FDA

Enforcement Report

May 19, 1999                                99-20


RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS I
________
PRODUCT
Vegetable Egg Rolls, packaged in 22-oz and 56-oz plastic bags.  
For 22-oz, each case contains 12 22-oz bags, with 16-18 egg roll 
pieces packed per bag.  For 56 oz, each case contains 8-56 oz 
bag, with 42-45 egg roll pieces packed per bag: a) Lumpia 
Vegetable Egg Roll;
b) Lumpia Vegetable Egg Roll, Pork Flavor
c) Lumpia Vegetable Egg Roll, Beef Flavor
d) Lumpia Vegetable Egg Roll, Chicken Flavor.
Recall #F-392/395-9.
CODE
All products produced and distributed between September 1, 1998 - 
February 28, 1999 are affected by the recall.  Product code only 
appears on the master cases and not on the retail packages.  Case 
codes correspond to the date product was packaged, which appears 
as "SEP 01 1998" through "FEB 28 1999".
MANUFACTURER
Princess Foods Company, Anaheim, California.

RECALLED BY
NR Foods Distributors, Anaheim, California, by letters issued 
between March 23 and 24, 1999, and by press release April 2, 
1999.  Firm-initiated recall ongoing.
DISTRIBUTION
California, Arizona, Hawaii, Illinois, Nevada, Texas.
QUANTITY
Amount of product distributed:
                      22 oz bag   56 oz bag
Beef flavor           44 cases    16 cases
Chicken flavor        62 cases    73 cases
Pork flavor           99 cases   111 cases
Vegetable             57 cases    96 cases.
REASON
The products contain undeclared egg whites.
________
PRODUCT
Oroweat brand Whole Wheat Bagels, 6 bagels per package, net 
weight 20 ounces.  Recall #F-397-9.
CODE
Sell by date April 8.
MANUFACTURER
Global Bakeries, Inc., Pacoima, California (contract 
manufacturer).
RECALLED BY
Bestfoods Baking Company, Bay Shore, New York, by telephone on 
March 31, 1999, and by press release on April 1, 1999, followed 
by visit.  Firm-initiated recall complete.
DISTRIBUTION
California, Oregon, Arizona.
QUANTITY
4,520 units were distributed.
REASON
Product contained undeclared walnuts.
________
PRODUCT
1.  Ultra-Pasteurized Heavy Whipping Cream
 a) Becker's Quart Ultra-Pasteurized Heavy Whipping Cream labeled 
as distributed by L. Pritikin & A. Becker, Inc., Chicago, IL 
(3/16 through 4/13)
 b) Kemps Pint Ultra-Pasteurized Heavy Whipping Cream distributed 
by Marigold Foods, Inc., Minneapolis, MN (3/01  through 3/22)
 c) Kemps 8 Fl. Oz. Ultra-Pasteurized Heavy Whipping Cream  
distributed by Marigold Foods, Inc., Minneapolis, MN (3/01  
through 4/05)
 d) Land O'Lakes Quart Gourmet Heavy Whipping Cream labeled  as 
product of Land O'Lakes, Inc., Arden Hills, MN (1/15 through 
2/28)
e) Land O'Lakes Pint Gourmet Heavy Whipping Cream Ultra-
Pasteurized labeled as product of Land O'Lakes, Inc., Arden 
Hills, MN (3/07 through 4/05)
f) Land O'Lakes Quart Gourmet Heavy Whipping Cream  Ultra-
Pasteurized labeled as product of Land O'Lakes, Inc., Arden 
Hills, MN (3/01 through 4/13)
g) Land O'Lakes Half Pint Gourmet Heavy Whipping Cream Ultra-
Pasteurized labeled as product of Land O'Lakes, Inc., Arden 
Hills, MN (3/01 through 4/05)
h) Muller Pinehurst Quart Grade A Ultra-Pasteurized Heavy  
Whipping Cream labeled as distributed by Muller-Pinehurst Dairy, 
Rockford, IL (3/07 through 3/16)
i) Muller Pinehurst Half Pint Ultra-Pasteurized Heavy Whipping 
Cream labeled as distributed by Muller-Pinehurst  Dairy, 
Rockford, IL (3/01 through 3/29)
j) Roundy's Half Pint Grade A Ultra-Pasteurized Heavy Whipping 
Cream labeled as distributed by Roundy's Inc., Milwaukee, WI 
(3/08 through 4/12)
2.  Ultra-Pasteurized 40% Heavy Whipping Cream
a) Becker's Quart Ultra-Pasteurized 40% Heavy Whipping Cream 
labeled as distributed by L. Pritikin & A. Becker, Inc., Chicago, 
IL (3/06 through 4/05)
3.  Ultra-Pasteurized Sweetened Whipping Cream
a) Kohler Mix Specialties Quart Ultra-Pasteurized  Artificially 
Flavored Sweetened Whipping Cream labeled as product of Kohler 
