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.

May 28, 1997 97-22

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ============
_______________
PRODUCT Cap'n Crunch Bars, Crunchy Marshmallow Treats, 8-0.78 ounces
individually wrapped bars per retail box, net weight 6.2 ounces, 12
boxes per case. Recall #F-411-7.
CODE 7CF20Bxx on bars and retail box, FEB 20 97 CF on case.
MANUFACTURER Campfire Foods, Clearfield, Utah.
RECALLED BY Quaker Oats Company, Chicago. Illinois., by memorandum dated
April 14, 1997, followed by letter dated April 15, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Wisconsin, Ohio, Iowa, Illinois.
QUANTITY 4,811 cases were distributed; firm estimated that 50 percent of the
product remained on market at time of recall initiation.
REASON Product fails to declare whey on the ingredient panel of the retail
cartons.

_______________
UPDATE Frozen Strawberry Fruit Bars, Recall #F-409-7, which appeared in
the May 21, 1997 Enforcement Report erroneously reported code
"11-04-96". This code is not under recall. Only bars with an
October 1996 code are under recall.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
===========
_______________
PRODUCT (a) Ethex brand Guaifenex LA, Guaifenesin Extended-release
Tablets, Expectorant, 600-mg tablets packaged in 100-tablet bottles,
RX, indicated for the temporary relief of coughs associated with
respiratory tract infections and related conditions
(b) Ethex brand Guaifenex-Rx Tablets, Guaifenesin/Pseudoephedrine
HCl Extended-release Tablets 14 Day Treatment Regimen, each
14-day treatment regimen consists of 56 tablets packaged in blister
packs containing 600-mg guaifenesin and 60-mg pseudoephedrine
HCl tablets to be used for the A.M. dosage and 600-mg. guaifenesin
tablets for the P.M. dosage, Rx, indicated for the temporary relief of
nasal congestion associated with respiratory tract infections and
related conditions. Recall #D-175/176-7.
CODE (a) Lot #L8541, EXP 8/98
(b) - Lot #L8877, EXP 8/98.
MANUFACTURER: KV Pharmaceutical Company, Maryland Heights, Missouri.
RECALLED BY Ethex Corporation, St. Louis, Missouri, by letter sent on April 21,
1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY (a) 3,418 bottles were distributed; (b) 21,494 cartons (56 tablets per
carton) were distributed.
REASON Product failed dissolution specifications.

_______________
PRODUCT Sedapap Tablets, (50 mg butalbital/650 mg, Acetaminophen)
packaged in bottles of 100, Rx, indicated for the relief of tension
headaches. Recall #D-177-7.
CODE Lot numbers: S609 and S610.
MANUFACTURER Graham Laboratories, Hobart, New York.
RECALLED BY Merz Pharmaceuticals, Greensboro, North Carolina, by letter on
April 23, 1997. Firm-initiated recall ongoing.
DISTRIBUTION North Carolina, South Carolina, Georgia, Florida, Alabama,
Mississippi, Virginia, West Virginia, Tennessee.
QUANTITY 4,636 bottles of lot S609 and 4,829 bottles of lot S610 were
distributed; firm estimated that 3,363 bottles remained on market at
time of recall initiation.
REASON Discoloration.

_______________
PRODUCT Ibuprofen Tablets, USP, 400 mg, in 500 count, for use as an anti-inflammatory, distributed by Par Pharmaceutical. Recall #D-178-7.
CODE Lot #13574 EXP 8/97.
MANUFACTURER Knoll Pharmaceutical Company, Mount Olive, New Jersey.
RECALLED BY Manufacturer, by telephone on February 24, 1997, followed by letter
on February 26, 1997 and March 6, 1997. Firm-initiated recall
complete.
DISTRIBUTION New York.
QUANTITY Approximately 4,718 bottles were distributed; firm estimates none
remains on the market.
REASON Dissolution specification failure.

_______________
PRODUCT Tussex-DM Expectorant Cough Suppressant, alcohol free, (100 mg
guaifenesin/15 mg dextromethorphan), in 2 fluid ounce bottles. Recall #D-179-7.
CODE Lot numbers: 555-215, 55-334, 56-201.
MANUFACTURER Ferndale Laboratories, Inc., Ferndale, Michigan.
RECALLED BY Manufacturer, by letter issued on April 22, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Alabama, Arizona, California, Colorado, Connecticut, Delaware,
Illinois, Indiana, Louisiana, Michigan, Missouri, New York, North
Carolina, Ohio, Tennessee, Texas, Virginia, West Virginia,
Wisconsin
QUANTITY 38,428 bottles were distributed.
REASON Ingredient non-uniformity.

