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.
ENFORCE
04/30/1991
FDA Enforcement for the week of 5/1/91
FDA ENFORCEMENT REPORT
FOR APRIL 1, 1991
May 1, 1991
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
NONE
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
NONE
Product: (a) Frozen Breaded Zucchini Slices/Discs, in various
sizes under the following labels: Pride of The West,
Flagship Food Products, Kronos-Central, C & E, Aspen
Bel Pak and Garden Foods;
(b) Frozen Breaded/Batter-Dipped Cauliflower in various
sizes under the following labels: Garden Foods, Grennan
Meats, Andoro, Charles Schmidtke, CSC, Droege's Finest,
Colony Lane, Ferko Meat, Vienna Beef, Quality Finest,
Happy Valley Packers. Recall # F-363/364-1.
-1-
Code: All lots.
Manufacturer: Garden Products, Inc., Piedmont, Missouri.
Recalled by: Manufacturer, by letter March 22, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: (a) 2,716 cases; (b) 2,037 cases were distributed.
Reason: Product contained undeclared FD&C Yellow No. 5.
----
Product: Tom's Nacho Cheese Tortilla Chips, 1.125 ounces
(36 bags/case), 1.25 ounces, (36 bags/case), 2.5 ounces
(28 bags/case), and 6.5 ounces (14 bags/case).
Recall #F-365-1.
Code: All packages coded K or K or K
APR10 A1 APR10 A2 APR10 A3.
Manufacturer: Tom's Foods Inc., Knoxville, Tennessee.
Recalled by: Manufacturer, by telephone and letter March 11, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 4,845 cases of package sizes were distributed.
Reason: Product is contaminated with sodium hydroxide and
sodium tripolyphosphate.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: (a) Salmon Caviar, in 2 ounce and 4 ounce jars;
(b) Golden Whitefish Caviar in 2 oz. and 4 oz. jars.
Recall #F-360/361-1.
Code: None.
Manufacturer: Epicurean International, Rockville, Maryland.
Distributed by: Iron Gate Products Company, Inc., New York, New York.
Recalled by: Manufacturer, telephone February 15, 1991. Firm-initiated
recall ongoing.
Distribution: New York.
Quantity: (a) 984/2 oz. , 492/4 oz. jars; (b) 1,056/2 oz. and 552/4
oz. jars were distributed.
Reason: New York State Department of Agriculture and Markets
collected and analyzed samples and determined that
products labeled "refrigerate after opening" should have
stated "keep refrigerated." Department of Agriculture
and Markets is monitoring the recall.
----
Product: Vitamin C Syrup in 4 oz. and 16 oz. glass bottles.
Recall #F-362-1.
Code: All lots within expiration date.
92024, 02002, 92234, 03229, 92448, 03551, 92689
-2-
Manufacturer: Barre National, Inc., Baltimore, Maryland.
Recalled by: Manufacturer, by letter January 28, 1991 with certified
return receipt. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 64,039 cases were distributed.
Reason: Container closures leak and fail to maintain product
integrity.
----
Product: Optimum brand Timed Release Niacin Tablets, 500 mg,
in 100 tablet and bulk (50,000) containers, a dietary
supplement under the Hi-School Pharmacy and Carter & Lee
labels. Recall #F-366-1.
Code: Lot numbers 1451 and 1453.
Manufacturer: Magno-Humphries, Inc., Tigard, Oregon.
Recalled by: Manufacturer, for lot 1453 by visit October 23, 1990 and
for lot 1451 by letter December 24, 1990. Firm-initiated
recall ongoing.
Distribution: Oregon, Washington state, California.
Quantity: 998 100-tablet containers of lot 1451 and 50,000 bulk
tablets and 479 100-tablet containers of lot 1453 were
distributed.
Reason: Product formulated as timed release, but not labeled as such.
----
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Repository Corticotropin Injection USP, 40 units/mL ACTH, 5
ml vials packaged in individual carton, 1008 vials per
shipping case, an Rx hormone product. Recall #D-313-1.
