FDA

Enforcement Report

June 23, 1999                                      99-25

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS I
________
PRODUCT
Peony Mark brand "Dried Chestnut Self", in 10 ounce flexible 
plastic packages.  Recall #F-466-9.
CODE
None.
MANUFACTURER
Sun Wing Hong Food Ltd., Chai Wan, Hong Kong, China 
(exporter/possible manufacturer).
RECALLED BY
Tai Wing Hong Importer Inc., Brooklyn, New York, by press release 
on October 26, 1998, and by letter October 30, 1999.  Completed 
field correction (relabeling) resulted from sample analysis and 
follow-up by the New York State Department of Agriculture and 
Markets.
DISTRIBUTION
New York.
QUANTITY
186 cartons (50 packages per carton) were distributed.
REASON
Product contained undeclared sulfites.
_______
PRODUCT
BBQ Beef on a Bun Sandwich.  Recall #F-474-9.
CODE
Lot #990508A EXP 5/13.
MANUFACTURER
Quality Meal Expediters, Inc., also known as Professional 
Services Unified, Tacoma, Washington.
RECALLED BY
Manufacturer, by visit on March 12, 1999.  Firm-initiated field 
correction (relabeling) complete.
DISTRIBUTION
Washington state.
QUANTITY
26 sandwiches were distributed.
REASON
Product contained undeclared eggs and soy protein.

