FDA

Enforcement Report

June 9, 1999                                       99-23

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS II
_______________
PRODUCT & CODE
Powdered Drink Mixes and Sugar Replacements:
F-424-9 VANILLA MEAL REPLACEMENT as follows:
a) Meijer EXTRA Thin Quick Vanilla Creme, Artificially Flavored 
Instant Meal Replacement for Weight Loss, Net Wt. 15 oz.(6 
units/case).  Responsible firm on the label: Meijer, Inc., Grand 
Rapids, MI. Lot #10599VA (case code: 10599A)
b) ULTRA Diet Quick Vanilla Creme, Artificially Flavored Instant 
Meal Replacement for Weight Control, Net Wt. 15 oz. (6 
units/case).  Responsible firm on the label: TKI Foods, Inc., 
Springfield, IL.  Lot #9074VA/E0900 (case code: 9074A)- For 
EXPORT and Lot #10599VA (case code: 10599A)
F-425-9 VANILLA MEAL REPLACEMENT (shake) as follows:
a) American Fare Low Fat Extra Thin & Trim Healthy Shake, Vanilla 
Creme artificially flavored Instant Meal Replacement Shake for 
Weight Loss, Net Wt. 30 oz. (4 units/case).  Responsible firm on 
the label: KMART Corporation, Troy, MI.  Lot #V EXP 09/00A (case 
code: 9076A) and Lot #V EXP 09/00A (case code: 9081A)
F-426-9 VANILLA MEAL REPLACEMENT as follows:
a) Food Club Ultra Diet Plan, Vanilla Creme, Artificially 
Flavored Instant Meal Replacement for Weight Loss, 15 oz.(6 
units/case).  Responsible firm on the label: TOPCO Assoc. Inc., 
Skokie, IL.  Lot #07199VA (case code: 07199A)
F-427-9 CHOCOLATE MEAL REPLACEMENT as follows:
a) American Fare Low Fat Extra Thin & Trim Healthy Shake,
Chocolate Supreme artificially flavored Instant Meal Replacement 
for Weight Loss, Net Wt 30 oz.(4 units/case).  Responsible firm 
on the label: KMART Corporation, Troy, MI.  Lot #C EXP 09/00A 
(case code: 9076A) and Lot #C EXP 09/00A (case code: 9081A)
F-428-9 DUTCH CHOCOLATE MEAL REPLACEMENT as follows:
a) Food Club Ultra Diet Plan, Dutch Chocolate, artificially
flavored Instant Meal Replacement for Weight Loss, Net Wt 15 oz. 
(6 units/case).  Responsible firm on the label: TOPCO Assoc., 
Inc., Skokie, IL.  Lot #07199CA (case code: 07199A)
b) Ultra Diet Quick, Dutch Chocolate, Artificially Flavored
Instant Meal Replacement for Weight Control, NET WT 15 oz. (6 
units/case).  Responsible firm on the label: TKI Foods, Inc., 
Springfield, IL.  Lot #9071CA/E0900 (case code: 9071A) - exported 
F-429-9 STRAWBERRY MEAL REPLACEMENT as follows:
a) Ultra Diet Quick, Strawberry Delight, Artificially Flavored 
Instant Meal Replacement for Weight Control, NET WT 15 oz. (6 
units/case). Responsible firm on the label: TKI Foods, Inc., 
Springfield, IL. Lot #9074SA/E0900 (case code: 9074A) - exported 
F-430-9 ICED TEA MIX as follows:
a) Shop Rite Natural Lemon Flavored Iced Tea Mix, Net Wt 24 oz. 
(12 units/case).  Responsible firm on the label: Wakefern Food 
Corporation, Elizabeth, NJ.  Lot #031101LTA (case code: 031101A) 
and Lot #041601LTA (case code: 04160A)
F-431-9 SUGAR REPLACEMENT (spoonable), with saccharin, as
follows: a) Sprinkle Sweet Sugar Replacement, NET WT 2 oz. (12 
units/case).  Responsible firm on the label: The Pillsbury Co., 
Minneapolis, MN.  Lot #9067A (case code: C908A)
F-432-9 SUGAR REPLACEMENT (spoonable) with Aspartame, as follows: 
 a) Food Club Sweet Measure Sweetener with Aspartame, Net Wt 2 
oz. (12 units/case).  Responsible firm on the label: TOPCO 
Associates, Inc., Skokie, IL.  