Code: Lot number L1005, EXP 9/91.
Manufacturer: Organics/LaGrange, Inc., Chicago, Illinois.
Recalled by: Manufacturer, by telephone on April 4, 1991. Firm-initiated
recall ongoing.
Distribution: Wisconsin and New York.
Quantity: 34,609 vials were distributed.
Reason: Subpotent.
----
-3-
Product: Colchicine Tablets 0.6 mg, in bottles of 100, 250 and 1000
tablets, an Rx product used for gout, under the following
labels: Major Pharmaceuticals, Purepac, Rugby, Genetco,
Best generics, Moore drug exchange, United Research,
Harber Pharmaceutical, and West-ward labels.
Recall #D-382-1.
Code: All lots.
Manufacturer: West-ward Pharmaceutical, Eatontown, New Jersey.
Recalled by: Manufacturer, by letters on February 25, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 18,500 bottles were distributed.
Reason: Subpotent.
----
Product: Carbamazepine Tablets, USP, 200 mg, unit dose packaged in
unit cartons of 100 tablets each, an Rx oral tablet used to
control and preclude epileptic episodes. Recall #D-384-1.
Code: lot numbers 9S847, 0B158, 0H460, 0I608, 0J702, 0J711, 0M910,
0S150, 0V211, 1A289.
Manufacturer: Pharmaceutical Basics, Inc., Denver Colorado.
Recalled by: UDL Laboratories, Rockford, Illinois (repacker), by letters
on March 19, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 26,986 unit cartons were distributed.
Reason: Lack of assurance of bioequivalency and ANDA discrepancies.
----
Product: Amino Acid Injection, 500 ml 8.5% FreAmine III with
Electrolytes, an Rx product indicated to prevent nitrogen
loss or treat negative nitrogen balance. Recall #D-385-1.
Code: Lot numbers: J0N008, J1A021.
Manufacturer: McGaw, Inc., Irvine, California.
Recalled by: Manufacturer, by letters on March 5, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: (a) 13,728 units were distributed.
Reason: Some unit box labels did not have the statement "With
Electrolytes".
----
Product: Thiothixene Capsules, USP, 1 mg., 2 mg., 5 mg., 10 mg., and
20 mg., packaged in bottles of 100's, 500's, and 1000's, an
Rx product for the management of psychotic disorders, under
the following labels: American Therapeutics, Best Generics,
Bioline, Genetco, Goldline, H.L. Moore, Qualitest, Scheir,
Harber, J.J. Balan, Major Pharmaceutical, Martec, Mason
Distributors, Parmed, Rugby. Recall #D-386/389-1.
Code: All lots within expiration period.
Manufacturer: American Therapeutics, Inc., Bohemia, New York.
Recalled by: Manufacturer, by letter on or about December 21, 1990.
Firm-initiated recall ongoing.
-4-
Distribution: Nationwide.
Quantity: 7 million capsules were distributed.
Reason: Lack of assurance of bioequivalence and Abbreviated
New Drug Application discrepancies.
----
Product: Metaproterenol Sulfate Tablets, 5 mg. and 20 mg.,
an Rx bronchodilator under the following labels:
ATI, Best Generics, Harber, H.L. Moore, Major, Schein,
Mason Distributors, Martec, Parmed, Qualitest, Rugby,
and URL. Recall #D-390-1.
Code: All lots.
Manufacturer: American Therapeutics, Inc., Bohemia, New York.
Recalled by: Manufacturer, by letter December 21, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 2,000,000 tablets remain on the market.
Reason: Lack of assurance of bioequivalence and Abbreviated New
Drug Application discrepancies.
----
Product: Prochlorperazine Maleate Tablets, USP, (a) 5 mg; (b) 10 mg;
(c) 25 mg, in 100 and 1,000 tablet bottles, an Rx
product under the following labels: Duramed, Best, Parmed,
Qualitest, and URL. Recall #D-391/393-1.
