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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.
November 26, 2008
08-47
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Kroger Value Semi Sweet Chocolate Chip, Net Wt. 12 oz. bags; UPC: 11110-86603, Recall # F-022-9
CODE
Best by date of May 30, 1010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Barry Callebaut USA, LLC, Chicago, IL, by letter on October 10, 2008.
Manufacturer: Barry Callebaut, LLC, Saint Albans, VT. Firm initiated recall is ongoing.
REASON
Product contains undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
709 cases
DISTRIBUTION
TN
___________________________________
PRODUCT
Nonna's Real Italiana Cuccine, Stuffed Artichoke, Net Wt. 15oz (425g), Recall # F-036-9
CODE
The product is not coded
RECALLING FIRM/MANUFACTURER
Nonna's Real Italiana Cuccine, Slidell, LA, by telephone and press release beginning on October 22, 2008. Firm initiated recall is complete.
REASON
The product contains undeclared soy flour. Additionally the product label lists ingredients derived from milk and wheat without listing milk and wheat as the source of these ingredients.
VOLUME OF PRODUCT IN COMMERCE
492 units
DISTRIBUTION
LA
___________________________________
PRODUCT
Harry & David Moose Munch Confection Milk Chocolate Gingerbread, 1 lb. 4 oz. box stating product name and ingredients, Recall # F-038-9
CODE
Best if used by date 06/28/09
RECALLING FIRM/MANUFACTURER
Harry and David Operations, Inc., Medford, OR, by e-mail on October 21, 2008 and by press release, e-mail and telephone on October 22, 2008. Firm initiated recall is complete.
REASON
Product contains undeclared pecans.
VOLUME OF PRODUCT IN COMMERCE
6,684 boxes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Jalapeno Peppers in bulk, 35-lb. plastic crates; Produce of Mexico, Recall # F-039-9;
b) Serrano Peppers in bulk, 35-lb. plastic crates; Produce of Mexico, Recall # F-040-9;
c) Avocados in bulk, labeled as "Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico", Recall # F-041-9
CODE
a) and b) All products shipped between May 17th and July 17th. No lot or other product codes;
c) Lot #HUE08160090889
RECALLING FIRM/MANUFACTURER
Recalling Firm: Grande Produce Ltd., Co., Hidalgo, TX, by press release and letter on July 19, 2008.
Manufacturer: Grande Produce, Jimenez, Mexico. Firm initiated recall is ongoing.
REASON
Products are contaminated with Salmonella based on the sampling and analysis by the Texas Department of State Health Services and the North Carolina Department of Health and Human Services..
VOLUME OF PRODUCT IN COMMERCE
2,230 units
DISTRIBUTION
NY, TX and Mexico
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
Progresso, Vegetable Classics, Hearty Tomato Soup. Net Wt. 19 oz. Ready to serve. Vegetarian. Ingredients: Tomato Puree (Water, Tomato Paste), Water, Tomatoes, Sugar. Contains Less Than 2% of: Corn Syrup Solids, Salt, Wheat Flour Bleached, Modified Corn Starch, Olive Oil, Dried Parsley, Garlic Powder, Spice, Calcium Chloride, Citric Acid, Ascorbic Acid, Onion Powder, Extractives of Turmeric, Natural Flavor. Contains Wheat Ingredients; UPC: 041196910681, Recall # F-037-9
CODE
Code date printed on bottom of can 19May10 NV VN-3
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Mills, Inc, Minneapolis, MN, by press release and letter dated October 31, 2008.
Manufacturer: General Mills, Inc, Vineland, NJ. Firm initiated recall is ongoing.
REASON
Some cans labeled as Tomato soup contain another product, Vegetable and Noodle soup with egg, milk, and soy ingredients.
VOLUME OF PRODUCT IN COMMERCE
22,709 cases (12 cans per case)
DISTRIBUTION
CT, DE, FL, GA, MA, MD, ME, NC, NJ, NY, OH, PA, TN, VA, VT
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Alka-Seltzer Plus® Cold Formula, Sparkling Original, each tablet contains Aspirin 325 mg, Chlorpheniramine maleate 2mg, and Phenylephrine bitartrate 7.8mg packaged in convenience packs which contain 4 effervescent tablets (2/2-tablet pouches per convenience pack), Recall # D-051-2009
CODE
Lot numbers: BTA6PP4, BTA6PP8, BTA6KU6, BTA6KU7, and BTA6KU4. All lot numbers have an exp. date of 10/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lil' Drug Store Products Inc., Cedar Rapids, IA, by telephone and e-mail letters beginning on October 10, 2008, October 13, (letter dated 10/14/08), and October 15, 2008.
Manufacturer: Peacock Engineering Company, LLC, Carol Stream, IL. Firm initiated recall is ongoing.
REASON
Mispacked; outer carton labeled to contain product with aspirin, chlorpheniramine maleate and phenylephring bitartrate actually contains product with acetaminophen, chlorpheniramine maleate and phenylephrine bitartrate.
VOLUME OF PRODUCT IN COMMERCE
73,116/2-pouch retail packages
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Formulation R(TM) Hemorrhoidal Ointment, 1 and 2 oz tubes, Also packaged as: Publix Hemorrhoidal Ointment, 1 oz. tubes; ShopRite Hemorrhoidal Ointment, 1 oz tubes; Exchange Select Hemorrhoidal Ointment, 2 oz tube; Laura Lynn Hemorrhoidal Ointment, 2 oz. tube; Food Lion Hemorrhoidal Ointment, 2 oz tube, Recall # D-052-2009
CODE
Lot 029807011, exp. 3/2009
RECALLING FIRM/MANUFACTURER
G&W Laboratories, Inc., South Plainfield, NJ, by e-mail on August 20, 2008 and by letters on August 27, 2008. Firm initiated recall is ongoing.
REASON
Phenylephrine hydrochloride level may exceed specification due to inadequate validation of blend uniformity.
VOLUME OF PRODUCT IN COMMERCE
7,128 x 1 oz tubes; 17,880 x 2 oz tubes
DISTRIBUTION
FL, IL, MN, NC, NJ, OH, TX, and VA
___________________________________
PRODUCT
Promethazine Hydrochloride Injection, USP, 25 mg/mL; 10 mL multi-dose vials; For deep Intramuscular or Intravenous use; NDC 67457-152-10, Recall # D-053-2009
CODE
Lot numbers: 070215, 070217 and 080525
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bioniche Pharma Group, Lake Forest, IL, by letters and fax dated November 5, 2008.
Manufacturer: Bioniche, Teo, Galway, Ireland. Firm initiated recall is ongoing.
REASON
Out of specification levels of a known degradant impurity.
VOLUME OF PRODUCT IN COMMERCE
30,139 vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Infants' Mylicon Gas Relief, (Simethicone-Anti-gas) Dye Free Drops Non-Staining, 20 mg/0.3 mL,1 oz plastic bottles; NDC 16837-911-01, Product Code 0491111-00, Recall # D-054-2009
CODE
Lot #: SMF007, exp 9/10; SMF008 exp 9/10
RECALLING FIRM/MANUFACTURER
Johnson & Johnson Merck, Fort Washington, PA, by press release and letters dated November 10, 2008. Firm initiated recall is ongoing.
REASON
Product may contain metal shavings.
