FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and
Drug Administration,
U.S. Public Health Service, Department of Health and Human
Services. It contains information
on actions taken in connection with agency regulatory
activities.
August 25, 1999 99-34
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______
PRODUCT
Chinese Herb Radix Puerariae, in 1 and 3 pound plastic bags.
Recall #F-648-9.
CODE
None.
MANUFACTURER
Tsang Fook Kee Company G/F, Hong Kong.
RECALLED BY
Wah Po Trading, Inc., Brooklyn, New York, by letter, telephone
and press release on May 19, 1999. Completed field correction
(relabeling) resulted from sample analysis and follow-up by the
New York State Department of Agriculture and Markets.
DISTRIBUTION
New York.
QUANTITY
448 pounds were distributed.
REASON
Product contained undeclared sulfites.
________
PRODUCT
Medstar brand Apricots, in 7 ounce (200g) plastic containers.
Recall #F-649-9.
CODE
None.
MANUFACTURER
Etem Ozsoy, Izmir, Turkey (packer).
RECALLED BY
Lantev Distributing Corporation, Brooklyn, New York
(distributor), by telephone, letter, visit, and press release on
November 3, 1998. Completed field correction (relabeling)
resulted from sample analysis and follow-up by the New York
Department of Agriculture and Markets.
DISTRIBUTION
New York and New Jersey.
QUANTITY
317 cases (24 packages per case) were distributed.
REASON
Product contained undeclared sulfites.
________
PRODUCT
Clover sprouts and mixed sprouts containing clover sprouts,
packaged in 6 ounce plastic bags or clear plastic clamshell
containers: a) Clover Sprouts; b) Alfalfa and Clover Sprouts; c)
Clover and Radish Sprouts. Recall #F-651/653-9.
CODE
Product is not coded. Product distributed prior to 5/28/99 was
recalled.
MANUFACTURER
Dover Sales Company, Inc., Piedmont, Oklahoma (seed supplier).
RECALLED BY
Rainbow Sprouts, Grand Junction, Colorado (sprouter), by
telephone on May 28-29, 1999, and by press release issued by the
Colorado Department of Public Health and Environment on May 28,
1999. Firm-initiated recall complete.
DISTRIBUTION
Colorado and Utah.
QUANTITY
Undetermined.
REASON
Products were associated with an outbreak of Salmonella
Typhimurium in Colorado.
________
PRODUCT
Clover sprouts and mixed sprouts containing clover sprouts,
packaged in 5 pound, 2 pound and 6 ounce flexible bags:
a) Clover Sprouts; b) Alfalfa-Clover Sprouts; c) Clover-Radish
Sprouts (these may be labeled as Clover-Radish Zesty Sprouts).
Recall #F-654/656-9.
CODE
Not Coded. Product distributed between 5/18/99 and 5/28/99 was
recalled.
MANUFACTURER
Dover Sales Company, Inc., Piedmont, Oklahoma (seed supplier).
RECALLED BY
Valley Farms, Arvada, Colorado (sprouter), by telephone on May
28, 1999. Press release issued by the Colorado Department of
Public Health and Environment on May 28, 1999, followed by
letters dated June 1 and 2, 1999. Firm-initiated recall
complete.
DISTRIBUTION
Colorado.
QUANTITY
9,480 pounds was distributed.
REASON
Products were associated with an outbreak of Salmonella
Typhimurium in Colorado.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________
PRODUCT
Ceramic Mugs, 16 ounces, 8 different designs.
Recall #F-644-9.
CODE
Item #058305, UPC #01249532312.
MANUFACTURER
China Dongguan Chyuan Chen Ceramic Products Co., Donguan, China
RECALLED BY
CVS Pharmacy, Inc., Woonsocket, Rhode Island, by E-mail sent on
or about May 4, 1999, followed by hard copy on May 14, 1999.
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
25 cases (32 mugs per case) were distributed.
REASON
The mugs contain excessive levels of leachable lead.
________
PRODUCT
a) Royal Bakery Gourmet Crisps, Cheddar and Sour Cream, net
weight, 6.5 ounces; b) Royal Bakery French Crisps, Jalapeno and
Cheese, net weight 6.5 ounces. Recall #F-657/658-9.
CODE
Bakery does not apply a code. The product is manufactured for a
chain of Ukrops Supermarkets, who apply a "pull date" to the
products on receipt from the bakery. Pull date is 60 days.
MANUFACTURER
Royal Bakery, Richmond, Virginia.
RECALLED BY
Manufacturer, by telephone on July 16, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Virginia.
QUANTITY
Firm estimated that 30 units of each product remained on market
at time of recall initiation.
REASON
Product contain undeclared FD&C Yellow No. 6.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________
PRODUCT
Naproxen Tablets, USP, 500 mg, Rx in 500 tablet bottles.
NDC #0781-1165-05 (Naprosyn),. Recall #D-310-9.
CODE
Lot #105820 EXP 04/2002.
MANUFACTURER
Geneva Pharmaceuticals, Inc., Broomfield, Colorado.
RECALLED BY
Manufacturer, by letter on June 16, 1999. Firm-initiated recall
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
3,440 bottles were distributed.
REASON
Metal wire/particle contamination.
________
PRODUCT
1. AntiliriumÆ Injection (Physostigmine salicylate), 1 mg/mL, 2
mL ampules, under the Forest label
2. Artificial Tears Plus - Lubricant, Ophthalmic Solution,
(Polyvinyl Alcohol 1.4%) 15 mL bottle, under the following
labels: Steris, Rugby, Schein, Canada
3. Artificial Tears- Lubricant, Ophthalmic Solution, (Polyvinyl
Alcohol 1.4%) 15 and 30 mL bottles, under the following labels:
Steris, Scein, AARP Pharmacy Service
4. Ascorbic Acid Injection, (Preserved) 222 mg/mL, 30 mL
Multiple Dose Vial, under the following labels: Steris, Schein,
McGuff, Merit
5. Atropine Sulfate Opthalmic Solution, USP, 1%, 15 mL bottle,
under the following labels: Steris, Schein, The Butler Company
6. Vitamin B Complex 100 Injection (Thiamine Hydrochloride 100
mg), 30 mL multiple dose vials, under the following labels:
Steris, Merit, McGuff, Darby Group, Hyrex, Key Company
7. Betamethasone Sodium Phosphate Injection, USP 4 mg/mL
(equiv. to Betamethasone 3 mg/mL), 5 mL vials, under the
following labels: Steris, Schein, Darby UAD Laboratories
8. Brompheniramine Maleate Injection, USP, 10 mg/mL, 10 mL
Multiple Dose Vials, under the following labels: Steris, Schein,
Forest, Hyrex, Clint
9. Chlorpheniramine Maleate Injection, USP, 10 mg/mL, 10 mL
Multiple Dose Vials, under the Steris label
10. Cyanocobalamin Injection, USP, 100 mcg/mL, 30 mL Multiple
Dose Vials, under the following labels Steris, Moore, Rugby,
Goldline
11. Cyanocobalamin Injection, USP, 1000 mcg/mL, 10 and 30 mL
Multiple Dose Vials, under the following labels: Steris, Schein,
Moore, Rugby, Goldline, Carlisle, International Ethical Lab,
