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.

June 24, 1998
98-25

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

PRODUCT

Gold Flower brand Dried Sliced Lotus Root packaged in flexible plastic bags, net weight 7 ounces, Product of China. Recall #F-508-8.

CODE
None. All product on market at time of recall initiation.

MANUFACTURER
Po Huat (H.K.), Co., Ltd., Hong Kong.

RECALLED BY
Summit Import Corporation, New York, New York, by press release and letter on May 13, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
New York, New Jersey, Pennsylvania, Massachusetts, Michigan, Maryland, North Carolina, South Carolina, Tennessee, Georgia, Florida.

QUANTITY
13 cartons (100 bags per carton) were distributed.

REASON
Products contain undeclared sulfites.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

PRODUCT

Dried fruit and vegetable products: a) Oriental Mascot brand Hua Mei Ginger packaged in flexible plastic bags, Net Wt. 6 oz., 50 bags per carton. Packed by Summit Import; b) Ka Po Preserved Licorice Prune packaged in flexible plastic bags, Net Wt. 40 g (1.4 oz.), 100 bags per carton. Product of China; c) Tang Hoi Kee brand Dried Cured Prune Special Selected packaged in flexible plastic bags, Net Wt. 205 g (8.7 oz.), 32 bags per carton. Product of Hong Kong. Recall #F-509/510-8.

CODE
None.

MANUFACTURER
a) Summit Import Corporation, New York, New York (importer); b) Wan Tom Food Company, Ltd., Kowloon, Hong Kong; c) Tan Hoi Moon Kee Company, Ltd., Hong Kong.

RECALLED BY
Import Corporation, New York, New York (importer), by letter on May 13, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
a) New York, Maryland, Florida; b) New York, Maryland, Delaware, Ohio, Florida, Missouri; c) New York, New Jersey, Pennsylvania, Tennessee, Ohio, District of Columbia.

QUANTITY
a) 10 cartons; b) 23 cartons; c) 17 cartons were distributed.

REASON
Products contain undeclared: a) saccharin; b) unapproved color additive, FD&C Yellow No. 6, saccharin, and sulfites; c) saccharin.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

PRODUCT

Gold Flower brand Chan Pui Mui Preserved Plum packaged in flexible bags, Net Wt. 14 oz., 40 bags per carton. Product of China. Recall #F-512-8.

CODE
None.

MANUFACTURER
Po Huat (H.K.) Company, Ltd., Hong Kong.

RECALLED BY
Summit Import Corporation, New York, New York (importer), by letter on May 13, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
New York, New Jersey, Pennsylvania, Virginia, Michigan, North Carolina, Florida, Georgia, California.

QUANTITY
12 cartons were distributed.

REASON
Product contains undeclared sulfites.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I

PRODUCT

a) Epi Pen, Auto Injector (Epinephrine Injection 1:1000), 0.3mL, 0.3 mg, 1 EpiPen per box, 12 units per carton or tray, RX, labeled under three different responsible firm names: (1) Dey Pharma label (NDC #49502-500-01) (2) Center label (NDC #0268-0301-01)and (3) Center label (NDC #0268-0301-01) b) EpiPen Jr., Auto-Injector 0.15 mg (Epinephrine Injection 1:2000), 0.3mL, 0.15 mg, for allergic emergencies (anaphylaxis), RX, labeled under three different responsible firm names: (1) Dey Pharma label - NDC #49502-501-01; (2) Center label - NDC #0268-0302-01; and (3) Center label - NDC #0268-0302-01. Recall #D-150/151-8.

CODE
Lot numbers: 7SX208, 7SX209, 7SX216, 7SX217, 7SX194, 7RX204, 7RX223, 7SR247, 7SR265, 7SR286, 7SR292, 7SR293, 7SR317, 7SR318, 7SR321, 7SR342, 7SR355, 7SR356, 7SR358, 7SR370, 7SR371, 7SR378, 7JR242, 7JR243, 7JR289, 7JR290, 7JR323, 7JR361, 7JR362, 7JR374, 7JR375, 8SR004, 8SS077, 8SS078, 7C6214, 7C6279, 7C8277, 7C8381, 7F7221, 7F7262, 7F7380, 7C5238, 7C5376, 7F8391, 7F8220, 7F8263, 7CA382.