Code: Lot numbers: (a) 90084, 90218, 90239, 90460, 90533;
(b) 90085, 90219, 90240; (c) 90086.
Manufacturer: Duramed Pharmaceuticals, Inc., Cincinnati, Ohio.
Recalled by: Manufacturer, by letter March 21, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Approximately one million tablets in each lot of 5 mg
and 10 mg strength and 800,000 tablets in the 25 mg
strength were distributed.
Reason: The products were not manufactured in accordance with
Abbreviated New Drug Apprication specifications.
----
Product: (a) Somatomax PM, distributed in either 100 gms of powdered
product per bottle or 100 500 mg capsules per bottle;
(b) GHB-PM, distributed in bottles containing 100 gms of
powder, an OTC product. Recall # D-395/396-1.
Code: All lots.
Manufacturer: (a) Amino Discounters, Tucson, Arizona; (b) Ultimate
Strength Systems, Newington, Connecticut.
Recalled by: Forcite Distributors, Inc., Lodi, New Jersey by letter
February 24, 1991. Firm-initiated recall ongoing. See
also FDA press release P90-53, November 8, 1990.
Distribution: New York and New Jersey.
Quantity: (a) 96 units; (b) 36 units were distributed.
-5-
Reason: Product marketed without new drug approval.
----
Product: GHB Granules (Gamma Hydroxybutryic Acid), packaged in 60 gm.
and 100 gm size bottles, an OTC product used to stimulate
growth hormones and prolactin release and cause an increase
in muscle mass and weight loss. Recall # D-398-1.
Code: All lots.
Manufacturer: Pacifico Enterprises, Dayton, Ohio.
Recalled by: Manufacturer, by letter on April 8, 1991. Firm-initiated
recall ongoing. See also FDA press release P90-53
November 8, 1990.
Distribution: Nationwide.
Quantity: 1,000 bottles (700/60 gm. and 300/100 gm size) were
distributed.
Reason: Product marketed without new drug approval.
----
Product: Gaviscon Liquid Antacid, 6 ounce, an OTC product.
Recall #D-400-1.
Code: Lot number K02452, EXP 8/92.
Manufacturer: Marion Merrell Dow, Inc., Kansas City, Missouri.
Recalled by: Marion Merrell Dow, Inc., Cincinnati, Ohio by
letter April 18, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 4,500 cases (12 bottles/case) were distributed.
Reason: Bacterial contamination with Klebsiella Pneumoniae.
----
Product: Intal Nebulizer Solution, 2 ml ampules (cromolyn sodium
inhalation, USP), an Rx product. Recall #D-401-1.
Code: Lot number HN3701A, EXP 11/94.
Manufacturer: Fisons plc, LeTrait, France.
Recalled by: Fisons Corporation, Rochester, New York, by telephone March
15, 1991, FAX March 18, 1991 and by letter March 2, 1991.
Firm-initiated recall ongoing.
Distribution: Illinois.
Quantity: 999 boxes were distributed.
Reason: Trace contamination with a detergent product.
