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 contain s information on actions taken in connection with agency regulatory activities.

ENFORCE
10/09/1996

ENFORCEMENT REPORT FOR 10/09/96

October 9, 1996 96-41

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Chocolate Chip Cookie Dough Ice Cream, under
the following labels: Galliker's -- 3 gallon
bulk containers, 1/2 gallon containers,
Leichtman's -- 1/2 gallon round containers,
CR's Friendly Markets - 1 pint rounds, 1/2
gallon rounds. Recall #F-737-6.
CODE All codes.
MANUFACTURER Galliker Dairy Company, Johnstown,
Pennsylvania.
RECALLED BY Manufacturer, by memorandum on July 12, 1996,
and by press release on July 26, 1996. Firm-
initiated recall complete.
DISTRIBUTION Pennsylvania, Maryland, Virginia, West
Virginia.
QUANTITY Firm estimated that little if any product
remained on market.
REASON Product contains undeclared eggs.

_______________
PRODUCT Jack & Jill Chocolate Chip Cookie Dough Ice
Cream, in 1/2 gallon containers.
Recall #F-738-6.
CODE 1/2 gallons code #23269-10027, dated APR497,
MAY0997, MAY2997, JUN0597, JUN1397, JUL1097
(printed on the end flaps of carton). Pint
cartons code #23269-18027 dated BB51597 and
BB71697 (printed on the bottom of cartons).
MANUFACTURER Simco Manufacturing, Inc., Cuyahoga Falls,
Ohio.
RECALLED BY Jack & Jill Ice Cream, Bensalem, Pennsylvania,
by press release on August 6, 1996. Firm-
initiated recall complete.
DISTRIBUTION Pennsylvania, New Jersey, Delaware, Maryland,
Virginia, West Virginia, New York, District of
Columbia.
QUANTITY Undetermined.
REASON Product contains undeclared eggs.

_______________
PRODUCT Reinhold's Chocolate Chip Cookie Dough Ice
Cream, in 1/2 gallon square, 1 quart round,
and 3 gallon round cardboard bulk containers.
Recall #F-739-6.
CODE All codes.
MANUFACTURER Reinhold Ice Cream Company, Pittsburgh,
Pennsylvania.
RECALLED BY Manufacturer, by press release on July 23,
1996. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY Firm estimated that 70 half-gallon squares, 70
1-pint rounds and 65 3-gallon bulk containers
remained on market at time of recall
initiation.
REASON Product contains undeclared eggs.

_______________
PRODUCT Hartley's Choice Chocolate Chip Cookie Dough
Ice Cream, in 1/2 gallon round cardboard
containers, distributed by Kings Family
Restaurants, Inc. Recall #F-740-6.
CODE All codes.
MANUFACTURER King's Country Shoppes, Inc., McKeesport,
Pennsylvania (distributor).
RECALLED BY Distributor, by press release on July 24,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania.
QUANTITY Firm estimated that 108 half-gallon containers
remained on market at time of recall
initiation.
REASON Product contains undeclared eggs.

-2-RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Eggstra Pasteurized Homogenized Liquid Egg
Product in cardboard cartons.
Recall #F-735-6.
CODE Lot #234-61 USE BY 9-17-96 and Lot 235-61 USE
BY 9 18 96.
MANUFACTURER National Food Corporation, Pacific Egg
Products Division, Arlington, Washington.
RECALLED BY Manufacturer, by telephone beginning August
28, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Washington state.
QUANTITY 215 cases (30 units per case) of lot 233-61
and 114 (30 units per case) of lot 234-61 were
distributed.
REASON Product is contaminated with salmonella.

_______________
PRODUCT Lay's Regular Potato chips, in 6 ounce size
bags. Recall #F-741-6.
CODE Manufacturing code 4351A63, Lot No. October
15, 1996.
MANUFACTURER Frito-Lay, Inc., Orlando, Florida.
RECALLED BY Frito-Lay, Inc., Plano, Texas, by computer on
September 13, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Florida and Georgia.
QUANTITY All product were distributed.
REASON Product contains undeclared dairy ingredients
and bears an inappropriate identity statement.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Apple & Eve 100% Pure & Natural Apple Juice,
8.45 fluid ounce 3-pak brick pack juice boxes.
Recall #F-742-6.
CODE EXP OCT 30 96B
MANUFACTURER Golden Town Apple Products, Montreal, Canada.
RECALLED BY Apple & Eve, Roslyn, New York, by letter June
13, 1996. Completed recall resulted from
sample analysis and followup by New York State
Department of Agriculture and Markets.
DISTRIBUTION New York, Vermont, New Jersey.
QUANTITY 1,440 cases were distributed; firm estimates
none remains on the market.
REASON Product contains undeclared potassium sorbate,
a preservative.