MANUFACTURER
Meridian Medical Technologies, Inc., St. Louis, Missouri.

RECALLED BY
Manufacturer, by press release on May 8, 1998, and by letter dated May 8, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
Approximately 1,000,000 auto-injectors were distributed.

REASON
Subpotency.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

PRODUCT

a) Cyclomydril (cyclopentotate hydrochloride, phenylephrine hydrochloride) a prescription Sterile Opthalmic Solution packaged in 2 ml and 5 ml plastic DROP-TAINER dispensers. Indications and Usage: Production of mydriasis (dilation of the pupil of the eye). NDC 0065-0359-02 (2 ml), NDC 0065-0359-05 (5 ml) b) Epinal 1% (epinephryl borate) a prescription Sterile Opthalmic Solution in 7.5 ml glass bottles with sterile dropper assembly. Indications and Usage: Control of simple (open angle) glaucoma; may be used in combination with miotics, beta blockers, hyperosmotic agents, or carbonic anhydrase. NDC 0065-0264-07, c) Mydfrin 2.5% (Phenylephrine Hydrochloride Opthalmic Solution) in 3 ml plastic DROP-TAINER dispensers Indications and Usage: Recommended as a vasoconstrictor, decongestant, and mydriatic in a variety of opthalmic conditions and procedures. NDC 0065-0342-03. Recall #D-177/179-8.

CODE

               Lot Code  Expiration Date
Cyclomydril         AAFP      8/31/98
(National)          ACFT      11/30/98
                    ADL7      4/30/99
                    AFDH      5/31/99
                    AFZA      9/30/99
                    AHYA      11/30/99
                    AHWX      12/31/99
                    AKAP      2/28/2000
                    AKWM      4/30/2000
Cyclomydril         AAMA 
(International)     ADHP
                    AHYAA
                    AKWMA
Epinal 1%           AH87      1/31/99
Mydfrin 2.5%        6FXA      5/31/98
                    6FXF      5/31/98
                    AAFL      8/31/98
                    AAYA      9/30/98
                    ACZ3      12/31/98
                    ACZ9      1/31/99
                    AC75      2/28/99
                    ADL3      3/31/99
                    AFC5      5/31/99
                    AFMU      7/31/99
                    AFY9      8/31/99
                    AHCY      8/31/99
                    AHCZ      10/31/99
                    AHC1      11/30/99
                    AHWP      11/30/99
                    AHWN      1/31/2000
                    AHWW      1/31/2000
                    AKAU      3/31/2000
                    10913F    4/30/2000.

MANUFACTURER
Alcon Laboratories, Inc., Fort Worth, Texas.

RECALLED BY
Manufacturer, by letter on May 22, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
a) Nationwide and international; b&c) Nationwide.

QUANTITY
a) 238,758 units; b) 3,838 units; c) 840,756 units were distributed.

REASON
Contamination - Some units could contain microscopic particles from the lining (glass) of the manufacturing vessel.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

PRODUCT

Generic and private label forms of over-the-counter liquid medications: a) Milk of Magnesia (Magnesium Hydroxide 400 mg), in 12 fluid ounce bottles; b) Tussin DM (Guaifenesin, USP 100 mg/Dextromethorphan Hydrobromide, USP 10 mg), in 4 fluid ounce bottles; c) Nite Time Adult (Acetaminophen, USP 1000 mg/Dextromethorphan Hydrobromide, USP 30 mg/Pseudoephedrine Hydrochloride, USP 12.5 mg), in 6 fluid ounce bottles; d) Pink Bismuth (Bismuth Subsalicylate 262 mg per 30 ml), in 12 fluid ounce bottles; e) Antacid Liquid with Simethicone (Magnesium Hydroxide 200 mg Aluminum Hydroxide 200 mg/Simethicone 20 mg), in 12 fluid ounce bottles; f) Antacid Liquid (Magnesium Hydroxide/Aluminum Hydroxide), in 12 fluid ounce bottles. Recall #D-161/163 & 165/168-8.