VOLUME OF PRODUCT IN COMMERCE
12,084 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Oxycodone and Acetaminophen Capsules, USP, CII, 5 mg/500 mg, Rx only, 100 count bottles; NDC # 52152-041-02, Recall # D-055-2009;
2) Chlorzoxazone Tablets, USP, 250 mg, Rx only, 100 count bottles, NDC # 52152-053-02, Recall # D-056-2009;
3) Ursodiol Capsules, USP, 300 mg, Rx only, NDC 52152-060-02 - 100 count bottles NDC 52152-060-03 - 250 count bottles, Recall # D-057-2009;
4) Naltrexone Hydrochloride Tablets, USP, 50 mg, Rx only, NDC 52152-105-30 - 30 count NDC 521520105-02 - 100 count bottles, Recall # D-058-2009;
5) Carisoprodol Tablets, USP, 350 mg, Rx only, NDC 52152-136-02 - 100 count NDC 52152-136-05 - 1000 count bottles, Recall # D-059-2009;
6) Meperidine Hydrochloride Tablets, USP, CII, 50 mg, Rx only, 100 count bottles, NDC 52152-158-02, Recall # D-060-2009;
7) Meperidine Hydrochloride Tablets, USP, CII, 100 mg, Rx only, 100 count bottles, NDC 52152-157-02, Recall # D-061-2009;
8) Betaxolol Tablets USP, 10 mg, Rx only, 100 count bottles; Also labeled as Kerlone (Be tazolol Hydrochloride) Sanofi-Synthelabo/Sanofi Aventis, NDC 52152-179-02 - Amide NDC 0024-2301-10 – Sanofi, Recall # D-062-2009;
9) Betaxolol Tablets USP, 20 mg, Rx only, 100 count bottles; Also labeled as Kerlone (Betaxolol Hydrochloride) Sanofi-Synthelabo/Sanofi Aventis NDC 52152-1180-02 - Amide NDC 0024-2300-20 – Sanofi, Recall # D-063-2009;
10) Trimethobenzamide Hydrochloride Capsules, USP, 300 mg, 100 count bottles, Rx only, NDC 52152-185-02, Recall # D-064-2009;
11) Loxapine Capsules, USP, 5 mg, Rx only, NDC 52152-191-02 - 100 count NDC 52152-191-05 - 1000 count, Recall # D-065-2009;
12) Loxapine Capsules, USP, 10 mg, Rx only, NDC 52152-192-02 - 100 count bottles NDC 52152-192-05 - 1000 count bottles, Recall # D-066-2009;
13) Loxapine Capsules, USP, 25 mg, Rx only, NDC 52152-193-02 - 100 count bottles NDC 52152-193-05 - 1000 Count bottles, Recall # D-067-2009;
14) Loxapine Capsules, USP, 50 mg, Rx only, NDC 52152-194-02 - 100 count bottles NDC 52152-194-05 - 1000 count bottles, Recall # D-068-2009;
15) Pentazocine HCL and Acetaminophen Tablets 25 mg (base) and 650 mg, CIV, Rx only, 100 count bottles, Also labeled as Talacen CIV pentazocine hydrochloride and acetaminophen. NDC 52152-213-02 - Actavis/Amide NDC 0024-1937-04 - Sanofi-Aventis, Recall # D-069-2009;
14) Oxycodone Hydrochloride Tablets, USP, CII, 15 mg, NDC 52152-214-02 -100 count bottle NDC 52152-214-11 - 10 x 10 blister packs, Recall # D-070-2009;
15) Oxycodone Hydrochloride Tablets, USP, 30 mg, CII, Rx only, NDC 52152-215-02 - 100 count bottles NDC 52152-215-11 - 10 x 10 blister pack, Recall # D-071-2009;
16) Rifampin Capsules, USP, 300 mg, Rx only, 30 count bottles, NDC 52152-217-30, Recall # D-072-2009;
17) Buspirone Hydrochloride Tablets, USP, 5 mg, Rx only, 100 and 500 count bottles, NDC 52152-222-02 - Actavis/Amide 100 count NDC 52152-222-04 - Actavos/Amide 500 count NDC 0904-5587-60 - Major 100 count NDC 0904-5587-60 - 500 count, Recall # D-073-2009;
18) Buspirone Hydrochloride Tablets, USP, 10 mg, Rx only, 100 and 500 count bottles, NDC 52152-223-02 - Actavis/Amide 100 count NDC 52152-223-04 - Actavis/Amide 500 count NDC 0904-5588-60 - Major - 100 count, Recall # D-074-2009;
19) Buspirone Hydrochloride Tablets, USP, 15 mg, Rx only, 100, 180 and 250 count bottles, Also labeled for Major Pharmaceuticals, 100 and 180 count bottles. NDC 52152-224-02 - Actavis/Amide 100 count NDC 52152-224-22 - Actavis/Amide 180 count NDC 52152-224-03 - Actavis/Amide 250 count NDC 0904-5589-60 - Major - 100 count NDC 0904-5589-93 - Major - 180 count, Recall # D-075-2009;
20) BusPIRone Hydrochloride Tablets, USP, 30 mg, Rx only, 60 and 180 Tablets, NDC 52152-280-01- 60 count; NDC 52152-280-22 - 180 count, Recall # D-076-2009;
21) Tizanidine Hydrochloride Tablets, 2 mg, Rx only, 150 and 500 count bottles, NDC 52152-236-21 - 150 count NDC 52152-236-04, Recall # D-077-2009;
22) Tizanidine Hydrochloride Tablets, 4 mg, Rx only, NDC 52152-234-21 - 150 count, NDC 52152-234-04 - 500 count, Recall # D-078-2009;
23) Mirtazapine Tablets, 15 mg, Rx only, NDC 52152-226-30 - 30 count bottles, NDC 52152-226-04 - 500 count bottles, Recall # D-079-2009;
24) Mirtazapine Tablets, 30 mg, Rx only, 30 and 500 count bottles, NDC 52152-227-30 Amide/Actavis 30 count NDC52152-227-30 Actavis - 500 count NDC 02274361 - Cobalt Recall # D-080-2009;
25) Mirtazapine Tablets, 45 mg, Rx only, 30 and 500 count bottles, NDC 52152-228-30 - 30 count NDC 52152-228-04 - 500 count, Recall # D-081-2009;
26) Quinaretic (Quinapril Hydrochloride and Hydrochlorothiazide) Tablets, 10 mg/12.5 mg, Rx only, 30 and 90 count bottles, NDC 52152-238-30 - 30 count NDC 52152-238-08 - 90 count, Recall # D-082-2009;
27) Quinaretic (Quinapril Hydrochloride and Hydrochlorothiazide Tablets) 20mg/12.5mg, Rx only, 30 and 90 count bottles, NDC 52152-239-30 - 30 count bottles NDC 52152-239-08 - 90 count bottles, Recall # D-083-2009;
28) Quinaretic (Quinapril Hydrochloride and Hydrochlorothiazide Tablets) 20mg/25 mg, Rx only, 30 and 90 count bottles, NDC 52152-240-30 - 30 count NDC 52152-240-08 - 90 count, Recall # D-084-2009;
29) Quinapril Tablets, USP, 5 mg, Rx only, 90 count bottles, NDC 49884-992-09, Recall # D-085-2009;
30) Quinapril Tablets, USP, 10 mg, Rx only, 90 count bottles, NDC 49884-993-09, Recall # D-086-2009;
31) Cilostazol Tablets, 100 mg, 60 tablets, Rx only, NDC 52152-250-01, Recall # D-087-2009;
32) Hydromorphone HCL CII Tablets, USP, 8 mg, Rx only, 100 Tablets, NDC 52152-260-02, Recall # D-088-2009;
33) Isradipine Capsules, USP, 2.5 mg, Rx only, 60 Capsules, NDC 52152-263-01, Recall # D-089-2009;
34) Isradipine Capsules, USP, 5 mg, Rx only, NDC 52152-264-01, Recall # D-090-2009;
35) Dipyridamole Tablets, USP, 25 mg, Rx only, Film coated tablets, 100 and 1000 count bottles, NDC 52152-265-02 - 100 count NDC 52152-265-05 - 1000 count, Recall # D-091-2009;
36) Dipyridamole Tablets USP, 50 mg, Rx only, Film coated tablets, 100 and 1000 count bottles, NDC 52152-266-02 100 count NDC 52152-266-05 1000 count, Recall # D-092-2009;
37) Dipyridamole Tablets, USP, 75 mg, Rx only, Film coated tablets, 100 and 1000 count bottles, NDC 52152-267-02 100 count NDC 52152-267-05 1000 count bottles, Recall # D-093-2009;
38) Meloxicam Tablets, 7.5 mg, Rx only, 100 and 500 count bottles, NDC 52152-285-02 100 count NDC 52152-285-04 500 count, Recall # D-094-2009;
39) Meloxicam Tablets, 15 mg, Rx only, 100 and 500 count bottles NDC 52152-286-02 100 count NDC 52152-186-04 500 count, Recall # D-095-2009;
40) Trimipramine Maleate Capsules, 25 mg, Rx only, 30 and 90 count bottles, NDC 52152-293-30 - 30 count, NDC 52152-293-08 - 90 count, Recall # D-096-2009;
41) Trimipramine Maleate Capsules, 50 mg, Rx only, 30 and 90 count bottles, NDC 52152-294-30 - 30 count NDC 52152-294-08 - 90 count, Recall # D-097-2009;
42) Trimipramine Maleate Capsules, 100 mg, Rx only, 30 count bottles, NDC 52152-295-30, Recall # D-098-2009;
43) Cyclobenzaprine HCL Tablets, USP, 5 mg, Rx only, Flm coated tablets, 100 count bottles, NDC 52152-301-02; NDC 50111-820-01, Recall # D-099-2009;
44) Cyclobenzaprine HCL Tablets, 10 mg, Rx only , Film coated tablets, 100 and 1000 count bottles, NDC 52152-302-02 - 100 count NDC 52152-302-05 - 1000 count, Recall # D-100-2009;
45) Hydroxyzine HCL Tablets, USP, 10 mg, Rx only; 100 and 1000 count bottles, NDC 52152-311-02 100 count NDC 52152-311-05 1000 count, Recall # D-101-2009;
46) Hydroxyzine HCl Tablets, USP, 25 mg, Rx only, 100 and 1000 count bottles, NDC 52152-312-02 100 count NDC 52152-312-05 1000 count, Recall # D-102-2009;
47) Hydroxyzine HCL Tablets, USP, 50 mg, Rx only, 100 and 1000 count bottles, NDS 52152-313-02 100 count NDC 52152-313-05 1000 count, Recall # D-103-2009;
48) Phendimetrazine Tartrate Tablets, USP, 35 mg, CIII, 1000 tablets;
NDC 52152-327-05, Recall # D-104-2009
CODE
1) All lots within expiry;
2) Lot: 70006A, Exp. Jan 09;
3) thru 48) All lots within expiry;
RECALLING FIRM/MANUFACTURER
Actavis Totowa LLC, Totowa, NJ, by letters on July 18, 2008. Firm initiated recall is ongoing.