Major, URL, IDE Interstate, Generics of Puerto Rico, Keene,
Darby, Sorter Laboratories, Clint, Cytex, Schein Canada, Taro,
Key Company, McGuff, Merz, San Jose Surgical, Martin Surgical,
Besse, Forest, Wesley, Merit, Robar, CO Truxton, Legere, Stewart
Jackson
12. Dalalone D.P.Æ (Dexamethasone Acetate Injectable Suspension,
USP), 16 mg/mL, 1 and 5 mL vials, under the Forest label
13. Dalalone D.P.Æ (Dexamethasone Acetate Injectable Suspension,
USP), 8 mg/mL, 5 mL vials, under the following labels: Steris,
Schein, Moore, Rugby, Goldline, Major, URL, AF Hauser, Keene,
Darby, Clint, Insource, Allied Pharmaceutical Group, Merz
Pharmaceuticals, San
Jose Surgical, Martin Surgical Supply, Besse Medical, Forest,
Teregen Labs, Radford Therapeutics, Robar, Legere
Pharmaceuticals, Stewart Jackson
14. Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 5 mL
Multiple Dose Vials, under the following labels: Steris, Schein,
Moore, Rugby, Goldline, URL, Ace Surgical Supply, Clint, RW
Enterprise, Merz Pharmaceuticals, Forest Pharmaceuticals, Teregen
Labs, Legere, Cytex, Taro
15. Dexamethasone Sodium Phosphate Injection, USP, 10 mg/mL, 10
mL Multiple Dose Vials, under the following labels: Steris,
Schein, Clint, Robar
16. Dexamethasone Sodium Phosphate (Ophthalmic Solution, USP),
0.1% , 5 mL Squeeze Dropper Bottle, under the following labels:
Steris, Schein, Moore, Rugby, URL, Butler, Darby, Akorn, E
Fougera, Pharmascience, Dioptic Laboratories
17. Dexpanthenol Injection, 250 mg/mL, 30 mL Multiple Dose
Vial, under the following labels: Steris, McGuff, Merit
18. Diazepam Injection, USP, 5 mg/mL, 10 mL Multiple Dose Vial,
under the following labels: Steris, Schein, Moore, Darby,
Goldline, URL, Ace Surgical Supply, Western Medical Supply
19. Dicyclomine Hydrochloride Injection, USP, 10 mg/ml, 10 mL
Multiple Dose Vial, under the Schein label
20. Dicyclomine Hydrochloride Injection, USP, 20 mg / 2mL, 2 mL
vial, under the Steris and Schein labels
21. Dimenhydrinate Injection, USP, 50 mg/mL, 1 and 10 mL vials,
under the Steris and Schein labels
22. Diphenhydramine HCL Injection, USP, 50 mg/mL, 10 mL Multiple
Dose Vials, under the following labels: Steris, Schein, Moore,
Goldline, Schein Canada, Pharmascience
23. Diphenhydramine HCL Injection, USP, 10 mg/mL, 30 mL Multiple
Dose Vials, under the Steris, Schein, Darby labels
24. Dobutamine Injection, USP, 250 mg/20mL, 20 mL Single Dose
Vial, under the Schein label
25. Doxapram Hydrochloride Injection, USP, 20 mg/mL, 20 mL
Multiple Dose Vials, under the Steris and Schein labels
26. Estradiol Cypionate Injection, USP, 5 mg/mL, 10 mL Multiple
Dose Vial, under the following labels: Steris, Schein, Darby,
Goldline, Forest, Clint
27. Estradiol Valerate Injection, USP, 20 mg/mL, 10 mL Multiple
Dose Vial, under the Steris, Schein, Flint labels
28. Estradiol Valerate Injection, USP, 40 mg/mL, 10 mL Multiple
Dose Vial, under the Steris, Schein, Clint labels
29. Gentamicin Sulfate, Ophthalmic Solution, USP, 0.3%, 5 mL
Squeeze Dropper Bottle, under the following labels:
Steris, Schein, Darby, Moore, E Fougera, Schein Canada, Technilab
30. Garatec-Gentamicin Sulfate OTIC Drops, 0.3%, 5 mL Bottle,
under the Technilab label
31. Heparin Sodium Injection, USP, 5,000 Units/mL, 10 mL
Multiple Dose Vial, under the Steris, Schein, URL labels
32. Heparin Sodium Injection, USP, 10,000 Units/mL, 10 mL
Multiple Dose Vial, Under the Steris, Schein, Rugby labels
33. Hydrocortisone Acetate Suspension, USP, (for injection), 25
mg/mL, 10 mL vial, under the Steris, Schein, URL, Darby labels
34. Hydromorphone HCL Injection, USP, 10 mg/mL, 1 mL ampul,
under the Marsam Pharmaceutical label
35. Hydromorphone HCL Injection, USP, 50 mg/5mL, 5 mL ampul,
under the Marsam Pharmaceutical label
36. Hydroxyprogesterone Caproate Injection, USP, 250 mg/mL, 5 mL
Multiple dose vial, under the following labels: Steris, Schein,
Rugby, Hyrex, Wintec
37. Hydroxyzine Hydrochloride Injection, USP, 25 mg/mL, 10mL
Multiple Dose Vial, under the Steris and Schein labels
38. Hydroxyzine Hydrochloride Injection, USP, 50 mg/mL, 10mL
Multiple Dose Vial, under the following labels: Steris, Schein,
Moore, Rugby, Goldline, Darby, Clint
39. Levothyroxine Sodium for Injection, lyophilized, 200
mcg/vial, single dose vial, under the Schein label
40. Levothyroxine Sodium for Injection, lyophilized, 500
mcg/vial, single dose vial, under the Steris and Schein labels
41. Lidocaine Hydrochloride Injection, USP, 1%, 50 mL, Multiple
Dose Vial, under the following labels: Steris, Schein, Moore,
Rugby, Goldline, Darby, Clint, Forest, Teregen Labs, URL
42. Lidocaine Hydrochloride Injection, USP, 2%, 50 mL, Multiple
Dose Vial, Steris, Schein, Moore, Goldline, Darby, Clint, Forest,
Teregen
43. Lincomycin Hydrochloride Injection, USP, 300 mg/mL, 10 mL
Multiple Dose Vial, under the following labels: Steris, Moore,
Goldline, Darby, Clint, Llorens, Keene, Besse, Radford
Therapeutics, Martin Surgical Supply
44. Lorazepam Injection, USP, 2 mg/mL, 1 and 10 mL vials, under
the Marsam label
45. Lorazepam Injection, USP, 4mg/mL, 10 mL vial, under the
Marsam label
46. Meperidine Hydrochloride Injection, USP, 300 mg/30mL, 30 mL
Single Dose Vial, under the Schein label
47. Meperidine Hydrochloride Injection, USP, 50 mg/mL, 30 mL
Multiple Dose Vial, under the Steris and Schein labels
48. Meperidine Hydrochloride Injection, USP, 100 mg/mL, 20 mL
Multiple Dose Vial, under the Steris and Schein labels
49. Mepivacaine Hydrochloride Injection, USP, 1%, (10 mg/mL), 50
mL Multiple Dose Vial, under the Steris and Schein labels
50. Mepivacaine Hydrochloride Injection, USP, 2%, (20 mg/mL), 50
mL Multiple Dose Vial, under the Steris and Schein labels
51. Methylprednisolone Acetate Injection Suspension, USP, 20
mg/mL, 10 mL Multiple Dose Vial, under the Steris and Radford
labels
52. Methylprednisolone Acetate Injection Suspension, USP, 40
mg/mL, 5 and 10 mL Multiple Dose Vial, Steris, Schein, Moore,
Goldline, URL, Clint, San Jose Surgical, Besse, Forest, A&G
Pharmaceuticals, Radford Therapeutics, Merz Pharmaceutical,
Stewart Jackson Pharmaceutical, Darby Group
53. Methylprednisolone Acetate Injection Suspension, USP, 80
mg/mL, 5 mL Multiple Dose Vial, under the following labels:
Steris, Schein, Moore, Rugby, Goldline, URL, Hyrex, Keene, Clint,
Merz, San Jose Surgical, Besse, Forest, Radford, Legere, Stewart
Jackson
54. Methocarbamol Injection, USP, 100 mg/mL, 10 mL Single Dose