CODE
All lot numbers.

MANUFACTURER
OTC Technologies, Inc., Atlanta, Georgia.

RECALLED BY
Manufacturer, by letter on May 1, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Michigan, California, Mississippi, North Carolina, Florida.

QUANTITY
Approximately 14,214 cases (12 units per case) were distributed.

REASON
Good manufacturing practice and formulation deviations (reduced or lack of active ingredients).

PRODUCT

Oxygen Medical, USP, Compressed, Rx, in M6, D, E, M, and H steel and aluminum cylinders and in 30L and 40L cryogenic vessels. Recall #D-173-8.

CODE
All lot numbers prior to 5/20/98.

MANUFACTURER
Home Health Care, Inc., doing business as Commonwealth Home Health Care, Inc., Danville, Virginia.

RECALLED BY
Manufacturer, by telephone on May 20, 1998, followed by visit. Firm-initiated recall ongoing.

DISTRIBUTION
Virginia and North Carolina.

QUANTITY
Firm estimates 1,500 cylinders of all sizes and 30 cryogenic vessels remain in commerce.

REASON
Good manufacturing practice deviations.

PRODUCT

Health Care brand Pink Bismuth (Bismuth Subsalicylate) in 6 fluid ounce clear plastic bottles, OTC for relief of indigestion, upset stomach, heartburn, diarrhea, and nausea. NDC #062091-805-06. Recall #D-174-8.

CODE
All lots.

MANUFACTURER
South Atlantic Industries, Greenville, South Carolina.

RECALLED BY
Great Lakes Wholesale, Wyoming, Michigan, by letter dated August 21, 1997. Firm-initiated recall complete.

DISTRIBUTION
Nationwide, Canada, Granada, West Indies, Puerto Rico.

QUANTITY
18,348 bottles were distributed.

REASON
Formulation problems - Clumps due to excess methylcellulose.

PRODUCT

Oxygen Medical, USP, Compressed, Rx, in B, C, D, E, M, and N-60 cylinders. Recall #D-175-8.

CODE
All lot numbers prior to 5/11/98.

MANUFACTURER
Advanced Health Care Services, Inc., Pulaski, Virginia.

RECALLED BY
Manufacturer, by visit on May 11, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Virginia and North Carolina.

QUANTITY
100 of all types of cylinders remain in commerce.

REASON
Good manufacturing deviations.

PRODUCT

Schein Pharmaceutical Potassium Chloride for Oral Solution, USP, 20 mEq, Orange Flavor, in 1.5 gram packets of 30 per carton, Rx for therapeutic use in patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis; and for the prevention of potassium depletion. NDC #0364-7378-30. Recall #D-176-8.

CODE
Lot numbers: KC60209-5, KC70203-1, KC60709-1, KC70203-5, KC60710-1, KC70713-4, KC60901-3, KC70819-7, KC60901-4, KC70819-6, KC61122-1, KC71125-6, KC61122-2, KC71125-4.

MANUFACTURER
Bajamar Chemical Company Inc., St. Louis, Missouri (repacker/responsible firm).

RECALLED BY
Repacker, by letter dated April 16, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
New York and Arizona.

QUANTITY
27,024 30-packet cartons were distributed.

REASON
Mislabeling - Exterior cartons incorrectly declare 2.5 grams of potassium chloride.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

PRODUCT

Red Blood Cells. Recall #B-142-8.

CODE
Unit #55K06996.

MANUFACTURER
American Red Cross, National Testing Laboratory, St. Louis, Missouri.

RECALLED BY
Manufacturer, by telephone on October 27, 1997. Firm-initiated recall complete.