Mix, White Bear Lake, MN (2/28 through 5/05)
b) Perkins Family Restaurant Quart Ultra-Pasteurized  
Artificially Flavored Sweetened Whipping Cream labeled as 
distributed by Kohler Mix, White Bear Lake, MN (3/28 through 
5/05)
4.  Pasteurized Half & Half
a) Dairy Fresh Quart Half & Half, a product of the Dairy Fresh 
Foods Division of Land O'Lakes, Inc., Arden Hills, MN (1/20 
through 2/21)
b) Muller Pinehurst Pint Half & Half labeled as distributed by 
Muller-Pinehurst Dairy, Rockford, IL (4/06)
5.  Ultra-Pasteurized Half & Half
a) Kemps Pint Ultra-Pasteurized Half & Half distributed by  
Marigold Foods, Inc., Minneapolis, MN (3/07 through 4/06)
b) Land O'Lakes Pint Gourmet Half & Half Ultra-Pasteurized  
labeled as product of Land O'Lakes, Inc., Arden Hills, MN   (3/07 
through 4/06)
c) Land O'Lakes Quart Gourmet Half & Half Ultra-Pasteurized  
labeled as product of Land O'Lakes, Inc., Arden Hills, MN   (2/07 
through 4/05)
d) Muller Pinehurst Quart Ultra-Pasteurized Half & Half  labeled 
as distributed by Muller-Pinehurst Dairy, Rockford, IL (3/07 
through 3/30)
 e) Roundy's Pint Grade A Ultra-Pasteurized Half & Half labeled 
as distributed by Roundy's, Inc., Milwaukee, WI (3/03 through 
4/13)
f) Roundy's Quart Grade A Ultra-Pasteurized Half & Half labeled 
as distributed by Roundy's, Inc., Milwaukee, WI (3/14 through 
4/12)
6.  Fat Free Ultra-Pasteurized Half & Half
a) Land O'Lakes Pint Gourmet Fat-Free Half & Half Ultra-
Pasteurized labeled as product of Land O'Lakes, Inc., Arden 
Hills, MN (3/07 through 4/13)
b) Land O'Lakes Quart Gourmet Fat-Free Half & Half Ultra-
Pasteurized labeled as product of Land O'Lakes, Inc., Arden 
Hills, MN (3/07 through 4/16)
7.  Sweetened Fat-Free Ultra-Pasteurized Half & Half
a) Kemps Pint Sweetened Fat-Free Half & Half Ultra-Pasteurized 
distributed by Marigold Foods, Inc., Minneapolis, MN (3/06 
through 4/07)
8.  Hazelnut flavored Fat-Free Ultra-Pasteurized Half & Half 
a) Land O'Lakes Pint New Gourmet HAZELNUT Fat-Free Half &  Half 
Ultra-Pasteurized labeled as product of Land O'Lakes, Inc., Arden 
Hills, MN (3/17 through 4/05)
9.  French Vanilla flavored Fat-Free Ultra-Pasteurized Half & 
Half 
a) Land O'Lakes Pint New Gourmet FRENCH VANILLA Fat Free Half & 
Half Ultra Pasteurized labeled as product of Land   O'Lakes, 
Inc., Arden Hills, MN (3/23 through 4/04)
10.  Ultra-Pasteurized Chocolate Milk with Added Calcium
 a) Land O'Lakes Pint Premium Chocolate Milk with Added  Calcium 
labeled as product of Land O'Lakes, Inc., Arden Hills, MN (2/26 
through 4/04)
b) Land O'Lakes Quart Premium Chocolate Milk with Added Calcium 
labeled as product of Land O'Lakes, Inc., Arden Hills, MN (2/26 
through 4/04)
11.  Ultra-Pasteurized Chocolate Lowfat Milk
a) Land O'Lakes 10 Fl. Oz. Ultra-Pasteurized Chocolate Lowfat 
Milk 1/2% Milkfat labeled as product of Land O'Lakes, Inc., Arden 
Hills, MN (2/21 through 3/30)
b) Land O'Lakes Pint Ultra-Pasteurized Chocolate Lowfat Milk 1/2% 
Milkfat labeled as product of Land O'Lakes, Inc., Arden Hills, MN 
(2/27 through 3/23)
c) Land O'Lakes Quart Ultra-Pasteurized Chocolate Lowfat Milk 
1/2% Milkfat labeled as product of Land O'Lakes, Inc., Arden 
Hills, MN (2/21 through 3/30)
d) Kohler Half-Pint Ultra-Pasteurized 1/2% Milkfat Vitamin  A&D 
Chocolate Lowfat Milk labeled as product of Kohler Mix, White 
Bear Lake, MN (2/21 through 3/30)
12.  Swiss Style Ultra-Pasteurized Chocolate Lowfat Milk
a) Kemps 8 Fl. Oz. Swiss Style Chocolate Lowfat Milk 1/2%  
Milkfat distributed by Marigold Foods, Inc., Minneapolis, MN
(2/27 through 3/30)
13.  Ultra-Pasteurized Milk
a) Land O'Lakes 10 Fl. Oz. Ultra-Pasteurized Milk labeled as 
product of Land O'Lakes, Inc., Arden Hills, MN (2/13 through 
3/22)
b) Land O'Lakes Pint Ultra-Pasteurized Milk labeled as product of 
Land O'Lakes, Inc., Arden Hills, MN (2/15 through 3/01)
c) Land O'Lakes Quart Ultra-Pasteurized Milk labeled as  product 
