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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December 03, 2008
08-48

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
Viril-Ity-Power (VIP), Maximum All-Natural Fast Acting Male Sexual Stimulant Dietary Supplement, Proprietary Blend of 560 mgs Per Serving, packaged in 2 tablets per blister pack and 8 count bottles, Polygonum Multiflorum, Epimedium Extract (leaves) 20% Extract, Dogwood Fruit-Cornus Officinalis, Foxglove Root (rehmannia Glutinosa), Gingko Biloba, Rhodiola Rosea (whole plant), Korean Ginseng Tribulus Terrestris Extract (70% Saponins), L-Arginine, Recall # D-113-2009
CODE
All Lot numbers (to include): 6J001, 6J009, 6K027, 6K028, 6K029
RECALLING FIRM/MANUFACTURER
Recalling Firm: International Pharmaceuticals Ltd., Haverhill, MA, by e-mail on May 28, 2008 and Press Release on May 29, 2008. Manufacturer: Kirk Pharmaceuticals, LLC, Fort Lauderdale, FL. Firm initiated recall is ongoing.
REASON
Unapproved New Drug; undeclared ingredient, hydroxyhomosildenafil, an analog of sildenafil. Sildenafil is the active chemical ingredient of an FDA-approved drug used for Erectile Dysfunction (ED).
VOLUME OF PRODUCT IN COMMERCE
930,864 tablets
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
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PRODUCT
a) Metoprolol Succinate Extended Release Tablets USP, 25mg, 100 count (NDC 0185-0281-01) and 1000 count (NDC 0185-0281-10) bottles, Rx only, Recall # D-108-2009;
b) Metoprolol Succinate Extended Release Tablets USP, 50mg, 100 count (NDC 0185-0282-01) and 1000 count (NDC 0185-0282-10) bottles, Rx only, Recall # D-109-2009;
c) Metoprolol Succinate Extended Release Tablets USP, 100mg, 100 count bottle, Rx only, NDC 0185-0283-01, Recall # D-110-2009;
d) Metoprolol Succinate Extended Release Tablets USP, 200mg, 100 count bottle, Rx only, NDC 0185-0284-01, Recall # D-111-2009
CODE
All lots with expiry date through August 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz, Inc., Princeton, NJ, by letters on September 17, 2008 and November 3, 2008.
Manufacturer: Sandoz Inc., Wilson, NC. Firm initiated recall is ongoing.
REASON
Inadequate documentation and in-process controls such that product may not meet specifications through shelf life.
VOLUME OF PRODUCT IN COMMERCE
6,369,592 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Medical grade oxygen - compressed gas in portable aluminum cylinders sizes M-6 or B (164 L), C (255 L), D (425 L), and E (680 L), Recall # D-114-2009
CODE
Batch #30768 - 30774, 30776, 30777, 30779-30781, 30788, 30789, 30791 - 30795, 30802 - 30804, 30806, 30807, 30809 - 30814, 30817, 30820, 30823, 30825 -30830, 30832 - 30835, 30837, 30838, 30840 - 30844, 30848 - 30850, 30852, 30853, 30855 - 30860, 30862, 30863, 30865, 30867 - 30870, 30872 - 30876, 30878, 30880 - 30882, 30884, 30886, 30887, 30889 - 30893, 30897, 30899 - 30904, 30906, 30913, 30914, 30916, 30917, 30919, 30920, 30924 - 30926, 30929 - 30931, 30934, 30936 - 30941, 30943 - 30954, 30957 -30959, 30961 - 30963, 30965, 30970 - 30976, and 30978 - 30982
RECALLING FIRM/MANUFACTURER
Conroe Welding Supply, Inc, Conroe , TX , by telephone beginning August 12, 2008. Firm initiated recall is ongoing.
REASON
Medical grade oxygen tanks may be contaminated with small amounts of cleaning solution/degreaser resulting in an off odor and potential irritant.
VOLUME OF PRODUCT IN COMMERCE
2,816 cylinders
DISTRIBUTION
TX
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PRODUCT
Primidone Tablets, USP, 50mg, Rx only, 500 count; NDC 0603-5371-28, Recall # D-116-2009
CODE
Lot No: T081C07A
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals, LLC, Huntsville , AL , by letter on July 29, 2008 and letter dated July 31, 2008. Firm initiated recall is ongoing.
REASON
Subpotent; 12 month stability
VOLUME OF PRODUCT IN COMMERCE
3,449 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Quinapril Tablets, USP, 5 mg, 90 Tablets, Rx only, NDC 49884-992-09, Recall # D-120-2009;
b) Quinapril Tablets, USP, 10 mg, 90 Tablets, Rx only, NDC 49884-993-09, Recall # D-121-2009
CODE
All lots within expiry
RECALLING FIRM/MANUFACTURER
Recalling Firm: Par Pharmaceutical, Inc. Woodcliff Lake, NJ, by letters on July 21, 2008. Manufacturer: Actavis Totowa, LLC, Totowa, NJ. Firm initiated recall is ongoing.