_______________
PRODUCT Aquaphilic TAC 1/4 (Triamcinolone Acetonide 0.025%) Ointment,
in 1 pound jars, Rx for dermatology indications. Recall #D-180-7.
CODE Lot #4382/025 EXP 2/28/97.
MANUFACTURER Medco Lab, Inc., Sioux City, Iowa.
RECALLED BY Manufacturer, by letter sent on or about November 15, 1996. Firm-initiated recall complete.
DISTRIBUTION Iowa.
QUANTITY 139 jars were distributed.
REASON Subpotency.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ========
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-672/673-7.
Code Unit numbers: 9513701, 9132464.
MANUFACTURER Oklahoma Blood Institute, Oklahoma City, Oklahoma.
RECALLED BY Manufacturer, by fax on July 11, 1995 or August 1, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Texas, Oklahoma, Pennsylvania.
QUANTITY 2 units of each component were distributed.
REASON Blood products were collected from a donor who emigrated from an
area considered endemic for malaria.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma. Recall
#B-703/705-7.
CODE Unit numbers: (a) 8401721, 8441420; (b) 8401721; (c) 8401721.
MANUFACTURER Community Blood Centers of South Florida, Inc., Lauderhill, Florida.
RECALLED BY Manufacturer, by fax or telephone on July 7, 1995. Firm-initiated
recall complete.
DISTRIBUTION Florida and New York.
QUANTITY (a) 2 units; (b) 1 unit; (c) 1 unit was distributed.
REASON Blood products were collected from a donor with a history of
receiving human pituitary-derived growth hormone.

_______________
PRODUCT Red Blood Cells. Recall #B-706-7.
CODE Unit #8553034.
MANUFACTURER Community Blood Centers of South Florida, Inc., Lauderhill, Florida.
RECALLED BY Manufacturer, by fax or telephone on January 4, 1996. Firm-initiated
recall complete.
DISTRIBUTION New York.
QUANTITY 1 unit was distributed.
REASON Blood product tested initially reactive for the Hepatitis B Surface
Antigen (HbsAg), but retested non-reactive at a different processing
laboratory using a different test methodology.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Frozen Plasma-Cryoprecipitate
Removed;
(d) Cryoprecipitate. Recall #B-707/710-7.
CODE Unit #8645910.
MANUFACTURER Community Blood Centers of South Florida, Inc., Lauderhill, Florida.
RECALLED BY Manufacturer, by fax or telephone on February 11, 1997. Firm-initiated recall complete.
DISTRIBUTION Florida, New York, North Carolina.
-4-QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who reported a history
of high risk behavior.

_______________
PRODUCT Red Blood Cells. Recall #B-715-7.
CODE Unit #29271-9739, 29271-9740.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on December 17, 1996. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY 2 units were distributed.
REASON Blood products were labeled as "Nonreactive for CMV Antibody"
but were not tested for CMV.

_______________
PRODUCT Red Blood Cells. Recall #B-716-7.
CODE Unit #29272-0662.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone and by letter dated February 20,1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who traveled to a malarial
endemic area.

_______________
PRODUCT Red Blood Cells. Recall #B-721-7.
CODE Unit #12LJ20509.
MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina.
RECALLED BY Manufacturer, by telephone and letter on February 7, 1997. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who traveled to an area
considered endemic for malaria.

_______________
PRODUCT Red Blood Cells. Recall #B-722-7.
CODE Unit #12E89701.
MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina.
RECALLED BY Manufacturer, by letter dated February 28, 1997. Firm-initiated
recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who traveled in an area
considered endemic for malaria.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-725/726-7.
CODE Unit #7501394.
MANUFACTURER Manatee Community Blood Center, Bradenton, Florida.
RECALLED BY Manufacturer, by letter dated April 6, 1995. Firm-initiated recall
complete.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor taking the drug Proscar.