_______________
PRODUCT Large Gumdrops and Spearmint Leaves candy
packaged in 7 ounce clear plastic bags.
Recall #F-743/744-6.
-3-CODE All codes.
MANUFACTURER Farley Foods USA, Chicago, Illinois.
RECALLED BY Salem's old Fashioned Candies, Inc., Salem,
Massachusetts, by telephone. Completed recall
resulted from sample analysis and followup by
State of New York Department of Agriculture
and Markets.
DISTRIBUTION Nationwide.
QUANTITY Approximately 84 packages of gumdrops and 396
packages of spearmint leaves.
REASON Product contains undeclared FD&C Yellow No. 5.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Bacitracin Zinc (500 units) and Polymyxin B
Sulfate (10,000 units) Ophthalmic Ointment
USP, under the following labels: Bausch &
Lomb, Rugby, Medical Ophthalmics, H.L. Moore,
and Akorn. Recall #D-275-6.
CODE (Bausch & Lomb Label) #'s 733661, 683082,
643531, 593411; (Rugby Labs label, Medical
Ophthalmics label, and H.L. Moore label) Lot #
683081; (Akorn label) Lot # 643532.
MANUFACTURER Bausch & Lomb Pharmaceutical Division, Tampa,
Florida.
RECALLED BY Manufacturer, by letter on August 5, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 93,491 units were distributed; firm estimated
that 2,000 units remained on market at time of
recall initiation.
REASON Potency is not assured through its shelf-life
due to possible degradation of bacitracin
zinc.

_______________
PRODUCT OTC Dental Cream (toothpaste) labeled as
manufactured by Colgate-Palmolive, Bombay,
India. Recall #D-278-6.
CODE Undetermined.
MANUFACTURER Undetermined except for labeled declaration
which indicated Colgate-Palmolive in Bombay,
India.
RECALLED BY International Marketing and Management
Services, Beverly Hills, California, by letter
on August 21, 1996, followed by telephone.
Firm-initiated recall complete.
DISTRIBUTION California and the United Kingdom.
QUANTITY 743 cases (144 tubes per case) were
distributed.

-4-REASON Colgate-Palmolive states that it is
counterfeit and its use is associated with
four complaints of mouth irritation.

_______________
PRODUCT Oxygen, USP, in size E cylinders.
Recall #D-280-6.
CODE Lot #090996 which included 3 cylinders with
serial numbers E12699, 28804, and E15539.
MANUFACTURER Respiratory Home Care Consultants, Inc., West
Middlesex, Pennsylvania.
RECALLED BY Manufacturer, by telephone on or about
September 12, 1996. Firm-initiated recall
complete.
DISTRIBUTION Pennsylvania.
QUANTITY 3 cylinders were distributed.
REASON Purity was not tested.

_______________
PRODUCT Apothe'Cure brand Adrenal Cortex Extract
Injectable, 2 mg/ml, Rx, various formulations
and vial sizes:
Adrenal Cortical Extract, 3 ml, 2 mg/ml in
Sesame Oil, Preservative Free, Sterile
Injection
Adrenal Cortical Extract, 10 ml, 2 mg/ml in
Sesame Oil, Preservative Free, Sterile
Injection
Adrenal Cortical Extract, 10 ml, 2 mg/ml in
Normal Saline, Preservative Free, Sterile
Injection
Adrenal Cortical Extract, 30 ml, 2 mg/ml in
Normal Saline, Preservative Free, Sterile
Injection
Adrenal Cortical Extract, 50 ml, 2 mg/ml in
Normal Saline, Preservative Free, Sterile
Injection
Adrenal Cortical Extract, 100 ml, 2 mg/ml in
Normal Saline, Preservative Free, Sterile
Injection
Adrenal Cortical Extract, 3 ml, 2 mg/ml in
pyrogen free Sterile Water, Preservative Free,
Sterile Injection
Adrenal Cortical Extract, 30 ml, 2 mg/ml in
pyrogen free Sterile Water, Preservative free,
Sterile Injection. Recall #D-001/003-7.
CODE All codes.
MANUFACTURER Apothe'Cure, Inc., Dallas, Texas.
RECALLED BY Manufacturer, by letter dated August 15, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 3,525 units were distributed.