REASON
McGMP Deviations (by mfr Actavis)
VOLUME OF PRODUCT IN COMMERCE
2 lots 5 mg, 15 lots 10 mg; 21,153 bottles of 90 count 5 mg and 171,894 bottles (90 count) of 10 mg
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Chlor-Trimeton Allergy, Chlorpheniramine maleate, 12mg, 10 tablets or 24 tablet Blister Packs, Recall # D-122-2009;
b) Drixoral Cold & Allergy, Dexbrompheniramine 6mg and Pseudoephedrine 120mg, Sustained Relief, maximum strength, 20 and 30 extended release tablets, blister packs, Recall # D-123-2009 CODE
a) Lot Number Exp. Date: 6-CTM-5 11/30/2008 6-CTM-5 11/30/2008 6-CTM-6 11/30/2008 7-CTM-1 01/31/2009 7-CTM-2 01/31/2009 7-CTM-3 03/31/2009 7-CTM-4 03/31/2009 7-CTM-4 06/30/2009 7-CTM-6 06/30/2009;
b) Lot Number Exp. Date: 6-DRT-26 07/31/2008 6-DRT-27 07/31/2008 6-DRT-28 07/31/2008 6-DRT-29 07/31/2008 6-DRT-31 10/31/2008 6-DRT-32 10/31/2008 6-DRT-33 10/31/2008 6-DRT-34 11/30/2008 6-DRT-35 12/31/2008 6-DRT-36 12/31/2008 6-DRT-37 12/31/2008 7-DRT-1 01/31/2009 7-DRT-2 01/31/2009 7-DRT-3 01/31/2009 7-DRT-4 01/31/2009 7-DRT-5 04/30/2009 7-DRT-6 04/30/2009 7-DRT-7 04/30/2009 7-DRT-8 04/30/2009 7-DRT-9 05/31/2009 7-DRT-10 05/31/2009 7-DRT-11 05/31/2009 7-DRT-12 05/31/2009 7-DRT-13 07/31/2009 7-DRT-15 08/31/2009 7-DRT-16 08/31/2009 7-DRT-17 09/30/2009 7-DRT-18 09/30/2009 7-DRT-20 09/30/2009 7-DRT-21 10/31/2009 7-DRT-22 10/31/2009 7-DRT-23 11/30/2009 7-DRT-24 11/30/2009 8-DRT-1 12/31/2009
RECALLING FIRM/MANUFACTURE
Recalling Firm: Schering-Plough HealthCare Products, Inc. Memphis, TN, by letters on July 28, 2008.
Manufacturer: Actavis Totowa, LLC, Totowa, NJ. Firm initiated recall is ongoing.
REASON
cGMP Deviations (by mfr Actavis)
VOLUME OF PRODUCT IN COMMERCE
40 lots
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Talwin NX Tablets, pentazocine and naloxone hydrochloride, USP, 50mg base/0.5mg base, Rx only, 100 tablet bottles; NDC 0024-1951-04, Recall # D-124-2009;
b) Kerlone Tablets, (betaxolol hydrochloride), 10 mg, Rx only, 100 tablet bottles, Sanofi-aventis/sanofi-synthelabo; NDC 0024-2301-10, Recall # D-125-2009;
c) Kerlone Tablets (betaxolol hydrochloride) 20 mg, Rx only, 100 Tablets, Sanofi-aventis/Sanofi-synthelabo; NDC 0024-2300-20, Recall # D-126-2009;
d) Talacen Tablets CIV, (pentazocine hydrochloride and acetaminophen), 25mg base/650mg base, Rx only, 100 tablets, Sanofi-Aventis; NDC 0024-1937-04, Recall # D-127-2009
CODE
a) b), and c) All lots within expiry; d) Batch # 70520A1, Exp. 10/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sanofi-aventis, US., LLC, Bridgewater, NJ, by letters on July 18, 2008 and July 22, 2008.
Manufacturer: Actavis Totowa, LLC, Totowa, NJ. Firm initiated recall is ongoing. REASON
cGMP Deviations (by mfr Actavis)
VOLUME OF PRODUCT IN COMMERCE
1 lot, 7351 bottles of Pentazocine HCL and APAP; 3 lots, 19526 bottles of Kerlone 10 mg; 2 lots, 7916 bottles of Kerlone 20 mg; 8 lots of Talwin NX
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
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PRODUCT
Senna Laxative (Standardized Senna Concentrate) sennosides 8.6 mg. per Tablets, OTC, Equaline brand, 250 tablets, NDC 41163-021-85, 100 tablets, NDC 41163-021-78 and 50 tablets, NDC 41163-021-71; Meijer brand, 100 tablets, NDC 41250-021-78; Hannaford brand, 100 tablets, NDC 41268-021-78; Healthy Generations brand, 100 tablets, NDC 38045-021-78; TopCare brand, 100 tablets, NDC 36800-021-78; GoodSense brand, 100 tablets, NDC 0113-0021-78; CareOne brand, 100 tablets, no NDC #; HyVee brand, 100 tablets, NDC 42507-021-78; Kroger brand, 100 tablets, NDC 30142-021-78; Longs brand, 100 tablets, NDC 12333-9611-1; and Sunmark brand, 100 tablets, NDC 49348-262-10, Recall # D-105-2009
CODE
Lots: 7CE0289, 7CE0792, 7DE0424, 7DE0426, 7DE0845, 7EE0058, 7EE0670, 7GE0066, 7GE0505, 7GE0982, 7HE0174, 7HE0528, 7JE0167, 7JE0528, 7JE0529, 7KE0559, 7LE0036, 7LE0535, 7LE0537, 7ME0269, 8AE0404, 8BE0070, 8BE0071, 8BE0087, 8BE0746, 8CE0043, 8CE0501, 8CE0502, 8DE0879, 8FE0141, 8FE0688, 8GE0279, 8GE0526, 8GE1213 and 8HE0263
RECALLING FIRM/MANUFACTURER
Recalling Firm: L. Perrigo, Co, Allegan, MI, by letter dated October 21, 2008.