REASON
cGMP Deviations
VOLUME OF PRODUCT IN COMMERCE
Too numerous to count
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Source Plasma, Recall # B-0259-09
CODE
Units: 379071389, 379066273, 379065960, 379065356, 379065039, 379063383, 379063053, 379062966, 379062661, 379062030, 379061711, 379061183, 379060773, 379059391, 379059091, 379041993, 379038404, 379038351, I59019792, I59019123, I59018851, I59018439, I59015559, I59015309, I59014124, I59013914, I59012464, I59011959, I59011719, I59010930, I59000701
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Lafayette, LA, by fax on February 25, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had been previously deferred for testing reactive for Hepatitis C (HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
NC
___________________________________
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0263-09;
b) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated, Recall # B-0264-09
CODE
a) Units: 4663316 (Parts 1 & 2), 4664042 (Parts 1 & 2), 4664074 (Parts 1 & 2), 4663143 (Parts 1 & 2), 4663162 (Parts 1 & 2), 4663335 (Parts 1 & 2), 4663295 (Parts 1 & 2), 4664236 (Parts 1 & 2), 4664230 (Parts 1 & 2), 4664223 (Parts 1 & 2), 4664053 (Parts 1 & 2), 4664066 (Parts 1 & 2), 4663036 (Parts 1 & 2);
b) Units: 4663294 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Northwest Florida Blood Center I, Pensacola, FL, by letter dated March 2, 2005. Firm initiated recall is complete.
REASON
Blood products, collected using equipment that was not validated for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
28 units
DISTRIBUTION
FL
___________________________________
PRODUCT
a) Recovered Plasma, Recall # B-0265-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0266-09;
c) Platelets, Recall # B-0267-09
CODE
a), b) and c) Units: 4294005
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on March 21, 2008, by e-mail on April 2, 2008, and by letter dated April 2, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX, Switzerland
___________________________________
PRODUCT
Source Plasma, Recall # B-0270-09
CODE
Units: TQ019781, TQ019601, TQ019060, TQ018811, TQ018326, TQ018075, TQ017834, TQ014813, TQ014706, TQ014472, TQ014374, TQ014145, TQ014010, TQ013804, TQ013680, TQ013486, TQ013375, TQ013166, TQ012322, TQ011373, TQ010813, TQ010418, TQ010338
RECALLING FIRM/MANUFACTURER
IBBI dba Knoxville Plasma Corp., Knoxville, TN, by telephone and facsimile on April 17, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
23 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma, Recall # B-0271-09
CODE
Units: TQ022741; TQ022388; TQ021472; TQ021244; TQ020363; TQ020180; TQ019704
RECALLING FIRM/MANUFACTURER
IBBI dba Knoxville Plasma Corp., Knoxville, TN, by facsimile on March 26, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
NC
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Source Plasma, Recall # B-0260-09
CODE
Unit: 378026121
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Baton Rouge, LA, by fax on February 19, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma, Recall # B-0261-09
CODE
Unit: 378029028
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Baton Rouge, LA, by fax on February 9, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma, Recall # B-0269-09
CODE
Unit: TQ021001
RECALLING FIRM/MANUFACTURER
IBBI dba Knoxville Plasma Corp., Knoxville, TN, by facsimile on April 17, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
____________________________________
PRODUCT
a) Battery Caps used with insulin pumps and glucose monitoring systems. The pump is used to help maintain blood glucose targets. Part Number: 100-158-01, Recall # Z-0290-2009;
b) Battery Caps used with OneTouch Ping Glucose Monitoring System. The pump is used to help maintain blood glucose targets. Part Numbers: 100-430-00, 100-431-00, 100-432-00, 100-434-00, and 100-435-00, Recall # Z-0291-2009;
c) Battery Caps used with Animas 2020 Insulin Pump. The pump is used to help maintain blood glucose targets. Part Numbers: 100-370-00, 100-370-02, 100-370-03, 100-370-51, 100-370-63, 100-370-65, 100-371-00, 100-371-02, 100-371-03, 100-371-51, 100-371-63, 100-371-65, 100-371-67, 100-372-00, 100-372-02, 100-372-03, 100-372-08, 100-372-51, 100-372-67, 100-374-00, 100-374-02, 100-374-51, 100-374-65, 100-375-00, 100-375-02, 100-375-08, 100-375-51, 100-375-60, 100-375-63, 100-375-65, 100-380-00, 100-380-02, 100-380-03, 100-380-05, 100-380-51, 100-380-57, 100-380-61, 100-380-63, 100-380-64, 100-380-65, 100-381-00, 100-381-03, 100-381-05, 100-381-51, 100-381-57, 100-381-61, 100-381-63, 100-381-65, 100-382-00, 100-382-02, 100-382-03, 100-382-51, 100-382-57, 100-382-63, 100-382-64, 100-382-65, 100-384-00, 100-384-51, 100-384-57, 100-384-65, 100-384-67, 100-385-00, 100-385-51, 100-385-65, 100-385-67, and 100-450-00, Recall # Z-0292-2009;
d) Battery Caps used with Animas IR1200 Insulin Pump. The pump is used to help maintain blood glucose targets. Part Numbers: 100-172-04, 100-200-00, 100-200-02, 100-200-03, 100-200-05, 100-200-08, 100-200-51, 100-200-53, 100-200-60, 100-200-61, 100-200-64, 100-200-65, 100-200-66, 100-201-00, 100-201-02, 100-201-03, 100-201-08, 100-201-51, 100-201-53, 100-201-63, 100-201-64, 100-201-65, 100-202-00, 100-202-02, 100-202-03, 100-202-04, 100-202-08, 100-202-51, 100-202-53, 100-202-60, 100-202-61, 100-202-64, 100-202-65, 100-202-66, and 100-400-00, Recall # Z-0293-2009;
e) Battery Caps used with Animas IR1250 Insulin Pump. The pump is used to help maintain blood glucose targets. Part Numbers: 100-250-00, 100-251-00, 100-252-00, and 100-399-00, Recall # Z-0294-2009
CODE
a) All units;
