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
09/13/1995
ENFORCEMENT REPORT FOR 09/13/95
September 13, 1995 95-37
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Croquettes, Milk Chocolate Candy shipped in 6 pound or 12
pound bulk cases. Recall #F-766-5.
CODE Not coded.
MANUFACTURER Philadelphia Candies, Inc., Sharon, Pennsylvania.
RECALLED BY Manufacturer, by letter, June 1, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Pennsylvania, Ohio, New Hampshire, Georgia, Michigan, New
York, Vermont.
QUANTITY All products are included.
REASON The product contains peanuts and the peanuts are not
declared as an ingredient.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
========================
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PRODUCT (a) Orchids of Hawaii Kiwi concentrate packed in 1 gallon
plastic bottles or 1 pint 9.4 ounce glass bottles; (b)
Orchids of Hawaii daiquiri margarita cocktail mix packed in
1 gallon plastic bottles or 1 pint 9.4 ounce glass bottles.
Recall #F-814/815-5.
CODE None.
MANUFACTURER Three Vee Food and Syrup Products, Inc., Brooklyn, New York.
RECALLED BY Orchids of Hawaii International, Inc., Bronx, New York, by
letter sent August 9, 1995. Firm-initiated recall ongoing.
DISTRIBUTION New York, Massachusetts, Virginia, Mississippi.
QUANTITY Firm estimates none remain on market.
REASON The products contain undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
=======================
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PRODUCT Frozen dough products:
French Bread, 24 per case; Square White Bread, 24 per case;
Baguette Bread, 36 per case; 1 lb. Seeded Rye Bread, 20 per
case; 1 lb. Plain Rye Bread, 20 per case; Raisin Bread, 20
per case; Oat Bran Bread, 24 per case; Sun flower Seed
Bread, 24 per case; Dinner Hard Rolls, 20 dozen per case;
Medium Hard Rolls, 18 dozen per case; Large Hard Rolls, 12
dozen per case; Twist Strips, 15 dozen per case; Twist
Rolls, 12 dozen per case; 3" Club Rolls, 14 dozen per case;
5" Steak Rolls, 12 dozen per case; 8" Sub Rolls, 12 dozen
per case; 10" Sub Rolls, 8 dozen per case; 12" Sub Rolls, 8
dozen per case; Hot Dog Rolls, 15 dozen per case; Wheat
Bread, 24 per case; Wheat Hard Rolls, 15 dozen per case;
Coffee Cakes, 20 per case. Recall #F-789/810-5.
CODE Products coded with julian date codes 191 through 194.
MANUFACTURER Al Cohen Bakery, Buffalo, New York.
RECALLED BY Manufacturer, by telephone July 18, 1995. Firm-initiated
recall complete.
DISTRIBUTION New York.
QUANTITY 75,000 pounds were distributed.
REASON The products are contaminated with metal shavings.
_______________
PRODUCT (a) Clinical Resource Standard, 250 calories, Strawberry
Artificial Flavor, medical food nutrition supplement, in 8
fluid ounces; (b) Clinical Resource Plus, 355 calories,
Vanilla Artificial Flavor in 8 fluid ounce boxes; (c)
Resource Plus Nutritionally Balanced Liquid Supplement,
three-flavor sample pak (chocolate, vanilla, and strawberry
flavors), in 8 fluid ounce drink boxes.
Recall #F-811/813-5.
CODE (a) "0635A EXP JU 96"; "0635B EXP JU 96"; "0645A EXP JU 96";
"0645B EXP JU 96"; (b) "0635A EXP JU 96", 0635B EXP JU 96";
(c) "0635A" on 8 fl. oz. vanilla flavor drink and "1015" on
plastic over-wrap of the Three-Flavor Sample Pak.
MANUFACTURER Sandoz Nutrition, Inc., St. Louis Park, Minnesota.
RECALLED BY Manufacturer, by letter July 12, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 11,000 cases 27 8-ounce drink boxes per case
were distributed.
REASON The product is contaminated with Pseudomonas Aeruginosa.
-2- RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Oxygen USP packed in various sizes of luxfer aluminum high
pressure cylinders including "E", "D", "C" and "M-6" of 682
liters, 400 liters, 240 liters and 180 liters, respectively.
Recall #D-244-5.
CODE Lot numbers 8-18-94F through 8-18-94F-6; 9-19-94F-1 through
9-19-94F-6; 10-4-94F-1 through 10-4-94F-6; 10-18-94F-1
through 10-18-94F-7; 11-10-94F-1 through 11-10-94F-7; 11-21-
94F-1 through 11-21-94F-6; 12-1-94F-1 through 12-1-94F-7;
12-21-94F-1 through 12-21-94F-7; 1-3-95F-1 through 1-3-95F-
8; 1-18-95F-1 through 1-18-95F-8; 2-1-95F-1 through 2-1-95F-
8; 2-8-95F-1 through 2-8-95F-9; 2-28-95F-1 through 2-28-95F-
9; 3-17-95F-1 through 3-17-95F-10; 4-5-95F-1 through 4-5-
95F-9; and 4-21-95F-1 through 4-21-95F-10.