Manufacturer: Time-Cap Labs, Farmingdale, NY. Firm initiated recall is ongoing.
REASON
Superpotent: senna concentrate
VOLUME OF PRODUCT IN COMMERCE
471,528 bottles
DISTRIBUTION
Nationwide
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PRODUCT
Propranolol Hydrochloride Injection, USP, 1 mg/mL, For intravenous use only, 10 x 1 mL Single Dose Vials, Rx only; NDC 0143-9872-01, Recall # D-106-2009
CODE
Lots: 082042.1 and 082142.2; Exp. 2/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: West-Ward Pharmaceutical Corp., Eatontown, NJ, by letters on November 12, 2008.
Manufacturer: Hikma Farmaceutica, Terrugem, Sintra, Portugal. Firm initiated recall is ongoing.
REASON
Propranolol HCL Injection, USP was found to exceed the pH specifications at the six month stability test station.
VOLUME OF PRODUCT IN COMMERCE
4,575 boxes (10 vials/box)
DISTRIBUTION
Nationwide
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PRODUCT
Liquid Barosperse® Barium Sulfate Suspension, Catalog No. 179312, Contents: 24 x 355 mL bottles, NDC 68240-325-24, RX. The label shows the product is Made in Mexico, Recall # D-107-2009
CODE
Lots: 805432-1 and 805432-2, Exp. 2011-May
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mallinckrodt Inc, Hazelwood, MO, letters on November 18, 2008.
Manufacturer: Mallinckrodt Medical S.A. de C.V., Mexico City, Mexico. Firm initiated recall is ongoing.
REASON
Shipping cartons labeled to as Liquid Barosperse® Barium Sulfate Suspension contain unlabeled bottles of the product.
VOLUME OF PRODUCT IN COMMERCE
209/24-bottle cases
DISTRIBUTION
Nationwide
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PRODUCT
PREMPRO® (conjugated estrogens/medroxyprogesterone acetate tablets) 0.3 mg/1.5 mg, Rx only, NDC 0046-0938-09. One carton contains 3 EZ-DIAL® Dispensers of 28 tablets each. One EZ-DIAL® Dispenser (NDC 0046-0938-08) contains 28 PREMPRO® Tablets containing 0.3 mg of the conjugated estrogens found in PREMARIN® & 1.5 mg of medroxyprogesterone acetate, Recall # D-112-2009
CODE
Lot: C75300 (exp July 2009)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Inc. Philadelphia PA, by letters dated November 20, 2008.
Manufacturer: Wyeth Pharmaceuticals, Inc., Rouses Point NY. Firm initiated recall is ongoing.
REASON
The lot does not conform to the dissolution specifications for conjugated estrogens as specified in the New Drug Application for PREMPRO.
VOLUME OF PRODUCT IN COMMERCE
23,788 cartons (3 dispensers/carton)
DISTRIBUTION
Nationwide
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PRODUCT
Tri-Legest Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 1 mg/20 mcg, 1 mg/30 mcg, 1 mg/35 mcg (norethindrone/ethinyl estradiol) and 75 mg ferrous fumarate tablets. 28 tablet blister pack, Packed 5 blisters per carton, Rx only, NDC 0555-9032-70, Recall # D-115-2009
CODE
Lot 700769 - Exp 01/09, Lot 700770 - Exp 02/09, Lot 700774 - Exp 02/09, Lot 305417 - Exp 06/09, Lot 701086 - Exp 06/09, Lot 701305 - Exp 12/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Barr Laboratories, Inc., Cincinnati, OH, by letters on November 10, 2008.
Manufacturer: Barr Laboratories, Inc., Pomona, NY. Firm initiated recall is ongoing.
REASON
A small amount of text was missing from the "Brief Summary Patient Package Insert" portion of the Combination Detailed Patient Labeling and Brief Summary Package Insert for the "Tri-Legest Fe 28" product. In the Brief Summary, under BEFORE YOU START TAKING YOUR PILLS, in statement #2, patients are instructed to LOOK AT YOUR PILL PACK TO SEE IF IT HAS 21 or 28 PILLS. Both the 21- and 28-day packs are then described. Both are identical for the first three weeks or 21 tablets (5 pink, 7 yellow and 9 blue tablets). It then states that in the 28 day pack, these are followed by 1 week of reminder brown pills (without hormones). Statement #3 in this section of the Brief Summary provides information on taking the pills and diagrams of the both the 21- and 28-day pill packs. This is where the text is missing. Next to the diagram for the 21-day pack the text reads: [Each Tri-Legest 21 tablet dispenser contains 5 light pink, 7 light yellow, and 9 light blue pills for WEEKS 1, 2, and 3. These tablets are to be taken in the following order one light pink tablet each day for five days, one light yellow tablet each day for seven days, and then one light blue tablet each day for nine days.] Next to the 28-day pack the section of text is missing. The missing section is 2 sentences long and reads exactly as the bracketed statement above except for the substitution of "Tri-Legest Fe 28" for "Tri-Legest 21" in the beginning, and the inclusion of the following phrase at the end: "and followed by one brown tablet each day for seven days." The diagram for the 28-day pack is presented next to the blank area of missing text.