Vial, under the following labels: Steris, Schein, Univet Pharm,
Pharmascience, Brock Vet Supply
55. Morphine Sulfate Injection, USP, 15 mg/mL, 20 mL Multiple
Dose Vial, under the Steris and Schein labels
56. Neomycin and Polymyxin B Sulfates and Hydrocortisone, OTIC
Solution, USP, 10 mL Sterile bottle with Sterilized Dropper,
under the following labels: Steris, Schein, Moore, Parmed, Darby,
Teva, E Fougera, Robar, Generics of Puerto Rico, Teral Labs, Erva
Pharmaceuticals, Pedinol Pharmaceutical, Akorn, Marlop, URL
57. Neomycin and Polymyxin B Sulfates and Hydrocortisone, OTIC
Suspension, USP, 10 mL Sterile bottle with Sterilized Dropper,
under the following labels: Steris, Schein, Moore, Rugby,
Goldline, UAD Labs, E Fougera, Generics
of Puerto Rico, Teral Labs, URL, Akorn
58. Neomycin and Polymyxin B Sulfates Solution For Irrigation,
USP, 20 mL Multiple Dose Vial, under the Schein label
59. Neomycin Sulfate and Desamethasone Sodium Phosphate,
Ophthalmic Solution, USP, 5 mL Squeeze Dropper Bottle, under the
Steris, Schein, E Fougera labels
60. Neostigmine Methylsulfate Injection, USP, 1:2000 (0.5 mg/mL-
500 micrograms/mL), 10 mL Multiple Dose Vials, under the Steris
and Schein labels
61. Orphenadrine Citrate Injection, USP, 60 mg/2 mL, in 2 mL
Ampul, under the following labels: Steris, Schein, International
Ethical Lab, Cytex
62. Orphenadrine Citrate Injection, USP, 30 mg/mL, in 10 mL
vial, under the following labels: Steris, Schein, Deliz, Clint,
Forest
63. Phenylephrine Hydrochloride Injection, USP, 1% (10 mg/mL) 1
mL vial, Single Dose, under the Schein label
64. Pilocarpine Hydrochloride Ophthalmic Solution, USP, 1%, 15
mL Sterile Squeeze Bottle, under the following labels: Steris,
Schein, Butler, Schein Canada, Technilab
65. Pilocarpine Hydrochloride Ophthalmic Solution, USP, 2%, 15
mL Sterile Squeeze Bottle, under the following labels: Steris,
Butler, Schein Canada, Technilab, Dioptic
66. Pilocarpine Hydrochloride Ophthalmic Solution, USP, 4%, 15
mL Sterile Squeeze Bottle, under the Steris, Schein, Technilab
labels
67. Prednisolone Acetate Suspension, USP (Sterile), for
intramuscular and intra-articular injection, 25 mg/mL, 30 mL
Multiple Dose Vial, under the Steris Schein, and Forest labels
68. Prednisolone Acetate Injectable Suspension, USP (Sterile),
for intramuscular and intra-articular injection, 50 mg/mL, 10 and
30 mL Multiple Dose Vial, under the following labels: Steris,
Schein, Forest, Darby, Goldline
69. Prednisolone Sodium Phosphate Ophthalmic Solution, USP,
1/8%, 5 mL Squeeze Dropper Bottle, under the Steris, Schein, and
Akorn labels
70. Prednisolone Sodium Phosphate Ophthalmic Solution, USP, 1%,
5, 10 & 15 mL Squeeze Dropper Bottles, under the following
labels: Steris, Schein, Akorn, E Fougera, Butler
71. Prochlorperazine Edisylate Injection, USP, 5 mg/mL, 10 mL
Multiple Dose Vial, under the Steris and Schein labels
72. Progesterone Injection, USP, 50 mg/mL, 10 mL Sterile
Multiple Dose Vial, under the following labels: Steris, Schein,
Moore Rugby, Goldline, Paddock, Eveready, URL, Cytex, Germiphene
73. Pyridoxine Hydrochloride Injection, USP, 100 mg/mL, 10 and
30 mL Multiple Dose Vial, Steris, Schein, McGuff, Merit, Key
Company, Legere, Kripps Pharmacy
74. Pentamidine Isethionate for Injection, 300 mg, Lyophilized,
Single Dose Vial, under the following labels: Marsam, Pasadena
Research Labs
75. Sulfacetamide Sodium and Prednisolone Sodium Phosphate
Ophthalmic Solution, 10% / 0.25%, 5 and 10 mL Squeeze Dropper
Bottle, under the following labels: Steris, Schein, E Fougera
76. Sulfacetamide Sodium Ophthalmic Solution, USP, 10 %, 15mL
Squeeze Dropper Bottle, under the Forest label
77. SUS-PHRINEÆ (epinephrine 5 mg/mL ) Injectable Suspension,
1:200 , 0.3 mL/Sterile ampul and 5 mL Multiple Dose Vial, under
the Forest label
78. Testosterone Cypionate-Estradiol Injection, 50 mg/2mg/mL, 10
mL Multiple Dose Vial, under the Steris, Schein, and Forest
labels
79. Testosterone Cypionate Injection, USP, 100 mg/mL, 10 mL
Multiple Dose Vial, under the following labels: Steris, Schein,
Goldline, Schein Canada, Cytex
80. Testosterone Cypionate Injection, USP, 200 mg/mL, 10 mL
Multiple Dose Vial, under the following labels: Steris, Schein,
Darby, Rugby, Goldline, Star, URL
81. Testosterone Enanthate-Estradiol Valerate Injection, 90 mg/
4 mg per mL, 10 mL Sterile Multiple Dose Vial, under the Steris
and A&G Pharm labels
82. Testosterone Enanthate Injection, USP, 200 mg/mL, 10 mL
Multiple Dose Vial, under the following labels: Steris, Schein,
Rugby, Forest, Darby, URL, Pharmascience, Taro
83. Testosterone Injection, USP, 100 mg/mL, 30 mL Multiple Dose
Vial, under the following labels: Steris, Schein, Univet,
Vetoquinol Canada, Brock Veterinary Supply
84. Testosterone Propionate Injection, USP, 100 mg/mL, 10 mL
Multiple Dose Vial, under the following labels: Steris, Schein,
Goldline, URL, Cytex, Taro, Germiphene
85. Thiamine Hydrochloride Injection, USP, 100 mg/mL, 30 mL
Sterile Multiple Dose Vial, under the Steris, McGuff and Merit
labels
86. Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL, Squeeze
Dropper Bottle, under the Steris, Schein, and E Fougera labels
87. TacÆ-3 Injectable Suspension (Triamcinolone Acetonide) 3
mg/mL, 5 mL Multi-dose vial, under the Parnell and Allergan
labels
88. Triamcinolone Acetonide Injectable Suspension, USP, 40
mg/mL, 1 and 5 mL vials, under the following labels: Steris,
Schein, Goldline, RW Enterprise, Schein Canada, Moore, Rugby,
URL, Major, Teregen, Clint, Besse, San Jose Surgical, Robar,
Forest, Darby, Legere, AF Hauser, CO Truxton, Merz, Cytex
89. Triamcinolone Diacetate Injectable Suspension, USP, 40
mg/mL, 5 mL Multiple Dose vials, under the following labels:
Steris, Schein, Moore, Rugby, Goldline, URL, Keene, Carlisle,
Clint, Besse, San Jose Surgical, Darby, Forest, Quality Research
Pharmaceuticals, Stewart Jackson Pharmaceutical, Hyrex, CO
Truxton, Wintec, Mayrand, Taro
Legere, Merz, Forest
90. Trifluridine Ophthalmic Solution, 1%, 7.5 mL Squeeze Dropper
Bottle, under the Schein label
91. Trimethobenzamide Hydrochloride Injection, USP, 100 mg/mL,
20 mL vial, under the Steris and Schein labels
92. Heparin Sodium Injection, USP, 20,000 Units/mL, 5 mL
Multiple Dose vial, under the Steris, Schein, and Rugby labels
93. Nandrolone Decanoate Injection, USP, 50 mg/mL, 2 mL Multiple
Dose Vials, under the Steris and Schein labels.