DISTRIBUTION
Arkansas.

QUANTITY
1 unit was distributed.

REASON
Blood product tested repeatedly reactive for the Hepatitis B Surface Antigen (HbsAg).

PRODUCT

Red Blood Cells. Recall #B-1139-8.

CODE
Units 24197-6245, 24197-6465, 24197-6466, 24197-6468, 24197-6472, 24197-6474, 24197-6784.

MANUFACTURER
Blood Systems, Inc., United Blood Services, Rapid City, South Dakota.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on September 4, 1997. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
7 units were distributed.

REASON
Blood products were exposed to unacceptable shipping temperatures.

PRODUCT

Diagnostic Human Plasma, L-781 (Rox Plasma). Recall #B-1149-8.

CODE
Unit #065-0108308.

MANUFACTURER
NABI BioMedical Center, Racine, Wisconsin.

RECALLED BY
North American Biologicals Inc., Boca Raton, Florida, by customer lookback report dated February 11, 1994. Firm-initiated recall complete.

DISTRIBUTION
Puerto Rico.

QUANTITY
1 unit was distributed.

REASON
Blood product tested repeatedly reactive for the antibody to the hepatitis C virus encoded antigen (anti-HCV).

PRODUCT

Fresh Frozen Plasma. Recall #B-1206-8.

CODE
Unit #23136-8800.

MANUFACTURER
United Blood Services, Billings, Montana.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on May 12, 1998. Firm-initiated recall complete.

DISTRIBUTION
Montana.

QUANTITY
1 unit was distributed.

REASON
Blood product corresponded to a unit of clotted red blood cells.

PRODUCT

Platelets, Pheresis, Split units A and B. Recall #B-1209-8.

CODE
Unit #11LF07410.

MANUFACTURER
American Red Cross Blood Services, St. Louis, Missouri.

RECALLED BY
Manufacturer, by telephone on October 30, 1997, and letter dated November 19, 1998. Firm-initiated recall complete.

DISTRIBUTION
Missouri.

QUANTITY
1 split unit was distributed.

REASON
Blood products had high platelet counts.

PRODUCT

a) Platelets, Pheresis Parts A and B of a split unit. Recall #B-1211-8.

CODE
Unit #11P31416.

MANUFACTURER
American Red Cross Blood Services, St. Louis, Missouri.

RECALLED BY
Manufacturer, by telephone on September 4, 1997, or October 1, 1997 and by letter dated September 12, 1997, or October 6, 1997. Firm-initiated recall complete.

DISTRIBUTION
Missouri.

QUANTITY
1 unit was distributed.

REASON
Blood products had high white blood cell counts.

PRODUCT

Red Blood Cells. Recall #B-1212-8.

CODE
Unit numbers: 11LX47322 and 11LC44712.

MANUFACTURER
American Red Cross Blood Services, St. Louis, Missouri.

RECALLED BY
Manufacturer, by telephone on June 24, 1997 and by letter dated July 1, 1997. Firm-initiated recall complete.

DISTRIBUTION
Illinois and Missouri.

QUANTITY
2 units were distributed.

REASON
Blood products were not quarantined after receiving information concerning post donation illnesses.

PRODUCT

Platelets, Pheresis, Part of a split unit. Recall #B-1213-8.

CODE
Unit 11LS11468.

MANUFACTURER
American Red Cross Blood Services, St. Louis, Missouri.

RECALLED BY
Manufacturer, by telephone on December 16, 1997, and by letter dated January 5, 1998. Firm-initiated recall complete.

DISTRIBUTION
Missouri.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled as leukoreduced but did not undergo leukoreduction.

PRODUCT

Red Blood Cells. Recall #B-1214-8.

C0DE
Unit #40GV12480.

MANUFACTURER
American Red Cross Blood Services, Peoria, Illinois.

RECALLED BY
Manufacturer, by letter dated May 7, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who traveled to an area considered endemic for malaria.

PRODUCT

Source Plasma. Recall #B-1216-8.