VOLUME OF PRODUCT IN COMMERCE
116,494 cartons (5 blister packs/carton)
DISTRIBUTION
Nationwide
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PRODUCT
a) Cortamox Lotion (hydrocortisone/pramoxine HCL/chloroxylenol), 10mg,/10mg/1mg, 60 mL (2 fl oz) Rx Only, NDC 68032-206-02, Recall # D-117-2009;
b) IV Derm Lotion (hydrocortisone/pramoxine HCL/chloroxylenol), 10mg/10mg/1mg, 60 mL (2 fl oz) Rx Only, NDC 68047-0090-60, Recall # D-118-2009
CODE
a) Lot #: 07G011, F07A001;
b) Lot #: F07F074, F07G010, F07G074, F07J039
RECALLING FIRM/MANUFACTURER
Harmony Labs Inc., Landis, NC, by telephone and letters on/about August 5, 2008. Firm initiated recall is ongoing.
REASON
Subpotent; hydrocortisone
VOLUME OF PRODUCT IN COMMERCE
8,785 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Tussinal 12 Suspension, Orange Pineapple Flavor; Each teaspoonful (5mL) for oral administration contains: Hydrocodone Tannate 6mg, Phenylephrine Tannate 10mg, and Dexchlorpheniramine Tannate 2 mg, Rx only, 4 fl oz bottle, NDC 51674-0330-4 and 15mL physician samples NDC 51674-0330-5, Recall # D-119-2009
CODE
Lot #61028 and 61120
RECALLING FIRM/MANUFACTURER
Elge, Inc., Rosenberg, TX, by letter on July 15, 2008. Firm initiated recall is ongoing.
REASON
Subpotent; (Phenylephrine Tannate)
VOLUME OF PRODUCT IN COMMERCE
36,105 bottles, 282,090 samples
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
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PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0256-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0257-09;
c) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0258-09
CODE
a) 027KM25838 (Bag 1 and 2), 027KM26723 (Bag 1 and 2), 027KM26728 (Bag 1 and 2), 027GG32189 (Bag 1 and 2), 027FX38606 (Bag 1 and 2);
b) Units: 027KJ32309, 027KJ32313, 027KT05580, 027KM24977, 027KM24980, 027FY42550, 027FY42556, 027KV04883, 027KV04897, 027FY42693, 027KJ32906, 027KJ32912, 027KM25424, 027KM25444, 027KJ33174, 027KJ33177, 027FX36389, 027KJ33246, 027KF18344, 027KF18345, 027KF18351, 027KF18357, 027KF18368, 027KF18374, 027KN09424, 027KN09437, 027KN09449, 027KJ34833, 027KJ34859, 027KS05729, 027KS05741, 027KF05757, 027GG31844, 027GG31849, 027KM26765, 027GJ69637, 027KM27273, 027KS06536, 027KS06547, 027KM27415, 027KM27420, 027KW06610, 027S 83644, 027KM28083, 027KM28093, 027GW38966, 027GW38973, 027GW38979, 027GG32183, 027GG32186, 027GG32196, 027KT07492, 027KT07505, 027KM28470, 027KM28477, 027KM28521, 027KM28523, 027KM28530, 027KM28556, 027KM28557, 027KM28558, 027KM28647,027KM28667, 027KW07689, 027KW07742, 027KW07779, 027KW07785, 027KW07789, 027LQ37249, 027LQ37293, 027KM28953, 027KJ38267, 027KM29648, 027KM29679, 027KM29685, 027KF20111, 027KF20114, 027KF20121, 027KJ38416, 027KM30016, 027H 52184, 027H 52186, 027H 52188, 027H 52191, 027FX38620, 027FX38728, 027KN11425, 027KN11428, 027KS10874, 027KJ39624;
c) Units: 027KJ34541, 027KT06850, 027KM29984
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone and fax on June 6, 2008 and July 7, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
103 units
DISTRIBUTION
PA, WV, OH, VA, KY, MD, and NC
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
a) Axiom Artis dFC, Axiom Artis Modular Angiography X-Ray System, Model number 7412807, Recall # Z-0120-2009;
b) Axiom Artis dBC-M, Axiom Artis Modular Angiography X-Ray System, Model number 5917054, Recall # Z-0121-2009;
c) Axiom Artis dTA, Axiom Artis Modular Angiography X-Ray System, Model number 7008605, Recall # Z-0122-2009;
d) Axiom Artis dTC, Axiom Artis Modular Angiography X-Ray System, Model number 7413078, Recall # Z-0123-2009;
e) Axiom Artis dBA, Axiom Artis Modular Angiography X-Ray System, Model number 7555357, Recall # Z-0124-2009;
f) Axiom Artis dFC-M, Axiom Artis Modular Angiography X-Ray System, Model number 7727717, Recall # Z-0125-2009;
g) Axiom Artis dFA, Axiom Artis Modular Angiography X-Ray System, Model number 7555373, Recall # Z-0126-2009;
h) Axiom Artis dMP, Axiom Artis Modular Angiography X-Ray System, Model number 7555365, Recall # Z-0127-2009;
i) Axiom Artis dBC, Axiom Artis Modular Angiography X-Ray System, Model number 7728392., Recall # Z-0128-2009
CODE
