257, 563387, 564684, 564685, 565284, 565285, 565353, 565955, 566684,
566905, 566906, 566907, 567383, 567513, 567728, 569474;
c) Lot Numbers: 546350, 551766, 551767, 554738, 558995, 560148, 560149, 564569, 567538.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Merit Medical Systems, Inc., South Jordan, UT, by letter on February 23, 2007.
Manufacturer: Unomedical, Ltd., Stonehouse, Glos, UK. Firm initiated recall is ongoing.
REASON
Sterility of some units may be compromised due to damaged packaging.
VOLUME OF PRODUCT IN COMMERCE
250,808 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
a) Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV
Valve and 8F Polyurethane Catheter, REF/Catalog No. 45-215,
UPN/Material No. M001452150, Recall # Z-0630-2007;
b) Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV
Valve and 8F Silicone Catheter, REF/Catalog No. 45-220, UPN/Material
No. M001452200, Recall # Z-0631-2007
CODE
a) Lots 1137363, 1137364, 1137733, and 1137734;
b) Lot 1137368
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Glens Falls, NY, letters dated September 27, 2006.
Manufacturer: Boston Scientific Corp., Glens Falls NY. Firm initiated recall is complete.
REASON
Sterile barrier may have been compromised. Firm received one complaint which demonstrated that the inner and outer seals of the port tray packaging had been compromised.
VOLUME OF PRODUCT IN COMMERCE
236 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
COOK Triple Lumen Central Venous Catheter Tray with Cook Spectrum® Glide® Antimicrobial Catheter with EZ--Pass® Hydrophilic Coating: Reorder Number C-UTLMY-701J-RSC-ABRM-HC-FST-A, Recall # Z-0637-2007
CODE
Lots 1794998 and 1793611
RECALLING FIRM/MANUFACTURER
Cook, Inc., Bloomington, IN, by telephone on January 2, 2007. Firm initiated recall is ongoing.
REASON
These catheters do not include the proximal sidehole as required by the specification.
VOLUME OF PRODUCT IN COMMERCE
100 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Recall # Z-0639-2007
CODE
Lot Numbers: 1445412, 1445512, 1445612, 1445712, 1561112
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, by letters on May 12, 2004. Firm initiated recall is complete.
REASON
Incorrect Test Results. Test results may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range).
VOLUME OF PRODUCT IN COMMERCE
6,893 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

___________________________________
PRODUCT
Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reagents, in vitro diagnostic; list 05J83-001; The probe set consists of a 200 microliter vial of Vysis LSI D13S319 SO/LSI 13q34 SA/CEP 12 SG Probe, reference 30-191024, and a 200 microliter vial of Vysis LSI ATM SG/p 53 SO Probe, reference 30-191025, Recall # Z-0595-2007
CODE
Lot numbers 79500, exp. 8-9-08 and 80178, exp.10-16-08
RECALLING FIRM/MANUFACTURER
Abbott Molecular, Des Plaines, IL, by telephone and/or letters on December 22, 2006. Firm initiated recall is ongoing.
REASON
The LSI D13S319 SO/13q34 SA/CEP 12 SG probe of the two mixture DNA-Probe was contaminated with LSI ATM SG/p53 SO probe. This contamination would result in 10 FISH signals in each normal cell rather than the expected 6 FISH signals in each normal cell.
VOLUME OF PRODUCT IN COMMERCE
109 Probe sets
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
19 Gauge Trocar Cannula Replacement Plug, Catalog Number 617.32, Recall Z-0610-2007
CODE
Lot F58507
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alcon Research, Ltd, Fort Worth, TX, by visit and by letter on January 22, 2007.
Manufacturer: Alcon Grieshaber AG, Schaffhausen, Switzerland. Firm initiated recall is complete.
REASON
Product is misbranded; 19 gauge Schlera Plugs distributed in containers labeled as 19 gauge Trochar Cannula Plugs.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS I

___________________________________
PRODUCT
a) Wild Kitty Cat Food -Raw All Natural Chicken with Clam Recipe,
Plastic 3.5 oz (100g) and 16 oz (1 lb) units packaged in plastic,
V-016-2007;
b) Wild Kitty Cat Food -Raw All Natural Duck with Clam Recipe,
Plastic 3.5 oz (100g) and 16 oz (1 lb) units packaged in plastic,
Recall # V-017-2007;
c) Wild Kitty Cat Food -Raw All Natural Tuna with Conch Recipe,
Plastic 3.5 oz (100g) packaged in plastic, Recall # V-018-2007
CODE
Product is not coded.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wild Kitty Cat Food, Inc., Arundel, ME., by letter on February 17, 2007, and by press release on February 16, 2007.
Manufacturer: Nodine, Torrington, CT. Firm initiated recall is ongoing.
REASON
Cat Food contaminated with Salmonella
VOLUME OF PRODUCT IN COMMERCE
29,258/3.5 oz. and 3,642/ lb units
DISTRIBUTION
CT, FL, IL, MA, MD, ME, MI, NM, NJ, NY, WA

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II

___________________________________
PRODUCT
Bulk cattle feed made with recalled Darling’s 85% Blood Meal, Flash Dried, Recall # V-024-2007
CODE
Cattle feed delivered between 01/12/2007 and 01/26/2007
RECALLING FIRM/MANUFACTURER
Pfeiffer, Arno, Inc, Greenbush, WI. by conversation on February 5, 2007. Firm initiated recall is ongoing.
REASON
Blood meal used to make cattle feed was recalled because it was cross-contaminated with prohibited bovine meat and bone meal that had been manufactured on common equipment and labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
42,090 lbs.
DISTRIBUTION
WI

___________________________________
PRODUCT
Custom dairy premix products: MNM ALL PURPOSE Pellet, HILLSIDE/CDL Prot-Buffer Meal, LEE, M.-CLOSE UP PX Pellet, HIGH DESERT/ GHC LACT Meal, TATARKA, M CUST PROT Meal, SUNRIDGE/CDL PROTEIN Blend, LOURENZO, K PVM DAIRY Meal, DOUBLE B DAIRY/GHC LAC Mineral, WEST PIONT/GHC CLOSEUP Mineral, WEST POINT/GHC LACT Meal, JENKS, J/COMPASS PROTEIN Meal, COPPINI – 8# SPECIAL DAIRY Mix, GULICK, L-LACT Meal (Bulk), TRIPLE J – PROTEIN/LACTATION, ROCK CREEK/GHC MILK Mineral, BETTENCOURT/GHC S.SIDE MK-MN, BETTENCOURT #1/GHC MILK MINR, V&C DAIRY/GHC LACT Meal, VEENSTRA, F/GHC LACT Meal, SMUTNY, A-BYPASS ML W/SMARTA, Recall # V-025-2007
CODE
The firm does not utilize a code - only shipping documentation with commodity and weights identified.
RECALLING FIRM/MANUFACTURER
Rangen, Inc, Buhl, ID, by letters on February 13 and 14, 2007. Firm initiated recall is complete.
REASON
Products manufactured from bulk feed containing blood meal that was cross contaminated with prohibited meat and bone meal and the labeling did not bear cautionary BSE statement.
VOLUME OF PRODUCT IN COMMERCE
9,997,976 lbs.
DISTRIBUTION
ID and NV

END OF ENFORCEMENT REPORT FOR MARCH 21, 2007

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