of Land O'Lakes, Inc., Arden Hills, MN (2/13 through 3/22)
14.  Ultra-Pasteurized 2% Milk
a) Hardee's Half Pint Ultra-Pasteurized 2% Milkfat Vitamin  A&D 
Lowfat Milk labeled as made for Hardee's Restaurants by Kohler 
Mix, White Bear Lake, MN (2/10 through 3/19)
b) Kemps 8 Fl. Oz. 2% Lowfat Milk distributed by Marigold  Foods, 
Inc., Minneapolis, MN (2/11 through 3/24)
c) Kohler Half Pint Ultra-Pasteurized 2% Milkfat Vitamin A&D 
Reduced Fat Milk labeled as product of Kohler Mix, White Bear 
Lake, MN (2/28 through 3/24)
d) Land O'Lakes 10 Fl. Oz. Ultra-Pasteurized 2% Reduced Fat Milk 
labeled as product of Land O'Lakes, Inc., Arden Hills, MN (2/10 
through 3/24)
e) Land O'Lakes Pint Ultra-Pasteurized 2% Reduced Fat Milk 
labeled as product of Land O'Lakes, Inc., Arden Hills, MN (2/14 
through 3/22)
f) Land O'Lakes Quart Ultra-Pasteurized 2% Lowfat Milk labeled as 
product of Land O'Lakes, Inc., Arden Hills, MN (2/14 through 
3/22)
g) Wendy's Half Pint 2% Reduced Fat Milk Ultra-Pasteurized, 
labeled as authorized by Wendy's International, Inc. (2/11  
through 3/05)
15.  Ultra-Pasteurized 1% Milk
a) Kohler 10 Fl. Oz. 1% Milkfat Lowfat Milk labeled as product of 
Kohler Mix, White Bear Lake, MN (2/14 through 3/22)
b) Land O'Lakes 10 Fl. Oz. Ultra-Pasteurized 1% Lowfat Milk 
labeled as product of Land O'Lakes, Inc., Arden Hills, MN   (2/14 
through 3/22)
c) Land O'Lakes Quart Ultra-Pasteurized 1% Lowfat Milk labeled as 
product of Land O'Lakes, Inc., Arden Hills, MN   (2/13 through 
3/22)
16.  Ultra-Pasteurized Fat-Free Skim Milk
a) Kemps 8 Fl. Oz. Skim Milk distributed by Marigold Foods, Inc., 
Minneapolis, MN (2/15 through 3/13)
b) Land O'Lakes 10 Fl. Oz. Ultra-Pasteurized Fat-Free Skim  Milk 
labeled as product of Land O'Lakes, Inc., Arden Hills, MN (2/15 
through 3/23)
c) Land O'Lakes Pint Ultra-Pasteurized Fat-Free Skim Milk  
labeled as product of Land O'Lakes, Inc., Arden Hills, MN (2/23 
through 3/22)
d) Land O'Lakes Quart Ultra-Pasteurized Fat Free Skim Milk  
labeled as product of Land O'Lakes, Inc., Arden Hills, MN (2/15 
through 3/23)
17.  Ultra-Pasteurized Lactose Reduced 2% Milk 
a) Kemps Quart Dairy Good 100% Lactose Reduced Lowfat Milk  2% 
Milkfat distributed by Marigold Foods, Inc., Minneapolis, MN 
(2/14 through 3/22)
b) Oak Grove Quart 100% Lactose Free 2% Lowfat Milk Ultra-
Pasteurized labeled as distributed by Oak Grove Dairy,
Norwood, MN (2/14 through 3/15)
18.  Ultra-Pasteurized Lactose Reduced 1% Milk
a) Kemps Quart Dairy Good 100% Lactose Reduced Lowfat Milk 1% 
Milkfat distributed by Marigold Foods, Inc., Minneapolis, MN 
(2/14 through 3/22)
19.  Ultra-Pasteurized Lactose Reduced Nonfat Skim Milk
a) Kemps Quart Dairy Good 100% Lactose Reduced Nonfat Milk  
distributed by Marigold Foods, Inc., Minneapolis, MN (2/14  
through 3/15)
b) Oak Grove Quart 100% Lactose-Free Skim Milk Ultra-Pasteurized 
labeled as distributed by Oak Grove Dairy,
Norwood, MN (2/14 through 3/15). Recall #F-399/417-9.
CODE
The products have "use by" dates on or between the dates listed 
above.  The use-by dates have three letters for the month and a 
date for example "MAR 15".  All of the products have the plant 
code "PLT 27-416".
MANUFACTURER
Kohler Mix Specialties, White Bear Lake, Minnesota.
RECALLED BY
Manufacturer, by fax on January 31, 1999, by letter February 6, 
1999, and by press release on February 2 & 6, 1999.  Firm-
initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
Approximately 500,000 gallons were distributed.
REASON
Products may be contaminated with Listeria monocytogenes.

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS II
________
PRODUCT
Pocono Springs Hickory Smoked Trout, 7.5 ounces, shipped in 25 
pound cartons.  Recall #F-396-9.
CODE
None.
MANUFACTURER
J.F. Martin & Sons, Inc., Stevens, Pennsylvania.
RECALLED BY
Aqua Life, Inc., Richland, Pennsylvania, by telephone on January 
22, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Pennsylvania.