a) Serial numbers: 34999, 35049, 35097, 35184, 35235, 35248, 35273, 35286, 35505, 35656, 35705, 35706, 35711, 35726, 35728, 35737, 35740, 35751, 35759, 35760, 35761, 35762, 35763, 35765, 35766, 35769, 35770, 35771, 35773, 35774, 35775, 35776, 35777, 35778, 35779, 35781, 35782, 35783, 35784, 35785, 35786, 35787, 35788, 35789, 35790, 35791, 35792, 35793, 35794, 35795, 35796, 35797, 35798, 35799, 35800, 35801, 35802, 35803, 35804, 35805, 35806, 35807, 35808, 35809, 35810, 35811, 35812, 35813, 35815, 35816, 35817, 35818, 35819, 35820, 35821, 35822, 35823, 35824, 35825, 35826, 35827, 35828, 35829, 35830, 35831, 35832, 35833, 35834, 35835, 35836, 35837, 35838, 35839, 35840, 35841, 35842, 35843, 35844, 35845, 35846, 35847, 35848, 35849, 35852, 35854, 35855, 35856, 35857, 35858, 35859, 35861, 35862, 35863, 35864, 35865, 35866, 35867, 35868, 35869, 35870, 35871, 35872, 35873, 35874, 35875, 35876, 35877, 35879, 35880, 35881, 35882, 35883, 35884, 35885, 35886, 35887, 35888, 35890, 35891, 35892, 37701, 37713, 37714, 37715, and 37716;
b) Serial numbers: 49001, 49008, and 49009;
c) Serial numbers: 55001, 55003, 55019, 55021, 55036, 55037, 55043, 55048, 55138, 55162, 55166, 55181, 55242, 55255, 55264, 55266, 55278, 55280, 55288, 55298, 55323, 55333, 55341, 55347, 55349, 55350, 55351, 55358, 55361, 55368, 55377, 55378, 55386, 55396, 55397, 55399, 55402, 55407, 55408, 55409, 55410, 55411, 55412, 55414, 55415, 55416, 55417, 55418, 55419, 55420, 55421, 55422, 55423, 55424, 55425, 55426, 55427, 55428, 55429, 55430, 55431, 55432, 55433, 55434, 55435, 55436, 55437, 55438, 55439, 55440, 55441, 55442, 55443, 55444, 55445, 55446, 55447, 55448, 55449, 55450, 55452, 55453, 55454, 55455, 55456, 55457, 55458, 55459, 55460, 55461, 55462, 55463, 55464, 55465, 55466, 55467, 55468, 55470, 55471, 55472, 55473, 55474, 55476, 55477, 55478, 55479, 55480, 55481, 55482, 55483, 55484, 55485, 55486, 55487, 55488, 55489, 55490, 55492, 55493, 55494, 55495, 55496, 55497, 55498, 55499, 55500, 55501, 55502, 55503, 55504, 55506, and 55507;
d) Serial numbers: 46129, 46189, 46190, 46206, 46208, 46209, 46210, 46211, 46212, 46213, 46214, 46215, 46216, 46217, 46218, 46219, 46220, 46221, 46222, 46223, 46224, 46225, 46226, 46227, 46228, 46229, 46230, 46231, 46232, 46233, 46234, 46235, 46236, 46237, 46238, 46239, 46241, 46242, 46243, 46244, 46245, 46246, 46248, 46249, 46250, 46251, 46253, 46254, and 46255;
e) Serial numbers: 53002, 53007, 53008, 53027, 53028, 53030, 53031, 53032, 53046, 53059, 53079, 53089, 53090, 53091, 53092, 53105, 53106, 53112, 53122, 53125, 53127, 53129, 53134, 53137, 53148, 53151, 53157, 53158, 53163, 53167, 53168, 53169, 53170, 53180, 53182, 53183, 53184, 53185, 53187, 53188, 53189, 53190, 53191, 53192, 53193, 53195, 53196, 53197, 53199, 53200, 53201, 53202, 53203, 53204, 53205, 53206, 53207, 53208, 53209, 53210, 53211, 53212, 53213, 53215, 53216, 53217, 53218, 53219, 53220, 53221, 53222, 53223, 53224, 53225, 53226, 53227, 53228, 53229, 53231, 53232, 53233, 53234, 53235, 53237, 53238, 53239, 53240, 53706, 53707, 53708, 53709, 53710, and 53711;
f) Serial numbers: 40000, 40061, 40062, 40063, 40064, 40065, 40066, 40067, 40069, 40070, and 40071;
g) Serial numbers: 50080, 50135, 50137, 50138, 50139, 50140, 50141, 50142, 50143, 50144, 50145, 50146, 50147, 501 48, 50149, 50151, 50152, 50153, 50154, 50155, 50156, 50157, 50158, 50159, 50160, 50161, 50163, 50164, 50165, 50166, 50167, 50169, 50170, 50171, 50172, 51708, 51709, 51710, 51711, 51712, and 51713;
h) Serial numbers: 57001, 57002, 57093, 57103, 57119, 57122, 57132, 57133, 57134, 57135, 57136, 57137, 57139, 57140, 57141, 57143, 57144, 57145, 57146, 57147, 57148, 57149, 57150, 57151, 57152, 57153, 57154, 57156, 57157, 57158, 57159, 57160, 57161, 57162, 571 63, 57164, 57165, 57166, 57167, 57168, 57169, 57170, 57171, 57172, 57173, 57174, 57175, 57177, 57178, 57179, 57181, 57182, 57183, 57184, 57185, and 57186;
i) Serial numbers: 44075, 44077, 44084, 44240, 44262, 44265, 44267, 44268, 44269, 44270, 44271, 44272, 44273, 44274, 44275, 44276, 44277, 44278, 44279, 44280, 44281, 44282, 44283, 44284, 44285, 44286, 44287, 44288, 44289, 44290, 44291, 44292, 44293, 44294, 44295, 44296, 44298, 44299, 44300, 44302, 44303, 44304, 44305, 44306, 44307, and 44308
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated August 29, 2008.
Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. Firm initiated recall is ongoing.
REASON
Incorrect contour finding: Image may be calibrated to the wrong size catheter.
VOLUME OF PRODUCT IN COMMERCE
577 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) PREMISE, Part No. 32650, 10 PACK UNIDOSE PREMISE A1, dental composite, Recall # Z-0229-2009;
2) PREMISE, Part No. 32651, 10 PACK UNIDOSE PREMISE A2, dental composite, Recall # Z-0230-2009;
3) PREMISE, PART NO. 32652, 10 PACK UNIDOSE PREMISE A3, dental composite, Recall # Z-0231-2009;
4) PREMISE, PART NO. 32653, 10 PACK UNIDOSE PREMISE A3.5, dental composite, Recall # Z-0232-2009;
5) PREMISE, PART NO. 32654, 10 PACK UNIDOSE PREMISE A4, dental composite, Recall # Z-0233-2009;
6) PREMISE, PART NO. 32655, 10 PACK UNIDOSE PREMISE B1, dental composite, Recall # Z-0234-2009;
7) PREMISE, PART NO. 32656, 10 PACK UNIDOSE PREMISE B2, dental composite, Recall # Z-0235-2009;
8) PREMISE, PART NO. 32657, 10 PACK UNIDOSE PREMISE B3, dental composite, Recall # Z-0236-2009;
9) PREMISE, PART NO. 32658, 10 PACK UNIDOSE PREMISE B4, dental composite, Recall # Z-0237-2009;
10) PREMISE, PART NO. 32659, 10 PACK UNIDOSE PREMISE C1, dental composite, Recall # Z-0238-2009;
11) PREMISE, PART NO. 32660, 10 PACK UNIDOSE PREMISE C2, dental composite, Recall # Z-0239-2009;
12) PREMISE, PART NO. 32661, 10 PACK UNIDOSE PREMISE C3, dental composite, Recall # Z-0240-2009;
13) PREMISE, PART NO. 32662, 10 PACK UNIDOSE PREMISE C4, dental composite, Recall # Z-0241-2009;
14) PREMISE, PART NO. 32663, 10 PACK UNIDOSE PREMISE D2, dental composite, Recall # Z-0242-2009;
15) PREMISE, PART NO. 32664, 10 PACK UNIDOSE PREMISE D3, dental composite, Recall # Z-0243-2009;
16) PREMISE, PART NO. 32665, 10 PACK UNIDOSE PREMISE D4, dental composite, Recall # Z-0244-2009;
17) PREMISE, PART NO. 32666, 10 PACK UNIDOSE PREMISE XL1, dental composite, Recall # Z-0245-2009;
18) PREMISE, PART NO. 32667, 10 PACK UNIDOSE PREMISE XL2, dental composite, Recall # Z-0246-2009;
19) PREMISE, PART NO. 32668, 10 PACK UNIDOSE PREMISE A2 OPAQUE, dental composite, Recall # Z-0247-2009;
20) PREMISE, PART NO. 32669, 10 PACK UNIDOSE PREMISE A3 OPAQUE, dental composite, Recall # Z-0248-2009;
21) PREMISE, PART NO. 32670, 10 PACK UNIDOSE PREMISE A3.5 OPAQUE, dental composite, Recall # Z-0249-2009;
22) PREMISE, PART NO. 32672, 10 PACK UNIDOSE PREMISE B1 OPAQUE, dental composite, Recall # Z-0250-2009;
23) PREMISE, PART NO. 32673, 10 PACK UNIDOSE PREMISE B2 OPAQUE, dental composite, Recall # Z-0251-2009;
24) PREMISE, PART NO. 32674, 10 PACK UNIDOSE PREMISE C2 OPAQUE, dental composite, Recall # Z-0252-2009;
25) PREMISE, PART NO. 32676, 10 PACK UNIDOSE PREMISE TRANS AMBER, dental composite, Recall # Z-0253-2009;
26) PREMISE, PART NO. 32677, 10 PACK UNIDOSE PREMISE TRANS GREY, dental composite, Recall # Z-0254-2009;
27) PREMISE, PART NO. 32678, 10 PACK UNIDOSE PREMISE TRANS CLEAR, dental composite, Recall # Z-0255-2009;
28) PREMISE, PART NO. 34086, 10 PACK UNIDOSE PREMISE A2 SAMPLE, dental composite, Recall # Z-0256-2009;
29) PREMISE, PART NO. 32811, 10 PACK UNIDOSE PREMISA A1 (INTERNATIONAL ONLY), dental composite, Recall # Z-0257-2009;
30) PREMISE, PART NO. 32812, 10 PACK UNIDOSE PREMISA A2 (INTERNATIONAL ONLY), dental composite, Recall # Z-0258-2009;
31) PREMISE, PART NO. 32813, 10 PACK UNIDOSE PREMISA A3 (INTERNATIONAL ONLY), dental composite, Recall # Z-0259-2009;
32) PREMISE, PART NO. 32814, 10 PACK UNIDOSE PREMISA A3.5 (INTERNATIONAL ONLY), dental composite, Recall # Z-0260-2009;
33) PREMISE, PART NO. 32815, 10 PACK UNIDOSE PREMISA A4 (INTERNATIONAL ONLY), dental composite, Recall # Z-0261-2009;
34) PREMISE, PART NO. 32817, 10 PACK UNIDOSE PREMISA B2 (INTERNATIONAL ONLY), dental composite, Recall # Z-0262-2009;
35) PREMISE, PART NO. 32818, 10 PACK UNIDOSE PREMISA B3 (INTERNATIONAL ONLY), dental composite, Recall # Z-0263-2009;
36) PREMISE, PART NO. 32822, 10 PACK UNIDOSE PREMISA C3 (INTERNATIONAL ONLY), dental composite, Recall # Z-0264-2009;
37) PREMISE, PART NO. 32823, 10 PACK UNIDOSE PREMISA C4 (INTERNATIONAL ONLY), dental composite, Recall # Z-0265-2009;