CODE
Unit numbers: DGK861, DMW091.

MANUFACTURER
Ohio Blood Plasma, Inc., Cincinnati, Ohio.

RECALLED BY
Manufacturer, by letter on November 7, 1997. Firm-initiated recall complete.

DISTRIBUTION
North Carolina.

QUANTITY
2 units were distributed.

REASON
Blood products which tested negative for HBsAg, but were collected from a donor who previously tested reactive for HBsAg.

PRODUCT

a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma. Recall #B-1217/1220-8.

CODE
Unit numbers: a) 7228271, 6044333, 6049765, 6052148, 1383110, 6059551, 6062808, 6064810; b) 7728271, 6052148, 6062808; c) 7728271, 6052148, 1383110, 6062808; d) 6044333, 6049765, 6059551, 6064810.

MANUFACTURER
LifeSource, Glenview, Illinois.

RECALLED BY
Manufacturer, by telephone on May 26, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois and Switzerland.

QUANTITY
a) 8 units; b) 3 units; c) 4 units; d) 4 units were distributed.

REASON
Blood products were collected from a donor whose spouse tested positive for hepatitis C.

PRODUCT

Platelets, Pheresis, Split units A and B. Recall #B-1221-8.

CODE
Unit #11LF07280.

MANUFACTURER
American Red Cross Blood Services, St. Louis, Missouri.

RECALLED BY
Manufacturer, by telephone on October 16, 1997 and by letters dated on or about October 16, 1997 and March 3, 1998. Firm-initiated recall complete.

DISTRIBUTION
Missouri.

QUANTITY
1 split unit was distributed.

REASON
Blood products had high platelet counts.

PRODUCT

a) Red Blood Cells; b) Platelets. Recall #B-1222/1223-8.

CODE
Unit #29448-8402.

MANUFACTURER
United Blood Services, Chicago, Illinois.

RECALLED BY
Manufacturer, by letter dated May 18, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT

Red Blood Cells. Recall #B-1224-8.

CODE
Unit numbers: 11FZ15443, 11FZ15444, 11FZ15453, 11FZ15462, 11FZ15465, 11FZ15447, 11FZ15452, 11FZ15460, 11FZ15464.

MANUFACTURER
American Red Cross Blood Services, St. Louis, Missouri.

RECALLED BY
Manufacturer, by telephone on September 19, 1997, and by letter September 29, 1997. Firm-initiated recall complete.

DISTRIBUTION
Illinois and Missouri.

QUANTITY
9 units were distributed.

REASON
Blood products were collected from donors who were offered monetary payment for donating, were mislabeled as volunteer donations.

PRODUCT

a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-1225/1227-8.

CODE
Unit #1400442.

MANUFACTURER
Central Kentucky Blood Center, Lexington, Kentucky.

RECALLED BY
Manufacturer, by letter dated April 9, 1998. Firm-initiated recall complete.

DISTRIBUTION
Kentucky.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor with a history of jaundice.

PRODUCT

a) Red Blood Cells; b) Fresh Frozen Plasma; c) Plasma, Frozen within 24 Hours after Phlebotomy; d) Red Blood Cells for Further Manufacture; e) Recovered Plasma, Frozen. Recall #B-1228/ 1232-8.

CODE
Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.

MANUFACTURER
American Red Cross Blood Services, Peoria, Illinois.

RECALLED BY
Manufacturer, by letters dated September 1, 1997, October 1, 1997, and January 13, 1998. Firm-initiated recall complete.

DISTRIBUTION
Florida, Illinois, Michigan, Minnesota, South Carolina, Washington state, California.

QUANTITY
a) 32 units; b) 1 unit; c) 3 units; d) 9 units; e) 40 units were distributed.

REASON
Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (HIV-1), but were collected from a donor who previously tested repeatedly reactive for the antibody, and was subjected to additional retesting.

PRODUCT

a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Recovered Plasma, Frozen; d) Recovered Plasma, Liquid. Recall #B-1233/1236-8.