Lot #9069A (case code: 9069A)
b) Stop & Shop Sweet Measure, Net Wt 2 oz. (12 units/case).
Responsible firm on the label: Stop &Shop Supermarket Company, 
Boston, MA.  Lot #9069A (case code: 9069A), Lot #9070A (case 
code: 9070A), and Lot #9095A (case code: 9095A)
c) Kroger Sweet Servings, Net Wt 2 oz. (12 units/case).
Responsible firm on the label: Kroger Co., Cincinnati, OH.  Lot # 
Sell By 030901A1 (case code: 9068A) and Lot # Sell By 030901A2 
(case code: 9068A).
MANUFACTURER
Ontario Foods, Inc., Albion, New York.
RECALLED BY
Manufacturer, by telephone, and by letters dated May 4,5, & 7, 
1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Florida, Illinois, Massachusetts, Maryland, Michigan, Nebraska, 
New Jersey, Ohio, Pennsylvania, Hungary,
QUANTITY
Approximately 12,500 cases of the various products were 
distributed.
REASON
Products may contain pieces of aluminum metal.
________
PRODUCT
Don Tomas brand Fresh Juice, in 16 ounce and 128 ounce bottles: 
a) Passion Fruit Juice; b) Guava Juice;
c) Acerola Juice.  Recall #F-434/436-9.
CODE
a) A02119    16 OZ.          
   B02119    16 OZ. & 128 OZ     
   C02119    16 OZ. & 128 OZ      
b) A012199   16 OZ.    
c) A021199   16 OZ. & 128 OZ.
   B021199   16 OZ. & 128 OZ.
   C021199   128 OZ.
   A021299   128 OZ.
   B021299   128 OZ.
   C021299   128 OZ.
   D021299   128 OZ.
   E021299   128 OZ.
MANUFACTURER
Don Tomas Foods, Inc., Catano, Puerto Rico.
RECALLED BY
Manufacturer, by vist on February 17, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Puerto Rico.
QUANTITY
Undetermined.
REASON
The Passion Fruit juice contains undeclared FD&C Yellow No. 5, 
FD&C Red No. 40, and sodium benzoate. The Guava juice and the 
Acerola juice contain undeclared FD&C Red No.40 and sodium 
benzoate.
________
PRODUCT
El Charrito Naranja Agria Bitter Orange, in 24 and 128 fluid 
ounce bottles.  Recall #F-438-9.
CODE
All codes.
MANUFACTURER
Lisy Corporation, Miami, Florida.
RECALLED BY
Manufacturer, by telephone on April 29-30, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Texas, North Carolina, Georgia, Florida.
QUANTITY
Firm estimated that approximately 1,186 24-ounce bottles and 84 
128-ounce bottles remained on market at time of recall 
initiation.
REASON
Product contains undeclared FD&C Yellow No. 5.
________
PRODUCT
Sze Chuan Preserved Hot Bean Curd, in 4.6 ounce (130 grams) and 
10.6 ounce (300 grams) jars.  Recall F-442-9.
CODE
None.
MANUFACTURER
Shenzhen Koon Yick Foods Company, Ltd., Shenzhen, China.
RECALLED BY
BCN Trading, Inc., Brooklyn, New York, by letter on September 28, 
1998.  Completed recall resulted by sample analysis and follow-up 
by the New York State Department of Agriculture and Markets.
DISTRIBUTION
New York, Connecticut, Pennsylvania, Massachusetts, New Jersey, 
Florida, District of Columbia.
QUANTITY
358 cartons (4.6 ounce) and 835 cartons (10.6 ounce) were 
distributed.
REASON
Product was produced under conditions that support the growth of, 
and toxin production by, Staph. aureus.

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS III
________
PRODUCT
Dioscorea Opposita Thunb. (Rhizome of Common Yam).
Recall #F-433-9.
CODE
None.
MANUFACTURER
Ming Fung Trading Company, Hong Kong, China (exporter).