QUANTITY
200 pounds were distributed.
REASON
Product contained sodium nitrite and sodium nitrate, and there 
are no food additive regulations authorizing the use of sodium 
nitrite or sodium nitrate in smoked rainbow trout.

RECALLS AND FIELD CORRECTIONS:  DRUGS -- 
CLASS II
________
PRODUCT
Lamprene(r) Soft Gelatin Capsules (Clofazimine), 50 mg, in 100 
capsule bottles, Rx used in the treatment of lepromatous leprosy. 
NDC #0028-0108-01.  Recall #D-064-9.
CODE
Lot #1028700 EXP 9/98.
MANUFACTURER
R.P. Scherer GMBH, Eberbach/Baden Germany.
RECALLED BY
Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, 
by fax on June 16, 1998, followed by mail.  Firm-initiated recall 
complete.
DISTRIBUTION
Nationwide.
QUANTITY
27,523 bottles were distributed.
REASON
Disintegration failure.
________
PRODUCT
Geneva brand Alprazolam Tablets, USP, 1 mg, in bottles of 100 and 
1,000, Rx indicated for the management of anxiety disorder.  NDC 
#0781-1328-10 and 0781-1328-01. 
Recall #D-109-9.
CODE
Lot #894JU EXP 5/01.
MANUFACTURER
Pharmacia & Upjohn Caribe, Inc., Barceloneta, Puerto Rico.
RECALLED BY
Manufacturer, by letter on December 21, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
27,113 bottles were distributed.
REASON
Product failed content uniformity testing at release.
________
PRODUCT
Various Rx drugs:
a) Levsin SL Tablets (Hyoscyamine/SL 0.125 mg), in 20 count 
units;
b) Ibuprofen Tablets, 800 mg, in 50 count units, 
c) Bactrim DS Tablets (Sulfamethoxazole/Trimethoprim DS 800/160), 
in 20 count units, 
d) Cimetadine Tablets, 400 mg in 60 count units
e) Atenolol Tablets, 50 mg in 30 count units, 
f) Hydrochlorothiazide Tablets, 25 mg in 30 and 60 count units, 
g) Chlorzoxazone Tablets, 500 mg, in 40 count units,
h) Chlopropamide Tablets, 250 mg, in 60 count units,
i) Verapamil Tablets, 120mg, in 60 count units.  
Recall #D-221/229-9.
CODE
Lot numbers: a) J32893; b) J32895; c) J60891; d) J60893;
e) J60894; f) J60895 and J60896; g) J91893; h) J91894;
i) J51893.
MANUFACTURER
Rural Health Services Consortium, Inc., Rogersville, Tennessee.
RECALLED BY
Manufacturer, by letter December 14, 1998.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Tennessee.
QUANTITY
Undetermined.
REASON
Possible penicillin and/or cephalasporin cross contamination.


RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS III
________
PRODUCT
a) Acetaminophen liquid, alcohol free, sugar free, 
"Tylenol", 160mg/5mL, in 120 mL units; 
b) Albuterol Sulfate Syrup, "Ventolin", 2mg/5mL, in 120 
mL units;
c) Sulfamethoxazole/Trimethoprim Syrup, "Bactrim", 
200/40mg, in 120mL units;
d) Phenylpropanolamine/Brompheniramine Elixir, "Dimetapp" 
12.5/2 mg, in 120 mL units;
e) Belladonna Alkaloids w/Phenobarbital Elixir, 
"Donnatal" 12.5 mg/5 mL in 120 mL;
f)  Diphenhydramine Elixir, "Benadryl", 12.5 mg/5 mL, OTC 
in 120 mL units;
g) Erythromycin Ethylsuccinate Suspension, 200 mg/5 mL, in 200 mL 
units;
h) Maalox-Donnatal Mix (1:1 mix-Liquid) Rx in 180 mL units;
i) Maalox-Donnatal-Lidocaine Mix (3:2:1-liquid) in 360 mL units;
j) Maalox-Lidocaine Mix (2:1-liquid)in 360 mL units;
k) Promethazine Syrup, "Phenergan", (6.25mg/5mL) in 120 mL units;
l) Theophylline-Guaifenesin Elixir, Theolate "Elixophylline GG", 
in 480mL units.  Recall #D-209/220-9.
CODE
All lot codes.
MANUFACTURER
Rural Health Services Consortium, Inc., Rogersville, Tennessee.
RECALLED BY
Manufacturer, by letter December 14, 1998.  Firm-initiated recall 
complete.
DISTRIBUTION
Tennessee.
QUANTITY
Undetermined.
REASON
Lack of data to support labeled expiration date.
________
PRODUCT
Fluorescein Sodium Injection, 10%, 100mg/mL, in 5mL  
sterile single dose vial, Rx indicated for ophthalmic 
angiography and angioscopy, sold under the Angiofluor J 
10% Injection and AK-Fluor 10% Injection labels.  Recall 
#D-230-9.