Recall #D-311/403-9.
CODE
Lot numbers:
1. 96N690, 97F720, 97M430, 98C350
2. 97D180, 97G520, 97J831, 97M300
3. 97A070, 97A730, 97B370, 97B650, 97B660, 97B870, 97C040,
97C681, 97C820, 97D200, 97D300, 97D340, 97D421, 97D430, 97B650,
97B660
4. 96F150, 96L590, 97B290, 97D090, 97J900, 98B800, 98E290
5. 97A520, 97B590, 97G470, 97G680, 97G681
6. 97B890, 97C880, 97C890, 97G530, 98A700, 98A710
7. 97B700
8. 97F080, 97L020
9. 96G970
10. 96F910
11. 96C240, 96F800, 96H640, 96J470, 96N760, 96A080, 97D050,
97D630, 97K240, 97K241, 97M240, 97M241, 96C410, 96E410, 96F160,
96H240, 96H410, 96J070, 96K920, 96L780, 96L940, 96N380, 96N381,
97A060, 97B720, 97C800, 97D220, 97D690, 97F820, 97G310, 97J580,
98A691
12. 97B740, 98C631 ,96B720, 96D110, 96F351, 96L681, 97B741,
97F090, 97M100, 98C630
13. 97A420, 97A930, 97C130, 97C690, 97E190, 97K610, 97L010,
97L140, 97L970,
98A280, 98A890, 98B930
14. 97G281, 97L161, 98E021
15. 97G510
16. 97A260, 97B940, 97H850, 97D280, 97F490, 97F741, 97G750,
97J220, 97J221, 97K930, 97M380, 98A790
17. 97B840, 97M220, 98A180
18. 97B100, 97C910, 97D460, 97D461, 97E130, 97F300, 97H940,
97L310, 98A220,
98A221, 98A900, 98A901, 98B950
19. 97F060 and 97J270
20. 97A160, 97C720, 97G721, 97H890, 97H891, 98A050
21. 97D450, 97H310, 98A020, 98E270, 98E271, 97B970, 97F140
22. 97A660, 97B020, 97B540, 97C180, 97F310, 97F330, 97F331,
97J160,
97K100, 97K320, 97K620, 97L380, 98B320, 98D780
23. 97C140 and 97J310
24. 97C400 and 98C810
25. 98A510 and 97C120
26. 96E840, 96G980, 97C230, 97F410, 97L930, 98B200
27. 96J250, 97F101, 97J420
28. 96B410, 96J370, 97M060
29. 97A900, 97A901, 97B310, 97D680, 97E120, 97G440, 97C850
30. 97C850
31. 97E390
32. 97F320 and 97G500
33. 96C120, 96L430, 96N540, 98A210, 98D430
34. 97D790 and 98A090
35. 97A680, 97B130, 97B140, 97C990, 97J170
36. 97M180, 97H370, 96C090
37. 96G920 and 97D410
38. 96E740 and 97B900
39. 96C310, 96C970, 96D910, 96L050, 96L100, 97B640, 97C630
40. 96J050 and 97C360
41. 96A560, 96A980, 96C080, 96C530, 96D050, 96E150, 96G730,
96K270, 96L420, 97B350, 97C840, 97F940
42. 97F130, 97A410, 96B370, 96D180, 96E160, 96J880, 97B610
43. 97A430, 97A690, 97A860, 97C830, 97F460, 97G770, 97J230,
97J550, 97M230, 98C810
44. 97B730, 97C450,97B731
45. 97A380
46. 97A170, 97C050, 97C240, 97D590, 97E210, 97F250, 97F260,
97J950, 97J960,
98B130, 98C010
47. 97G190 and 97J630
48. 97A190
49. 97D970, 97G130, 97H960, 97M280, 98B830
50. 97B260, 97G260, 97K730, 98B870, 98B880, 98D190
51. 97L300 and 97M450
52. 97A590, 97A910, 97F200, 97F201, 97H590, 97J430, 97J540,
97L510, 97B580, 97F420, 97K420, 97K490, 97M140, 98B300
53. 97A810, 97C870, 97H930, 97H931, 97J290, 97L440, 97M030,
98B520, 98B960
54. 97F480
55. 97B9890 and 97D841
56. 96A360, 96A490, 97A090, 97A640, 97A870, 97C030, 97D710,
97D711, 97E030, 97E580, 97E581, 97E590, 97E670, 97E671, 97E920,
97E921, 97F910, 97F911, 97G160, 97G161, 97H050, 97H051, 97H430,
97H431, 97H510, 97H630, 97H631, 97J400, 97J490, 97J910, 97K150,
97K410, 97L130, 97L390, 97M370, 98B400, 98B470, 98B840, 98B910,
98B911, 98C130, 98C320, 98C510, 98C512
57. 97A500, 97A560, 97A580, 97A600, 97A610, 97A700, 97A790,
97A800, 97A960, 97A970, 97B040, 97B050, 97B750, 97B760, 97B761,
97B850, 97B860, 97B920, 97B930, 97C100, 97C110, 97C160, 97C170,
97C920, 97C930, 97D030, 97D040, 97D880, 97D891, 97D930, 97D940,
97E060, 97E070, 97E170, 97E180, 97E240, 97E250, 97E350, 97E351,
97E360, 97E630, 97E640, 97E710, 97E720, 97E730, 97E740, 97E750,
97E751, 97E760, 97E770, 97E780, 97E790, 97E800, 97E810, 97E820,
97F920, 97G030, 97G040, 97G080, 97G090, 97G360, 97G370, 97G860,
97G870, 97G930, 97H080, 97H090, 97H160, 97H410, 97H420, 97H440,
97H450, 97H470, 97H480, 97H540, 97H550, 97H650, 97H660, 97H661,
97H920, 97H921, 97J440, 97J450, 97J790, 97J800, 97J810, 97K010,
97K170, 97K180, 97K220, 97K221, 97K230, 97K300, 97K310, 97L060,
97L070, 97L170, 97L180, 97L181, 97L340, 97L350, 97L420, 97L430,
97M050, 97M150, 98A400, 98A410, 98A730, 98A740, 98A741, 98B220,
98B230, 98B430, 98B440, 98B660, 98B850, 98B851, 98B860, 98C180,
98C190, 98C401, 98C402, 98C410, 98C411, 98C480, 98C550, 98C600,
98C820, 98C821, 98D120, 98D160, 98D170, 98D220, 98D230, 98D320,
98D330, 98D400, 98D410, 98D412, 98D490, 98D491, 98D550, 98D640,
98E160, 98E200, 98E201, 98E330, 98E420
58. 96F420, 96H870, 97C330, 98A360, 98B150
59. 97A710 and 97H320
60. 96D290
61. 96G600, 96H960, 96J940, 97A950, 97D100, 97D650, 97E550,
97E600, 97J080, 97L580, 97M250, 98A290, 98A840, 98C040
62. 96A200, 96B070, 97B300, 97F900
63. 96A870, 96C280, 96D940, 96H990, 96L270, 97B080, 97B800,