RECALLED BY
KSH (Kwok Shing) Trading Company, Inc., Brooklyn, New York, by 
telephone on August 27, 1998.  Completed field correction 
(relabeling) resulted from sample analysis and follow-up by the 
New York State Department of Agriculture and Markets.
DISTRIBUTION
New York, Florida, California.
QUANTITY
186 cartons (56 boxes per case) were distributed.
REASON
Product contains undeclared sulfites.
________
PRODUCT
El Charrito Coco Rallado Shredded Coconut, in 2 ounce packs.
Recall #F-439-9.
CODE
All codes.
MANUFACTURER
Lisy Corporation, Miami, Florida.
RECALLED BY
Manufacturer, by telephone on March 23, 1999. Completed field 
correction (relabeling) resulted from sample analysis and follow-
up by the North Carolina Department of Agriculture and Consumer 
Services, Food and Drug Protection Division.
DISTRIBUTION
Texas, North Carolina, Georgia, Florida.
QUANTITY
Firm estimated that 3,984 units remained on market at time of 
recall initiation.
REASON
Product contains undeclared sulfites.

RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS I
________
PRODUCT
Rejuvamin PM Capsules (Gammadeoxytetronic Acid), OTC in 
packets of 4 units.  Recall #D-231-9.
CODE
All lot numbers
MANUFACTURER
Tishcon Corporation, Westbury, New York (contract Manufacturer).
RECALLED BY
Biocentrics, A Division of Unique Products Company, Brentwood, 
Tennessee, by letter dated April 20, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
Approximately 150 cases (each case containing 24 boxes with 30 
packets inside the box) were manufactured.  All of the product 
was distributed except 5 boxes (150 packets).
REASON
Product is an unapproved new drug.

RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS II
________
PRODUCT
Dilantin 30 mg Kapseals (Extended Phenytoin Sodium Capsules, 
USP), in bottles of 100. NDC N0071-0365-24.
Recall #D-232-9.
CODE
Lot #27458L EXP 6/00.
MANUFACTURER
Warner Lambert Company, Morris Plains, New Jersey.
RECALLED BY
Park Davis, Division of Warner Lambert Company, Morris Plains, 
New Jersey, by letter dated February 17, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
36,376 units were distributed.
REASON
Dissolution failure (at 3 month stability testing).
________
PRODUCT
Indomethacin Extended Release Capsules, USP, 75 mg, packaged in 
7, 10, 14, 20 and 30 capsule unit containers, Rx non-steroidal 
anti-inflammatory drug used for the treatment of osteoarthritis, 
ankylosing spondylitis and rheumatoid arthritis, NDC #0258-3607-
01  Recall #D-237-9.
CODE
Product #1518-0: lots 8230204, 8201099, 8161047, 8154080, 
9048138, 9034225, 8266102, 8247110, 9076111, 9070061, 9050087
Product #1518-1: lots 8166183, 8154081, 8258129, 8239032, 
8253084, 8209090, 9006096, 8336136, 8335170, 8316110, 9096140, 
9091075, 9084013, 9049091
Product #1518-2: 8303074, 8259121, 8247043, 8142062, 9085035, 
9070002, 8355066, 8328097
Product #1518-3: 8237077, 8233057, 8230127, 8210077, 8341203, 
8335171, 8327166, 8237157
Product #1518-6: lots 9068141, 9067119, 9039184, 8362154, 
8308179, 8307158, 8280168, 8160142, 8147139.
MANUFACTURER
Inwood Laboratories, Inc., Inwood, New York.
RECALLED BY
Allscripts, Inc., Libertyville, Illinois (repacker), by letter 
dated April 28, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Indiana, Illinois, California, Missouri, Pennsylvania, Wyoming, 
Iowa, Maine, Nevada, Ohio, Colorado, Washington state, Florida, 
Tennessee, Michigan, Connecticut.
QUANTITY
62 bottles of 30, 300 bottles of 7, 280 bottles of 14, 91 bottles 
of 20 and 124 bottles of 10 capsules were distributed.  Firm 
estimates that less than 25% of the product remained on the 
market at time of recall initiation.
REASON
Dissolution failure.

RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS III
________
PRODUCT
Trifluoperazine HCl Tablets, USP, a) 1mg, in 100 count bottles; 
b) 2mg, in 100 count bottles; c) and 5mg, in 100 and 500 count 
bottles; d) Fluphenazine HCl Tablets, USP, 1 mg, in 100 and 500 
count bottles, Rx prescribed for the management of the 
manifestations of psychotic disorders and non-psychotic anxiety. 
 Recall #D-233/236-9.
CODE
a-c) Strength  Lot No    NDC No.        Size(Tabs)  Exp Date
     1 mg      E132L	 00378-2401-01	  100         10/00
     2 mg      E131L     00378-2402-01    100         10/00
     5 mg      E128L     00378-2405-01    100         10/00
     5 mg      E128L     00378-2405-05    500         10/00
d)   1 mg      E235E     00378-6004-01    100         08/00
                         00378-6004-05    500         08/00.
MANUFACTURER
Mylan Pharmaceuticals, Inc., Morgantown, West Virginia.
RECALLED BY
Manufacturer, by letters on or about April 12, 1999, and May 6, 
1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
a-c) Firm estimated that 14,392 bottles of 100 tablets, and 200 
bottles of 500 tablets; d) 9,047 bottles of 100 and 960 bottles 
of 500 tablets remained on market at time of recall initiation.
REASON
Subpotency (at 3 month stability).

________
PRODUCT
Rx oral tablets in unit dose blister packages of 100 tablets, 10 
strips of 10 tablets, indicated for the management of psychotic 
disorders:
a) Trifluoperazine Hydrochloride Tablets, USP, 1 mg, in 
unit dose packages of 100 (10 strips of 10 tablets).  NDC 
#51079-572-20 
b) Trifluoperazine Hydrochloride Tablets, USP, 2 mg, in 
unit dose packages of 100 (10 strips of 10 tablets). NDC 
#51079-573-20  
c) Trifluoperazine Hydrochloride Tablets, USP, 5mg, in 
unit dose packages of 100 (10 strips of 10 tablets). NDC 
#51079-574-20  
d) Fluphenazine Hydrochloride Tablets, USP, 1 mg, in unit 
dose packages of 100 (10 strips of 10 tablets).
NDC #51079-485-20.  Recall #D-238/241-9.
CODE
Lot numbers:  a) 9A159; b) 9A160 and 9B358; c) 9A161 and 
9C485; d) 8S844.
MANUFACTURER
Mylan Pharmaceucticals, Inc., Morgantown, West Virginia.
RECALLED BY
UDL Laboratories, Inc., Rockford, Illinois (repacker), by 
letter dated May 13, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
a) 100; b) 275; c) 374; d) 1,404 unit cartons were distributed; 
firm estimated that 40% of the products remained on the market at 
time of recall initiation.
REASON
Subpotency (at 3 month stability).

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS II
________
PRODUCT
Red Blood Cells.  Recall #B-712-9.
CODE
Unit #36FL06986.
MANUFACTURER
American Red Cross Blood Services, Columbia, South Carolina.
RECALLED BY
Manufacturer, by telephone on November 12, 1996, and by letter 
dated November 14, 1996.  Firm-initiated recall complete.
DISTRIBUTION
South Carolina.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who had ear piercing 
within 12 months of donation.
________
PRODUCT
Red Blood Cells.  Recall #B-790-9.
CODE
Unit #35FH27443.
MANUFACTURER
American Red Cross Blood Services, Roanoke, Virginia.
RECALLED BY
Manufacturer, by telephone on December 29, 1998, and by letter 
dated January 19, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Virginia.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled as leukoreduced but did not undergo 
leukoreduction.
________
PRODUCT
Red Blood Cells.  Recall #B-816-9.
CODE
Unit numbers: 12LF30806, 12FN08259, 12LE38133.
MANUFACTURER
American Red Cross Blood Services, Charlotte, North Carolina.
RECALLED BY
Manufacturer, by telephone on May 31, 1996, or June 3, 1996, and 
by letter dated June 3, 1996.  Firm-initiated recall complete.
DISTRIBUTION
North Carolina.
QUANTITY
3 units were distributed.
REASON
Blood products tested non-reactive for the antibody to the 
Hepatitis B core antigen (anti-HBc), but were collected from a 
donor who was previously repeatedly reactive for anti-HBc on two 
separate donations.