_______________
PRODUCT Fresh Frozen Plasma. Recall #B-727-7.
CODE Unit #1382123.
MANUFACTURER LifSource, Glenview, Illinois.
RECALLED BY Manufacturer, by letter dated March 11, 1997. Firm-initiated recall
complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with a history of cancer.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-728/729-7.
CODE Unit #28028-0015.
MANUFACTURER United Blood Services, San Angelo, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated May 30,
1996. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for the antibody to the human T-lymphotropic virus type I (anti-HTLV-1), but were collected from a
donor who previously tested repeatedly reactive for anti-HTLV-1 on
two occasions.

_______________
PRODUCT Red Blood Cells. Recall #B-730-7.
CODE Unit #13FY16091.
MANUFACTURER American Red Cross Blood Services, Detroit, Michigan.
RECALLED BY Manufacturer, by telephone on January 27, 1997. Firm-initiated
recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who subsequently
requested that his blood not be used was distributed after receipt of
the post donation information.

_______________
PRODUCT Whole Blood, CPD. Recall #B-734-7.
CODE Unit #29443-7931.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on March 14, 1997. Firm-initiated recall
complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was held at room temperature for an unknown period
of time and released for distribution.

_______________
PRODUCT Cytogam-(CVM-IGIV), Cytomegalovirus Immune Globulin
Intravenous (Human).
Recall #B-736-7.
CODE Unit #MV1CMV-38 Exp 8/15/97.
MANUFACTURER Massachusetts Public Health Biologic Laboratories, Jamaica Plains,
Massachusetts.
RECALLED BY Manufacturer, by letter dated May 6, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Delaware and Maryland.
QUANTITY 3,677 vials were distributed.
REASON Immune Globulin product was found in post-release testing to have
elevated levels of the plasma Pre-Kallikrein Activator (PKA).

_______________
PRODUCT Platelets, Pheresis. Recall #B-739-7.
CODE Unit numbers: 53LT50666, 53LT50321, 53LT50042, 53LT49459,
53LT48864.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY Manufacturer, by letter dated January 9, 1997. Firm-initiated recall
complete.
DISTRIBUTION Maryland and District of Columbia.
QUANTITY 5 units were distributed.
REASON Blood products were collected from a donor who reported travel to
an area considered endemic for malaria.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-742/743-7.
CODE Unit numbers: 55KH05716, 55L90976, 55H28304, 55H30829,
55L97114, 55W04648, 55H37746, 55W07783.
MANUFACTURER American Red Cross Blood Services, Little Rock, Arkansas.
RECALLED BY Manufacturer, by letter dated August 27, 1996. Firm-initiated recall
complete.
DISTRIBUTION Arkansas, California, Switzerland.
QUANTITY 8 units were distributed.
REASON Blood products were collected from a donor with a history of cancer.

_______________
PRODUCT Red Blood Cells. Recall #B-745-7.
CODE Unit numbers: 1607205, 1607206, 1607207.
MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana.
RECALLED BY Manufacturer, by telephone on November 8, 1996. Firm-initiated
recall complete.
DISTRIBUTION Indiana.
Quantity 3 units were distributed.
REASON Blood products had an extended expiration date.

_______________
PRODUCT (a) Platelets; (b) Recovered Plasma, Frozen. Recall #B-747/748-7.
CODE Unit #13Q93764.
MANUFACTURER American Red Cross, Detroit, Michigan.
RECALLED BY Manufacturer, by letter dated January 7, 1997. Firm-initiated recall
complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit of each component was distributed.
REASON Blood products corresponded to Red Blood Cells which were
returned because of confirmed hemolyzed segments.

_______________
PRODUCT Red Blood Cells. Recall #B-749-7.
CODE Unit #13FJ18182.
MANUFACTURER American Red Cross, Detroit, Michigan.
RECALLED BY Manufacturer, by telephone on January 12, 1997. Firm-initiated
recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who received a tattoo
within twelve months of donation.

_______________
PRODUCT Platelets. Recall #B-751-7.
CODE Unit numbers: 13FS42641, 13FS42647.
MANUFACTURER American Red Cross, Detroit, Michigan.
RECALLED BY Manufacturer, by telephone on November 13, 1996, and by letter
dated December 12, 1996. Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 2 units were distributed.
REASON Blood products which corresponded to Red Blood Cells were
returned because of confirmed clotted segments.