38) PREMISE, PART NO. 32824, 10 PACK UNIDOSE PREMISA D2 (INTERNATIONAL ONLY), dental composite, Recall # Z-0266-2009;
39) PREMISE, PART NO. 32830, 10 PACK UNIDOSE PREMISA DESTIN A3 (INTERNATIONAL ONLY), dental composite, Recall # Z-0267-2009;
40) PREMISE, PART NO. 32837, 10 PACK UNIDOSE PREMISA TRANSLUCENT AMBER (INTERNATIONAL ONLY), dental composite, Recall # Z-0268-2009;
41) PREMISE KIT, PART NO. 32612, UNIDOSE PREMISE MASTER KIT, dental composite, Recall # Z-0269-2009;
42) PREMISE KIT, Part No. 33882, Unidose Premise Mini Kit, dental composite, Recall # Z-0270-2009
CODE
1) Lot Number’s: 2981424, 3001270, 3001273, 3027780, and 3031654;
2) Lot Number’s: 2981427, 2990911, 2997977, 3001277, 3018924, 2983068, 2991212, 3001276, 3008211, 3018925, and 2990753;
3) Lot Number’s: 2989376, 2998295, 3027232, 3032714, 2979610, 2992904 3001278, 3032367, 2961138, 2999887, and 2994827;
4) Lot Number’s: 3001279, 3001280, 3027784, 3031663, and 3045735;
5) Lot Number’s: 300128, and 3031666;
6) Lot Number’s: 2981430, 3001285, 3001286, and 3001288;
7) Lot Number’s: 3001289, and 3001290;
8) Lot Number’s: 3001292, and 3001293;
9) Lot Number’s: 3001295, and 3001296;
10) Lot Number’s: 2999213, 2999888, 3001298, and 3032735;
11) Lot Number: 3001299;
12) Lot Number’s: 2999220, 3001301, 3001302, 3018174, and 3031244;
13) Lot Number’s: 3001304, 3001305, 3019086, and 3032740;
14) Lot Number’s: 3001306, 3001307, and 3001308;
15) Lot Number’s: 3001309, 3001311, and 3032745;
16) Lot Number’s: 2999264, and 3028525;
17) Lot Number’s: 3001312, 3001313, and 3009770;
18) Lot Number’s: 3001314, and 3027204;
19) Lot Number’s: 3001335, 3001336, and 3032769;
20) Lot Number: 3001338;
21) Lot Number: 3001339;
22) Lot Number’s: 3001341, and 3001342;
23) Lot Number: 3001343;
24) Lot Number’s: 3001345, and 3001346;
25) Lot Number’s: 3015352, and 3001330;
26) Lot Number: 3001332;
27) Lot Number’s: 3001334, and 3018923;
28) Lot Number: 2990913;
29) Lot Number’s: 3001316, and 3011566;
30) Lot Number’s: 3001318, and 3018916;
31) Lot Number’s: 3001320, and 3018915;
32) Lot Number’s: 3001322, and 3018914;
33) Lot Number’s: 3001323, and 3001324;
34) Lot Number: 3001326;
35) Lot Number: 3001327;
36) Lot Number: 3034871;
37) Lot Number: 3001328;
38) Lot Number: 3018912;
39) Lot Number: 3001351;
40) Lot Number’s: 3001347, and 3016070;
41) Lot Number’s: 3000205, and 3013662;
42) Lot Number’s: 2989348, 2993142, 2993144, 3004342, 3028177, 2993141, 2993143,
RECALLING FIRM/MANUFACTURER
Kerr Corporation, Orange, CA, by letter beginning September 8, 2008. Firm initiated recall is ongoing.
REASON
Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
VOLUME OF PRODUCT IN COMMERCE
22,478 packs
DISTRIBUTION
Nationwide, Australia, Canada, Hong Kong, Malaysia, Mexico and Singapore
___________________________________
PRODUCT
Uni-CP Compression Forceps (spreader); Non-sterile, R only, Catalog number: 339001ND, Intended to open the UNI-Compression Plate olive, which creates a compression, Recall # Z-0307-2009
CODE
Lot numbers: E6WS, E7UY and E86M
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corporation, Plainsboro, NJ, by letters on September 30, 2008. Manufacturer: NewDeal SA, Lyon, France. Firm initiated recall is ongoing.
REASON
Reports of the Uni-CP Compression Forceps breaking during the Compression of the Uni-CP plate.
VOLUME OF PRODUCT IN COMMERCE
90 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Axiom Luminos dRF with ST filter. Solid state x-ray imager (flat panel/digital imager). Model number 10252047. Universal fluoroscopic x-ray diagnostic system, Recall # Z-0326-2009;
b) Axiom Luminos dRF without ST filter. Solid state x-ray imager (flat panel/digital imager). Model number 10252048. Universal fluoroscopic x-ray diagnostic system, Recall # Z-0326-2009
CODE
a) Serial Numbers: 10017, 10044, and 10049;
b) Serial Number: 10046
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated August 2008.
Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. Firm initiated recall is ongoing.