----
Class III -
Product & Various unit-dose, strip packed Rx and OTC drugs:
Codes: ASSIGNED
LOT EXPIRATION
PRODUCT/STRENGTH/SIZE NUMBER DATE
1. ACTIGALL, 300 mg., 1's 188 06/17/91
(URSODIOL) 194 06/19/91
-6-
2. ALBUTEROL, 2 mg., 1's 912410 05/02/91
3. AMANTIDINE HCl, 100 mg., 1's 50277 07/02/91
50306 07/02/91
4. AMILORIDE/HYDROCHLOROTHIAZIDE, 14464 06/12/91
5 mg./50 mg., 1's
5. AMOXAPINE, 50 mg., 1's 9K15676 05/02/91
6. ARTANE SEQUELS, 5 mg., 1's 282342 05/30/91
(TRIHEXYPHENIDYL HCl) 282342 07/22/91
7. ASPIRIN, 800 mg., E00890 07/07/91
CONTROLLED RELEASE, 1's
8. AXID, 150 mg., 1's 4LZ37A 05/01/91
(NIZATIDINE) 4LZ37A 05/05/91
4LZ37A 05/09/91
4LZ37A 05/20/91
4LZ37A 05/30/91
4MJ89A 06/14/91
4MJ90A 05/12/91
4MJ90A 05/19/91
4MJ90A 05/26/91
4MJ90A 05/30/91
4MJ90A 06/10/91
9. BACLOFEN, 10 mg., 1's 4096722 05/01/91
4096725 05/20/91
10. CARDIZEM SR, 60 mg., 1's E00024 06/26/91
(DILTIAZEM)
11. CARISOPRODOL, 350 mg., 1's 70866 07/22/91
12. CEPHALEXIN, 500 mg., 1's 51180 06/04/91
13. CHLORDIAZEPOXIDE/AMITRIPTYLINE, OB244EY 06/17/91
5 mg./12.5 mg., 1's OB244EY 07/23/91
T042N 06/24/91
T042N 07/14/91
M757-01 05/30/91
M757-01 06/18/91
14. CLONIDINE HCl, 0.3 mg., 1's 136389 05/01/91
15. CLONIDINE HCl/CHLORTHALIDONE, T069M 06/11/91
0.1 mg./15 mg., 1's
16. CYSTOSPAZ, 0.15 mg., 1's 20BN 06/18/91
(HYOSCYAMINE SULPHATE)
17. CYTOTEC, 200 mcg., 1/2's 1090-233 06/27/91
(MISOPROSTOL) 1090-236 06/17/91
1290-245 07/23/91
18. DIAZEPAM, 5 mg., 1/2's 3926809 05/05/91
19. DIETHYLSTILBESTEROL, 1 mg., 1's 4LL89B 01/01/91
4MK08A 05/19/91
4NA53A 07/22/91
4NA53A 07/23/91
20. DILITRATE SR, 40 mg., 1's 890501 06/24/91
(ISOSORBIDE DINITRATE)
21. DYMELOR, 250 mg., 1's 3D576B 05/12/91
(ACETOHEXAMIDE)
22. ELDEPRYL, 5 mg., 1's 1270390 06/12/91
(SELEGILINE HCl) 1350390 06/03/91
1350390 07/22/91
-7-
23. ESTRATAB, 0.625 mg., 1's 81801 07/22/91
(ESTERIFIED ESTROGENS)
24. FUROSEMIDE, 20 mg., 1/2's 31101C0 07/02/91
25. HALOPERIDOL, 0.5 mg., 1/2's 70216 06/19/91
1's 70216 05/19/91
70216 05/28/91
70216 06/11/91
70216 06/26/91
70216 07/02/91
70216 07/16/91
V078B 07/03/91
26. HALOPERIDOL, 1 mg., 1's 4079B 07/09/91
27. HALOPERIDOL, 5 mg., 1's 91270 07/16/91
28. IBUPROFEN, 200 mg., 1's 14315 06/27/91
29. IBUPROFEN, 300 mg., 1's 13142 05/20/91
13142 06/12/91
30. ISORDIL TEMBIDS, 40 mg., 1's 1890596 05/29/91
(ISOSORBIDE DINITRATE) 9903072 06/24/91
9903080 06/24/91
31. ISOSORBIDE DINITRATE, 5 mg., 1's 116689 07/23/91
32. K PHOS NEUTRAL, 1's 0511 07/22/91
(PHOSPHOROUS SUPPLEMENT)
33. KU-ZYME, 1's 17926 06/17/91
(AMYLASE, LIPASE, 17931 07/23/91
PROTEASE AND CELLULASE)
34. LEVSIN/SL, 0.125 mg., 1's 16003 05/05/91
(HYOSCYAMINE SULPHATE) 17193 05/12/91
17194 05/26/91
17194 06/10/91
17194 06/17/91
17194 06/24/91
35. LOXAPINE, 25 mg., 1's 37102G0 07/02/91
36. MAG-TAB SR, 84 mg., 1's M383 05/26/91
(MAGNESIUM SUPPLEMENT) M631 06/24/91
37. METHYLDOPA/HYDROCHLOROTHIAZIDE 0553340 07/23/91
250 mg./15 mg., 1's
38. METOCLOPRAMIDE, 10 mg., 1/2's 70957 06/11/91
90B045 06/27/91
39. NEOTHYLLINE, 200 mg., 1's 7704 06/10/91
(DYPHYLLINE) 7704 06/17/91
40. NEOTHYLLINE, 400 mg., 1's 7559 06/18/91
(DYPHYLLINE) 7923 07/15/91
41. NEOTHYLLINE-GG, 1's 8031 06/27/91
(DYPHYLLINE/GUAIFENESIN) 8031 07/03/91
(200 mg./200 mg.)