_______________
PRODUCT (a) Plasma - Cryoprecipitate Reduced; (b) Recovered Plasma. Recall
#B-752/753-7.
CODE Unit #55R91924.
MANUFACTURER American Red Cross, Little Rock, Arkansas.
RECALLED BY Manufacturer, by letter dated March 25, 1997. Firm-initiated recall
complete.
DISTRIBUTION Arkansas.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who received ear
piercing within twelve months of donation.

_______________
PRODUCT Source Plasma. Recall #B-754-7.
CODE Unit numbers: T92158, T93290, T95320, T96418, T96744,
T97379, T97797, T98483, T99565, T9V169, T9W132, T9Z477,
VR2554, VR5660, VR5809, VRW277, VRX023, VRY455,
VRZ367, VSH681, VSI111, VSJ463, VSK641.
MANUFACTURER Centeon Bio Services, Inc., Fort Worth, Texas.
RECALLED BY Manufacturer, by letter dated July 10, 1996. Firm-initiated recall
complete.
DISTRIBUTION Illinois.
QUANTITY 23 units were distributed.
REASON Blood products were collected from a donor with a history of IV
drug use.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma; (d)
Recovered Plasma.
Recall #B-755/757-7.
CODE Unit numbers: 17030-3908, 17030-7406, 17032-1780, 17032-6076,
17034-6362, 17175-7608, 17176-2627, 17178-2371, 17034-6362,
17175-7608, 17176-2627, 17178-2371, 17178-7260, 28029-2509,
28105-6870, 28105-7910, 28105-9152, 28106-1523, 28106-2227,
17178-2371, 17178-7260; (b) 17302-6076, 17175-7608, 28029-2509, 28105-7910, 28105-9152; (c) 17030-3908, 17030-7406,
17032-6076, 17034-6362, 17175-7608, 17176-2627, 28105-6870,
28106-1523.
MANUFACTURERS United Blood Services, San Angelo, Texas; United Blood Services,
McAllen, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letters dated May 30 or
31, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Texas, Florida, Switzerland.
QUANTITY (a) 21 units; (b) 5 units; (8 units were distributed.
REASON Blood products tested negative for the antibody to the human T-lymphotropic virus type 1 (anti-HTLV-I), but were collected from
donors who previously tested repeatedly reactive for anti-HTLV-1
on two occasions.

_______________
PRODUCT Red Blood Cells. Recall #B-759-7.
CODE Unit #18N57687.
MANUFACTURER American Red Cross Blood Services, Lansing, Michigan.
RECALLED BY Manufacturer, by letter dated January 6, 1997. Firm-initiated recall
complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported travel to an
area considered endemic for malaria.

_______________
PRODUCT Plasma, Pheresis. Recall #B-760-7.
CODE Unit #3077567.
MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas.
RECALLED BY Manufacturer, by fax on January 15, 1997. Firm-initiated recall
complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of Platlets, Pheresis, that was
positive for Staphylococcus aureus.

_______________
PRODUCT Platelets. Recall #B-761-7.
CODE Unit #T75691.
MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY Manufacturer, by telephone on March 17, 1997. Firm-initiated recall
complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for the antibody to the hepatitis C
virus encoded antigen (anti-HCV), but was collected from a donor
who previously tested repeatedly reactive for anti-HCV.

_______________
PRODUCT Recovered Plasma. Recall #B-762-7.
CODE Unit #21Q49876.
MANUFACTURER American Red Cross Blood Services, Portland, Oregon.
RECALLED BY Manufacturer, by letter dated March 18, 1997. Firm-initiated recall
complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported a history of
cancer.

_______________
PRODUCT Red Blood Cells. Recall #B-763-7.
CODE Unit #21Y34370.
MANUFACTURER American Red Cross Blood Services, Portland, Oregon.
RECALLED BY Manufacturer, by letter dated December 13, 1996. Firm-initiated
recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with a history of hepatitis
A.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitaed AHF. Recall
#B-764/766-7.
CODE Unit number #03H03346.
MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia.
RECALLED BY Manufacturer, by letter dated January 29, 1997. Firm-initiated recall
complete.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood products tested negative for the antibody to the hepatitis C
virus encoded antigen (anti-HCV), but were collected from a donor
who previously tested repeatedly reactive for anti-HCV.