CODE
Unit numbers: a) P44782, M84934; b) P48634, W00754, P45834; c) P48634, P45834, M84934; d) P44782.

MANUFACTURER
Tacoma-Pierce County Blood Bank, doing business as Cascade Regional Blood Services, Tacoma, Washington.

RECALLED BY
Manufacturer, by letter dated February 9 and 18, 1998. Firm-initiated recall complete.

DISTRIBUTION
Washington state, Missouri, California, Switzerland.

QUANTITY
a) 2 units; b) 3 units; c) 3 units; d) 1 unit was distributed.

REASON
Blood Products were collected from a donor with a positive test for the Hepatitis C virus (HCV) and/or history of Hepatitis, were distributed.

PRODUCT

Platelets. Recall #B-1237-8.

CODE
Unit #29449-7481.

MANUFACTURER
United Blood Services, Chicago, Illinois.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated May 20, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
1 unit was distributed.

REASON
Platelets were prepared from a unit collected from a donor who had taken aspirin within three days of donation.

PRODUCT

Fresh Frozen Plasma. Recall #B-1239-8.

CODE
Unit #17183-4543.

MANUFACTURER
United Blood Services, McAllen, Texas.

RECALLED BY
United Blood Services, a Division of Blood Systems, Inc., Scottsdale, Arizona, by telephone on March 2, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit was distributed.

REASON
Blood product corresponded to a unit of clotted red blood cells.

PRODUCT

Platelets, Pheresis. Recall #B-1244-8.

CODE
Unit #29448-2544.

MANUFACTURER
United Blood Services, Chicago, Illinois.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated May 22, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who reported living in an area designated as endemic for malaria.

PRODUCT

a) Red Blood Cells; b) Platelets. Recall #B-1245/1246-8.

CODE
Unit #2123590.

MANUFACTURER
LifeSource, Glenview, Illinois.

RECALLED BY
Manufacturer, by letter dated April 6, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT

a) Red Blood Cells; b) Platelets. Recall #B-1247/1248-8.

CODE
Unit numbers: 49X50959, 49X55187.

MANUFACTURER
American Red Cross Blood Services, Tulsa, Oklahoma.

RECALLED BY
Manufacturer, by letter dated March 19, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas and Oklahoma.

QUANTITY
2 units of each component were distributed.

REASON
Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT

Red Blood Cells. Recall #B-1255-8.

CODE
Unit #H77614.

MANUFACTURER
Tacoma-Pierce County Blood Bank, doing business as Cascade Regional Blood Services, Tacoma, Washington.

RECALLED BY
Manufacturer, by telephone on March 30, 1998. Firm-initiated recall complete.

DISTRIBUTION
Washington state.

QUANTITY
1 unit was distributed.

REASON
Blood product tested negative for antibody to the human immunodeficiency virus type 1/ 2 (anti-HIV-1/2), HIV-2 non-reactive, and Western Blot negative, but collected from a donor who previously tested repeat reactive for anti-HIV-1, Western Blot negative and was incorrectly reentered.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

PRODUCT

Red Blood Cells. Recall #B-1152-8.

CODE
Unit #10535-5790.

MANUFACTURER
United Blood Services, Scottsdale, Arizona.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on September 18, 1997. Firm-initiated recall complete.

DISTRIBUTION
Arizona.

QUANTITY
1 unit was distributed.

DISTRIBUTION
Arizona.

QUANTITY
1 unit was distributed.

REASON
Blood product was prepared from a unit of whole blood designated as a difficult collection, was distributed without a visual inspection for clots.

PRODUCT

Platelets, Pheresis. Recall #B-1210-8.

CODE
Unit #X23001.

MANUFACTURER
The Blood Center of Central Iowa, Des Moines, Iowa.

RECALLED BY
Manufacturer, by letter dated December 24, 1997. Firm-initiated recall complete.

DISTRIBUTION
Iowa.

QUANTITY
1 unit was distributed.