97C420, 97E990, 97G760, 97G960, 97H820, 97H910
64. 97D380 and 97K500
65. 97C190
66. 97B401
67. 96D140, 96N290, 97B410, 97D230
68. 96M630, 96B670, 96E260, 96L540, 96M640, 97B490, 97C980,
97L650
69. 97M260
70. 97H330, 97L810, 98A820, 97L740, 97L610, 98A040
71. 97B060, 97B770, 97D210, 97D211, 97E440, 97E450, 97F120,
97F190, 97G850, 97L410, 98A540
72. 97D020, 97F070, 97F450, 97H060, 97H770, 97J120, 98A390,
98B710
73. 97E100, 97E101, 98D890, 97A480, 97F351, 98B280, 98B290
74. 97B520, 97K640, 97L250, 97L520, 98E800, 98A480
75. 97K360, 97K450, 97L840, 97L940, 97L950, 98A880, 97K340,
97L950, 98A960, 98B590
76. 97A980, 97B420, 97C750, 97E230
77. 97M040, 96N400. 97K480, 98B240
78. 97F360
79. 96E830, 96N630, 97K120
80. 96C050, 96F970, 96H930, 96K130, 96M050, 97C900, 97E040,
97F770, 97H530, 97K680, 97K681, 98A130
81. 97F290
82. 96A160, 96H300, 96K320, 96K510, 97E310, 97E490, 97G550,
97G900, 97L030, 98A760, 98B970, 98D390
83. 96J990, 96M040, 97F850, 97J970, 97L150, 97L600, 98B410
84. 96E062, 96K430, 97C760, 97K590, 97L980, 98C460
85. 97B480 and 97C410
86. 97C950, 97F240, 97H300, 97L050, 97L720, 98A860, 98A870
87. 96B600, 97E500, 98A770
88. 97D830, 97D831, 97F830, 97J340, 97K670, 97K160, 98A330,
98B700, 98C370, 98C720, 98D090, 97A250, 97B360, 97D800, 97D810,
97D820, 97F270, 97F831, 97G050, 97J330, 97J341, 97K161, 97K540,
97K671, 97M170, 97M410, 98A331, 98B271, 98B701, 98C200, 98C371,
98C560, 98C721, 98D091, 98D210, 98D470, 98D310
89. 96A640, 96B490, 96C360, 96C470, 96D340, 96E390, 96H050,
96J730, 96M460, 97B830, 97E080, 97F500, 97K660, 98E360, 98B490,
98B940
90. 97C300, 97F030, 97F370, 97F620, 97G340, 97H840, 98A850,
98D240
91. 96D020, 97D260
92. 96D020, 97D260
93. 97F890, 97J620.
MANUFACTURER
Steris Laboratories, Phoenix, Arizona.
RECALLED BY
Manufacturer, by letters on February 19, 1999, and April 1, 1999.
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
Number of vials or units distributed:
1) 230,412 vials; 2) 35,012 vials; 3) 389,970 15-ml bottles and
34,337 30-ml bottles; 4) 159,381 vials; 5) 66,529 bottles; 6)
131,795 vials; 7) 78,126 vials; 8) 32,374 vials;
9) 13,450 vials; 10) 29,990 vials; 11) 1,244,548 10-ml vials and
1,088,261 30-ml vials; 12) 64,210 1-ml and 363,968 5-ml vials;
13) 1,118,536 vials; 14) 97.821 vials; 15) 31,960 vials; 16)
386,874 vials; 17) 10,970 vials; 18) 713,274 vials; 19) 70,527
vials; 20) 569,200 vials; 21) 973,200 1-ml vials and 102,529 10-
ml vials; 22) 336,186 vials; 23)48,926 vials; 24) 87,824 vials;
25) 13,068 vials; 26) 210,813 vials; 27) 127,826 vials; 28)
107,441 vials; 29&30) 449,494 vials; 31) 10,018 vials; 32) 17,058
vials; 33) 78,638 vials; 34) 163,090 ampuls; 35) 139,070 ampuls;
36) 96,192 vials;
37) 45,361 vials; 38) 136,607 vials; 39) 82,786 vials;
40) 28,794 vials; 41) 338,345 vials; 42) 173,074 vials;
43) 311,675 vials; 44) 65,512 (1 ml) and 4,901 (10 ml) vials; 45)
1,591 vials; 46) 98,145 vials; 47) 17,775 vials; 48) 8,643 vials;
49) 147,894 vials; 50) 111,133 vials;
51) 33,620 vials; 52) 484,679 (5 ml) and 202,836 (10 ml) vials;
53) 683,697 vials; 54) 94,269 vials; 55) 47,769 vials; 56)
2,811,407 bottles; 57) 5,730,538 bottles;
58) 48,995 vials; 59) 119,418 vials; 60) 6,727 vials;
61) 1,347,045 ampuls; 62) 139,521 vials; 63) 1,685,494 vials; 64)
43,929 vials; 65) 35,018 bottles; 66) 28,874 bottles; 67) 54,170
vials; 68) 16,984 (10 ml) and 83,115 (30 ml) vials; 69) 18,057
bottles; 70) 67,234 (5 ml), 30,933 (10 ml) and 28,277 (15 ml)
bottles; 71) 210,270 vials;
72) 534,974 vials; 73) 78,350 (10 ml) and 161,085 (30 ml) vials;
74) 40,581 vials; 75) 167,238 (5 ml) and 68,219 (10 ml) bottles;
76) 141,019 bottles; 77) 188,280 (0.3 ml) and 15,057 (5 ml)
vials; 78) 12,619 vials; 79) 115,140 vials; 80) 745,750 vials;
81) 14,773 vials; 82) 409,785 vials;
83) 36,590 vials; 84) 229,098 vials; 85) 34,072 vials;
86) 280,424 bottles; 87) 338,524 vials; 88) 892,567 (1 ml) and
1,568,078 (5 ml) vials; 89) 1,065,376 vials;
90) 142,586 bottles; 91) 45,948 vials; 92) 24,721 vials;
93) 20,740 vials
REASON
Lack of sufficient data from an adequately validated laboratory
test method to assure products meet all regulatory requirments;
including but not limited to: methods validation and potency.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________
PRODUCT
Allegra-DÆ Extended Release Tablets (Fexofenadine HCL 60 mg and
Pseudoephedrine HCL 120 mg), in physician (6ís) samples, 30 and
100 tablet bottles/blister strips, Rx, for the relief of symptoms
associated with seasonal allergic rhinitis. Recall #D-309-9.