_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-767/768-7.
CODE Unit #03GM26308.
MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia.
RECALLED BY Manufacturer, by telephone on September 4, 1996, followed by letter
dated September 12, 1996. Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor whose high risk
behavior screening was inadequately performed.

_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma; (c) Recovered Plasma.
Recall #B-771/773-7.
CODE Unit numbers: (a) 12FV38026, 12FY25986, 12FT49949,
12FP01786; (b) 12FV38026, 12FY25986, 12FT49949; (c)
12FP01786.
MANUFACTURER American Red Cross, Charlotte, North Carolina.
RECALLED BY Manufacturer, by letters dated on August 9-12, 1996. Firm-initiated
recall complete.
DISTRIBUTION North Carolina, Florida, California.
QUANTITY (a) 4 units; (b) 3 units; (c) 1 unit was distributed.
REASON Blood products which tested negative for the antibody to Hepatitis B
core antigen (anti-HBc), but were collected from a donor who
previously tested repeatedly reactive for anti-HBc.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma; (d)
Recovered Plasma.
Recall #B-774/777-7.
CODE Unit numbers: (a) 12V77765, 12R57387;
(b) 12R57387, (c) 12R57387; (d) 12V77765.
MANUFACTURER American Red Cross, Charlotte, North Carolina.
RECALLED BY Manufacturer, by letter dated July 31, 1996. Firm-initiated recall
complete.
DISTRIBUTION North Carolina and California.
QUANTITY (a) 2 units; (b) 1 unit; (c) 1 unit; (d) 1 unit was distributed.
REASON Blood products tested negative for the antibody to Hepatitis B core
antigen (anti-HBc), but were collected from a donor who previously
tested repeatedly reactive for anti-HBc.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. Recall #B-778/780-7.
CODE Unit numbers: (a) 56K35228, 56G59861, 56L06878; (b) 56G59861;
(c) 56L06878.
MANUFACTURER American Red Cross, Syracuse, New York.
RECALLED BY Manufacturer, by letter dated on or about November 1995. Firm-initiated recall complete.
DISTRIBUTION New York and California.
QUANTITY (a) 3 units; (b) 1 unit; (c) 1 unit was distributed.
REASON Blood products were collected from donors who tested repeatedly
reactive for HBsAg.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-785/786-7.
CODE Unit numbers: N28473, N29264.
MANUFACTURER Mississippi Valley Regional Blood Center, Davenport, Iowa.
RECALLED BY Manufacturer, by letter dated August 14, 1996. Firm-initiated recall
complete.
DISTRIBUTION New York, New Jersey, California.
QUANTITY 2 units of each component was distributed.
REASON Blood products tested repeatedly reactive for the antibody to the
human immunodeficiency virus type 1 (anti-HIV-1), Western Blot
negative, then later reinterpreted and reported as indeterminate.

_______________
PRODUCT Platelets; (b) Fresh Frozen Plasma.
Recall #B-787/788-7.
CODE Unit #13LG37815.
MANUFACTURER American Red Cross Blood Services, Detroit, Michigan.
RECALLED BY Manufacturer, by telephone on November 5, 1996, followed by letter
dated November 6, 1996. Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit of each component was distributed.
REASON blood products corresponded to a unit of red blood cells that was
reported as clotted.

_______________
PRODUCT (a) Platelets; (b) Fresh Frozen Plasma.
Recall #B-790/791-7.
CODE Unit #13GM03525.
MANUFACTURER American Red Cross Blood Services, Detroit, Michigan.
RECALLED BY Manufacturer, by telephone on December 2, 1996. Firm-initiated
recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit of each component was distributed.
REASON blood products corresponded to a unit of red blood cells that was
reported as having clotted segments.

_______________
PRODUCT Red Blood Cells. Recall #B-794-7.
CODE Unit #38FC07433.
MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana.
RECALLED BY Manufacturer, by letter dated January 16, 1996. Firm-initiated recall
complete.
DISTRIBUTION Indiana, Florida.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who lived in an area
considered endemic for malaria.

