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
11/08/1995

ENFORCEMENT REPORT FOR 11/08/95

November 8, 1995 95-45

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT DAPA brand Extra Strength Acetaminophen Capsules, all size
packages, OTC. Recall #D-011-6.
CODE All lots.
MANUFACTURER Ferndale Laboratories, Inc., Ferndale, Michigan.
RECALLED BY Manufacturer, by letter dated February 14, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 4,900,000 capsules were distributed.
REASON Product does not meet dissolution specifications.

_______________
PRODUCT Physician samples of Pramasone (Pramoxine Hydrochloride and
Hydrocortisone Acetate) Lotion 1%, 2.5%, 7.5 ml, in 15 ml
bottle, Rx indicated for topical relief of the inflammatory
and pruritic manifestations of corticosteroid-responsive
dermatosis. Recall #D-012-6.
CODE Physician sample lot numbers: 54-600, 53-234, 53-232.
MANUFACTURER Ferndale Laboratories, Inc., Ferndale, Michigan.
RECALLED BY Manufacturer, by letter May 22, 1995. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 308,995 bottles were distributed
REASON Subpotency of the pramoxine component.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-037/038-6.
CODE Unit 28J21081.
MANUFACTURER American Red Cross Blood Services, Savannah, Georgia.
RECALLED BY Manufacturer, by letters dated March 24, 1995 and May 12,
1995. Firm-initiated recall complete.
DISTRIBUTION Georgia and Switzerland.
QUANTITY 1 unit of each component.
REASON Blood products, which were not tested for antibody to the
hepatitis C virus encoded antigen (anti-HCV), were
distributed.

_______________
PRODUCT (a) Whole Blood CPDA-1; (b) Red Blood Cells.
Recall #B-041/042-6.
CODE Unit numbers: (a) DD00806; (b) 131255.
MANUFACTURER Blood Bank of Alaska, Anchorage, Alaska.
RECALLED BY Manufacturer, by letter dated January 24, 1995. Firm-
initiated recall complete.
DISTRIBUTION Alaska.
QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a donor who had a
medical history of cancer, were distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-046/048-6.
CODE Unit #128386.
MANUFACTURER Blood Bank of Alaska, Anchorage, Alaska.
RECALLED BY Manufacturer, by letter dated August 2, 1994. Firm-
initiated recall complete.
DISTRIBUTION Alaska and Florida.
QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a donor with a
history of IV drug use, were distributed.

_______________
PRODUCT Platelets. Recall #B-054-6.
CODE Unit #28105-8168.
MANUFACTURER Blood Systems, Inc., doing business as United Blood
Services, San Angelo, Texas.
RECALLED BY Manufacturer, by telephone on May 2, 1995. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product, which was prepared from a whole blood unit
with an extended collection time, was distributed.

-2-RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Platelets. Recall #B-040-6.
CODE Unit #27C82850.
MANUFACTURER American National Red Cross, Johnstown, Pennsylvania.
RECALLED BY Manufacturer, by letter dated September 3, 1993. Firm-
initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit.
REASON Blood product, which tested positive for the anti-P1
antibody but labeled as negative for unexpected
alloantibodies, was distributed.

_______________
PRODUCT Recovered Plasma. Recall #B-043-6.
CODE Unit #131255.
MANUFACTURER Blood Bank of Alaska, Anchorage, Alaska.
RECALLED BY Manufacturer, by letter dated January 24, 1995. Firm-
initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product, which was collected from a donor who had a
medical history of cancer, was distributed.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
========================
_______________
PRODUCT APEX brand Universal Irrigation System One-Connection
Arthroscopic Tubing Sets, Model C7120, indicated for joint
distention. Recall #Z-069-6.
CODE Lot numbers: 29989-30036.
MANUFACTURER Zimmer Patient Care Division, Dover, Ohio.
RECALLED BY Linvatec, Inc., Largo, Florida, by letter September 8, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 19,144 units were distributed.
REASON There is a leak at the isolator valve at the junction of the
small tubing line and isolator cap.