CODE
Lot #98069654, EXP 7/99 - 100-tablet blister strip boxes (10/10-
tablet strips), NDC #0088-1090-49
Lot #98069082, EXP 7/99 - 30-tablet physician sample bottles, no
NDC number
Lot #98071706, EXP 8/99 - 30-tablet physician sample bottles
Lot #98071693, EXP 8/99 - Physician blister samples, no NDC
number
Lot #98071987, EXP 8/99 - Physician blister samples
Lot #98073257, EXP 9/99 - 100-tablet bottles,
NDC #0088-1090-47
Lot #98073353, EXP 9/99 - 100-tablet bottles
Lot #98073354, EXP 9/99 - 100-tablet bottles
Lot #98072117, EXP 10/99 - Physician blister samples
Lot #98072972, EXP 10/99 - Physician blister samples
Lot #98073503, EXP 10/99 - Physician blister samples
Lot #98073641, EXP 10/99 - 100-tablet bottles
Lot #98073642, EXP 10/99 - 100-tablet bottles
Lot #98073920, EXP 10/99 - 100-tablet bottles
Lot #98074492, EXP 11/99 - 100-tablet bottles.
MANUFACTURER
Hoechst Marion Roussel, Inc., Kansas City, Missouri.
RECALLED BY
Manufacturer, by voice mail, E-mail and letter faxed on May 17,
1999, and second E-mail on May 20, 1999, followed by telephone on
May 28, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
The firm has distributed the following amounts of product:
100-tablet blister strip boxes - 5,326 boxes between
3/5/98-12/22/98
30-tablet bottles (physician samples) - 62,514 bottles between
2/13/98-11/3/98
Physician blister samples - 129,264 boxes containing 8/3-day
starter boxes between 4/3/98-5/27/98
100-tablet bottles - 90,676 bottles between 4/27/98-6/22/98.
REASON
Dissolution rate failure.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________
PRODUCT
AngioCOMM Workstation (previously StatVIEW)
1. AngioCOMM Review Station reviews and analyzes angiographic
injection image sequences acquired by the Network Interface
Station or by downloading DICOM studies from a CD-ROM:
a) AngioCOMM Single Sequence Review Station;
b) AngioCOMM Mobile Review Station;
2. AngioCOMM Network Interface Station (NIS) provides the
capability to capture, review, and archive coronary injection
sequence images from an x-ray system in the cath lab:
c) AngioCOMM Single Sequence Network Interface Station, Pentium
Pro
d) AngioCOMM Single Sequence NIS Pentium.
Recall #Z-1116/1119-9.
CODE
a) Catalog #00406-003, Serial #s 901130, 901171, 931143
b) Catalog #00411-001, Serial #s 107, 109
Catalog #00411-003, Serial #s 101, 102, 103, 143, 145
Catalog #00411-005, Serial #101
c) Catalog #00429-001, Serial #s 101, 104
Catalog #00429-003, Serial #s 143, 144, 154
d) Catalog #31740-001, Serial #s 901169, 901170.
MANUFACTURER
Quinton Instrument Company, Bothell, Washington.
RECALLED BY
Manufacturer, by telephone, followed by letter dated June 28,
1999. Firm-initiated field correction complete.
DISTRIBUTION
Alabama, New York, Texas, West Virginia, Washington state.
QUANTITY
11 Review Stations and 7 Sequence NIS Stations were distributed.
REASON
Under certain specific circumstances, sequences of a single plane
study may overlap sequences of bi-plane study when viewing both
on the AngioCOMM Single Sequence Review Station or the Single
Sequence Network Interface Station (NIS).
________
PRODUCT
Light Handle Covers, single use cover for OR light handles to
maintain sterility during OR procedures, sold in single and
multi-packs and as a component in surgical trays.
Recall #Z-1146-9.
CODE
116 lots manufactured from 4/1/99 to 6/25/99.
MANUFACTURER
Atlanta Thermoplastics, Tucker, Georgia.
RECALLED BY
Deroyal Surgical, Rose Hill, Virginia, by letter on June 25,
1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
631,000 covers were distributed.
REASON
Surgical device cover on handle may come off and compromise
sterility during surgery.
________
PRODUCT
Hoyer Power Lifter Actuators, a 12 volt DC electromechanical
device marketed as a component of several patient lifting
devices, part of a retrofit kit for unpowered patient lifting
devices or as a stand alone component:
a) Model No. 59105, Retro-fit Power Conversion Kit;
b) Model No. 53005, Power Partner Lifter;
c) Model No. 53006, Power Partner Stand-Assist Hoyer Lifter;
d) Model No. P-C-HLA, Power Chrome Lifter;
e) Model No. 400-2543 - Assigned to kit that includes the
motor/ballscrew assembly, the battery charger and the hand
control;
f) Model No. 400-2546 - assigned to the motor/ballscrew assembly
(Actuator only);
g) Model No. 400-2384, Replacement Battery Pack.
Recall #Z-1147/1153-9.
CODE
All serial numbers.
MANUFCTURER
Scanac of Sweden acquired in 1998 by Warner Electric, AB,
Partille, Sweden.
RECALLED BY
Sunrise Medical Home Healthcare Group, Inc., Chula Vista,
California, by letter sent on May 14, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide, Puerto Rico, Thailand.
QUANTITY
1,803 units, representing the actuators, were shipped. The
actuators were situated in finished products.
REASON
A short circuit in the system will cause the batteries to
discharge, resulting in the generation of heat which may cause
fire, fumes, smoke or loss of power.
________
PRODUCT
Bennett Contour2, Stereotactic Ready Mammography Machine, an x-
ray device. Recall #Z-1209-9.
CODE
BMC-27993 BMC-27915 BMC-28168 BMC-27920
BMC-27837 BMC-28042 BMC-28128 BMC-27809
BMC-27973 BMC-28000 BMC-28054 BMC-28151
BMC-28231 BMC-27990 BMC-27831 BMC-28051
BMC-28136 BMC-27768 BMC-27944 BMC-27996
BMC-28050 BMC-27987 BMC-27823 BMC-27759
BMC-28118 BMC-27896 BMC-27936 BMC-27931
BMC-27754 BMC-27889 BMC-27600 BMC-27801
BMC-27841 BMC-27842 BMC-27803 BMC-27739
BMC-27927 BMC-27985 BMC-27771 BMC-27741
BMC-27942 BMC-28141 BMC-28183 BMC-27904
BMC-28223 BMC-27871 BMC-27998 BMC-27637
BMC-28187 BMC-27828 BMC-28182 BMC-27772
BMC-27848 BMC-28190 BMC-27914 BMC-28005
BMC-28046 BMC-27762 BMC-28230 BMC-28109
BMC-28110 BMC-27943 BMC-28094 BMC-28052
BMC-28176 BMC-27611 BMC-28098 BMC-28099
BMC-28185 BMC-27850 BMC-27855 BMC-27925
BMC-27834 BMC-28063 BMC-27846 BMC-28019
BMC-28116 BMC-28126 BMC-28133 BMC-28134
BMC-28188 BMC-28253 BMC-28219 BMC-28224
BMC-27909 BMC-27961 BMC-27962 BMC-28022
BMC-28152 BMC-27778 BMC-27805 BMC-27891
BMC-27957 BMC-28067 BMC-28074 BMC-29160
BMC-29007 BMC-29021 BMC-29055 BMC-29081
BMC-29129 BMC-29144 BMC-29113 BMC-29152
BMC-29131 BMC-29161 BMC-29022 BMC-29125
BMC-29138 BMC-29085 BMC-29004 BMC-29186
BMC-29130 BMC-29061 BMC-29073 BMC-29174
BMC-29119 BMC-29122 BMC-29162 BMC-29137
BMC-29156 BMC-29008 BMC-29028 BMC-29078
BMC-29115 BMC-29063 BMC-29082 BMC-29132
BMC-29049 BMC-29172 BMC-29173 BMC-29179
BMC-29056 BMC-29116 BMC-29133 BMC-29184
BMC-29080 BMC-29023 BMF-25723 BMF-25725
BMF-25735 BMF-26541 BMF-25808 BMF-26082
BMF-26498 BMF-26133 BMF-26517 BMF-26169
BMF-26494 BMF-26193 BMF-26275 BMF-26337
BMF-26372 BMF-26530.