REASON
Blood product was exposed to unacceptable shipping temperatures.

PRODUCT

Fresh Frozen Plasma. Recall #B-1215-8.

CODE
Unit #11317-4510.

MANUFACTURER
United Blood Services, El Paso, Texas.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on March 26, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit was distributed.

REASON
Blood product was prepared from a unit of whole blood with an extended collection time.

PRODUCT

Platelets. Recall #B-1238-8.

CODE
Unit #50F06108.

MANUFACTURER
American Red Cross Blood Services, Toledo, Ohio.

RECALLED BY
Manufacturer, by telephone on December 1, 1997, and by letter on December 11, 1997. Firm-initiated recall complete.

DISTRIBUTION
Puerto Rico.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a unit of whole blood with an extended collection time.

PRODUCT

Red Blood Cells. Recall #B-1240-8.

CODE
Unit #26152-9491.

MANUFACTURER
United Blood Services, Fort Smith, Arkansas.

RECALLED BY
United Blood Services, a Division of Blood Systems, Inc., Scottsdale, Arizona, by telephone on April 22, 1998, and by letter dated May 5, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who exceeded the donation acceptance criteria for body temperature.

PRODUCT

a) Amicus Apheresis Kit, Single Needle, Catalog numbers 4R2312, R4R2316, D4R2316, and J4R2320; b) Amicus Apheresis Kit, Double Needle, 4R2310, R4R2314, D4R2314, J4R2318. Recall #B-1241/1242-8.

CODE
Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual lot numbers recalled.

MANUFACTURER
Baxter Healthcare Corporation, San German, Puerto Rico.

RECALLED BY
Baxter Healthcare Corporation, Biotech Group/Fenwal Division, Deerfield, Illinois, by letter dated May 12, 1997. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
42,006 kits were distributed.

REASON
Apheresis Kits contained pump tubing that does not seat properly due to a variation in length.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

PRODUCT

Tempest Orthopedic Pump Tube Set, Accessory to Orthopedic Pump, which is used to deliver saline solution to distend joints, knee and shoulder to facilitate Arthroscopic surgery. Recall #Z-601-8.

CODE
Part Number: 350-200-000; Affected lot Numbers: 98030682, 98040822, 98040782, 98050962, 98040802.

MANUFACTURER
Stryker Puerto Rico, Arroyo, Puerto Rico.

RECALLED BY
Stryker Endoscopy, Santa Clara, California, by letter sent on June 5, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and China.

QUANTITY
1,518 units were distributed.

REASON
A minute crack in the blister pack may compromise the sterility of the device.

PRODUCT

Hu-Friedy Dental Hand Instruments with, Advantouch Resin Handles, dental hand instruments including scalers, curettes, explorers, probes, mirror handles and operative instruments used for the manual removal of plaque and calculus from teeth, examination of teeth for caries detection, screening for periodontal disease states, holding mirror heads and cavity preparation and restorations. Recall #Z-603-8.

CODE
All instruments with the cream color Advantouch resin handles (306 catalog numbers).

MANUFACTURER
Hu-Friedy Manufacturing Company, Inc., Chicago, Illinois.

RECALLED BY
Manufacturer, by letters dated May 20 and 28, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
756,387 devices were distributed.

REASON
The device handle may snap or break during use.

PRODUCT

Pelorus brand Stereotatic Surgical Kits: a) Skull Mount Kit, Catalog #744A1330; b) Biopsy Kit Catalog #744A1335; c) MRI Skull Mount Kit, Catalog #744A1486, single use, sterile devices used to perform neurological surgeries on the brain, under the Ohio Medical Instrument label. Recall #Z-620/622-8.

CODE
All codes.

MANUFACTURER
Ohio Medical Instrument Company, Cincinnati, Ohio.

RECALLED BY
Manufacturer, by letter on May 29, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Puerto Rico.

QUANTITY
453 kits were distributed.

REASON
Sterilization of the device has not been adequately validated.