________
PRODUCT
Plasma Pooling Bottle II.  Recall #B-828-9.
CODE
Lot #R-0480.
MANUFACTURER
Alpha Therapeutic Corporation Plastics Plant, Compton, 
California.
RECALLED BY
Alpha Therapeutic Corporation, Los Angeles, California, by fax on 
February 6, 1999, and by letter on February 8, 1999.  
Firm-initiated recall complete.
DISTRIBUTION
Alabama, Arizona, Colorado, California, Florida, Idaho, Illinois, 
Louisiana, New Mexico, Nevada, Oklahoma, Tennessee, Texas, Utah.
QUANTITY
41,985 units were distributed.
REASON
Plasma pooling bottle had loose bottle caps.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma for Injectable Use.
Recall #B-829/830-9.
CODE
Unit #42FW54759.
MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.
RECALLED BY
Manufacturer, by letter dated February 23, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Ohio and California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who had received a 
rabies vaccination.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma;
d) Cryoprecipitated AHF; e) Recovered Plasma.
Recall #B-831/835-9.
CODE
Unit numbers:  a) 13C56192, 13E84399, 13FT41779, 13FT54339, 
13H65225, 13K59604, 13M06561, 13X16504, 13Y73124
b) 13FT41779, 13FT54339, 13H65225, 13K59604, 13M06561, 13X16504, 
13Y73124; c) 13K59604; d) 13C56192
e) 13E84399, 13C56192, 13FT41779, 13FT54339, 	13H65225, 
13M06561, 13Y73124.
MANUFACTURER
American Red Cross, Detroit, Michigan.
RECALLED BY
Manufacturer, by letter on either January 2, 6, 12, 1998, and/or 
March 11, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Michigan and California.
QUANTITY
a) 9 units; b) 7 units; c) 1 unit; d) 1 unit; e) 7 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, 
Western Blot negative.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma;
d) Recovered Plasma.  Recall #B-836/839-9.
CODE
Unit numbers: a) 3000219, 4004205; b) 3000219, 4004205
c) 3000219; d) 4004205.
MANUFACTURER
Community Blood Center, Dayton, Ohio.
RECALLED BY
Manufacturer, by letter dated either June 23 or 26, 1998.  Firm-
initiated recall complete.
DISTRIBUTION
Ohio and California.
QUANTITY
a) 2 units; b) 2 units; c) 1 unit; d) 1 unit was distributed.
REASON
Blood products were collected from a donor with a history of 
hepatitis.
________
PRODUCT
Recovered Plasma.  Recall #B-851-9.
CODE
Unit #V18402.
MANUFACTURER
Tacoma-Pierce County Blood Bank, doing business as Cascade 
Regional Blood Services, Tacoma, Washington.
RECALLED BY
Manufacturer, by letter dated January 8, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who failed to answer the 
question regarding having received Hepatitis B Immune globulin.
________
PRODUCT
Red Blood Cells.  Recall #B-852-9.
CODE
Unit #10586-7129.
MANUFACTURER
United Blood Services, Scottsdale, Arizona.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated January 
6, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Texas.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who had been diagnosed 
with ulcerative colitis and has an antithrombin deficiency.
________
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma; 
c) Cryoprecipitate AHF.  Recall #B-853/855-9.
CODE
Unit numbers:  a) 12K96657, 12Y73263, 12Y58953, 12V03964, 
12Y64970, 12K04349, 12Y69854, 12Y61855, 12S01940, 12Y54867, 
12LM01196, 12F64037, 12R35532, 12F59357, 12G94163, 12F52714,
12F67602, 12H81989, 12R32517, 12G97067, 12F56393, 12G99706
b) 12Y69854, 12S01940, 12Y54867, 12LM01196, 12F64037, 12R35532, 
12H81989, 12R32517, 12G99706  
c) 12G97067.
MANUFACTURER
American Red Cross Blood Services, Charlotte, North Carolina.
RECALLED BY
Manufacturer, by letters dated June 11, 13, 25, 28, 1996, July 1, 
12, or 29, 1996.  Firm-initiated recall complete.
DISTRIBUTION
North Carolina.
QUANTITY
22 units; b) 9 units; c) 1 unit.