-5-REASON Product is an unapproved new drug; FDA
inspection found current good manufacturing
practice deficiencies and FDA analysis found
units lacking the labeled active ingredient.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Royce brand Pindolol Tablets, USP, Rx in 100
tablet bottles, 10 mg and 5 mg strengths, used
in the management of hypertension.
Recall #D-276/277-6.
CODE Lot numbers: MD-1196 (5 mg); MD-1193 (10 mg).
MANUFACTURER Royce Laboratories, Miami, Florida.
RECALLED BY Manufacturer, by survey conducted in April 18
through 29, 1996. Firm-initiated recall
complete.
DISTRIBUTION California, New Jersey, Ohio, Mississippi,
Michigan, New York, Illinois, Florida,
Louisiana, Kentucky, Arkansas.
QUANTITY 4,688 10-mg bottles and 4,437 5-mg bottles
were distributed.
REASON Normally white tablets may turn pink.

_______________
PRODUCT Compressed Oxygen USP in aluminum cylinders.
Recall #D-279-6.
CODE Lot numbers: 021396-1 021396-2 022096-1
022296-1 022296-2 022696-3 022796-1
022996-1 030596-1 030596-2 031496-1
040496-1 041196-1 041196-2 041696-1
041696-2 042396-1 042396-2 043096-1
050996-1 051096-1 051696-1 052196-1
052196-2 060496-1 060496-2 061196-1
070296-1 080796-1 080896-1 082996-1
082996-2 052296-2 091796-1.
MANUFACTURER Laurel Medical Supplies, Inc., Ebensburg,
Pennsylvania.
RECALLED BY Manufacturer, by visit beginning on September
24, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania.
QUANTITY Approximately 100 cylinders per month were
distributed between February 1996 through
September 1996.
REASON Purity was below specification or not tested.

_______________
PRODUCT Nitro-Bid IV (nitroglycerin injection USP),
packaged in 1-ml., 5-ml., and 10-ml. vials,
for the treatment of perioperative

-6- hypertension, for control of congestive heart
failure in the setting of acute myocardial
infarction, for the treatment of angina
pectoris, and for induction of intraoperative
hypotension. Recall #D-004-7.
CODES S00141, S00117, S00116, S00115, S00109,
S00098, S00082.
MANUFACTURER Sanofi Winthrop Pharmaceuticals, McPherson,
Kansas (contract manufacturer).
RECALLED BY Hoechst Marion Roussel, Inc., Kansas City,
Missouri (responsible firm), by letter dated
September 10, 1996. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 10,893/1-ml vials between 9/30/94-8/28/96;
2,584/5-ml vials between 10/23/95-8/12/96;
2,327/10-ml vials between 6/1/96-4/23/96 were
distributed.
REASON Insert incorrectly states the dosage
concentration as mg/ml and mg/min rather than
mcg/ml and mcg/min.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Platelets. Recall #B-649-6.
CODE Unit #29135-0871.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by letter dated June 13, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
Whole Blood designated as a "difficult"
collection.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-651/652-6.
CODE Unit #18022-6877.
MANUFACTURER United Blood Services, Cheyenne, Wyoming.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated April 1, 1996. Firm-initiated
recall complete.
DISTRIBUTION Tennessee, North Carolina.
QUANTITY 1 unit of each component were distributed.
REASON Blood products were collected from a donor
with a history of hepatitis.

_______________
PRODUCT Blood Grouping Reagent Anti-D (anti-Rho).
Recall #B-653-6.

-7-CODE Lot numbers: D145-1A, IC, ID, IE, IG, IBA,
IBB, IFA, IFB EXP 12/23/95; D146-1A, IC, ID,
IBA, IBB EXP 9/15/96; D147-1A, 1B, 1C, 1DA,
IDB, 1DC EXP 7/5/97.
MANUFACTURER Dade International of Puerto Rico, Aguada,
Puerto Rico.
RECALLED BY Manufacturer, by letter dated December 1995,
and by fax. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 11,046 packages were distributed
between March 22, 1994 and September 22, 1995.
REASON Blood grouping reagent gave weaker than
expected antigen typing results.