CODE
Lot numbers: 6341AL EXP 5/31/99, 6588AL EXP 8/31/99, 
6995AL EXP 12/31/99, 7327AL EXP 4/30/00, 7610AL EXP 
8/31/00, 7850AL EXP 11/30/00, 8216AL EXP 3/31/01, 8543AL 
EXP 8/31/01, 8838AL EXP 11/30/01, 6341AK EXP 5/31/99, 
6345AK EXP 5/31/99, 6995AK EXP 12/31/99.
MANUFACTURER
Luitpold Pharmaceuticals, Inc., Shirley, New York.
RECALLED BY
Manufacturer, by telephone on April 27, 1999, followed by 
fax and mail.  Firm-initiated recall ongoing.
DISTRIBUTION
Tennessee.
QUANTITY
AK-FLUOR: 
Lot 6341AK:    24,168 units were distributed
Lot 6345AK:    74,100 units were distributed
Lot 6995AK:    49,224 units were distributed
Angiofluor:
Lot 6341AL:    49,044 units were distributed
Lot 6588AL:    98,472 units were distributed
Lot 6995AL:    12,720 units were distributed
Lot 7327AL:   101,076 units were distributed
Lot 7610AL:    60,216 units were distributed
Lot 7850AL:    49,752 units were distributed
Lot 8216AL:   101,628 units were distributed
Lot 8543AL:    93,708 units were distributed
Lot 8838AL:   101,892 units were distributed.
REASON
Crystal formation.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS II
________
PRODUCT
Recovered Plasma.  Recall #B-641-9.
CODE
Unit #1691725.
MANUFACTURER
Mississippi Blood Services, Jackson, Mississippi.
RECALLED BY
Manufacturer, by letter dated April 17, 1998, followed by fax on 
October 28, 1998, and by letter dated November 2, 1998.  Firm-
initiated recall complete.
DISTRIBUTION
Switzerland.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who had a tattoo within 
12 months of donation.
________
PRODUCT
Carticel (Autologous Cultured Chondrocytes).
Recall #B-702-9.
CODE
Lot #C80284.
MANUFACTURER
Genzyme - Tissue Repair, Cambridge, Massachusetts.
RECALLED BY
Manufacturer, by telephone on November 14 and 16, 1998 and by 
letter dated November 16, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Florida.
QUANTITY
1 unit was distributed.
REASON
Tissue repair product was contaminated with Staphylococcus 
warneri (coagulase negative).
________
PRODUCT
Fresh Frozen Plasma.  Recall #B-756-9.
CODE
Unit #1208857.
MANUFACTURER
Inland Northwest Blood Center, Spokane, Washington.
RECALLED BY
Manufacturer, by letter dated November 12, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Washington state.
QUANTITY
1 unit was distributed.
REASON
Blood product was not quarantined after receiving post donation 
information concerning illness.
________
PRODUCT
a) Red Blood Cells; b) Red Blood Cells, Leukocytes Removed; c) 
Recovered Plasma.  Recall #B-770/772-9.
CODE
Unit numbers: a) 20H02535, 20W01270; b) 20E08731; 
c) 20W01270.
MANUFACTURER
American Red Cross Blood Services, Murray, Utah; American Red 
Cross Blood Services, Missoula, Montana (collection sites).
RECALLED BY
American Red Cross, Boise, Idaho, by letter dated either 
September 22, 1998, November 2, 1998, or November 5, 1998.  
Firm-initiated recall complete.
DISTRIBUTION
Montana, Utah, California.
QUANTITY
a) 2 units; b) 1 unit; c) 1 unit was distributed.
REASON
Blood products were collected from donors who provided post 
donation information regarding having tested reactive for either 
hepatitis or HTLV.
________
PRODUCT
a) Red Blood Cells; b) Platelets.  Recall #B-743/744-9.
CODE
Unit numbers: a) 19GN34682, 19GJ42042, 19LM04763;
b) 19GJ42042, 19LM04763.
MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY
Manufacturer, by letter dated October 21, 1998, and/or October 
22, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Tennessee.
QUANTITY
a) 3 units; b) 2 units were distributed.
REASON
Blood products were collected from donors who reported travel 
to areas designated as endemic for malaria.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma.  
Recall #B-745/747-9.
CODE
Unit numbers:  a) 19GJ32487, 19GM09449, 19GM07413;
b) 19GJ32487; c) 19GJ32487, 19GM07413.
MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY
Manufacturer, by letter dated March 19, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Tennessee.
QUANTITY
a) 3 units; b) 1 unit; c) 2 units were distributed.
REASON
Blood products were collected from a donor taking the drug 
Methotrexate.
________
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma. 
Recall #B-748/749-9.
CODE
Unit #19GZ29479.
MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY
Manufacturer, by letter dated April 1, 1998, and by telephone on 
March 12, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Tennessee and Kentucky.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from an unsuitable donor.
________
PRODUCT
Red Blood Cells.  Recall #B-750-9.
CODE
Unit  #19GF51139.
MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY
Manufacturer, by letter dated July 27, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Tennessee and Massachusetts.
QUANTITY
1 unit was distributed.
REASON
Blood products were collected from an unsuitable donor.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
Recall #B-752/754-9.
CODE
Unit #19GW15894.
MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY
Manufacturer, by letter dated February 12 and 24, 1998.  
Firm-initiated recall complete.
DISTRIBUTION
Tennessee, Kentucky, California.