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS II
________
PRODUCT
Stewart's brand Extract - Flavorings, in 2 ounce and 32 ounce 
bottles: a) Stewart's Banana Extract - Flavoring;
b) Stewart's Orange Extract - Flavoring; c) Stewart's Pure 
Peppermint Extract - Flavoring.  Recall #F-443/445-9.
CODE
Not coded.  All product distributed prior to 5/19/99.
MANUFACTURER
Stewart's House of Spice, Middle Point, Ohio.
RECALLED BY
Manufacturer, by visit beginning May 20, 1999, and by letter 
mailed beginning May 28, 1999.  Ongoing field correction 
(relabeling) resulted from an inspection conducted by the Ohio 
Department of Agriculture.
DISTRIBUTION
Ohio and Indiana.
QUANTITY
Approximately 96 2-ounce bottles and 12 32-ounce bottles were 
distributed.
REASON
a) and c) The products contain undeclared FD&C Yellow No. 5.
b) The product contains undeclared FD&C Yellow No. 6.
________
PRODUCT
a) Valentini Italian Ice Pineapple, in 6 fluid ounce plastic 
container; b) Pineapple Sherbet, in 3-gallon container labeled 
with product name and plant number.
Recall #F-450/451-9.
CODE
Not coded - All product with undeclared FDC Yellow #5.
MANUFACTURER
Valentini Italian Specialties Company, Miami, Florida.
RECALLED BY
Manufacturer, by visit beginning April 29, 1999, and by letter on 
April 29, 1999.  Firm-initiated field correction (relabeling) 
ongoing.
DISTRIBUTION
Florida.
QUANTITY
Approximately 3,922 cases of the 6 oz. Pineapple Italian Ice 
product has been shipped out in the 12 months.  Approx. 7 3-
gallon tubs of Pineapple Sherbet are estimated to have been in 
commerce at the initiation of the recall.
REASON
Products contain undeclared FD&C Yellow No. 5.
________
PRODUCT
Flavors, Food Colors and Syrups:
a) Medina Brand Orange (Food Color), 32 fluid ounce size
b) Medina Brand Lemon Light Syrup, 128 fluid ounce size
c) Medina Brand Artificial Pineapple Light Syrup, 128 fluid ounce 
size
d) Medina Brand Chocolate Powder One Pound
e) Medina Brand Red Cherry Mamey (Food Color), 32 fluid ounce and 
128 fluid ounce size
f) Medina Brand Egg Shade 4% (Food Color), 128 fluid ounces
g) Medina Brand Orange Artificial Flavor Emulsion, 32 fluid ounce 
size and 1-gallon size
h) Medina Brand Red Tomatoes (Food Color), 32 fluid ounce size
i) Medina Brand Artificial Orange Light Syrup, 128 ounce size
j) Medina Brand Artificial Strawberry Flavor 1/32, 128 ounce 
size.  Recall #F-452/461-9.
CODE
All lot numbers without the required declarations.
MANUFACTURER
Medina Baking & Powder Products, Inc., Miami, Florida.
RECALLED BY
Manufacturer, letter and visit (a-d) on May 17, 1999; (e-j) 
beginning June 7, 1999.  Firm-initiated field correction 
(relabeling) ongoing.
DISTRIBUTION
Florida.
QUANTITY
4,498 gallons and 21 quarts of liquid product and 14 pounds of 
chocolate powder were distributed.
REASON
a-d) Products contain undeclared FD&C Yellow No. 5;
e-j) Products contain undeclared FD&C Yellow No. 6.
________
PRODUCT
Dip and jellies packaged under the Hartman's Home Fresh Foods 
label in 8 fluid ounce and 16 fluid ounce glass jars and packaged 
under the Amish Wedding label in 9 ounce glass jars: a) Hot 
Pepper Mustard Dip; b) Hot Pepper Jelly;
c) Mild Pepper Jelly.  Recall #F-462/464-9.
CODE
Not coded -- All of the referenced products which entered 
distribution prior to 4/20/99.  
MANUFACTURER
Hartman's Home Fresh Foods, Berlin, Ohio.
RECALLED BY
Manufacturer, by telephone on or around April 20, 1999, or by 
visit.  Ongoing field correction (relabeling) resulted from an 
inspection conducted by the Ohio Department of Agriculture.
DISTRIBUTION
Ohio and Indiana.
QUANTITY
Approximately 200 jars were distributed.
REASON
Products contain undeclared FD&C Yellow No. 5.
________
PRODUCT
Orange Beverage Base for use in vending machines, in 5 gallon 
containers.  Recall #F-465-9.
CODE
None.
MANUFACTURER
Frozen Beverages and Desserts, Inc., Dorado, Puerto Rico.
RECALLED BY
Manufacturer, by visits on February 18 & 19, 1999, followed by 
letter mailed on February 26, 1999.  Firm-initiated field 
correction (relabeling) complete.
DISTRIBUTION
Puerto Rico.
QUANTITY
Undetermined.
REASON
Product contains undeclared FD&C Yellow No. 5 and FD&C Red No.40.
________
PRODUCT
a) Flavorite Season 'n Bake, Seasoning and Roasting Bag, Pork 
Chops, packaged in foil pouches, net weight 1.25 oz., 12 
pouches/case;
b) Cub Foods Original Season 'n Bake for Pot Roast, packaged in 
foil pouches, net weight .81 oz., 12 pouches/case.  
Products are labeled as Distributed by Preferred Products, Inc.  
Recall #F-468/469-9.
CODE
All codes.
MANUFACTURER
Williams Foods, Inc., Lenexa, Kansas.
RECALLED BY
Manufacturer, by telephone and by letter on February 4 and 5, 
1999.  Firm-initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
a) 4,366 12-pouch cases were distributed between 10/16/97-
1/25/99; b) 894 12-pouch cases were distributed between 8/20/97-
1/20/99.
REASON
Products claim no monosodium glutamate (MSG) on the front label 
but contain MSG as an ingredient.
________
PRODUCT
Mariani brand Tropical Medley, a mixture of dried fruit, in 6-
ounce flexible packages.  Recall #F-471-9.
CODE
8364  9004  9025  9026  9036  9039  9040  9049  9050  9064  9067.
MANUFACTURER
Mariani Packing Company, Inc., San Jose, California.
RECALLED BY
Manufacturer, by fax on March 23, 1999, followed by telephone.  
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
9,912 cases (12 packages per case) were distributed.
REASON
Product contains undeclared FD&C Yellow No. 6.