_______________
PRODUCT Red Blood Cells. Recall #B-654-6.
CODE Unit #0474644.
MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo,
Texas.
RECALLED BY Manufacturer, by telephone and letters dated
August 14, 1995. Firm-initiated recall
complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood products were collected from a donor
diagnosed with a history of malignant prostate
cancer.

_______________
PRODUCT Aplitest, Tuberculin, Purified Protein
Derivative Multiple Puncture Device for
Intradermal Testing. Recall #B-656-6.
CODE Lot #00504P EXP 9/95.
MANUFACTURER Parke-Davis, Division of Warner-Lambert
Company, Rochester, Michigan.
RECALLED BY Manufacturer, by letter on March 27, 1995.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 1,848 units were distributed.
REASON Product failed antigen potency test.

_______________
PRODUCT Red Blood Cells. Recall #B-660-6.
CODE Unit #137088.
MANUFACTURER Blood Bank of Alaska, Anchorage, Alaska.
RECALLED BY Manufacturer, by letter dated July 13, 1996.
Firm-initiated recall complete.
DISTRIBUTION Alaska.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to a malarial endemic area.

-8-_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-661/663-6.
CODE Unit #685832.
MANUFACTURER Community Blood Center, Dayton, Ohio.
RECALLED BY Manufacturer, by letters dated January 24,
1996, and February 9, 1996. Firm-initiated
recall complete.
DISTRIBUTION Ohio and California.
QUANTITY 1 unit of each component.
REASON Blood products were collected from a donor
with a reported history of a contaminated
needle stick.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-670/671-6.
CODE Unit #BB141067.
MANUFACTURER Blood Bank of Alaska, Anchorage, Alaska.
RECALLED BY Manufacturer, by letter dated August 22 and
23, 1995. Firm-initiated recall complete.
DISTRIBUTION Alaska and California.
QUANTITY 1 unit of each component were distributed.
REASON Blood products were collected from a donor
with a history of ear piercing within 12
months of donation.

_______________
PRODUCT Red Blood Cells. Recall #B-676-6.
CODE Unit numbers: 2N8887, 4H1726, 1S3086, 1S3082.
MANUFACTURER Puget Sound Blood Center, Seattle, Washington.
RECALLED BY Manufacturer, by telephone on October 5, 1995.
Firm-initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY 4 units were distributed.
REASON Red Blood Cells were labeled incorrectly as
Red Blood Cells, Leukocytes Removed by
Filtration.

_______________
PRODUCT Recovered Plasma. Recall #B-679-6.
CODE Unit #23-15112.
MANUFACTURER University Medical Center-Mesabi, Hibbing,
Minnesota.
RECALLED BY Manufacturer, by telephone on April 19, 1996.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Blood product tested repeatedly reactive for
the antibody to the human immunodeficiency
virus types 1 and 2 (anti-HIV-1/2), Western
blot indeterminate.

-9-_______________
PRODUCT (a) Platelets; (b) Fresh Frozen Plasma.
Recall #B-680/681-6.
CODE Unit #KX70309.
MANUFACTURER Central Blood Bank, Pittsburgh, Pennsylvania.
RECALLED BY Manufacturer, by letter dated July 7, 1994.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit of each component were distributed.
REASON Blood products containing anti-K antibodies
were labeled as negative for the unexpected
antibodies.

_______________
PRODUCT Red Blood Cells. Recall #B-688-6.
CODE Unit numbers: 10FQ01278, 10FH13013,
10FG14964.
MANUFACTURER American Red Cross Blood Services,
Springfield, Missouri.
RECALLED BY Manufacturer, by telephone on October 10,
1995. Firm-initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 3 units were distributed.
REASON Blood products were collected from a donor who
traveled to an area designated as endemic for
malaria.

_______________
PRODUCT Red Blood Cells. Recall #B-691-6.
CODE Unit #R00541.
MANUFACTURER Tacoma-Pierce County Blood Bank, doing
business as Cascade Regional Blood Services,
Tacoma, Washington.
RECALLED BY Manufacturer, by fax on January 12, 1996.
Firm-initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY 1 unit.
REASON Blood product was collected from a donor with
a history of cancer.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-693/694-6.
CODE Unit #9520956.
MANUFACTURER Lorain County Blood Bank, Elyria, Ohio.
RECALLED BY Manufacturer, by telephone on December 11,
1995, followed by letter dated January 16,
1996. Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit of each component was distributed.