42. PARLODEL, 2.5 mg., 1's 767M1496 06/11/91
(BROMOCRIPTINE MESYLATE)
43. PARLODEL, 5 mg., 1's 109P1761 06/10/91
(BROMOCRIPTINE MESYLATE)
44. PBZ, 25 mg., 1's
GEIGY 1B130513 07/23/91
(TRIPELENNAMINE HCl)
45. PEDAMETH, 200 mg., 1's 7895 05/21/91
(RACEMETHIONINE)
-8-
46. PRAZOSIN HCl, 1 mg., 1's 904102 01/31/91
47. PRILOSEC, 20 mg., 1's 59401 06/11/91
(OMEPRAZOLE)
48. PRIMIDONE, 250 mg., 1/2's 03540C 06/11/91
49. PROBENECID/COLCHICINE 2193110 06/18/91
500 mg./0.5 mg., 1's 2193117 07/22/91
50. RESERPINE/HYDROCHLOROTHIAZIDE 03334C 07/08/91
0.125 mg./50 mg., 1's
51. RESERPINE/HYDROCHLOROTHIAZIDE/ 02892C 07/16/91
HYDRALAZINE HCl
0.1 mg./25 mg./15 mg., 1's
52. ROCALTROL, 0.25 mcg., 1's 0181 07/08/91
(CALCITROL)
53. ROCALTROL, 0.5 mcg., 1's 0561 07/02/91
(CALCITROL)
54. SLOW MAG DR, 1's 0D082 06/10/91
(MAGNESIUM CHLORIDE, EQUIVALENT
TO 64 mg. OF MAGNESIUM)
55. SORBITRATE, 10 mg., 1's 4283K 06/17/91
(ISOSORBIDE DINITRATE) 4283K 07/16/91
56. SYNTHROID, 112 mcg., 1's JE210A 06/12/91
(LEVOTHYROXINE SODIUM)
57. SYNTHROID, 175 mcg., 1's JE200 06/12/91
(LEVOTHYROXINE SODIUM)
58. SYNTHROID, 200 mcg., 1's JD220 06/18/91
(LEVOTHYROXINE SODIUM)
59. THEO-DUR, 100 mg., 1/2's 90184 07/22/91
(THEOPHYLLINE)
60. THIORIDAZINE HCl, 200 mg., 1's 70472 07/08/91
71199 07/08/91
61. TOLFRINIC, 1's G026971 07/22/91
(IRON/VITAMINS)
62. TRAZODONE HCl, 50 mg., 1's 005PR021 07/02/91
63. TRICOSAL, 500 mg., 1's 9H14 06/18/91
(CHOLINE SALICYLATE, 293 mg. &
MAGNESIUM SALICYLATE, 362 mg.)