b) Serial Numbers: 01-02000-1, 02-02001-15, 03-2002-15, 03-02003-15, 04-0201 0-15, 05-02004-15, 05-02011-15, 06-02012-15, 06-02100-15, 07-02013-15, 07-02101-15, 08-02007-15, 08-02102-15, 09-02008-15, 09-02110-15, 10-02009-15, 10-02104-15, 10-02111-15, 11-02112-15, 12-02032-15, 12-02106-15, 12-02113-15, 12-02120-15, 13-02033-15, 13-02040-15, 13-02107-15, 13-02121-15, 13-02202-15, 14-02027-15, 14-02034-15, 14-02108-15, 14-02203-15, 14-02210-15, 15-02028-15, 15-02035-15, 15-02042-15, 15-02123-15, 15-02204-15, 16-02029-15, 16-02036-15, 16-02050-15, 16-02117-15, 16-02124-15, 16-02131-15, 16-02205-15, 16-02300-15, 17-02037-15, 17-02051-15, 17-02118-15, 17-02132-15, 17-02213-15, 17-02220-15, 18-02038-15, 18-02126-15, 18-02140-15, 18-02221-15, 19-02039-15, 19-02053-15, 19-02060-15, 19-02127-15, 19-02208-15, 19-02222-15, 20-02047-15, 20-02054-15, 20-02142-15, 20-02209-15, 20-02216-15, 20-02223-15, 20-02304-15, 21-02048-15, 21-02129-15, 21-02136-15, 21-02143-15, 21-02150-15, 21-02217-15, 21-02224-15, 21-02231-15, 22-02049-15, 22-02056-15, 22-02063-15, 22-02144-15, 22-02151-15, 22-02225-15, 22-02232-15, 23-02057-15, 23-02071-15, 23-02152-15, 23-02219-15, 23-02233-15, 23-02240-15, 24-02058-15, 24-02065-15, 24-02072-15, 24-02139-15, 24-02160-15, 24-02241-15, 25-02059-15, 25-02066-15, 25-02080-15, 25-02147-15, 25-02228-15, 25-02235-15, 26-02148-15, 26-02155-15, 26-02162-15, 26-02236-15, 26-02243-15, 26-02250-15, 26-02331-15, 27-02149-15, 27-02156-15, 27-02163-15, 27-02237-15, 27-02244-15, 28-02076-15, 28-02090-15, 28-02157-15, 28-02164-15, 28-02171-15, 28-02245-15, 28-02319-15, 28-02333-15, 29-02091-15, 29-02158-15, 29-02172-15, 29-02246-15, 29-02253-15, 29-02260-15, 30-02092-15, 30-02166-15, 30-02173-15, 30-02180-15, 30-02247-15, 30-02254-15, 30-02261-15, 30-02342-15, 31-02093-15, 31-02167-15, 31-02248-15, 31-02255-15, 31-02262-15, 31-02336-15, 32-02094-15, 32-02168-15, 32-02175-15, 32-02256-15, 32-02263-15, 32-02351-15, 33-02088-15, 33-02169-15, 33-02176-15, 33-02190-15, 33-02345-15, 34-02096-15, 34-02177-15, 34-02184-15, 34-02191-15, 34-02258-15, 35-02178-15, 35-02185-15, 35-02192-15, 35-02259-15, 36-02098-15, 36-02186-15, 36-02193-15, 36-02348-15, 37-02099-15, 37-02195-15, 39-02189-15, 39-02196-15, 40-01901-15, 40-02197-15, 41-02198-15, 42-01910-15, 42-02199-15, 43-01911-15, 44-01912-15, 45-01906-15, 45-01913-15, 45-01920-15, 48-01909-15, 48-01930-15, 49-01924-15, 49-01931-15, 50-01918-15, 50-01925-15, 51-01926-15, 51-01940-15, 52-01927-15, 52-01934-15, 52-01941-15, 53-01928-15, 53-01942-15, 54-01936-15, 54-01943-15, 54-01950-15, 55-01951-15, 56-01864-15, 56-01938-15, 56-01952-15, 57-01939-15, 57-01946-15, 57-01953-15, 57-01960-15, 58-01866-15, 58-01873-15, 58-01947-15, 58-01961-15, 59-01874-15, 59-01948-15, 59-01948-15, 60-01868-15, 60-01882-15, 60-01949-15, 60-01963-15, 60-01970-15, 61-01869-15, 61-01876-15, 61-01883-15, 61-01890-15, 61-01957-15, 62-01877-15, 62-01884-15, 62-01891-15, 62-01958-15, 63-01885-15, 63-01892-15, 63-01959-15, 63-01973-15, 64-01886-15, 64-01893-15, 64-01974-15, 64-01981-15, 65-01887-15, 67-01889-15, 67-01896-15, 67-01991-15, 68-01897-15, 68-01985-15, 68-01992-15, 69-01898-15, 69-01979-15, 69-01993-15, 70-01899-15, 70-01987-15, 70-01994-15, 71-01995-15, 72-01996-15, 73-01997-15, 74-01998-15, and 75-01999-15;
c) Serial Numbers: 14-31419-12, 12-31343-12, 42-30788-12, 19-30811-12, 08-31420-12, 32-31398-12, 14-31345-12, 04-32205-12, 35-30781-12, 01-32202-12, 36-30782-12, 28-32197-12, 30-32199-12, 43-30789-12, 16-31347-12, 31-31397-12, 41-30787-12, 26-32188-12, 26-31378-12, 10-32218-12, 10-32070-12, 13-32147-12, 97-32110-12, 05-32118-12, 13-32059-12, 18-32085-12, 27-31379-12, 27-31386-12, 15-32082-12, 07-32053-12, 15-32068-12, 22-31381-12, 23-32192-12, 16-32069-12, 11-32064-12, 13-32066-12, 14-32148-12, 04-32117-12, 19-32093-12, 98-32104-12, 17-32084-12, 16-32083-12, 09-31407-12, 00-30229-12, 96-30218-12, 27-30738-12, 04-30254-12, 21-30806-12, 14-30278-12, 19-30804-12, 13-30284-12, 98-30308-12, 99-30235-12, 01-30237-12, 35-30774-12, 00-30236-12, 25-30736-12, 33-30765-12, 01-30244-12, 99-30228-12, 09-30280-12, 32-30764-12, 09-30259-12, 22-30807-12, 03-31401-12, 24-30742-12, 09-32062-12, 10-30281-12, 17-31348-12, 11-31342-12, 21-30813-12, 39-30785-12, 06-32207-12, 29-32198-12, 37-30790-12, 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d) Serial Numbers: 00-58941-10, 00-65798-10, 00-65879-10, 00-65886-10, 00-65893-10, 00-65967-10, 00-65974-10, 00-65981-10, 01-59576-10, 01-65799-10, 01-65887-10, 01-65894-10, 01-65968-10, 01-65975-10, 01-65982-10, 02-65888-10, 02-65895-10, 02-65969-10, 02-65990-10, 03-65889-10, 03-65896-10, 03-65991-10, 04-64999-10, 04-65992-10, 05-65993-10, 06-65899-10, 06-65897-10, 06-65994-10, 07-65988-10, 07-65995-10, 08-65989-10, 08-65996-10, 10-58958-10, 15-58977-10, 34-64025-10, 37-65102-10, 37-66000-10, 38-64029-10, 38-66001-10, 39-61283-10, 39-65104-10, 39-66002-10, 40-63154-10, 40-65024-10, 40-65112-10, 40-66003-10, 40-66010-10, 41-52199-10, 41-65025-10, 41-65113-10, 41-66004-10, 41-66011-10, 42-61286-10, 42-61286-10, 42-63406-10, 42-65107-10, 42-65114-10, 42-65121-10, 42-66005-10, 43-63319-10, 43-64312-10, 43-65041-10, 43-65041-10, 43-65115-10, 43-66006-10, 43-66013-10, 43-66101-10, 44-51494-10, 44-65042-10, 44-65123-10, 44-65130-10, 44-65204-10, 44-66007-10, 44-66014-10, 44-66021-10, 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e) Serial Numbers: 06-42218-11, 07-42240-11, 07-42240-11, 07-51400-11, 08-42308-11, 08-42308-11, 08-43206-11, 10-43310-11, 10-43310-11, 11-52221-11, 12-51236-11, 13-43320-11, 13-44028-11, 14-42328-11, 14-50178-11, 14-51421-11, 15-45009-11, 15-55000-11, 16-42270-11, 16-53050-11, 16-55001-11, 17-42419-11, 17-43162-11, 17-44039-11, 17-44039-11, 18-41624-11, 18-55003-11, 18-55010-11, 19-50359-11, 19-55011-11, 20-54040-11, 20-55005-11, 20-55100-11, 21-44307-11, 21-54203-11, 21-55013-11, 21-55020-11, 21-55020-11, 22-45044-11, 22-55007-11, 22-55014-11, 23-54212-11, 23-55008-11, 23-55103-11, 23-55103-11, 23-56001-11, 24-36312-11, 24-55009-11, 24-55023-11, 24-55030-11, 24-55104-11, 24-55111-11, 25-55017-11, 25-55112-11, 25-55200-11, 25-56003-11, 