MANUFACTURER Family Home Care Inc., Tifton, Georgia.
RECALLED BY Manufacturer, by visit August 28, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates none remain on market.
REASON Current good manufacturing practice deficiencies.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Red Blood Cells
Frozen; (d) Platelets; (e) Platelets, Pheresis; (f)
Platelets for further manufacture; (g) Cryoprecipitated AHF;
(h) Fresh Frozen Plasma; (i) Granulocytes/Platelets,
Pheresis; (j) Leukocytes; (k) Recovered Plasma; (l) Source
Leukocytes, Recall #B-591/602-5.
CODE Contact FDA, Center for Biologics Evaluation and Research,
Office of Compliance, (301) 594-1070, for individual unit
numbers recalled.
MANUFACTURER American Red Cross Blood Service, Rochester, New York.
RECALLED BY Manufacturer, by letters issued with dates ranging from
August 1994 to January 1995. Firm-initiated recall
complete.
DISTRIBUTION New York, Pennsylvania, Maryland, California, Switzerland.
QUANTITY (a) 2 units; (b) 31 units; (c) 2 units; (d) 16 units; (e) 39
units; (f) 5 units; (g) 2 units; (h) 7 units; (i) 3 units;
(j) 1 unit; (k) 32 units; (l) 6 units.
REASON Blood products, which tested repeatedly reactive for
antibody to human immunodeficiency virus type 1 (anti-HIV-
1); or tested negative for anti-HIV-1 but were collected
from donors who previously tested repeatedly reactive for
anti-HIV-1, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-603/604-5.
CODE Unit #X79092.
-3-
MANUFACTURER Central California Blood Center, Fresno, California.
RECALLED BY Manufacturer, by letters dated March 31, 1995. Firm-
initiated recall complete.
DISTRIBUTION California
QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a donor who was
diagnosed as a Streptococcus carrier, were distributed for
transfusion.
_______________
PRODUCT Platelets. Recall #B-605-5.
CODE Unit #s 19223-2935, 19223-2937, 19223-2939, 19223-2945,
19223-2950.
MANUFACTURER United Blood Services Blood Systems, Inc., Reno, Nevada.
RECALLED BY United Blood Services Blood Systems, Inc., Lubbock, Texas,
by telephone January 4, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Texas.
QUANTITY 5 units.
REASON Blood products, which were possibly exposed to unacceptable
shipping temperatures and were in transit for greater than
forty-eight hours, were distributed.
_______________
PRODUCT Pyrotell(R) Limulus Amebocyte Lysate. Recall #B-607-5.
CODE Lot #42-128-570.
MANUFACTURER Associates of Cape Cod, Inc., Falmouth, Massachusetts.
RECALLED BY Manufacturer, by letter dated July 2, 1993. Firm-initiated
recall complete.
DISTRIBUTION California, Indiana, Kansas, Michigan, Montana,
Massachusetts, New Hampshire, New Jersey, Pennsylvania,
Vermont, Puerto Rico.
QUANTITY 3,368 5-ml vials.
REASON Limulus Amebocyte Lysate (LAL), which was packaged in a
container labeled with an incorrect volume, was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Recovered Plasma. Recall #B-576-5.
CODE Unit #s 42T25023, 42T25025, 42T25009.
MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio.
RECALLED BY Manufacturer, by letters dated January 9, 1995 and July 11,
1995. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 3 units.
REASON Blood products, associated with a unit of pooled Platelets
which was contaminated with Staphylococcus epidermidis, were
distributed.
-4- _______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma.
Recall #B-588/590-5.
CODE Unit numbers: (a) 4515808, 4515824, 4525305, 4528390,
4530589, 8056963; (b) 4515808, 4525305, 4528390; (c)
8056963.
MANUFACTURER Blood Care, Dallas, Texas.
RECALLED BY Manufacturer, by telephone on April 6, 1995, and by follow-
up letter dated May 18, 1995. Firm-initiated recall
complete.
DISTRIBUTION Pennsylvania, New York, Maryland, California, Switzerland.
QUANTITY (a) 6 units; (b) 3 units; (c) 1 unit.
REASON Blood products, which were improperly tested for the
antibody to the human T-lymphotropic virus type 1 (anti-
HTLV-1), were distributed.
_______________
PRODUCT Columbia Calibre 0.9% Sodium Chloride Solution,
Recall #B-606-5.