QUANTITY
1 unit of each component was 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.
________
PRODUCT
Red Blood Cells.  Recall #B-755-9.
CODE
Unit #20FH00600.
MANUFACTURER
American Red Cross, Missoula, Montana (collection site).
RECALLED BY
American Red Cross, Boise, Idaho, by telephone on July 1, 1998.  
Firm-initiated recall complete.
DISTRIBUTION
Montana.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who was taking an oral 
antiviral drug.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.  
Recall #B-757/758-9.
CODE
Unit #21GZ02853.
MANUFACTURER
American Red Cross Blood Services, Portland, Oregon.
RECALLED BY
Manufacturer, by telephone and by fax on January 29, 1999.  
Firm-initiated recall complete.
DISTRIBUTION
Washington state and Switzerland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor with a history of 
hepatitis A.
________
PRODUCT
Platelets, Pheresis.  Recall #B-759-9.
CODE
Unit #0318938 and 0319314.
MANUFACTURER
Inland Northwest Blood Center, Spokane, Washington.
RECALLED BY
Manufacturer, by letters dated November 12 and 17, 1998.  
Firm-initiated recall complete.
DISTRIBUTION
Washington state.
QUANTITY
2 units were distributed.
REASON
Blood products were collected from a donor who was exposed 
to hepatitis A.
________
PRODUCT
Platelets.  Recall #B-762-9.
CODE
Unit #FP00020.
MANUFACTURER
Healthcare Provider Services, Inc., doing business as Rhode 
Island Blood Center, Providence, Rhode Island.
RECALLED BY
Manufacturer, by telephone on October 26, 1998.  
Firm-initiated recall complete.
DISTRIBUTION
Rhode Island.
QUANTITY
1 unit was distributed.
REASON
Blood product may have been collected in a manner that could 
compromise the sterility of the product.
________
PRODUCT
Platelets, Pheresis.  Recall #B-763-9.
CODE
Unit #J34286.
MANUFACTURER
Healthcare Provider Services, Inc., doing business as Rhode 
Island Blood Center, Providence, Rhode Island.
RECALLED BY
Manufacturer, by telephone on September 29, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Rhode Island.
QUANTITY
1 unit was distributed.
REASON
Blood product was incorrectly labeled as irradiated.
________
PRODUCT
a) Red Blood Cells; b) Platelets.  Recall #B-764/765-9.
CODE
Unit numbers:  a) H95682, R89522, S92978; b) H95682 and R89522.
MANUFACTURER
Healthcare Provider Services, Inc., Providence, Rhode Island.
RECALLD BY
Manufacturer, by telephone on December 2, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Massachusetts, Rhode Island, Texas.
QUANTITY
a) 3 units; b) 2 units were 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-766/767-9.
CODE
Unit numbers: a) R90002, N44426, S92611; b) R90002.
MANUFACTURER
Healthcare Provider Services, Inc., doing business as Rhode 
Island Blood Center, Providence, Rhode Island.
RECALLED BY
Manufacturer, by telephone on December 11, 1998.  
Firm-initiated recall complete.
DISTRIBUTION
Rhode Island.
QUANTITY
a) 3 units; b) 1 unit 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-768-9.
CODE
Unit #R93086.
MANUFACTURER
Healthcare Provider Services, Inc., doing business as Rhode 
Island Blood Center, Providence, Rhode Island.
RECALLED BY
Manufacturer, by telephone on December 10, 1998.  
Firm-initiated recall complete.
DISTRIBUTION
Rhode Island.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported 
travel to an area designated as endemic for malaria.
________
PRODUCT
a) Red Blood Cells; b) Cryoprecipitated AHF; c) Plasma;
d) Recovered Plasma.  Recall #B-775/778-9.
CODE
Unit numbers:  a) 21GG74071, 21GG91397, 21GH69137;
b) 21GG74071, 21GG91397, 21GH69137;
c) 21GG74071, 21GG91397; d) 21GH69137.
MANUFACTURER
American Red Cross Blood Services, Portland, Oregon.
RECALLED BY
Manufacturer, by telephone on December 17, 1998, and by 
letters on December 23, 1998, and February 3, 1999.  
Firm-initiated recall complete.
DISTRIBUTION
Oregon, North Carolina, Idaho, California, Washington state, 
Switzerland.
QUANTITY
a) 3 units; b) 3 units; c) 2 units; d) 1 unit was distributed.
REASON
Blood products were collected from a donor with a history of 
cancer.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma.  
Recall #B-779/781-9.
CODE
Unit numbers: a) 20K01308, 20LC25389, 20GC07843, 20LC26529, 
20GC08589; b) 20LC26529; c) 20LC25389.
MANUFACTURER
American Red Cross Blood Services, Boise, Idaho.
RECALLED BY
Manufacturer, by letters dated October 8 and 26, 1998.  
Firm-initiated recall complete.
DISTRIBUTION
Utah, Idaho, Montana, California.
QUANTITY
a) 5 units; b) 1 unit; c) 1 unit was distributed.
REASON
Blood products were incorrectly labeled as CMV negative.
________
PRODUCT
Platelets, Pheresis.  Recall #B-782-9.
CODE
Unit #42FR75059 (split unit).
MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.