64. URIDON MODIFIED, 1's 9D088 05/14/91
(METHENAMINE, 40.8 mg./ATROPINE SULPHATE, 0.03 mg./
HYOSCYAMINE, 0.03 mg./METHYLENE BLUE, 5.4 mg./
BENZOIC ACID, 4.5 mg./PHENYLSALICYLATE, 18.1 mg.)
65. UROQID-ACID NO. 2, 1's 0K08 07/07/91
(METHENAMINE MANDELATE, 500 mg./
SODIUM ACID PHOSPHATE MONOHYDRATE, 500 mg.)
66. VERAPAMIL, 80 mg., 1's 70815 06/11/91
34305B0 06/03/91
67. VERAPAMIL, 120 mg., 1/2's T085K 05/05/91
68. WELLBUTRIN, 75 mg., 1's 903014 06/12/91
(BUPROPION). Recall #D-314/381-1.
Manufacturer: Various.
Recalled by: Pharmaceutical Services of Middle Tennessee, Inc.
Nashville, Tennessee (repacker), by telephone on or about
January 31, 1991 followed by letter February 1, 1991.
Firm-initiated recall ongoing.
Distribution: Tennessee.
-9-
Quantity: 20,633 unit dose packages were distributed; firm
estimates none remains on the market.
Reason: Repacking firm assigned expiration dates in excess of
permitted expiration periods.
----
Product: Kasdenol, in 10 gram amber glass bottles, an OTC product.
Recall #D-383-1.
Code: Lot #60-8903 EXP 7/91.
Manufacturer: United Guardian, Inc., Hauppauge, New York.
Recalled by: Manufacturer, by letter March 15 and 18, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 4,130 bottles were distributed.
Reason: Available chlorine is below specification.
----
Product: Nifedipine Soft gelatin Capsules, 100 mg, in bottles of
100 and 300 capsules, an Rx drug indicated as an
anti-anginal and calcium channel blocker, under the
following labels: Purepac, Drug Guild, Darby Drug
VIP, H.L. Moore Drug Exchange, Novopharm, Mason
Distributors. Recall #D-394-1.
Code: Lot #032HO EXP 10/92.
Manufacturer: Kalipharma, Inc., Elizabeth, New Jersey.
Recalled by: Manufacturer, by telephone February 27-28, 1991.
Firm-initiated recall ongoing.
Distribution: Connecticut, Florida, New Jersey, New York.
Quantity: 8,023 units of 100 and 7,721 units of 300 were distributed.
Reason: Expiration date of 10/92 was used instead of correct
date of 8/92.
----
Product: Esscolloid Blue Label Bulk Forming Laxative Made
from All Natural Ingredients, an OTC product.
Recall #D-397-1.
Code: Lot #69026.
Manufacturer: Wisconsin Pharmacal Company, Inc., Jackson, Wisconsin
(repacker).
Recalled by: Repacker., by telephone November 1990. Firm-initiated
recall ongoing.
Distribution: Midwest.
Quantity: 605 units were distributed.
Reason: Irradiation used to treat presence of yeast and mold in
product.
----
Product: Oxygen U.S.P. in size E and 265 cubic foot cylinders.
Recall #D-399-1.
Code: Lot numbers: 11-120-B and 15-011-B.
Manufacturer: 77 Welding Supply, Inc., San Benito, Texas.
Recalled by: Manufacturer, by visit January 17, 1991. Firm-initiated
-10-
recall ongoing.
Distribution: Texas.
Quantity: 931 cylinders were distributed.
Reason: Current good manufacturing practice deficiencies.
----
Product: Blood Grouping Reagent Anti-K, in 3 ml vials, an in-vitro
diagnostic test reagent. Recall #B-215-1.
Code: Lot #LK144B EXP 15 JAN 92.
Manufacturer: Ortho Diagnostic Systems, Inc., Raritan, New Jersey.
Recalled by: Manufacturer, by letter February 14, 1991 and by FAX
February 19, 1991. Firm-initiated field correction
complete.