PRODUCT

Richard-Allan Scientific brand Bouins Fluid Specimen Management System for fixation of pathological specimens in 1 gallon containers, Reorder Number 57211, Allegiance catalog number C4340-3. The product is a general fixative for histology. Recall #Z-624-8.

CODE
Lots numbers: 97A17, EXP 01/99; 97C12, EXP 03/99; 97F20, EXP 06/99; 97H07, EXP 08/99; 97K20, EXP 10/99 and 97M19, EXP 12/99. All lots produced since January 1997.

MANUFACTURER
Richard-Allan Scientific, Kalamazoo, Michigan.

RECALLED BY
Manufacturer, by letter on April 30, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
797 gallons were distributed.

REASON
The amount of formaldehyde in the formula was decreased in error from 23% to 2%.

PRODUCT

Model Chromos 694 Ruby Laser System, used in dermatology (hair removal). Recall #Z-630-8.

CODE
Model Chromos 694.

MANUFACTURER
Mehl/Biophile International (SLS Biophile in Wales is the actual manufacturer, owned by Mehl).

RECALLED BY
Mehl/Biophile International Corporation, Gainesville, Florida. FDA approved the firm's corrective action plan June 5, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
51 units were distributed.

REASON
The device failed to comply with 21 CFR 1040.10(f)(2)(iii) in that it lacked a fail-safe fiber interlock, lacked certain labels per 1010.2, 1040.10(g)(4) and (g)(6), and the operators manual lacked calibration procedures per 1040.11(a)(2).

PRODUCT

Medi-trace 1210H Combination Defibrillation, Pacing and ECG Electrodes, part #31177721, intended for use in defibrillation and pacing procedures. Recall #Z-632-8.

CODE

HC80001        HC80006        HC80011
HC80002        HC80007        HC80013
HC80003        HC80008        HC80015
HC80004        HC80009        HC80016
HC80005        HC80010.

MANUFACTURER
Graphic Controls Canada, Ltd., Ganonoque, Ontario, Canada.

RECALLED BY
Graphic Controls Corporation, Buffalo, New York, by letter dated May 20, 1998, and by fax on May 22 & 26, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, Canada, Spain, Australia, Brazil.

QUANTITY
908.5 cases were distributed.

REASON
The lead wire of the electrode may become detached from the electrode body upon opening the electrode pouch.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

PRODUCT

Molteno brand, Sterile, Double Plate and Dual Chamber Plate Glaucoma Shunt Implants, used to reduce the intraocular pressure in severe and complex cases of glaucoma where conventional drainage procedures have failed or offer little prospect of success. Recall #Z-608-8.

C0DE
Lots R21005, R22005, L21003 & L22003.

MANUFACTURER
Molteno Ophthalmic, Dunedin, New Zealand. RECALLED BY
Innovative Ophthalmic Products, Inc. (IOP), Costa Mesa, California, by telephone, and by letters dated from March 20, 1998 to April 10, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
California, Connecticut, Florida, Indiana, Massachusetts, Michigan, Minnesota, Missouri, New York, Ohio, Pennsylvania, South Carolina, Texas, Vermont, Washington state, Wisconsin, Puerto Rico, Canada.

QUANTITY
146 units were distributed.

REASON
Tube is curved instead of straight.

PRODUCT

VDRL U.S. Reference Antigen, in 5ml glass vials. Recall #Z-629-8.

CODE
Lot #96-0044N EXP 8/98. MANUFACTURER
Centers for Disease Control, Atlanta, Georgia.

RECALLED BY
Manufacturer, by letter on July 7, 1997. Firm-initiated recall complete.

DISTRIBUTION
Georgia, Kansas, Louisiana, Rhode Island, Texas, Wisconsin, Spain.

QUANTITY
Approximately 26 vials were distributed.

REASON
The product declined in reactivity before the expiration date.

END OF ENFORCEMENT REPORT FOR JUNE 24, 1998. BLANK PAGES MAY FOLLOW.

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(Hypertext updated by jch 1998-JUN-24) ####