MANUFACTURER
Trex Medical Corporation, Copaigue, New York.
RECALLED BY
Manufacturer, by letter on August 29, 1997. Firm-initiated field
correction complete.
DISTRIBUTION
Nationwide and international.
QUANTITY
154 units were distributed.
REASON
The subtray mandrels (pins) used to attach the mammography Bucky
tray or the optional Cytoguide to the vertical C-Arm of the
mammography machine can, overtime, become loose or bend and
break.
________
PRODUCT
Apligraft (Graftskin), indicated for use with standard
therapeutic compression for the treatment of non-infected partial
and full thickness skin ulcers due to venous insufficiency of
greater than 1-month duration which has not adequately responded
to conventional therapy.
Recall #Z-1210-9.
CODE
Unit Numbers: 68, 69, 71, 73, 74, 76, 78, 80 through 83, 87
through 89, 91, 99. Lot #GS9906.08.02 EXP 07/04/99.
MANUFACTURER
Organigenesis, Inc., Canton, Massachusetts.
RECALLED BY
Manufacturer, by telephone on July 1, 1999, followed by letter
issued July 13, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Alabama, Arizona, Florida, Massachusetts, Minnesota, Washington
state, Texas.
QUANTITY
16 units were distributed for commercial use.
REASON
Burkholderia cepacia contamination.
________
PRODUCT
ITI Extender System Octa Abutment (also referred to as the Bone
Graft Octa Abutment, H 2.1 mm) a component of the ITI Extender
System. Recall #Z-1211-9.
CODE
Catalog Number: 048.426, Lot #1010.
MANUFACTURER
Institut Sraumann AG, Waldenbrug, Switzerland.
RECALLED BY
The Straumann Company, Waltham, Massachusetts, by telephone
between July 7 and 8, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Connecticut, Iowa, Florida, Minnesota.
QUANTITY
27 units were distributed.
REASON
Potential for abutment to fracture due to error on the tolerance
value for the depth of the hole on the modified engineering
drawing.
________
PRODUCT
Shiley Adult Tracheostomy Tubes, intended for use in providing
tracheal access for airway management:
a) Catalog Nos. DCT, DFEN, DCFS, DCFN, & PERC;
b) Catalog Nos. LPC, FEN, CFN, CFS, & LGT.
Recall #Z-1213/1214-9/
CODE
Lot Numbers: a) M80233000 through M86559000, M88059000 &
M88080000; b) M85013000 through M86544000, M88053000, M88054000,
M88055000, M88058000, M88073000, M88074000, M88049000, &
M88293000.
MANUFACTURER
Mallinckrodt, Inc., Irvine, California.
RECALLED BY
Manufacturer, by letters on July 6 and 26, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
263,246 tubes were distributed. Firm estimated that little
product remained on market at time of recall initiation.
REASON
The lug pin, which hold the soft swivel flange to the cannula may
break, causing displacement of the flange.
________
PRODUCT
Synchron Systems Digoxin Reagent, Catalog No. 650182, used in
conjunction with the SYNCHRON Systems Drug Calibrator 2 set and
is intended for the quanitative determination of total digoxin
concentration in human serum or plasma on SYNCHRON CX Systems.
Recall #Z-1216-9.
CODE
Lot numbers: M810065 EXP 30Nov00, M901265 EXP 28Feb01, and
#M904060, EXP 31May01.
MANUFACTURER
Beckman Coulter, Carlsbad, California.
RECALLED BY
Beckman Coulter, Inc., Brea, California, by letter, dated June 4,
1999, Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and International.
QUANTITY
2,554, units of lot M810065, 1917 units of lot M904060 and 678
units of M901265 were distributed.
REASON
The devices may produce false low digoxin results.
PRODUCT
Heart Valve Harvested from a cadaveric donor.
Recall #Z-1217-9.
CODE
Donor ID #33986.
MANUFACTURER
New York Organ Donor Network (NYODN), New York, New York.
RECALLED BY
Manufacturer, by letter on March 13, 1998. Firm initiated-
recall complete.
DISTRIBUTION
Georgia.
QUANTITY
1 unit was distributed.
REASON
The specimen collected from donor was found to be repeatedly
reactive for HbsAg.
_________
PRODUCT
Sorin Blood Cardioplegia Console, Model BCC-02,
Part #R DP48-0001-102, designed for use during cardiopulmonary
bypass procedures to control the introduction of blood and
crystaloid delivery in the management of cardioplegia delivery.
Recall #Z-1218-9.
CODE
Serial numbers:
02960020R 04960037 06960053R 0890071R 02970088R
02960021R 04960038 06960054 12960073R 02970089
02960022R 04960039 06960055R 12960074 03970090R
02960023R 04960040R 06960056 12960075R 02970092R
02960024 04960041 06960057 12960076R 03970095R
02960025 04960042R 06960058R 12960077 03970097
02960026 04960043 06960059 12960078R 03970098
02960028 04960044 06960062R 12960079R 03970099R
02960029R 04960045R 08960063 12960080R 03970100R
02960030 04960046 08960064 12960081 03970101R
04960031R 04960047R 08960065 12960082R 03970102R
04960032R 04960048R 08960066R 02970083 03970103R
04960033R 04960049R 08960067R 02970084R 04960034R
06960050 08960068 08960072R 03970105R 04960035R
06960051R 08960069R 02970086 03970107R 04960036R
06960052R 08960070 02970087 03970109R.
MANUFACTURER
Seamed Corporation, Redmond, Washington.
RECALLED BY
Sorin Biomedical, Inc., Irvine, California by visit on March 15,
1999. Firm-initiated recall ongoing.
DISTRIBUTION
Florida, Georgia, Illinois, Massachusetts, Maine, Michigan,
Missouri, Nebraska, Pennsylvania, Rhode Island, Texas, Washington
state, Canada, Italy, Japan.
QUANTITY
80 Units were distributed.
REASON
The device may deliver the blood/cardioplegia solution at
uncontrolled high speed (overspeed pump condition).
________
UPDATE
CPI Endotak DSP Implantable Leads, Recall #Z-1144/1145-9 which
appeared in the August 18, 1999 Enforcement Report should read:
QUANTITY: 29,500 leads.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________
PRODUCT
Omega Plus Compression Hip Screw System with varied product
codes:
a) Product Code 33630304; b) Product Code 33630305;
c) Product Code 33630354; d) Product Code 33630355;
e) Product Code 33630405; f) Product Code 33630454;
g) Product Code 33630455; h) Product Code 33631002;
i) Product Code 33631002; j) Product Code 33631004;
k) Product Code 33631004; l) Product Code 33631005;
m) Product Code 33631008; n) Product Code 33631102;
o) Product Code 33631103; p) Product Code 33631106;
q) Product Code 33631108; r) Product Code 33631204;
s) Product Code 33631306; t) Product Code 33631406.
Recall #Z-1182/1201-9.