REASON
Blood products tested non-reactive for the antibody to the 
Hepatitis B core antigen (anti-HBc), but were collected from a 
donor who was previously repeatedly reactive for anti-HBc on two 
separate donations.
________
PRODUCT
Red Blood Cells.  Recall #B-856-9.
CODE
Unit numbers: 12FR02043, 12Z13552, 12FJ91965.
MANUFACTURER
American Red Cross Blood Services, Charlotte, North Carolina.
RECALLED BY
Manufacturer, by telephone on June 3, 1996, and by letter dated 
June 3 or 4, 1996.  Firm-initiated recall complete.
DISTRIBUTION
North Carolina.
QUANTITY
3 units were distributed.
REASON
Blood products tested non-reactive for the antibody to the 
Hepatitis B core antigen (anti-HBc), but were collected from a 
donor who was previously repeatedly reactive for anti-HBc on two 
separate donations.
________
PRODUCT
Red Blood Cells.  Recall #B-860-9.
CODE
Unit #19GS20631.
MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY
Manufacturer, by letters dated December 17, 1997 and January 16, 
1998.  Firm-initiated recall complete.
DISTRIBUTION
Tennessee.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported travel to 
an area designated as endemic for malaria.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS III
________
PRODUCT
Fresh Frozen Plasma.  Recall #B-647-9.
CODE
Unit 16342-6217.
MANUFACTURER
Blood Systems, Inc., Meridian, Mississippi.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on March 
9, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Mississippi.
QUANTITY
1 unit was distributed.
REASON
Fresh Frozen Plasma was not separated and frozen within eight 
hours of phelbotomy.
________
PRODUCT
Platelets, Pheresis.  Recall #B-818-9.
CODE
Unit numbers:  26KP11401 and 26KP11402.
MANUFACTURER
American Red Cross Blood Services, Mobile, Alabama.
RECALLED BY
Manufacturer, by letters dated April 21, 1998, and May 21, 1998. 
 Firm-initiated recall complete.
DISTRIBUTION
Alabama.
QUANTITY
2 units were distributed.
REASON
Blood products were distributed without platelet counts being 
performed.
________
PRODUCT
a) Platelets; b) Recovered Plasma.  Recall #B-826/827-9.
CODE
Unit numbers:  a) 1669976; b) 1674724 and 1672164.
MANUFACTURER
Mississippi Blood Services, Inc., Jackson, Mississippi.
RECALLED BY
Manufacturer, by letter dated November 26, 1997, or by fax on 
December 17, 1997, and October 28, 1998.  Firm-initiated recall 
complete.
DISTRIBUTION
Mississippi, California, Switzerland.
QUANTITY
a) 1 unit; b) 2 units were distributed.
REASON
Blood products were produced from whole blood units that were 
lipemic, or considered a "poor quality" product.
________
PRODUCT
Allergenic Extract, Hickory, Shagbark, 1:10w/v Non-Glycerin, 50 
Ml.  Recall #B-862-9.
CODE
Lot #188B3296.
MANUFACTURER
Bayer Corporation/Pharmaceutical Division, Allergy Products, 
Spokane, Washington.
RECALLED BY
Manufacturer, by telephone on March 24, 1999, and by letter dated 
March 25, 1999.  Firm-initiated recall complete.
DISTRIBUTION
New York and Tennessee.
QUANTITY
4 vials were distributed.
REASON
Allergenic extract was labeled with an extended expiration date.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS II
________
PRODUCT
Hemoglobin Reagent.  Recall #Z-947-9.
CODE
HEC-506, Lot: #801164, Expiration: 1 JAN 2000.
MANUFACTURER
EG & G Wallace, Inc., Norton, Ohio.
RECALLED BY
EG & G Wallace, Inc., Akron, Ohio, by fax on April 21, 1999.  
Firm-initiated recall ongoing.
DISTRIBUTION
Tennessee, Virginia, California, Illinois, Massachusetts, 
Nebraska, New York, Canada, Brazil.
QUANTITY
33 sets were distributed.
REASON
Product is packaged with an insert sheet which incorrectly 
identifies the control as Hb A/S in the heading, instead of the 
correct control identification of Hb A/F.