_______________
PRODUCT Baxter Surgical Group Pouched Procedure Trays.
Recall #Z-079/110-6.
1. Catalog No. 4547, Baxter Pharmaseal Genetic
Amniocentesis Tray with 22 Ga x 3-1/2" Spinal Needle with
Depth Calibrations at 1 cm Intervals;
2. Catalog No. BAK2015, Baxter Pharmaseal Illinois
Sternal/Iliac Bone Marrow Aspiration Tray with 15 Ga
Aspiration Needle (Adjustable 3/8" - 1-7/8");
3. Catalog No. BAK2018, Baxter Pharmaseal Illinois
Sternal/Iliac Bone Marrow Aspiration Tray with 18 Ga
Aspiration Needle (Adjustable Length 1/16" - 1-7/16");

-3- 4. Catalog No. BAK3353, Baxter Pharmaseal Jamshidi Bone
Marrow Biopsy Tray with 13 Ga, 3-1/2" Biopsy/Aspiration
Needle;
5. Catalog No. BAK3411, Baxter Pharmaseal Jamshidi Bone
Marrow Biopsy Tray with 11 Ga, 4" Biopsy/Aspiration Needle;
6. Catalog No. BAK3583, Baxter Pharmaseal Jamshidi Bone
Marrow Biopsy and Aspiration Tray with 13 Ga, 3-1/2"
Biopsy/Aspiration Needle and 18 Ga Aspiration Needle
(Adjustable Length 1/16" - 1-7/16");
7. Catalog No. BAK4508, Baxter Pharmaseal Jamshidi Bone
Marrow Biopsy and Aspiration Tray with 8 Ga, 4"
Biopsy/Aspiration Needle and 18 Ga Aspiration Needle
(Adjustable Length 3/8" - 1-7/8");
8. Catalog No. BAK4511, Baxter Pharmaseal Jamshidi Bone
Marrow Biopsy and Aspiration Tray with 11 Ga, 4"
Biopsy/Aspiration Needle and 15 Ga Aspiration Needle
(Adjustable Length 3/8" - 1-7/8");
9. Catalog No. BEK2015, Baxter Pharmaseal Economy Illinois
Sternal/Iliac Bone Marrow Aspiration Tray with 15 Ga
Aspiration Needle (Adjustable 3/8" - 1-7/8");
10. Catalog No. BEK3411, Baxter Pharmaseal Economy Jamshidi
Bone Marrow Biopsy Tray with 11 Ga, 4" Biopsy/Aspiration
Needle;
11. Catalog No. BEK4511, Baxter Pharmaseal Economy Jamshidi
Bone Marrow Biopsy and Aspiration Tray with 11 Ga, 4"
Biopsy/Aspiration Needle and 15 Ga Aspiration Needle
(Adjustable Length 3/8" - 1-7/8");
12. Catalog No. BK1000, Baxter Pharmaseal Bone Marrow
Biopsy Tray Without Needle;
13. Catalog No. CAK3411, Baxter Pharmaseal Contoured
Jamshidi Bone Marrow Biopsy Tray with 11 Ga, 4" Bone Marrow
Aspiration Needle;
14. Catalog No. CAK4511, Baxter Pharmaseal Contoured
Jamshidi Bone Marrow Biopsy Tray with 11 Ga, 4" Aspiration
Needle and 15 Ga Illinois Sternal/Iliac Aspiration Needle
(3/8" - 1-7/8");
15. Catalog No. EJT3353, Baxter Pharmaseal Jamshidi Bone
Marrow Biopsy Tray with 13 Ga, 3-1/2" Ergonomically Designed
Biopsy/Aspiration Needle;
16. Catalog No. EJT3411, Baxter Pharmaseal Jamshidi Bone
Marrow Biopsy Tray with 11 Ga, 4" Ergonomically Designed
Biopsy/Aspiration Needle;
17. Catalog EJT3583, Baxter Pharmaseal Jamshidi Bone Marrow
Biopsy and Aspiration Tray with 13 Ga, 3-1/2" Ergonomically
Designed Biopsy/Aspiration Needle and 18 Ga Aspiration
Needle (Adjustable 1/16" - 1-7/16");
18. Catalog No. EJT4508, Baxter Pharmaseal Jamshidi Bone
Marrow Biopsy and Aspiration Tray with 8 Ga, 4"
Ergonomically Designed Biopsy/Aspiration Needle and 15 Ga
Aspiration Needle (Adjustable 3/8" - 1-7/8");