CODE
Lot numbers: a) C6JYB; b) C6JYA; c) BXYPJH, BXYPJG;
d) BXYPOH; e) C6KBL; f) C6KDA; g) C6KED; h) BXYPKEA;
i) C6JWH, C6JWG; j) BXYPKA; k) C6JWE; l) C6JWJ;
m) C6KGA, C6KGB; o) BXYPKE; p) BXYPKF, BXYPKG, BXYPML, BZFBMC,
BZFBMD; q) BXYPKC; r) C5ACC, C6GZE;
s) C6KAA, C6KAC; t) C6KEH; u) C6KFA;
MANUFACTURER
Pfizer Hospital Products Group, Howmedics, Inc. Rutherford, New
Jersey.
RECALLED BY
Howmedica Osteonics Corporation, Rutherford, New Jersey, by E-
mail letters on January 20, 1999 to Europe, and on February 9,
1999 to Canada. Firm-initiated recall ongoing.
DISTRIBUTION
Korea, Ireland and Canada.
QUANTITY
1,218 were distributed.
REASON
The inner dimension of the sideplate had dimensions that were too
small, resulting in the sideplate not sliding fully into the lag
screw.
________
PRODUCT
Series 7000 Total Knee Modular Tibial Tray, a component of the
Total Knee System, implanted into a patient along with other knee
system components as part of a knee replacement.
Recall #Z-1202-9.
CODE
Catalog #7376-0005, Case Code T98T477.
MANUFACTURER
Howmedica Osteonics Corporation, Allendale, New Jersey.
RECALLED BY
Manufacturer, by telephone on January 20,1999. Firm-initiated
recall complete.
DISTRIBUTION
Florida, Massachusetts, Michigan, North Carolina, New York,
England.
QUANTITY
6 devices were distributed.
REASON
The Tibial Tray labeled as Catalog No. 7376-0005 was laser etched
with the wrong Catalog No. 7115-0005.
________
PRODUCT
Cryovalve Allograft (Heart Valve). Recall #Z-1203-9.
CODE
Model #PVOO, Serial #6506224.
MANUFACTURER
CryoLife, Inc., Kennesaw, Georgia.
RECALLED BY
Manufacturer, by telephone on June 11, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Colorado.
QUANTITY
1 unit.
REASON
Additional information for the organ procurement agency
concerning this donor revealed that the donor possessed genital
Condylomata (genital warts).
________
PRODUCT
Human Beta-2 Microglobulin Kits, products are in-vitro diagnostic
kits and an antiserum:
a) Product Code No. LK043.B, Human Beta-2 Microglobulin Behring
Nephelometric Analyzer (BNA) Kit;
b) Product Code No. LK043.BH, Elevated Level Human Beta-2
Microglobulin Enhanced Nephelometric BNA Kit;
c) Product Code No. CUS1303, Human Beta-2 Microglobulin Enhanced
Nephelometric BNA Kit;
d) Product Code No. LA043.B, Human Beta-2 Microglobulin Latex
Enhanced Antisera BNA;
e) Product Code No. LK043.C, Human Beta-2 Microglobulin
Turbidometric Roche Cobas Mira (MIRA) Kit.
Recall #Z-1204/1208-9.
CODE
Lot Numbers: a) 030349, 034392, EXP 01/00;
b) 034393, EXP Jan. 2000;
c) 035818, EXP March 2000; 035018, EXP Jan. 2000
d) 035019, EXP Jan. 2000; 035819, EXP Mar. 2000;
e) 031386 EXP 01/00.
MANUFACTURER
The Binding Site, Ltd., Birmingham, England.
RECALLED BY
The Binding Site, Inc., San Diego, California, by fax and
telephone on May 19 and 20, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Alabama, California, Colorado, Florida, Oklahoma, Massachusetts,
New Jersey, New York.
QUANTITY
87 kits and 75 vials were distributed.
REASON
We are classifying the firm's action as a voluntary recall. We
consider the devices to be adulterated in that they may give
falsely elevated levels with urine samples.
________
PRODUCT
Architect Free T3 Reagent Kit, a Chemiluminescent Microparticle
Immunoassay (CMIA) for the quantitative determination of free
triiodothyronine(Free T3) in human serum and plasma. Recall #Z-
1212-9.
CODE
List 6C48-30 (2000 test kit), lot 47106M200;
List 6C48-25 (100 test kit), lot 47107M200.
MANUFACTURER
Abbott Laboratories, Abbott Park, Illinois.
RECALLED BY
Manufacturer, by telephone on August 4, 1999, and by letter dated
August 2, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Alabama, Florida, Illinois, Kansas, Maryland, Michigan, New
Hampshire, New York, Ohio, Pennsylvania, Texas, California,
Germany, Japan, and Canada.
QUANTITY
247 kits were distributed.
REASON
Low recovery when used with multi-constituent controls.
________
PRODUCT
KaVo Intrasept 905, INTRAsurg 500 Dental Operative Unit, an AC
powered drilling device intended to supply power to and serve as
a base for other dental devices such as a dental handpiece during
dental and maxillofacial surgery.
Recall #Z-1215-9.
CODE
Serial numbers: 824-828, 830, and 831.
MANUFACTURER
KAVO DENTAL GmBH, Biberach-Riss, Germany.
RECALLED BY
The Straumann Co., Waltham, Massachusetts by letter on June 30,
1999. Firm-initiated recall ongoing.
DISTRIBUTION
Arizona, California, Delaware, Massachusetts, Montana, Texas.
QUANTITY
7 units were distributed.
REASON
Software defect may cause the unit to shutdown prior to reaching
the preset torque limit.
________
PRODUCT
Apligraf (Graftskin), indicated for use with standard therapeutic
compression for the treatment of non-infected partial and full
thickness skin ulcers due to venous insufficiency of greater than
1-month duration which has not responded to conventioanl therapy.
Recall #Z-1219-9.
CODE
Lot Numbers: GS9906.22.03.1A and GS9906.22.03.2A EXP 7/23/99.
MANUFACTURER
Organogenesis, Inc., Canton, Massachusetts.
RECALLED BY
MANUFACTURER, by telephone and letter on on July
21 and 22, 1999. Firm-initiated recall ongoing.
Firm-initiated recall ongoing.
DISTRIBUTION
Alabama, Arizona, California, Georgia, Illinois, Indiana, New
York, Massachusetts, Maryland, Maine, Michigan, Missouri, North
Carolina, Ohio, Pennsylvania, South Carolina, Texas.
QUANTITY
58 units were distributed.
REASON
The pH was found to be out of specification range.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS - CLASS II
________
PRODUCT
Various animal feeds intended for non-ruminant animals packed and
distributed in 50 pound bags, or bulk units:
a) #4542220/Pullet Starter/Finisher, medicated
b) #11314/Country Choice Meat Maker Finisher A, medicated
c) #11067/Country Choice Turkey & Game Bird Grower
d) #12841/Top Wean Phase 3 250, medicated
e) #126BJ/Pork Supreme L.G.Premix 100/75 lysine
f) #10401/Country Choice Balancer
g) #13324/Pro Leader, Swine Grow/Finish Supplement.
Recall #V-074/080-9.
CODE
All lot numbers from 9190M1 through 9207M3.
MANUFACTURER
Land O' Lakes, Inc., Fort Dodge, Iowa.
RECALLED BY
Land Oí Lakes, Inc., Massillon, Ohio, by telephone on July 29,
1999, followed by letter on July 31, 1999. Firm-initiated recall
ongoing.
DISTRIBUTION
Indiana.
QUANTITY
2,384 50-pound bags and 350 tons (bulk feed) were distributed.
REASON
Product contained protein derived from mammalian tissue and
according to regulation must bear the statement "Do not feed to
cattle or other ruminants" on the label.
END OF ENFORCEMENT REPORT FOR AUGUST 25, 1999.
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