-10-REASON Blood products were collected from a donor who
traveled to an area designated as endemic for
malaria.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Recovered Plasma.
Recall #B-699/702-6.
CODE Unit numbers: (a) 94-0191, 94-0833, 94-2032,
94-2174, 94-2453, 94-3196, 94-3767, 94-3970,
94-4047, 95-0770, 95-1138, 95-1726, 95-2450,
95-3084, 95-3125, 95-3903, 96-0623, 96-0975,
96-1428;
(b) 94-3196, 95-1726, 95-3125, 96-0623;
(c) 94-4047, 95-1138, 96-0975, 96-1428;
(d) 94-0191, 94-0833, 94-2032, 94-2174,
94-2453, 94-3196, 94-3970, 95-0770, 95-1726,
95-2450, 95-3084, 95-3125, 95-3903, 96-0623.
MANUFACTURER Merced County Blood Bank, Merced, California.
RECALLED BY Manufacturer, by letter dated July 9, 1996.
Firm-initiated recall complete.
DISTRIBUTION California and New York.
QUANTITY (a) 19 units; (b) 4 units; (c) 4 units (d) 14
units were distributed.
REASON Blood products tested non-reactive to anti-
HIV-1, were collected from donors who
previously tested repeatedly reactive for
anti-HIV-1, EIA negative, Western Blot
negative and donors were subsequently re-
entered improperly.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-704/705-6.
CODE Unit #GJ51025.
MANUFACTURER Blood Bank of San Bernardino and Riverside
Counties, San Bernardino, California.
RECALLED BY Manufacturer, by letter dated February 28,
1994. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
whose spouse has history of IV drug use.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-646/648-6.
CODE Unit #5Y2587.
MANUFACTURER Puget Sound Blood Center, Seattle, Washington.

-11-RECALLED BY Manufacturer, by letters dated July 27, 1995
and August 11, 1995. Firm-initiated recall
complete.
DISTRIBUTION Washington state, California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
received a corneal transplant within one year
of donation.

_______________
PRODUCT Whole Blood. Recall #B-650-6.
CODE Unit 29132-7664.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on February 24,
1996. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Autologous blood product tested positive for
the hepatitis B surface antigen (HBsAg).

_______________
PRODUCT Recovered Plasma. Recall #B-655-6.
CODE Unit #0474644.
MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo,
Texas.
RECALLED BY Manufacturer, by letter on August 14, 1995.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood products were collected from a donor
diagnosed with a history of malignant prostate
cancer.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-657/659-6.
CODE Unit numbers: (a) 0557005 EXP 12/10/94; (b)
0557005 EXP 11/3/94; (c) 0557005 EXP 12/13/94.
MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo,
Texas.
RECALLED BY Manufacturer, by telephone on January 4, 1995.
Firm-initiated recall complete.
DISTRIBUTION Tennessee and Texas.
QUANTITY 1 unit of each component were distributed.
REASON Blood products were collected from a donor who
received a tissue transplant (surgery) within
a year of donation.

_______________
PRODUCT Source Plasma. Recall #B-669-6.
CODE Unit #XQ64057.
MANUFACTURER Community Bio-Resources, Inc., Birmingham,
Alabama.
-12-RECALLED BY Manufacturer, by letter dated October 13,
1995. Firm-initiated recall complete.
DISTRIBUTION Austria.
QUANTITY 1 unit was distributed.
REASON Blood product was untested for syphilis.

_______________
PRODUCT Red Blood Cells. Recall #B-677-6.
CODE Unit #07H25891.
MANUFACTURER American Red Cross Blood Services, Tucson,
Arizona.
RECALLED BY Manufacturer, by telephone on February 21,
1992. Firm-initiated recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.

_______________
PRODUCT Irradiated Red Blood Cells. Recall #B-678-6.
CODE Unit numbers: C52846, E65455, C52958, C52212.
MANUFACTURER Tri-Counties Blood Bank, Inc., Santa Barbara,
California.
RECALLED BY Manufacturer, by telephone on March 17, 1994.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 4 units were distributed.
REASON Irradiated blood products were labeled with an
extended expiration date.