25-56010-11, 26-41653-11, 26-43435-11, 26-55018-11, 26-55032-11, 26-55113-11, 26-55120-11, 26-56004-11, 26-56011-11, 27-42545-11, 27-42545-11, 27-51286-11, 27-54223-11, 27-55019-11, 27-55033-11, 27-55114-11, 27-55121-11, 27-55202-11, 27-56005-11, 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63-55808-11, 63-55815-11, 63-55822-11, 63-55903-11, 63-55910-11, 63-56287-11, 63-56294-11, 63-56368-11, 63-56382-11, 63-56449-11, 63-56456-11, 63-56537-11, 63-56544-11, 63-56551-11, 63-56618-11, 63-56625-11, 63-56632-11, 63-56713-11, 63-56720-11, 63-56801-11, 63-57185-11, 64-45927-11, 64-46751-11, 64-48607-11, 64-54763-11, 64-55397-11, 64-55478-11, 64-55485-11, 64-55492-11, 64-55566-11, 64-55573-11, 64-55580-11, 64-55647-11, 64-55654-11, 64-55661-11, 64-55728-11, 64-55735-11, 64-55742-11, 64-55809-11, 64-55823-11, 64-55904-11, 64-55911-11, 64-56288-11, 64-56295-11, 64-56376-11, 64-56383-11, 64-56390-11, 64-56457-11, 64-56538-11, 64-56545-11, 64-56552-11, 64-56619-11, 64-56626-11, 64-56633-11, 64-56640-11, 64-56707-11, 64-56714-11, 65-52975-11, 65-54676-11, 65-54683-11, 65-55398-11, 65-55479-11, 65-55486-11, 65-55493-11, 65-55567-11, 65-55574-11, 65-55581-11, 65-55648-11, 65-55662-11, 65-55729-11, 65-55736-11, 65-55743-11, 65-55750-11, 65-55817-11, 65-55824-11, 65-55831-11, 65-55905-11, 65-56289-11, 65-56377-11, 65-56391-11, 65-56465-11, 65-56472-11, 65-56539-11, 65-56546-11, 65-56553-11, 65-56560-11, 65-56634-11, 65-56641-11, 65-56708-11, 65-56715-11, 65-56722-11, 66-55399-11, 66-55487-11, 66-55494-11, 66-55568-11, 66-55649-11, 66-55656-11, 66-55663-11, 66-55670-11, 66-55737-11, 66-55744-11, 66-55751-11, 66-55818-11, 66-55825-11, 66-55832-11, 66-55906-11, 66-55913-11, 66-55920-11, 66-56297-11, 66-56378-11, 66-56385-11, 66-56392-11, 66-56459-11, 66-56466-11, 66-56473-11, 66-56480-11, 66-56547-11, 66-56554-11, 66-56561-11, 66-56628-11, 66-56635-11, 66-56642-11, 66-56709-11, 66-56719-11, 66-56723-11, 66-56730-11, 67-55495-11, 67-55569-11, 67-55583-11, 67-55657-11, 67-55664-11, 67-55671-11, 67-55738-11, 67-55745-11, 67-55752-11, 67-55819-11, 67-55826-11, 67-55833-11, 67-55840-11, 67-55907-11, 67-55914-11, 67-55921-11, 67-56298-11, 67-56379-11, 67-56386-11, 67-56467-11, 67-56474-11, 67-56481-11, 67-56548-11, 67-56555-11, 67-56562-11, 67-56629-11, 67-56636-11, 67-56643-11, 67-56650-11, 67-56717-11, 67-56724-11, 67-56731-11, 67-56805-11, 67-56900-11, 68-43987-11, 68-48713-11, 68-52897-11, 68-55489-11, 68-55496-11, 68-55577-11, 68-55584-11, 68-55658-11, 68-55665-11, 68-55672-11, 68-55739-11, 68-55746-11, 68-55753-11, 68-55760-11, 68-55827-11, 68-55834-11, 68-55841-11, 68-55908-11, 68-55915-11, 68-55922-11, 68-56299-11, 68-56387-11, 68-56394-11, 68-56475-11, 68-56482-11, 68-56549-11, 68-56556-11, 68-56563-11, 68-56570-11, 68-56644-11, 68-56651-11, 68-56718-11, 68-56725-11, 68-56732-11, 68-56813-11, 68-56820-11, 68-56901-11, 69-55497-11, 69-55585-11, 69-55592-11, 69-55659-11, 69-55666-11, 69-55673-11, 69-55680-11, 69-55747-11, 69-55754-11, 69-55761-11, 69-55828-11, 69-55835-11, 69-55842-11, 69-55909-11, 69-55923-11, 69-56388-11, 69-56395-11, 69-56476-11, 69-56483-11, 69-56557-11, 69-56564-11, 69-56571-11, 69-56638-11, 69-56652-11, 69-56719-11, 69-56726-11, 69-56733-11, 69-56740-11, 69-56814-11, 69-56902-11, 70-47662-11, 70-54688-11, 70-55579-11, 70-55586-11, 70-55667-11, 70-55674-11, 70-55681-11, 70-55748-11, 70-55755-11, 70-55829-11, 70-55836-11, 70-55843-11, 70-55850-11, 70-55924-11, 70-55931-11, 70-56389-11, 70-56396-11, 70-56477-11, 70-56491-11, 70-56558-11, 70-56565-11, 70-56572-11, 70-56639-11, 70-56646-11, 70-56653-11, 70-56660-11, 70-56727-11, 70-56734-11, 70-56741-11, 70-56808-11, 70-56822-11, 70-56903-11, 71-38739-11, 71-47825-11, 71-54689-11, 71-54872-11, 71-55499-11, 71-55587-11, 71-55594-11, 71-55668-11, 71-55675-11, 71-55682-11, 71-55749-11, 71-55756-11, 71-55763-11, 71-55837-11, 71-55844-11, 71-55851-11, 71-55918-11, 71-55925-11, 71-55932-11, 71-56397-11, 71-56478-11, 71-56485-11, 71-56559-11, 71-56566-11, 71-56573-11, 71-56580-11, 71-56647-11, 71-56654-11, 71-56661-11, 71-56728-11, 71-56735-11, 71-56742-11, 71-56823-11, 71-56830-11, 71-56904-11, 72-46928-11, 72-55588-11, 72-55669-11, 72-55676-11, 72-55683-11, 72-55690-11, 72-55757-11, 72-55764-11, 72-55771-11, 72-55838-11, 72-55845-11, 72-55852-11, 72-55919-11, 72-55926-11, 72-55933-11, 72-55940-11, 72-56398-11, 72-56479-11, 72-56486-11, 72-56493-11, 72-56567-11, 72-56574-11, 72-56581-11, 72-56648-11, 72-56662-11, 72-56729-11, 72-56736-11, 72-56743-11, 72-56750-11, 72-56824-11, 72-56831-11, 73-43999-11, 73-48468-11, 73-53895-11, 73-54874-11, 73-55596-11, 73-55677-11, 73-55684-11, 73-55691-11, 73-55758-11, 73-55765-11, 73-55772-11, 73-55839-11, 73-55853-11, 73-55860-11, 73-55927-11, 73-55941-11, 73-56399-11, 73-56487-11, 73-56494-11, 73-56568-11, 73-56575-11, 73-56582-11, 73-56656-11, 73-56663-11, 73-56737-11, 73-56744-11, 73-56751-11, 73-56825-11, 73-56832-11, 73-56913-11, 73-56920-11, 74-47747-11, 74-47916-11, 74-48645-11, 74-52998-11, 74-55597-11, 74-55678-11, 74-55685-11, 74-55692-11, 74-55759-11, 74-55766-11, 74-55773-11, 74-55847-11, 74-55854-11, 74-55861-11, 74-55928-11, 74-55935-11, 74-55942-11, 74-56495-11, 74-56569-11, 74-56576-11, 74-56583-11, 74-56590-11, 74-56657-11, 74-56671-11, 74-56738-11, 74-56745-11, 74-56752-11, 74-56833-11, 74-56840-11, 74-56907-11, 74-56914-11, 74-56921-11, 75-55598-11, 75-55679-11, 75-55686-11, 75-55693-11, 75-55767-11, 75-55774-11, 75-55781-11, 75-55848-11, 75-55855-11, 75-55862-11, 75-55929-11, 75-55936-11, 75-56496-11, 75-56577-11, 75-56584-11, 75-56591-11, 75-56739-11, 75-56746-11, 75-56753-11, 75-56760-11, 75-56827-11, 75-56834-11, 75-56922-11, 76-54972-11, 76-55599-11, 76-55694-11, 76-55768-11, 76-55775-11, 76-55782-11, 76-55849-11, 76-55856-11, 76-55863-11, 76-55870-11, 76-55937-11, 76-55944-11, 76-55951-11, 76-56578-11, 76-56585-11, 76-56592-11, 76-56659-11, 76-56673-11, 76-56680-11, 