RECALLED BY
Manufacturer, by letter dated March 16, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distributed.
REASON
Blood products were collected from a donor who traveled to an 
area considered endemic for malaria.
________
UPDATE
Red Blood Cells (American Red Cross, Portland, Oregon), Recall 
#B-710-9, which appeared in the May 5, 1999 Enforcement Report 
should read:  
CODE:  Unit #21KJ01991.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS III
________
PRODUCT
Tripedia Multidose Injection (Diphtheria and Tetanus Toxoids 
Accellular Pertussis Vaccine Adsorbed), 7.5 ml, in 10 ml vials.  
Recall #B-730-9.
CODE
Lot #0916490.
MANUFACTURER
Pasteur Merieux Connaught USA, Swiftwater, Pennsylvania.
RECALLED BY
Manufacturer, by letter sent on January 27, 1999, and by 
telephone on January 26, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
45,682 units were distributed.
REASON
Diphtheria component of the injectable vaccine was found to be 
subpotent at the nine month stability test point.
________
PRODUCT
Red Blood Cells.  Recall #B-740-9.
CODE
Unit #19GW18643.
MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY
Manufacturer, by letter dated March 18, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Kentucky.
QUANTITY
1 unit was distributed.
REASON
Blood product was stored at unacceptable temperatures.
________
PRODUCT
Platelets, Pheresis, Irradiated.  Recall #B-741-9.
CODE
Unit #19GL17874.
MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY
Manufacturer, by letter dated March 27, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Tennessee.
QUANTITY
1 unit was distributed.
REASON
Blood product was stored at unacceptable temperatures.

________
PRODUCT
Red Blood Cells.  Recall #B-742-9.
CODE
Unit #19GN21835.
MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY
Manufacturer, by letter dated March 6, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Tennessee.
QUANTITY
1 unit was distributed.
REASON
Blood product was stored at unacceptable temperatures.
________
PRODUCT
Recovered Plasma for Non-Injectable Use.  Recall #B-751-9.
CODE
Unit #19GF51139.
MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY
Manufacturer, by telephone on July 24, 1998, and by letter August 
31, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Massachusetts.
QUANTITY
1 unit was distributed.
REASON
Blood products were collected from an unsuitable donor.
________
PRODUCT
Irradiated Red Blood Cells.  Recall #B-760-9.
CODE
Unit #4451600.
MANUFACTURER
Inland Northwest Blood Center, Spokane, Washington.
RECALLED BY
Manufacturer, by letter dated April 5, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Washington state.
QUANTITY
1 unit was distributed.
REASON
Blood product may have remained at room temperature for an 
unacceptable length of time.
________
PRODUCT
Red Blood Cells.  Recall #B-761-9.
CODE
Unit #20LC23399.
MANUFACTURER
American Red Cross Blood Services, Boise, Idaho.
RECALLED BY
Manufacturer, by telephone on May 15, 1998.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Utah.
QUANTITY
1 unit was distributed.
REASON
Leukodepleted blood product failed the requirement for red cell 
recovery.
________
PRODUCT
Washed Platelets.  Recall #B-769-9.
CODE
Unit #21P86704.
MANUFACTURER
American Red Cross, Portland, Oregon.
RECALLED BY
Manufacturer, by letter dated December 23, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Oregon.
QUANTITY
1 unit was distributed.
REASON
Blood product was processed in a centrifuge that was set at the 
incorrect speed.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
Recall #B-773/774-9.
CODE
Unit #7630529.
MANUFACTURER
New York Blood Services, New York, New York.
RECALLED BY
Manufacturer, by letter dated August 21, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
New York and Switzerland.
QUANTITY
1 unit was distributed.
REASON
Blood products were initially tested negative for the antibody to 
the Human T-Lymphotropic virus type I (anti-HTLV-I), but 
retrospectively tested repeatedly reactive for anti-HTLV-I/II, 
PCR negative.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- 
CLASS II
________
PRODUCT
All IMMULITE 2000 Automated Immunoassay Analyzers with Software 
Version 1.1, a clinical automated immunoassay analyzer intended 
for in-vitro diagnostic use for detection of analytates in human 
specimens.  Recall #Z-909-9.
CODE
All serial numbers in commercial distribution (Note:  The recall 
product was initially released with Software Version 1.1 on March 
2, 1998).
MANUFACTURER
DPC Cirrus, Inc., a subsidiary of Diagnostic Products 
Corporation, Randolph, New Jersey.
RECALLED BY
Manufacturer, by telephone March 2 & 3, 1999, and by Technical 
Bulletins dated March 2 and 3, 1999.  Firm-initiated field 
correction complete.
DISTRIBUTION
Nationwide and international.
QUANTITY
334 units were distributed.
REASON
If the initial counts of the reaction tubes are exactly 10,000 
cps, this leads to erroneously low calculated results.
________
PRODUCT
All Architect I System Processing Modules with Software Versions 
1.0 and 1.01.  Recall #Z-910-9.
CODE
List #08C89-00-01.
MANUFACTURER
Abbott Laboratories, Irving, Texas.
RECALLED BY
Manufacturer, by letter and telephone on April 12, 1999.  Firm-
initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
173 units were distributed.