________
PRODUCT
Acoma X1000 Hydraulic Stand, Item #SSB-T0959-6, part of the Trans 
X-1000 Fully Automatic Chest X-ray system, intended for use in 
general radiographic applications.  The Trans X-1000 is a fully 
automatic chest film changer.  It provides a direct film 
transport mechanism between the film supply magazine and the film 
processor,.a fully automatic chest film changer.  Recall #Z-942-
9.
CODE
Serial numbers:  300002, 300007, 300010, 300011, 300012.
MANUFACTURER
Canon, Inc., Tokyo, Japan.
RECALLED BY
Canon USA, Inc., Lake Success, New York, by letter on January 19, 
1999.  Firm-initiated field correction complete.
DISTRIBUTION
Missouri, Ohio, Florida, New York, Pennsylvania, Illinois.
QUANTITY
6 units were distributed.
REASON
The arm support mechanism (handle) can break.
________
PRODUCT
CMV IgM ELISA Test System, an enzyme-linked immunosorbent assay 
(ELISA) for the detection of IgM antibodies to cytomegalovirus.  
Recall #Z-943-9.
CODE
Lot #9VIRO17456, Product #9Z9501M EXP 11/30/99.
MANUFACTURER
Zeus Scientific, Inc., Branchburg, New Jersey.
RECALLED BY
Manufacturer, by letter sent October 29, 1998.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide, China, Indonesia.
QUANTITY
66 kits were distributed.
REASON
The product may produce false positive test results.
________
PRODUCT
Lasers and Laser Pointers:
a) Model No. LCM-T Lasers;
b) Model No. LP-1M Laser Pointers;
c) Model No. LP-2M Laser Pointers;
d) Model No. GP-2 (Pulsed) Laser Pointers.
Recall #Z-950/953-9.
CODE
a) Model No. LCM-T Lasers;
b) Model No. LP-1M Laser Pointers;
c) Model No. LP-2M Laser Pointers;
d) Model No. GP-2 (Pulsed) Laser Pointers.
MANUFACTURER
Power Technology, Inc., Mabelvale, Arkansas.
RECALLED BY
Manufacturer.  FDA approved the firm's corrective action plan on May 
21, 1999.  Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
59 units were distributed.
REASON
The LCM-T lasers were introduced into commerce uncertified and did 
not comply with the performance standard (Section 538 of the Federal 
Food and Drug and Cosmetic Act and 21 CFR 1010.2) The LP-1M and the 
GP-2 (pulsed) laser pointers exceeded the Class IIIa and Class II 
single pulse energy limits of the laser standard (21 CFRE 
1040.10(c)(1).  The LP-2M laser pointer failed to have a remote 
interlock connector, an adequate beam attenuator and the correct 
text on the warning logotype label (21 CFR 1040.10(g)(2)(iii).

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS III
________
PRODUCT
Minnova Pelvic Floor Stimulation System; and InnoSense Pelvic 
Floor Stimulation and Electromyography System.  Both systems use 
mild electrical stimulation to help control urinary incontinence. 
Recall #Z-865/866-9.
CODE
Affected Minnova serial numbers:  
82004**, with the ** equal to 52, 53, 57, 59, 63-65, 67, 68, 70, 
71, 73, 75, 76, 81-85, 87, 92, 93, 99
82005**, with the ** equal to 10, 12-29, 31, 35-38, 41-50, 52-54, 
58, 59, 64, 66, 68-74, 77-79, 81-84, 88, 89, 92, 95, 96, 98, 99
82006**, with the ** equal to 03, 04, 06-10, 12-15, 17, 19, 21-
23, 42, 68, 73-77, 83, 95-99
8200700
The affected InnoSense serial numbers are:  
8000499
80005**, with the ** equal to 00-11, 13-20, 24, 93
8000602
80506**, with the ** equal to 51-71
80507**, with the ** equal to 49-58, 60-62, 71-74, 76-86.
MANUFACTURER
EMPI, Inc., St. Paul, Minnesota.
RECALLED BY
Manufacturer, by letter dated March 6, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
126 Minnova devices and 73 InnoSense devices were distributed.
REASON
An oversized dimension of an electrical pin connector in a socket 
in each device will result in an incorrect electrical connection 
between the patient electrode and the device.

END OF ENFORCEMENT REPORT FOR JUNE 9, 1999.