76-56747-11, 76-56754-11, 76-56761-11, 76-56828-11, 76-56835-11, 76-56842-11, 76-56909-11, 76-56916-11, 76-56930-11, 77-46873-11, 77-46954-11, 77-49296-11, 77-49641-11, 77-54973-11, 77-54980-11, 77-55688-11, 77-55695-11, 77-55769-11, 77-55776-11, 77-55783-11, 77-55790-11, 77-55857-11, 77-55864-11, 77-55871-11, 77-55938-11, 77-55952-11, 77-56498-11, 77-56579-11, 77-56586-11, 77-56593-11, 77-56674-11, 77-56681-11, 77-56748-11, 77-56755-11, 77-56762-11, 77-56836-11, 77-56843-11, 77-56850-11, 77-56917-11, 77-56931-11, 78-54879-11, 78-55689-11, 78-55696-11, 78-55777-11, 78-55784-11, 78-55791-11, 78-55858-11, 78-55865-11, 78-55872-11, 78-55939-11, 78-55946-11, 78-55953-11, 78-55960-11, 78-56587-11, 78-56594-11, 78-56675-11, 78-56749-11, 78-56756-11, 78-56763-11, 78-56770-11, 78-56844-11, 78-56851-11, 78-56918-11, 78-56925-11, 78-56932-11, 79-55778-11, 79-55785-11, 79-55792-11, 79-55859-11, 79-55880-11, 79-55947-11, 79-55954-11, 79-55961-11, 79-56588-11, 79-56595-11, 79-56669-11, 79-56676-11, 79-56683-11, 79-56690-11, 79-56757-11, 79-56764-11, 79-56771-11, 79-56838-11, 79-56852-11, 79-56919-11, 79-56933-11, 79-56490-11, 80-48665-11, 80-54976-11, 80-55698-11, 80-55779-11, 80-55786-11, 80-55793-11, 80-55867-11, 80-55874-11, 80-55881-11, 80-55948-11, 80-55955-11, 80-55962-11, 80-56589-11, 80-56596-11, 80-56677-11, 80-56684-11, 80-56691-11, 80-56758-11, 80-56765-11, 80-56772-11, 80-56839-11, 80-56846-11, 80-56860-11, 80-56941-11, 81-54977-11, 81-54984-11, 81-54991-11, 81-55699-11, 81-55794-11, 81-55868-11, 81-55875-11, 81-55882-11, 81-55949-11, 81-55956-11, 81-55963-11, 81-55970-11, 81-56597-11, 81-56678-11, 81-56685-11, 81-56692-11, 81-56759-11, 81-56766-11, 81-56773-11, 81-56847-11, 81-56854-11, 81-56861-11, 81-56928-11, 81-56935-11, 82-54992-11, 82-55788-11, 82-55795-11, 82-55869-11, 82-55890-11, 82-55957-11, 82-55964-11, 82-55971-11, 82-56598-11, 82-56679-11, 82-56686-11, 82-56693-11, 82-56767-11, 82-56774-11, 82-56848-11, 82-56855-11, 82-56929-11, 82-56936-11, 82-56950-11, 83-54986-11, 83-54993-11, 83-55789-11, 83-55796-11, 83-55877-11, 83-55884-11, 83-55958-11, 83-55965-11, 83-55972-11, 83-56599-11, 83-56687-11, 83-56694-11, 83-56768-11, 83-56775-11, 83-56849-11, 83-56856-11, 83-56937-11, 84-38956-11, 84-54994-11, 84-55878-11, 84-55885-11, 84-55892-11, 84-55966-11, 84-55980-11, 84-56688-11, 84-56695-11, 84-56769-11, 84-56776-11, 84-56857-11, 84-56864-11, 84-56871-11, 84-56938-11, 84-56952-11, 85-55798-11, 85-55886-11, 85-55893-11, 85-55967-11, 85-55981-11, 85-56689-11, 85-56696-11, 85-56777-11, 85-56858-11, 85-56865-11, 85-56872-11, 85-56939-11, 85-56953-11, 85-56960-11, 86-55799-11, 86-55887-11, 86-55894-11, 86-55968-11, 86-55975-11, 86-56697-11, 86-56778-11, 86-56866-11, 86-56873-11, 86-56954-11, 86-56961-11, 87-54997-11, 87-55888-11, 87-55895-11, 87-55969-11, 87-55990-11, 87-56698-11, 87-56874-11, 87-56955-11, 87-56962-11, 88-47884-11, 88-48782-11, 88-48944-11, 88-55889-11, 88-55896-11, 88-55991-11, 88-56868-11, 88-56875-11, 88-56882-11, 88-56956-11, 88-56963-11, 88-56970-11, 89-49674-11, 89-55897-11, 89-55985-11, 89-55992-11, 89-56869-11, 89-56876-11, 89-56957-11, 89-56964-11, 89-56971-11, 90-55898-11, 90-55986-11, 90-55993-11, 90-56877-11, 90-56958-11, 90-56965-11, 90-56972-11, 91-55987-11, 91-55994-11, 91-56885-11, 91-56959-11, 91-56966-11, 91-56980-11, 92-56798-11, 92-56893-11, 92-56967-11, 92-56974-11, 93-55989-11, 93-56799-11, 93-56968-11, 94-55997-11, 94-56895-11, 94-56969-11, 94-56976-11, 95-56896-11, 95-56977-11, 96-55999-11, 96-56978-11, 97-56898-11, and 98-56899-11
RECALLING FIRM/MANUFACTURER
Animas Corp., West Chester, PA, by letter and telephone on August 5, 2008. Firm initiated recall is ongoing.
REASON
Unintentional rebooting--Pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. The failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia.
VOLUME OF PRODUCT IN COMMERCE
7,152 units
DISTRIBUTION
Nationwide, Australia, Austria, Canada, Czech Republic, Finland, France, Israel, Italy, New Zealand, Spain, Switzerland, and Sweden
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
Physio-Control Lifepak 20 defibrillator/monitor is intended for the termination of certain fatal arrhythmias, Recall # Z-2388-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Physio Control, Inc., Redmond, WA, by letter on June 18, 2008. Firm initiated recall is ongoing.
REASON
Potential for the coin battery to drain prematurely causing the monitor clock time and date to be incorrect and the service light indicator to illuminate.
VOLUME OF PRODUCT IN COMMERCE
44,851 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
One Touch Ultra Test Strips, part number 020-994-02, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use 0outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm, Recall # Z-0004-2009
CODE
Lot number: 2829235
RECALLING FIRM/MANUFACTURER
Lifescan Inc., Milpitas, CA, by letters, dated September 19, 2008. Firm initiated recall is ongoing.
REASON
Products exceed inaccuracy threshold, with many complaints resulting from inaccurate low results.
VOLUME OF PRODUCT IN COMMERCE
35,308 vials
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Bone Marrow Aspiration Kit consists of 3 main components packaged in a box. 1. Marrow Loc (Bone Marrow Specimen Acquisition System), 2. "J" Style Bone Marrow Biopsy Needle (11g (3.0mm)x10cm (4.0)) 3. BD 20ml Syringe.
Part Number is 50-20-001, Recall # Z-0272-2009
CODE
Lot #: 100549 Overall kit Exp. Date: 02/2010, Syringe Exp. Date 10/2009, Marrow Loc Exp. Date: 02/2010 and "J" Style Bone Marrow Biopsy Needle Exp. Date: 02/2010; Lot #103016 Overall kit Exp. Date: 10/2010, Syringe Exp Date: 10/2009, Marrow Loc Exp. Date: 10/2010 and "J" Style Bone Marrow Biopsy Needle Exp. Date: 10/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Theken Spine LLC, Akron, OH, by letters on August 27, 2008 and by telephone on August 28, 2008.