REASON
The device may report incorrect results for diluted samples; 
and/or when used with the Laboratory Information System or Host 
Information Systems, the system may incorrectly associate test 
results with patient ID or incorrectly associate control results 
with patient records.
________
PRODUCT
8F Zuma Guiding Catheter, designed to provide a pathway through 
which therapeutic devices are introduced. The guiding catheter is 
intended to be used in the coronary or peripheral vascular 
system.  Recall #Z-911-9.
CODE
All lots.
MANUFACTURER
Medtronic Interventional Vascular, Inc., Danvers, Massachusetts.
RECALLED BY
Manufacturer, by letter dated March 31, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
6,752 units were distributed.
REASON
Instructions for use are inadequate.
________
PRODUCT
Coaxial Biopsy System composed of an introducer (coaxial needle) 
and an 18 gauge biopsy needle for specimen sampling, marketed 
under the Achieve label, Bauer Medical, Inc., packaged 5 systems 
per box.  Recall #Z-914-9.
CODE
Catalog #CA18/15, Lot B07/99D99.
MANUFACTURER
Allegiance Healthcare Corporation, Clearwater, Florida.
RECALLED BY
Allegiance Healthcare Corporation, McGaw Park, Illinois, by 
letter dated April 29, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Florida, New Jersey, Minnesota, Nebraska, Missouri, North 
Carolina, Louisiana, Texas, Oregon, Illinois, New York, Hawaii, 
Georgia, California.
QUANTITY
205 units were distributed.
REASON
The introducer needle (19 gauge) is too small in diameter for the 
18 gauge biopsy needle to insert through it, preventing specimen 
sampling.
________
PRODUCT
System 1000 and Tina Single Patient Hemodialysis Delivery System 
with DPSND and SPSND options that are fitted with a J089700 
Arterial Line Clamp. Also there are Spare Part Kits that are 
under recall because they contain the suspect Arterial Line 
Clamp, their spare part numbers J08970S and K100DRC.  Recall #Z-
912/913-9.
CODE
System 1000 and TINA Single Patient Hemodialysis Delivery Systems 
with DPSND and SPSND Options that are fitted with a J089700 
Arterial Line Clamp with the following serial numbers:  11521-
11525, 11971-11975, 12106-12131, 51701-51703, 51718-51730, 51760-
51794, 51795-51805, 51809-51810, 51817-51829, 51830-51850, 51865-
51869, 51870-51873, 51894-51896, 51901-51904, 51905-51916, 51919-
51921 and 51934. is a Spare Part Arterial Clamp part numbers 
involved are: J08970S. The firm also markets a Spare Parts 
Kits that contains the recalled Clamp it is labeled with Item # 
K100DRC.
MANUFACTURER
Althin Medical, Inc., Miami Lakes, Florida.
RECALLED BY
Manufacturer, by letter December 21, 1998.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Illinois, Georgia, international.
QUANTITY
162 machines and 102 spare part kits with the recalled clamp were 
distributed.
REASON
Damaged, leaking blood lines.
________
PRODUCT
Mobilite Electric Homecare Bed.  Recall #Z-915-9.
CODE
All beds manufactured prior to June 1993.
MANUFACTURER
Invacare Corporation, Sanford, Florida.
RECALLED BY
Manufacturer, by letter on February 8, 1999.  
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
319,714 beds were distributed.
REASON
Old style pull ring may cause serious finger injuries.
________
PRODUCT
Millipore Vented Millex GS Sterilizing Filter Unit 
(Sterile and Non-Pyrogenic), intended for sterilizing 
aqueous solutions, such as antibodies and critical care 
solutions dispensed with a syringe.  Recall #Z-918-9.
CODE
Catalog #SLGS V25 5F, Lot #R8EM78710.
MANUFACTURER
Millipore, Cork, Ireland
RECALLED BY
Millipore Corporation, Bedford, Massachusetts, by letter on May 
7, 1998.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
113 boxes (50 units per box) were distributed.
REASON
Sterile Filter exceeds USP limits for Bacterial Endotoxins.

________
UPDATE
Baxter Healthcare Corporation, (Deerfield, IL) 
Colleague 3 Volumetric Infusion Pump (Triple Channel) for 
continuous or intermittent delivery through clinically acceptable 
routes of administration such as intravenous, intra-arterial, 
subcutaneous, epidural or irrigation of fluid spaces 
applications, Recall #Z-872-9 which appeared in the May 12, 1999 
Enforcement Report should read:
CODE:  Product Code 2M8153, all serial numbers.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS III
________
PRODUCT
Visitec Visidrape, sterile disposable surgical drape used 
primarily for ophthalmic surgery:  Catalog Numbers 581087 and 
581088.  Recall #Z-919/920-9.
CODE
Catalog No. 581087 lot number 050199
Catalog No. 581088 lot number 040199.
MANUFACTURER
Becton Dickinson Surgical Systems, Sarasota, Florida.
RECALLED BY
Manufacturer, by telephone on February 23, 1999, followed by 
letter on March 3, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
California, Florida, Texas, Australia.
QUANTITY
37 boxes of 10 each were distributed.
REASON
Surgical orientation mark is incorrect.


ENFORCEMENT REPORT FOR MAY 19, 1999.