-4- 19. Catalog No. EJT4511, Baxter Pharmaseal Jamshidi Bone
Marrow Biopsy and Aspiration Tray with 11 Ga, 4"
Ergonomically Designed Biopsy/Aspiration Needle and 15 Ga
Aspiration Needle (Adjustable 3/8" - 1-7/8");
20. Catalog No. LNT9000, Baxter Pharmaseal Lazarus-Nelson
Peritoneal Lavage Tray;
21. Catalog No. PC-1000, Baxter Pharmaseal Paracentesis
Tray with Boasberg Catheter Set;
22. Catalog No. PTC6022A, Baxter Pharmaseal Jamshidi
Percutaneous Transhepatic Cholangiography Procedure Tray
with 22 Ga X 6" Skinny-Chiba Needle with Centimeter Depth
Markings;
23. Catalog No. PTC8022A, Baxter Pharmaseal Jamshidi
Percutaneous Transhepatic Cholangiography Procedure Tray
with 22 Ga X 8" Skinny-Chiba Needle with Centimeter Depth
Markings;
24. Catalog No. SK1015A, Baxter Pharmaseal Jamshidi Soft
Tissue Biopsy Tray with 15 Ga (100 mm x 1.9 mm)
Needle/Syringe with Centimeter Depth Markings;
25. Catalog No. SK1016A, Baxter Pharmaseal Jamshidi Soft
Tissue Biopsy Tray with 16 Ga (100 mm x 1.6 mm)
Needle/Syringe with Centimeter Depth Markings;
26. Catalog No. SK1017A, Baxter Pharmaseal Jamshidi Soft
Tissue Biopsy Tray with 17 Ga (100 mm x 1.4 mm)
Needle/Syringe with Centimeter Depth Markings;
27. Catalog No. SK1018A, Baxter Pharmaseal Jamshidi Soft
Tissue Biopsy Tray with 18 Ga (100 mm x 1.2 mm)
Needle/Syringe with Centimeter Depth Markings;
28. Catalog No. SK7015A, Baxter Pharmaseal Jamshidi Soft
Tissue Biopsy Tray with 15 Ga (70 mm x 1.9 mm)
Needle/Syringe with Centimeter Depth Markings;
29. Catalog No. SK7016A, Baxter Pharmaseal Jamshidi Soft
Tissue Biopsy Tray with 16 Ga (70 mm x 1.6 mm)
Needle/Syringe with Centimeter Depth Markings;
30. Catalog No. SK7017A, Baxter Pharmaseal Jamshidi Soft
Tissue Biopsy Tray with 17 Ga (70 mm x 1.4 mm)
Needle/Syringe with Centimeter Depth Markings;
31. Catalog No. SK7018A, Baxter Pharmaseal Jamshidi Soft
Tissue Biopsy Tray with 18 Ga (70 mm x 1.2 mm)
Needle/Syringe with Centimeter Depth Markings;
32. Catalog No OB-1000, Baxter Circumcision Tray;
CODE All lots beginning with L4 and L5, excluding lots L5K019,
L5K024, L5K025, L5K023, L5K043, L5K022, L5K040, L5K041,
L5K042, L5K060, L5K026, L5J058.
MANUFACTURER Baxter Healthcare Corporation, Mannford, Oklahoma.
RECALLED BY Baxter Healthcare Corporation, McGaw Park, Illinois, by
letters dated September 22, 1995, and October 2, 1995, and
by Federal Express October 10, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 254,546 tray were distributed; firm estimated that 25
percent of the product remained on market at time of recall
initiation.
-5-REASON The sterility of the device has been compromised due to loss
of package seal integrity.

_______________
PRODUCT Medlite and MedAlex Laser Systems, used in dermatology.
Recall #Z-111/112-6.
CODE Undetermined.
MANUFACTURER Continuum Biomedical, Inc., Livermore, California.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan October 12, 1995. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 361 Medlite units and 3 MedAlex units were distributed.
REASON Device failed to comply with 21 CFR 1040.11(a)(2) in that
the operator's manual lacked adequate calibration
procedures.