_______________
PRODUCT Platelets. Recall #B-798-7.
CODE Unit #FY67726.
MANUFACTURER Inova Health Care Services, Annandale, Virginia.
RECALLED BY Manufacturer, by letter dated November 26, 1996. Firm-initiated
recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product tested repeatedly reactive for the antibody to the
hepatitis C virus encoded antigen (anti-HCV).

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-800/801-7.
CODE Unit #49F91516.
MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma,
RECALLED BY Manufacturer, by letters dated February 5 and 12, 1997. Firm-initiated recall complete.
DISTRIBUTION Oklahoma, California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor taking the drug Lupron.

_______________
PRODUCT Platelet, Pheresis. Recall B-802-7.
CODE Unit #0291982A1.
MANUFACTURER Inland Northwest Blood Center, Spokane, Washington.
RECALLED BY Manufacturer, by telephone on December 13, 1996. Firm-initiated
recall complete.
DISTRIBUTION Washington state.
QUANTITY 1 unit was distributed.
REASON Blood product had an extended expiration date.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. Recall #B-823/825-7.
CODE Unit #24GV24716.
MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letters dated February 27 and 28, 1996. Firm-initiated recall complete.
DISTRIBUTION Indiana, California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products which had undergone atypical viral testing for
HBsAg were then tested into compliance with no confirmatory test.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III =======
_______________
PRODUCT Platelets, Pooled. Recall #B-412-7.
CODE Unit #3N-8721, Pool #ES 0967.
MANUFACTURER Puget Sound Blood Center, Seattle, Washington.
RECALLED BY Manufacturer, by telephone on June 14, 1996. Firm-initiated recall
complete.
DISTRIBUTION Washington state.
QUANTITY 1 unit was distributed.
REASON Platelets were used in platelet pool procedures that had expired prior
to pooling.

_______________
PRODUCT Source Plasma. Recall #B-617-7.
CODE Unit #77798B.
MANUFACTURER Ohio Blood Plasma, Inc., Cincinnati, Ohio.
RECALLED BY Manufacturer, by telephone on September 12, 1996. Firm-initiated
recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was not tested for syphilis.

_______________
PRODUCT Red Blood Cells, Irradiated - Leukocytes Reduced. Recall #B-718-7.
CODE Unit #29443-8108.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on March 10, 1997, followed by letter
dated March 31, 1997. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was held at unacceptable room temperature.

_______________
PRODUCT Fresh Frozen Plasma. Recall #B-737-7.
CODE Unit #26147-9857.
MANUFACTURER United Blood Services, Hot Springs, Arkansas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on February
5, 1997. Firm-initiated recall complete.
DISTRIBUTION Arkansas.
QUANTITY 1 unit.
REASON Blood product was prepared from a unit of Whole Blood which may
have had an extended collection time.

_______________
PRODUCT Fresh Frozen Plasma. Recall #B-738-7.
CODE Unit #26147-8820.
MANUFACTURER United Blood Services, Fort Smith, Arkansas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated February
20, 1997. Firm-initiated recall complete.
DISTRIBUTION Arkansas.
QUANTITY 1 unit was distributed.
REASON Blood product was not frozen within eight hours of collection.

_______________
PRODUCT Red Blood Cells for further manufacture. Recall #B-740-7.
CODE Unit #53GJ86771.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY Manufacturer, by letter dated January 9, 1997. Firm-initiated recall
complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who traveled to an area
considered endemic for malaria.

_______________
PRODUCT Platelets. Recall #B-741-7.
CODE Unit numbers: 53GF06145, 53FV03956, 53FV03985,
53FV03972, 53FV03963, 53GF06126, 53GF06131,
53FH46303, 53GF06135, 53FV03983, 53FV03986,
53FV03987, 53FV03976, 53FV03977, 53FV03974,
53FV03973, 53FV03971, 53FV03968, 53FV03965,
53FV03962, 53FV03961, 53FV03960, 53FV03958,
53GF06124, 53GF06133, 53GF06136, 53GF06146,
53GF06150, 53GF06149, 53GF06148, 53GF06147,
53FV03981, 53FV03984, 53FV03975, 53FV03969,
53FV03967, 53FV03964, 53FV03959, 53FV03957,
53FH46304.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated November 1,
1995. Firm-initiated recall complete.
DISTRIBUTION Maryland and District of Columbia.
QUANTITY 40 units were distributed.
REASON Blood products were stored at an unacceptable
temperature.