REASON
Issue may occur where an intended movement of the joystick may unintentionally initiate an x-ray exposure.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
"LOCATOR Abudment for 5.7 Screw-Vent & Compatibles." Zest Anchors, Inc. Product is sold for use with any Zimmer Dental 5.7 mm diameter Tapered Screw-Vent Implant. The product is used with supra-gingival, universal hinge, resilient overdenture attachment for endosseous implants, Recall # Z-0298-2009
CODE
Product Codes: 8190 (1.0 mm), 8191 (2.0 mm), 8192 (3.0mm), 8193 (4.0mm), 8194 (5.0 mm) and 8195 (6.0mm)
RECALLING FIRM/MANUFACTURER
Zest Anchors, Inc., Escondido, CA, by letter on April 23, 2008. Firm initiated recall is complete.
REASON
The recall was initiated after the firm discovered through a customer complaint that the Locator Abutments for 5.7 Screw-vent & Compatibles do not fit properly in all sizes of the Zimmer Dental 5.7mm diameter Tapered Screw-Vent Implants (TSV6B8, TSV6B10, TSV6B11, TSV6B13, TSV6B16, TSV6H8, TSV6H10, TSV6H11, TSV6H13 and TSV6H16). The Locator Abutment bottoms out in the pilot hole of these implants causing up to a half millimeter gap between the seating surface of the Locator Abutment and the implant. This gap in the fit could allow bacteria to enter into the implant body, contaminating the implant, or allow screw loosening with the risk of abutment fracture.
VOLUME OF PRODUCT IN COMMERCE
996 units
DISTRIBUTION
Nationwide, Spain, Canada, Australia and South Africa
___________________________________
PRODUCT
a) Boston Scientific Easy Core" Biopsy System, 18 ga. x 10 cm, REF 43-452, UPN MOO1434521, Sterilized with ethylene oxide gas. UPN for inner pouch M001434520. Indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate, Recall # Z-0328-2009;
b) Boston Scientific Easy Core" Biopsy System, 15 ga. x 10 cm, REF 43-450, UPN M001434501, Sterilized with ethylene oxide gas . UPN for inner pouch M001434500 Indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate, Recall # Z-0329-2009;
c) Boston Scientific Easy Core" Biopsy System, 15 ga. x 15 cm, REF 43-451, UPN M001434511, Sterilized with ethylene oxide gas. UPN for inner pouch M001434510. Indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate, Recall # Z-0330-2009;
d) Boston Scientific Easy Core" Biopsy System, 18 ga. x 15 cm, REF 43-453 , M001434531, Sterilized with ethylene oxide gas. UPN for inner pouch M001434530. Indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate, Recall # Z-0331-2009;
e) Boston Scientific Easy Core" Biopsy System, 18 ga. x 21 cm, REF 43-454, UPN M001434541, Sterilized with ethylene oxide gas. UPN for inner pouch M001434540. Indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate, Recall # Z-0332-2009;
f) Boston Scientific Easy Core" Biopsy System, 15 ga. x 10 cm, REF 43-456, UPN M001434561, Sterilized with ethylene oxide gas. UPN for inner pouch M001434560. Indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate, Recall # Z-0333-2009;
g) Boston Scientific Easy Core" Biopsy System, 15 ga. x 15 cm, REF 43-457, UPN M001434571, Sterilized with ethylene oxide gas. UPN for inner pouch M001434570. Indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate, Recall # Z-0334-2009;
h) Boston Scientific Easy Core" Biopsy System, 18 ga. x 10 cm, REF 43-458, UPN M001434581, Sterilized with ethylene oxide gas. UPN for inner pouch M001434580. Indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate, Recall # Z-0335-2009;
i) Boston Scientific Easy Core" Biopsy System, 18 ga. x 15 cm, REF 43-459, UPN M001434591, Sterilized with ethylene oxide gas. UPN for inner pouch M001434590. Indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate, Recall # Z-0336-2009;
j) Boston Scientific Easy Core" Biopsy System, 18 ga. x 21 cm, REF 43-460, UPN M001434601, Sterilized with ethylene oxide gas. UPN for inner pouch M001434600. M001434601 43-460 Indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate, Recall # Z-0337-2009
CODE
a) Lot #’s: 11516922, 11532173, 11547760, and 11569929;
b) Lot #’s: 11524375 and 11535831;
c) Lot #’s: 11532167 and 11554902;
d) Lot #’s: 11520532, 11539484, 11579252, and 11642796;
e) Lot #’s: 11520676 and 11551300;
f) Lot #43-456;
g) Unit: 11546134;
h) Units: 11516921 and 11550539;
i) Units: 11518343, 11535832, and 11634771;
j) Unit: 11520769
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Maple Grove, MN, by letter dated October 21, 2008.
Manufacturer: Boston Scientific Corporation, Spencer, IN. Firm initiated recall is ongoing.
REASON
Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device.
VOLUME OF PRODUCT IN COMMERCE
3,808 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Fredrick’s Converse Retractor #5 F/O, Model Number: 01-0485. A fiber optic retractor used in plastic surgery procedures to retract tissue, Recall # Z-0415-2009
CODE
Lot #: 042408D08
RECALLING FIRM/MANUFACTURER
Biomet Microfixation, Inc., Jacksonville, FL, by letter dated October 24, 2008. Firm initiated recall is ongoin
REASON
Fiber optic cable is missing from the Frederick’s Converse Retractor.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR DECEMBER 3, 2008

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