Manufacturer: Promex Technologies, LLC, Franklin, IN. Firm initiated recall is ongoing.
REASON
The kits were manufactured in 2005 with syringes that expire on 10/2009 and labeled with an overall expiration on 10/2010.
VOLUME OF PRODUCT IN COMMERCE
115 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Biomet Vanguard(TM) DCM PS Plus 16mm x 63/67mm Tibial Bearing (REF. 183726), ARCOM UHMWPE, sterile. A knee prosthesis intended for single use implantation to replace the auricular portions of the knee joint, Recall # Z-0289-2009
CODE
Lot numbers: 713910, 806560, 816560 and 871750
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated September 22, 2008. Firm initiated recall is ongoing.
REASON
The package is properly labeled, but the laser etch for size incorrectly reads "16 X 63/63" instead of the correct size, "16 X 63/67".
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Nationwide and Finland
___________________________________
PRODUCT
a) Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 28 mm diameter, neck length -3.5 mm, sterile; REF 00-6418-028-01 and 00-6428-028-01. The Alumina Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures, Recall # Z-0299-2009;
b) Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 28 mm diameter, neck length 0 mm, sterile; REF 00-6418-028-02 and 00-6428-028-02. The Alumina Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures, Recall # Z-0300-2009;
c) Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 28 mm diameter, neck length +3.5 mm, sterile; REF 00-6418-028-03 and 00-6428-028-03. The Alumina Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures, Recall # Z-0301-2009;
c) Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length -3.5 mm, sterile; REF 00-6418-032-01 and 00-6428-032-01. The Alumina Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures, Recall # Z-0302-2009;
d) Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length 0 mm, sterile; REF 00-6418-032-02 and 00-6428-032-02. The Alumina Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures, Recall # Z-0303-2009;
e) Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length +3.5 mm, sterile; REF 00-6418-032-03 and 00-6428-032-03. The Alumina Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures, Recall # Z-0304-2009;
CODE
All lots
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN, by letter, dated June 11, 2008. Firm initiated recall is ongoing.
REASON
When used with cobalt/chromium hip stems, the average test values for ceramic head bursting falls below the guidance document limits if the taper is made by casting instead of by forging.
VOLUME OF PRODUCT IN COMMERCE
49,474 units
DISTRIBUTION
Nationwide, Austria, Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Dubai, England, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Korea, Lebanon, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Slovakia, Spain, Switzerland and Ukraine
___________________________________
PRODUCT
Giraffe OmniBed® is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand, Recall # Z-0305-2009
CODE
All lots
RECALLING FIRM/MANUFACTURER
Datex Ohmeda, Inc., dba, GE Healthcare, Laurel, MD, by letter on June 20, 2008. Firm initiated recall is ongoing.
REASON
Manufacturer of neonatal incubators changed the device labeling to account for new use and care instructions.
VOLUME OF PRODUCT IN COMMERCE
7,878 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
CELL-DYN Sapphire Hematology Analyzer, List numbers 08H00-01, 08H00-03 A multi- parameter, automated hematology analyzer designed for in vitro diagnostic use in counting and characterizing blood cells, Recall # Z-0306-2009
CODE
All pre production units with Serial numbers: S-001 to S-026 and all production units with Serial numbers: 42003AZ-42007AZ, 42010AZ-42030AZ, 42032AZ-42033AZ, 42037AZ-42059AZ, 42061AZ-42062AZ, 42064AZ-42067AZ, 42072AZ-42074AZ, 42076AZ-42081AZ, 42083AZ-42123AZ, 42125AZ-42852AZ, 42854AZ-42944AZ, 42946AZ-42949AZ, 42951AZ, 42953AZ, 42955AZ-42961AZ, and 42963AZ-42964AZ
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, by a Technical service bulletin on August 22, 2008. Firm initiated recall is ongoing.
REASON
Exposed wire resulted in minor electrical shock and burn to the service technician.
VOLUME OF PRODUCT IN COMMERCE
958 units
DISTRIBUTION
Nationwide, Argentina, Australia, Brazil, Canada, Chile, China WFOTC, Colombia, Germany, Hong Kong, Japan, Mexico, New Zealand, Panama, Paraguay, Peru, Singapore, South Korea, Taiwan and Venezuela
___________________________________
PRODUCT
Proven Cemented Semi-Constrained Total Knee. Part number SC1591-38. The size is 38 and the thickness is 10 mm. The Proven Knee System is a single use device intended for cemented reconstruction of the femoral and/or tibial portion of severely disabled and/or painful knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis with or without varus, valgus or flexion deformities, and revision surgery provided that there is radiographic evidence of sufficient sound bone to seat the prosthesis, Recall # Z-0308-2009
CODE
Lot number 19906-052008
RECALLING FIRM/MANUFACTURER
Stelkast Co., Mcmurray, PA, by telephone on September 4, 2008. Firm initiated recall is complete.
REASON
Five (5) Three Peg Patella SC1591-29 were packaged in containers labeled for SC1591-38 sharing the same lot number.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040. The Terumo(R) Advanced Perfusion System 1 is indicated for use in extracorpeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only, when used by a qualified perfusionist who is experienced in the operation of Sarns(TM) or similar equipment, Recall # Z-0309-2009;
b) Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. The Terumo ® Advanced Perfusion System 1 is indicated for use in extracorpeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only, when used by a qualified perfusionist who is experienced in the operation of Sarns™ or similar equipment, Recall # Z-0310-2009
CODE
a) Serial numbers 0028 through 0111, 0113 through 0527, 0700 through 1310, 1358, 2322, 2325, 2327, 2328 and 2330 through 2333;
b) Serial numbers 0030, 0032 through 0587, 0700 through 1527, 1529, 1531 through 1533, 1563 through 1569, 1572, 1575, 1577 through 1581, 1584 through 1587, 1607, 2230 through 2235, 2239 through 2242, 2581 through 2583 and 2587 through 2594
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by telephone and letter dated July 18, 2008. Firm initiated recall is ongoing.
REASON
The pumps may fail to power up or experience unplanned pump stops.