CODE Lot 032395.
MANUFACTURER Val Tech Diagnostics, Inc., Brackenridge, Pennsylvania.
RECALLED BY Columbia Diagnostics, Inc., Springfield, Virginia, by
telephone on April 5, 1995, and by follow-up letter dated
April 6, 1995. Firm-initiated recall complete.
DISTRIBUTION Maryland, Virginia, Pennsylvania, Connecticut.
QUANTITY 96 5-gallon containers.
REASON Columbia Calibre 0.9% Sodium Chloride (NaCl) solution, which
demonstrated a diluted form of 0.9% NaC1, was distributed.
_______________
PRODUCT Source Plasma. Recall #B-613-5.
CODE Contact FDA, Center for Biologics Evaluation and Research,
Office of Compliance, (301) 594-1070, for individual unit
numbers recalled.
MANUFACTURER Plasma Services of Lackland, San Antonio, Texas.
RECALLED BY United Blood Services Blood Systems, Inc., Scottsdale,
Arizona, by letters dated December 21 and 28, 1994, and May
25, 1995. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 3,649 units.
REASON Source Plasma, exposed to unacceptably elevated storage
temperatures, and not relabeled as Source Plasma, Salvaged,
was distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Semi-Circular Knife, Model No A3576. Recall #Z-1145-5.
CODE Lot 4YW01.
MANUFACTURER Olympus Winter and Ibe GmbH, Hamburg, Germany.
RECALLED BY Olympus America Inc., Melville, New York, by letter April
12, 1995. Firm-initiated recall ongoing.
-5- DISTRIBUTION Pennsylvania, California.
QUANTITY 5 units were distributed.
REASON Device is missing the index notch at the proximal end,
allowing the blade to improperly locate or lock into place
inside the working element, potentially affecting the
handling of the scalpel during a procedure.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
=====================
_______________
PRODUCT Vascular Tri-Adapter and Vascular Y-Adapter with Hemostasis
Valve:
(1) Y-Adapter with Plastic and Metal Introducers, Catalog
Nos. IM4001, IM4002-P, IM4002-M.
(2) Tri-Adapter with Plastic and Metal Introducers; Catalog
Nos. IM4002, IM4002-P, IM4002-M;
(3) Y-Adapter Accessory Pack with Plastic and Metal
Introducers; Catalog Nos. IM4003-P, IM4003-M;
(4) Tri-Adapter Accessory Pack with Plastic and Metal
Introducers, Catalog Nos. IM4004-P; IM4004-M.
Recall #Z-1104/1107-5.
CODE All lot numbers manufactured prior to 11/23/93.
MANUFACTURER Medtronic Interventional Vascular, Inc., Danvers,
Massachusetts.
RECALLED BY Manufacturer, by letter December 3, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 464 packs were distributed; firm estimates none remains on
market.
REASON Product may not open to their original dimension of 0.110
inch, and may not accommodate passage of certain large
devices through the adapter.
_______________
PRODUCT Disposable Aorta Punch, a device used to produce circular
openings in myocardial tissue. Recall #Z-1146/1151-5.
CODE Lot #s 4041118, 4041206, 4041115.
MANUFACTURER Specialized Medical Devices, Lancaster, Pennsylvania.
RECALLED BY Pilling Weck, Research Triangle Park, North Carolina, by
certified mail March 14, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,848 units were distributed.
REASON Punctures were found in the plastic package, therefore
compromising the sterility of the product.
_______________
UPDATE: Recall #Z-1135/1136-5, which appeared in the Enforcement
Report dated September 6, 1995, should read: Product: (b)
Protector Latex, Powder-Free Examination Gloves, instead of
Proctor Latex; Code: Reorder #FXS, FXM, FXL. All lots
labeled "Made in China", Manufacturer: Unknown, Chinese
manufacturer.
-6- MEDICAL DEVICE SAFETY ALERTS:
============================================
_______________
PRODUCT ElectroCautery Probes:
(1) L-Tip Electrode (Part #250-070-415)
(2) J-Hook Electrode (Part #250-070-416)
(3) Spatula Tip Electrode (Part #250-070-417)
(4) Needle Tip Electrode (Part #250-070-418).
Safety Alert #N-043/046-5.
CODE None.
MANUFACTURER Stryker Endoscopy, Santa Clara, California.
ALERTED BY Manufacturer, by letter July 5, 1995.
DISTRIBUTION Nationwide.
QUANTITY Approximately 400 units.
REASON If electricity is applied while the electroprobe is in a
position or condition that is in contraindication of the
instructions for use, an electric shock hazard is present.
-7-
END OF ENFORCEMENT REPORT FOR SEPTEMBER 13, 1995. BLANK PAGES MAY
FOLLOW.
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