Distribution: Nationwide and international.
Quantity: 1,191 vials were distributed.
Reason: Product gives weak reactivity with some examples of k
(Cellano) negative, Rho(D) positive cells.
----
Product: Red Blood Cells. Recall #B-223-1.
Code: Unit numbers: 4427138 and 4227407.
Manufacturer: J.K. and Susie L. Wadley Research Institute and
Blood Bank, doing business as The Blood Center at
Wadley, Dallas, Texas.
Recalled by: Manufacturer, by visit September 6, 1990. Firm-
initiated recall complete.
Distribution: Texas, Illinois.
Quantity: 2 units.
Reason: Blood products labeled with incorrect expiration dates.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
Product: Reusable, Pre-Set Magnetic PEEP Valve, BE 171,
BE 142 and BE30-142 series:
1. BE 171-2.5, Pre-Set Magnetic PEEP Valve for 2.5 cm
H20;
2. BE 171-5.0, Pre-Set Magnetic PEEP Valve for 5.0 cm
H20;
3. BE 171-7.5, Pre-Set Magnetic PEEP Valve for 7.5 cm H20;
4. BE 171-10.0, Pre-Set Magnetic PEEP Valve for 10.0 cm HC2;
5. BE 171--12.5, Pre-Set Magnetic PEEP Valve for 12.5 cm
H20;
6. BE 171-15.0, Pre-Set Magnetic PEEP Valve for 15.0 cm
H20;
7. BE-171-20.0, Pre-Set Magnetic PEEP Valve for 20.0 cm
H20;
8. BE 171/10, Any Combination of ten PEEP Valves;
9. BE-171/20, Any Combination of twenty PEEP Valves;
10. BE 142, Magnetic PEEP Valve;
-11-
11. BE 142-10, Magnetic PEEP valve with Spring Loaded Valve;
12. BE 142-40, Magnetic PEEP Valve with Pressure Port;
13. BE 142-3, Amber Outlet Port 22 mm O.D. (component);
14. BE-30-142-3, Amber Outlet Port 30 mm O.D. (component);
15. BE-30-142, Magnetic PEEP Valve with 30 mm Standard;
16. BE 30-142-10, Magnetic PEEP Valve with Spring Valve
Port and 30 mm Standard;
17. BE 30-142-40, Magnetic PEEP Valve with Pressure Port and
30 mm Standard;
18. BE 171-3, Replacement 30 mm O.D. Outlet Port (component);
19. BE-142-70A, Non-Rebreathing valve with PEEP and
Standard 22 mm Bag Port;
20. BE-142-70B, Non-Breathing valve with PEEP and Laerdal
23 mm Port. Recall #Z-578/597-1.
Code: All units shipped after January 1, 1988 are being recalled.
Manufacturer: Instrumentation Industries, Inc., Bethel Park, Pennsylvania.
Recalled by: Manufacturer, by letter October 3, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: Undetermined.
Reason: Product may have received improper machine threading
during manufacture. This defect would allow the outlet
port to thread too far into the center body precluding
the magnetic valve from opening during exhalation.
----
Class II -
Product: Davol, Inc., CV Catheter 8 French with Groshong Valve,
Long Term, Single Lumen, Percutaneous Procedure Tray,
Recall #Z-479-1.
Code: Catalog #60312, Lot #36KA9323.
Manufacturer: Davol, Inc., subsidiary of C.R. Bard, Inc., Salt Lake
City, Utah.
Recalled by: Manufacturer, by FAX February 7, 1991 and by letter
February 11, 1991. Firm-initiated recall complete.
Distribution: Alabama, New Jersey.
Quantity: 55 units were distributed.
Reason: Kit contains incorrect instructions for the sheath
introducer.
----
Product: Hawkins I Breast Lesion Localization System, Catalog #42-503,
Needle gauge 20, needle length 5 cm. Recall #Z-558-1.
Code: Lot numbers: 260582 and 260682.