_______________
PRODUCT Red Blood Cells. Recall #B-746-7.
CODE Unit #2370040.
MANUFACTURER Central Indiana Regional Blood Center,
Indianapolis, Indiana.
RECALLED BY Manufacturer. Consignee returned the unit on
August 27, 1995. Firm-initiated recall
complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product was typed as E antigen positive
but labeled as E antigen negative.

_______________
PRODUCT Recovered Plasma. Recall #B-758-7.
CODE Unit numbers: 17033-9644, 28-29-2509, 17032-1780, 17178-2371, 28105-7910, 28105-9152,
28106-2227.
MANUFACTURERS United Blood Services, San Angelo, Texas;
United Blood Services, McAllen, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letters dated May 30 or 31, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Texas, Florida, Switzerland.
QUANTITY 7 units were distributed.
REASON Blood products tested negative for the
antibody to the human T-lymmphotropic virus
type 1 (anti-HTLV-I), but were collected from
donors who previously tested repeatedly
reactive for anti-HTLV-1 on two occasions.

_______________
PRODUCT Red Blood Cells. Recall #B-769-7.
CODE Unit numbers: 24195-2533, 21363-5602,
21363-5234.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by letter dated February 20,
1997. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 3 units.
REASON Blood products, which were incorrectly tested
for CMV antibody were distributed labeled as
CMV negative.

_______________
PRODUCT Red Blood Cells. Recall #B-770-7.
CODE Unit #6157892.
MANUFACTURER LifeShare Blood Centers, Beaumont, Texas.
RECALLED BY Manufacturer, by telephone on December 17,
1996. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was irradiated and labeled with
an extended expiration date.

_______________
PRODUCT Platelets, for further manufacture.
Recall #B-795-7.
CODE Unit #38FC07433.
MANUFACTURER American Red Cross Blood Services, Fort Wayne,
Indiana.
RECALLED BY Manufacturer, by letter dated January 16,
1996. Firm-initiated recall complete.
DISTRIBUTION Indiana and Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
lived in an area considered endemic for
malaria.

RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II ==========
_______________
PRODUCT Pressure monitoring kits, lines, single put-up
flush devices:
(a) Pressure Monitoring Kits
(b) Pressure Monitoring Lines
(c) Single Put-Up Flush Devices
(d) Single Put-Up Monitoring Lines
(e) Extension Sets
(d) CDXPress Transducers.
Recall #Z-572/577-7.
CODE Products manufactured from 12/26 to 3/97.
MANUFACTURER Medical, Argon Division, Athens,
Massachusetts.
RECALLED BY Maxxim Medical, Argon Division, Athens, Texas,
by letter, March 28, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 338,883 items were distributed.
REASON The monitoring lines are separating from
connectors and flushing devices.

_______________
PRODUCT LifePort Infuse-a-Port Implantable Port
Systems:
(a) Snap-LockTM MacroPortTM Arterial Access
System, Catalog No. 39514,
(b) Snap-LockTM MicroPortTM Arterial Access
System, Catalog No. 39615.
Recall #Z-578/579-7.
CODE Lot Nos. (a) 13914, 14106, 14190, 13973,
13845; (b) 13282, 13757.
MANUFACTURER Strato/Infusaid , Inc., Norwood,
Massachusetts.
RECALLED BY Manufacturer, by telephone between April 30,
1997 and May 1, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Missouri, New York, Indiana, Colorado,
Massachusetts, Texas, Florida, Alabama,
Connecticut, international.
QUANTITY 2,927 units were distributed.
REASON The catheters or ports of certain lots of
arterial Infuse-a-ports may contain stainless
steel spheres which could result in the
metallic spheres flushing from the catheter or
port.