_______________
PRODUCT Nd:YLF Ophthalmic Laser System, Model 2001, used in
ophthalmic surgery. Recall #Z-113-6.
CODE Model 2001.
MANUFACTURER Intelligent Surgical Lasers, Inc., San Diego, California.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plant October 12, 1995. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 24 units.
REASON Device failed to comply with 21 CFR 1040.11(a)(2) in that
the operator's manual lacked adequate calibration
procedures.

_______________
PRODUCT LB-6L Bicarb Concentrate, in gallon containers.
Recall #Z-116-6.
CODE 117H530.
MANUFACTURER Renal Systems, Division of Minntech Corporation,
Minneapolis, Minnesota.
RECALLED BY Manufacturer, by telephone and by fax on or about October 4,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Maryland, Missouri, Mississippi, North Carolina, New Jersey,
New York.
QUANTITY 1,223 cases (4 1-gallon bottles per case) were distributed.
REASON The pH of 8.5 exceeds the specification of 8.3.

_______________
PRODUCT 3M Sarns D4 Aortic Arch Cannula with Luer:
(a) Catalog No. 165264, 3M Part No. 98-0702-0317-3
(b) Catalog No. 165265, 3M Part No. 98-0702-0318-1
(c) Catalog No. 165266, 3M Part No. 98-0702-0319-9
(d) Catalog No. 165267, 3M Part No. 98-0702-0320-7
(e) Catalog No. 165268, 3M Part No. 98-0702-0321-5
(f) Catalog No. 165269, 3M Part No. 98-0702-0322-3

-6- (g) Custom, 3M Part No. 98-0702-0907-1
(h) Custom, 3M Part No. 98-0702-0946-9
(i) Custom, 3M Part No. 98-0702-0950-1.
Recall #Z-117/125-6.
CODE All lot numbers.
MANUFACTURER Sarns 3M Health Care, Ann Arbor, Michigan.
RECALLED BY Manufacturer, by visits held between August 1 and 12, 1994,
and by letter dated July 27, 1994. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 70,740 units were distributed.
REASON A potential packaging defect which may compromise the
sterility of the product.

_______________
PRODUCT DVI Rotating Hemostatic Valve, Model #CA3100, indicated for
maintaining a fluid-tight seal around a catheter during
percutaneous atherectomy or angioplasty. Recall #Z-126-6.
CODE Lot numbers 507514 and 507515.
MANUFACTURER Devices for Vascular Intervention, Temecula, California.
RECALLED BY Manufacturer, by letter sent June 26, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and France.
QUANTITY 986 units were distributed.
REASON A missing weld causes valve to separate during use.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
=====================
_______________
PRODUCT Kodak RP XOMAT Developer and Replenisher, acetic acid
solution, 2.68 gallons/10.1 liters. Recall #Z-067-6.
CODE Catalog #1249259, Lot Batch numbers: 9515, 9516, 9517,
9518. These kits may contain the suspect Part C, Batch
#9515.
MANUFACTURER Eastman Kodak Company, Rochester, New York.
RECALLED BY Manufacturer, by letters dated August 3 and 9, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 19,458 units were distributed.
REASON The Part "C" solution has the potential to cause a drop in
speed and contrast.

_______________
PRODUCT Abiomed BVS 36 Fr. Bendable Atrial Cannula, intended for use
with the BVS-500 Bi-Ventricular support System.
Recall #Z-127-6.
CODE Catalog #0506-0070, Control numbers: D9505060170P01 to P12
and E9505060170P01 to P28.
MANUFACTURER Abiomed, Inc., Danvers, Massachusetts.
RECALLED BY Manufacturer, by letter August 23, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.

-7-QUANTITY 39 individual packages were distributed.
REASON The instructions for use for the cannula were inadvertently
omitted from the cannula packages.

_______________
PRODUCT Lifepak 11 Diagnostic Cardiac Monitor with 12 Lead ECG
Cable, designed for pre-hospital use to detect early ECG
indicators of AMI. Recall #Z-128-6.
CODE All serial numbers.
MANUFACTURER Physio Control Corporation, Redmond, Washington.
RECALLED BY Manufacturer, by letter issued on September 19, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 849 cables were distributed.
REASON There is a potential for the 12 lead ECG cable to break.

-8-

END OF ENFORCEMENT REPORT FOR NOVEMBER 8, 1995. BLANK PAGES MAY
FOLLOW.

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