Manufacturer: Medical Device Technologies (formerly National Standard
Medical Products) Gainesville, Florida.
Recalled by: Manufacturer, by letter September 17, 1990. Firm-initiated
recall ongoing.
-12-
Distribution: Massachusetts.
Quantity: 225 units were distributed.
Reason: The sterility of the device has been compromised by loss
of package integrity.
----
Product: Model #665.400 14" x 14" Multiformat Spot Filmer,
Catalog #6650.400. Recall #Z-559-1.
Code: Serial numbers: 887808, 889307, 892317, 894702, 896715,
898426, 898427, 898711, 900012, 901002, 902007, 902507,
903207, 904320, 904506, 904903, 905930, 905932, 907108,
907416, 909316.
Manufacturer: Continental X-Ray Corporation, Broadview, Illinois.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan March 22, 1991. Firm-initiated field correction
ongoing.
Distribution: Nationwide.
Quantity: 22 units.
Reason: Noncompliance with 21.CFR 1020.32(a)(1), Primary
Protective Barrier. The fluoroscopy system may operate
in the fluoroscopic mode even when the spot film device
(which acts as the primary protective barrier) does not
intercept the entire useful beam.
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Product: Patella Reamer Clamp, Catalog #00-5120-070-00, a
manual orthopedic surgical instrument used to hold
in place and guide the patella reamer bit as the patella
bone is reamed in preparation for implantation of the
patellar component of a knee prosthesis. Recall #Z-560-1
Code: Lot numbers: 73304000 and 73457700.
Manufacturer: Nemco, Inc., Hicksville, Ohio.
Recalled by: Zimmer, Inc., Warsaw, Indiana, by telephone and by
letter March 8, 1991. Firm-initiated recall ongoing
Distribution: Nationwide and Japan.
Quantity: 97 units were distributed.
Reason: The set screw that holds the spring-loaded "stop"
of the depth gauge in place, backs out during use.
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Product: Motor-driven radiologic and spot-film tilt tables:
(a) CXT-90 90/90 Diagnostic Tilt Table, Catalog #T-8501;
(b) CXT-45 90/45 Diagnostic Tilt Table, Catalog #T-8800.
Recall #Z-566/567-1.
Code: (a) Model 6806.100, serial numbers: 886613, 894701,
906929, 905201;
(b) Model 6806.101, serial numbers: 883907, 884934,
887809, 889306, 892205, 896714, 897801, 898303, 898504,
900006, 901001, 901716, 902606, 903206, 904319, 904505,
904904, 905931, 907424, 909315.
-13-
Manufacturer: Continental X-Ray Corporation, Broadview, Illinois,
Manufacturer, by field service bulletin #9109,
February 6, 1991. Firm-initiated field correction ongoing.
Distribution: Nationwide.
Quantity: 24 units were distributed.
Reason: A relay in the table top drive printed circuit board,
(part #5284.061.08 rev. 1), has a component with
marginal rating for its application.
----
Class III -
Product: Hawkins III Breast Lesion Localization System, needle
gauge 20, needle length 3.0 cm. used to assist surgeons
in pinpointing potential problem areas in the breast as
identified by mammography. Recall #Z-568-1.
Code: Catalog #42-534, Lot numbers: 31082 and 1310182.
Manufacturer: Medical Device Technologies (formerly National Standard
Medical Products), Gainesville, Florida.
Recalled by: Manufacturer, by telephone November 6, 1990 followed by
letter November 15, 1990. Firm-initiated recall ongoing.
Distribution: Massachusetts.
Quantity: 725 units were distributed.
Reason: The cable inner core calibration markings are missing.
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VETERINARY PRODUCTS
NONE
Medical Device Safety Alerts:
RETRACTION: Medical Device Safety Alert #M-005-1 which appeared in
the April 24, 1991 Enforcement Report was reprinted in error.
This Safety Alert originally appeared in the December 19,
1990 Enforcement Report.