______________
PRODUCT Renasol Acid Concentrate, hemodialysis
concentrate, in .91 gallon (3.43 liter)
bottles. Recall #Z-584-7.
CODE Product #SB-1020, Lot #107B716.
MANUFACTURER Minntech Corporation, Minneapolis, Minnesota.
RECALLED BY Manufacturer, by telephone on April 4, 1997.
Firm-initiated recall complete.
DISTRIBUTION Maine.
QUANTITY 41 cases (4 bottles per case) were
distributed; firm estimates none remains on
the market.
REASON The immediate bottle containers were labeled,
"Part A Renasol Acid Concentrate, SB-1019".
The cases were properly labeled.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III =========
_______________
PRODUCT Radiation Oncology Computer Systems (ROCS)
Treatment Planning System Software Version
5.0.X. Recall #Z-564-7.
CODE Software version 5.0.X.
MANUFACTURER Radiation Oncology Computer Systems, Inc.,
Carlsbad, California.
RECALLED BY Manufacturer, by letters dated September 27,
1996, and November 6, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 248 sets of disks were distributed.
REASON An error occurs when using this software
version for brachytherapy dose estimations for
user specified calculation points for re-oriented linear sources.

_______________
PRODUCT Pinnacle Radiation Therapy Planning Software
Version 2.1f. Recall #Z-565-7.
CODE None.
MANUFACTURER ADAC Laboratories, Milpitas, California.
RECALLED BY Manufacturer, by telephone, followed by letter
on February 14, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 83 tapes of the software version 2.1f were
distributed.
REASON Due to a software problem, the wedge scatter
fields will be calculated incorrectly if the
wedge filter is not square.

_______________
PRODUCT Innovasive Retractor Blade (Arm), 20 mm x 80
mm, used in orthopedic procedures.
Recall #Z-583-7.
CODE Catalog #2513, Lot #10664.
MANUFACTURER Innovasive Devices, Inc., Marlborough,
Massachusetts.
RECALLED BY Manufacturer, by letter dated May 2, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Oregon, South Carolina, Massachusetts, Texas.
QUANTITY 30 units (15 sets) were distributed.
REASON The arm length was found to measure 65 mm
instead of the 80 mm as labeled.

_______________
PRODUCT Abbott Vision CHEM Control Kit, in-vitro
diagnostic. Recall #Z-585-7.
CODE Control Kit, List No. 1433-02, Lot Nos.
08001M401, 08001M402.
MANUFACTURER Abbott Laboratories, Diagnostics Division,
Abbott Park, Illinois.
RECALLED BY Manufacturer, by technical bulletin letters
dated March 4, 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 2,631 kits were distributed.
REASON These lots may exhibit an elevated
triglyceride concentration.

_______________
PRODUCT Pressure Sentinel Intramedullary Flexible
Reamers:
1. Catalog No. 00-2228-005-00
2. Catalog No. 00-2228-005-05
3. Catalog No. 00-2228-006-00
4. Catalog No. 00-2228-006-05
5. Catalog No. 00-2228-007-00
6. Catalog No. 00-2228-007-05
7. Catalog No. 00-2228-008-00
8. Catalog No. 00-2228-008-05
9. Catalog No. 00-2228-009-00
10. Catalog No. 00-2228-009-05
11. Catalog No. 00-2228-010-00
12. Catalog No. 00-2228-010-05
13. Catalog No. 00-2228-011-00
14. Catalog No. 00-2228-011-05
15. Catalog No. 00-2228-012-00
16. Catalog No. 00-2228-012-05

-20- 17. Catalog No. 00-2228-013-00
18. Catalog No. 00-2228-013-05
19. Catalog No. 00-2228-014-00
20. Catalog No. 00-2228-014-05
21. Catalog No. 00-2228-015-00
22. Catalog No. 00-2228-015-05
23. Catalog No. 00-2228-016-00
24. Catalog No. 00-2228-016-05
25. Catalog No. 00-2228-017-00
26. Catalog No. 00-2228-017-05
27. Catalog No. 00-2228-018-00
28. Catalog No. 00-2228-018-05
29. Catalog No. 00-2228-019-00
30. Catalog No. 00-2228-019-05
31. Catalog No. 00-2228-020-00
32. Catalog No. 00-2228-020-05
33. Catalog No. 00-2228-021-00
34. Catalog No. 00-2228-021-05
35. Catalog No. 00-2228-022-00.
Recall #Z-590/624-7.
CODE All lot numbers.
MANUFACTURER Zimmer, Inc., Warsaw, Indiana.
RECALLED BY Manufacturer, by E-mail on February 7, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Singapore.
QUANTITY Approximately 1,285 units were distributed.
REASON Cracks were found on the cutting tips.

END OF ENFORCEMENT REPORT FOR MAY 28, 1997. BLANK PAGES MAY FOLLOW.

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End of Enforcement Report for