VOLUME OF PRODUCT IN COMMERCE
2,548 (1,444 Nationwide and 1104 International)
DISTRIBUTION
Nationwide, Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Israel, Japan, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Vietnam
___________________________________
PRODUCT
a) Arjo Maxi 500 Patient Lift with 2 Point Spreader Bar and Scale; a Non-AC-Powered Patient Lift; Model KM560101; The Maxi 500 is a mobile passive lift intended to be for lifting and transferring of patients in hospitals, nursing homes, or other health care facilities, Recall # Z-0322-2009
b) Arjo Maxi 500 Patient Lift with 4 Point DPS (Dynamic Positioning System) and Scale; a Non-AC-Powered Patient Lift; Models KM560181; The Maxi 500 is a mobile passive lift intended to be for lifting and transferring of patients in hospitals, nursing homes, or other health care facilities, Recall # Z-0323-2009
CODE
a) Serial numbers: KM5610713, KM5610729, KM5610737, KM5610114, KM5610115, KM5610550, KM5610711, KM5610551, KM5610693, KM5610694, KM5610696, KM5611003, KM5611004, KM5611005, KM5611006, KM5611007, KM5611008, KM5611009, KM5611010, KM5611011, KM5611012, KM5611013, KM5611014, KM5611015, KM5611016, KM5611017, KM5611018, KM5611019, KM5611020, KM5611021, KM5611022, KM5611023, KM5611024, KM5611025, KM5611026, KM5611027, KM5610813, and KM5610667;
b) Serial numbers: KM5610785, KM5610162, KM56510020, KM5610290, KM5610251, KM5610309, KM5610428, KM5610247, KM5610165, KM5610278, KM5610282, KM5610752, KM5610824, KM5610826, KM5610852, KM5610410, KM5610420, KM5610302, KM5610294, KM5610045, KM5610701, KM5610407, KM5610916, KM5610985, KM5610881, KM5610239, KM5610243, KM5610249, KM5610177, KM5610726, KM5610272, KM5610297, KM5610187, KM5610333, KM5610051, KM5610164, KM5610057, KM5610736, KM5610100, KM5610101, KM5610104, KM5610329, KM5610429, KM5610241, KM5610735, KM5610285, KM5610750, KM5610056, KM5610806, KM5610118, KM5610702, KM5610152, KM5610153, KM5610784, KM5610788, KM5610808, KM5610047, KM5610304, KM5610892, KM5610158, KM5610434, KM5610437, KM5610105, KM5610335, KM5610815, KM5610276, KM5610326, KM5610037, KM5610166, KM5610126, KM5610982, KM5610246, KM5610046, KM5610280, KM5610756, KM5610167, KM5610858, KM5610337, KM5610341, KM5610890, KM5610913, KM5610915, KM5610755, KM5610988, KM5610041, KM5610424, KM5610427, KM5611002, KM5610043, KM5610132, KM5610418, KM5610323, KM5610704, KM5610050, KM5610096, KM5610098, KM5610179, KM5610438, KM5610831, KM5610155, KM5610035, KM5610331, KM5610097, KM5610296, KM5610236, KM5610240, KM5610242, KM5610305, KM5610237, KM5610954, KM5611001, KM5610841, KM5610843, KM5610855, KM5610235, KM5610827, KM5610830, KM5610840, KM5610833, KM5610832, KM5610264, KM56510017, KM5610440, KM56510023, KM5610992, KM5610110, KM5610298, KM5610342, KM5610814, KM5610816, KM5610818, KM5610891, KM5610888, KM5610117, KM5610121, KM5610125, KM5610127, KM5610163, KM5610168, KM5610169, KM5610176, KM5610406, KM5610426, KM5610999, KM5610292, KM5610293, KM5610310, KM5610336, KM5610317, KM5610123, KM5610430, KM5610441, KM5610432, KM56510019, KM5610054, KM5610107, KM5610173, KM5610413, KM56510018, KM5610036, KM5610055, KM5610271, KM5610238, KM5610722, KM5610724, KM5610758, KM5610981, KM5610338, KM5610129, KM5610300, KM5610226, KM5610059, KM5610723, KM5610263, KM5610260, KM5610113, KM5610340, KM5610303, KM5610306, KM5610315, KM5610339, KM5610160, KM5610161, KM5610128, KM5610049, KM5610857, KM5610596, KM5610343, KM56510015, KM5610879, KM5610914, KM5610978, KM5610109, KM5610262, KM5610265, KM5610439, KM5610725, KM5610314, KM5610320, KM5610244, KM5610245, KM5610042, KM5610786, KM5610301, KM5610753, KM5610757, KM5610805, KM5610281, KM5610703, KM5610058, KM5610415, KM5610321, KM5610120, KM5610124, KM5610131, KM5610157, KM5610181, KM5610286, KM5610178, KM5610850, KM5610116, KM5610284, KM5610409, KM5610106, KM5610112, KM56510021, KM56510022, KM56510024, KM5610983, KM5610182, KM5610828, KM5610998, KM5610122, KM5610849, KM5610853, KM5610334, KM5610989, KM5610064, KM5610052, KM5610312, KM5610044, KM5610170, KM5610953, KM5610787, KM5610250, KM5610436, KM5610066, KM5610102, KM5610856, KM5610408, KM5610878, KM5610274, KM5610061, KM5610103, KM5610332, KM5610119, KM5610130, KM5610275, KM5610416, KM5610419, KM5610133, KM5610980, KM5610065, KM5610154, KM5610159, KM5610414, KM5610990, KM5610269, KM5610288, KM5610421, KM5610433, KM5610327, KM5610322, KM5610268, KM5610700, KM5610048, KM56510016, KM5610253, KM5610257, KM5610889, KM5610099, KM5610108, KM5610422, KM5610880, KM5610751, KM5610984, KM5610987, KM5610156, KM5610270, KM5610038, KM5610749, KM5610754, KM5610411, KM5610316, KM5610319, KM5610324, KM5610817, KM5610053, KM5610295, KM5610254, KM5610062, KM5610039, KM5610325, KM5610180, KM5610171, KM5610435, KM5610311, KM5610423, KM5610991, KM5610950, KM5610951, KM5610952, KM5610425, KM5610417, KM5610328, KM5610063, KM5610412, KM5610111, KM5610267, KM5610060, KM5610308, KM5610825, KM5610261, KM5610839, KM5610842, KM5610854, KM5610431, KM5610748, KM5610307, KM5610313, KM5610289, KM5610291, KM5610299, KM5610851, KM5610318, and KM5610330
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL, by letter dated October 20, 2008.
Manufacturer: B.H.M. Medical, Inc., Magog, Canada. Firm initiated recall is ongoing.
REASON
The pivot bolt that attaches the hanger bar to the scale of the patient lift can break, resulting in the hanger bar falling.
VOLUME OF PRODUCT IN COMMERCE
374 units
DISTRIBUTION
Nationwide
___________________________________
STERRAD 100S Sterilizer (Product Code 10101). The sterilizer includes software and hardware components. The STERRAD Sterilization System is a low-temperature, general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices, Recall # Z-0340-2009
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Advanced Sterilization Products, Irvine, CA, by letter beginning November 24, 2008. Firm initiated recall is ongoing.
REASON
1) Inability of the sterilizer to detect when an injection takes place without hydrogen peroxide being transferred to the vaporizer bowl. This situation can result in a cycle completion with the injection of insufficient hydrogen peroxide sterilant and 2) Inability of the sterilizer to detect an obstruction in the door travel path while the door is closing. This situation can result in a hand becoming pinched and bruised while the door is closing.
VOLUME OF PRODUCT IN COMMERCE
6,324 units (USA 2,623 units and internationally 3,701 units)
DISTRIBUTION
Nationwide, France, Germany, Italy, UK, Switzerland, Benelux, Uruguay, Venezuela, Argentina, Chile, Colombia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indonesia, Mexico, Philippines, Australia, Austria, China, Greece, Israel, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, Turkey, Middle East, Peru, Canada, Czech Republic, Portugal, South Africa, Spain, Sweden, Hungary, Poland, Brazil, Russia, Egypt, India and Slovenia
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
Reflex Hybrid 4.0 x 14 mm Variable, Self-Tapping Bone Screw (Non- sterile). The bone screw (Reference # 48694014) is a 04.0 x 14mm used to attach the Reflex Hybrid Anterior Cervical Plate (ACP) to the anterior surface of the spine. The intended use of the system is as an aid in cervical spinal fusion through unilateral fixation, Recall # Z-0217-2009
CODE
Lot code: NSZ
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Spine, Allendale, NJ, by letter on August 18, 2008.
Manufacturer: Stryker Spine, Cestas, Aquitane, France. Firm initiated recall is complete.
REASON
The Reflex Hybrid 4.0 x 14 mm Variable, Self Tapping Bone Screw, Lot NSZ, was determined to have been anodized with the incorrect color for that screw.
VOLUME OF PRODUCT IN COMMERCE
183 units
DISTRIBUTION
Nationwide
___________________________________
AxSYM Digoxin II Reagent Pack, Disk Version 1. (3D53-01 or 3D53-02) The AxSYM Digoxin II assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of digoxin, a cardiovascular drug, in serum or plasma. The measurements obtained are used in the treatment of digoxin overdose and monitoring levels of digoxin to ensure appropriate therapy, Recall # Z-0297-2009
CODE
Lot 61275Q100, exp. date: 09/09/08; Lot 58167Q100, exp. date: 08/30/08; Lot 56039Q101, exp. date: 07/13/08; Lot 56039Q100, exp. date: 07/13/08
RECALLING FIRM/MANUFACTURER
Abbott Diagnostic International, Ltd., Barceloneta, PR, by letter, dated May 22, 2008. Firm initiated recall is ongoing.
REASON
AxSYM TDM/ Transplant Assay Disks 3D53-03 and higher do not contain the AxSYM Digoxin II Assay file. The instrument might require installation of the AxSYM Digoxin II assay file.
VOLUME OF PRODUCT IN COMMERCE
9,069 units
DISTRIBUTION
AL, AZ, AR, CA, CT, FL, GA, IL, KS, MD, MA, MI, MN, MS, MO, NV, NJ, NY, ND, OK, OR, PA, RI, TX, VA, WA, Hawaii, Puerto Rico, Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Ecuador, Peru, Chile, Uruguay, Argentina, Puerto Rico, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, South Korea, Australia, New Zealand, Curacao, and Panama
END OF ENFORCEMENT REPORT FOR NOVEMBER 26, 2008
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