_______________
PRODUCT Red Blood Cells. Recall #B-689-6.
CODE Unit numbers: 0275565 and 5521402.
MANUFACTURER Inland Northwest Blood Center, Spokane,
Washington.
RECALLED BY Manufacturer, by telephone in September 1995.
Firm-initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY 2 units were distributed.
REASON Blood products were labeled with an extended
expiration date.

_______________
PRODUCT Red Blood Cells. Recall #B-690-6.
CODE Unit numbers: 2241462 and 2241422.
MANUFACTURER Inland Northwest Blood Center, Spokane,
Washington.
RECALLED BY Manufacturer, by letter dated June 12, 1995.
Firm-initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY 2 units were distributed.
REASON Blood products were labeled with an extended
expiration date.
-13-_______________
PRODUCT Recovered Plasma. Recall #B-692-6.
CODE Unit #R00541.
MANUFACTURER Tacoma-Pierce County Blood Bank, doing
business as Cascade Regional Blood Services,
Tacoma, Washington.
RECALLED BY Manufacturer, by fax on January 12, 1996.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product was collected from a donor with
a history of cancer.

_______________
PRODUCT Red Blood Cells. Recall #B-703-6.
CODE Unit numbers: 07F71730 and 07F71731.
MANUFACTURER American Red Cross, Tucson, Arizona.
RECALLED BY Manufacturer, by telephone on or about June
23, 1993. Firm-initiated recall complete.
DISTRIBUTION Arizona.
QUANTITY 2 units were distributed.
REASON Blood products were exposed to unacceptable
temperatures.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Hand-Held Controllers for the Maxxus Dual Head
Imaging Systems and the Optima Integrated
Multi-Dector Imaging System.
Recall #Z-1235/1236-6.
CODE All serial numbers.
MANUFACTURER IGE (International General Electric) Ltd., St.
Albans, United Kingdom.
RECALLED BY General Electric Company, Medical Systems
Division, Waukesha, Wisconsin, by field
modification instructions issued on July 24,
1996. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 315 units were distributed.
REASON Excessive electronic noise in the hand-held
controllers could cause unintended motion of
the gantry, which could result in collision of
the gantry with the patient.

_______________
PRODUCT C Optima Imaging System, Model 9SYS0088 with
Granite Central Processing Units (CPU's), a
nuclear medicine imaging system.
Recall #Z-1237-6.
CODE Systems with granite CPU's.

-14-MANUFACTURER General Electric Company, Medical Systems
Division, Waukesha, Wisconsin.
RECALLED BY Manufacturer, by field modification
instructions issued on August 30, 1995. Firm-
initiated field correction complete.
DISTRIBUTION Florida, Georgia, North Carolina, Tennessee,
Singapore.
QUANTITY 5 units were distributed.
REASON There could be unintended motion of the
gantry.

_______________
PRODUCT Threaded Plastic Cannula Sleeves:
(a) Catalog No. 140834;
(b) Catalog No. 140835;
(c) Catalog No. 140836;
(d) Catalog No. 140916.
Recall #Z-1238/1241-6.
CODE All lot numbers.
MANUFACTURER Gebrueder Pajunk, Geisingen, Germany.
RECALLED BY Pilling Weck, Inc., Research Triangle Park,
North Carolina, by letter on November 1, 1995.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 64 sleeves were distributed; firm estimates
none remains on the market.
REASON Capacitive coupling may occur when the plastic
cannula is used in conjunction with a metal
cannula.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT One Day ACUVUE (etafilcon A) Daily Wear
Disposable Contact Lenses, -2.75 power/9.0 mm
base curve. Recall #Z-1242-6.
CODE Lot Numbers: 1601200868, 1601200967,
1601201063, 1601201162.
MANUFACTURER Vistakon, Inc., Johnson and Johnson Vision
Products, Inc., Jacksonville, Florida.
RECALLED BY Manufacturer, by telephone from September 5 to
10, 1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 1,751 unit cartons (30 units per carton) were
distributed.
REASON The correctly labeled outside carton of the
9.0mm base curve product may be labeled with
an incorrect base curve (8.5mm) on the inner
primary package label.

-15-

END OF ENFORCEMENT REPORT FOR OCTOBER 9, 1996. BLANK PAGES MAY FOLLOW.
####