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS III
________
PRODUCT
Optimum brand Vitamin B-2 Tablets, in plastic bottles.
Recall #F-449-9.
CODE
Lot 5003.
MANUFACTURER
Magno-Humphries Laboratories, Inc., Tigard, Oregon.
RECALLED BY
Manufacturer, by letter on April 22, 1999.  Firm-initiated recall 
complete.
DISTRIBUTION
Arizona, California, Colorado, Louisiana, Maryland, Michigan, 
Minnesota, Ohio, Oklahoma, Oregon, South Carolina, Texas, 
Washington state, Wisconsin.
QUANTITY
456 bottles were distributed.
REASON
Product is misbranded because the side panel claims the product 
contains thiamine, when in fact it contains riboflavin.
________
PRODUCT
Cub Foods Original Mushroom Fat Free Gravy Mix, packaged in foil 
pouches, net weight .75 ounces. Product labeled as Distributed by 
Preferred Products, Inc., Eden Prairie, MN.
Recall #F-470-9.
CODE
All codes.
MANUFACTURER
Williams Foods, Inc., Lenexa, Kansas.
RECALLED BY
Manufacturer, by telephone on February 5, 1999, and by letter 
dated February 8, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
1,041 24-pouch cases were distributed.
REASON
Product declares MSG as an ingredient but contains no monosodium 
glutamate (MSG).
________
PRODUCT
Good Taste brand (brand also identified as Ka Hiang Pai) 
Preserved Fruits, packaged in 3.5 ounce flexible plastic bags.  
Recall #F-467-9.
CODE
None.
MANUFACTURER
Zhuhai Minmetals International, China.
RECALLED BY
Wicsun Trading, Inc., Brooklyn, New York, by letter on October 
16, 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, Maryland, Virginia, District of Columbia.
QUANTITY
32 cases (50 packages per case) were distributed.
REASON
Product contained undeclared sulfites.

RECALLS AND FIELD CORRECTIONS:  DRUGS --CLASS II
________
PRODUCT
Heparin Sodium 100 units/mL in 0.9% Sodium Chloride 5 mL fill in 
a 12 mL syringe.  The pre-filled heparin syringe is not intended 
to provide any therapeutic value.
Recall #D-264-9.
CODE
Lot numbers:  990202A and 990202B.
MANUFACTURER
E.M.T.-Rx, Raleigh, North Carolina.
RECALLED BY
Manufacturer, by telephone on May 26, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
10,440 units were distributed.
REASON
Mislabeling - Label states heparin concentration at 100 unit/mL 
while manufacturing records indicate concentration at 10 
units/mL.
________
PRODUCT
Forest Levothroid Tablets, Rx indicated as replacement or 
substitution for diminished or absent thyroid function:
a) LevothroidÆ Tablets, (Levothyroxine Sodium), 25 mcg, in 100 
tablet bottles, NDC #0456-0320-01 
b) LevothroidÆ Tablets, (Levothyroxine Sodium), 50 mcg, in 100 
and 5,000 tablet bottles, NDC #0456-0321-51
c) LevothroidÆ Tablets, (Levothyroxine Sodium),  88 mcg, in  
5,000 tablet bottles, NDC #0456-0329-01
d) LevothroidÆ Tablets, (Levothyroxine Sodium), 112 mcg, in 5,000 
tablet bottles, NDC #0456-0330-01.  
Recall #D-265/268-9. 
CODE
Lot Numbers: a) 10981 and 1992; b) 109830, 109832, 109833 and 
1995; c) 119829 and 119830; d) 119835 and 12988.
MANUFACTURER
Forest Pharmaceuticals, Inc., Cincinnati, Ohio.
RECALLED BY
Forest Pharmaceuticals, Inc., St. Louis, Missouri, by letter 
dated April 2, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
a) 20,123 100-tablet bottles; b) 7,356 5000-tablet bottles; c) 
27,487 100-tablet bottles; d) 14,366 100-tablet bottles were 
distributed.
REASON
Subpotency.

RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS III
________
PRODUCT
Miacalcin Nasal Spray (Calcitonin-Salmon), 200 IU/dose, in 2 mL 
vials, Rx for the treatment for postmenopausal osteoporosis in 
females greater than five years postmenopause, with low bone mass 
relative to healthy premenopausal females. NDC 0078-0311-90.  
Recall #D-254-9.
CODE
Lot #355A9473 EXP Date: December 2001 
Lot #206Z4722 EXP Date - Aug / 2000 
Lot #236Z5438 EXP Date - Oct / 2000 
Lot #362B9718 EXP Date - Jan / 2002 
Lot #362B9719 EXP Date - Jan / 2002 
Lot #362B9971 EXP Date - Jan / 2002 
Lot #200Z4716 EXP Date - Jul / 2000 
Lot #201Z4717 EXP Date - Jul / 2000 
Lot #202Z4718 EXP Date - Aug / 2000 
Lot #203Z4719 EXP Date - Aug / 2000 
Lot #204Z4720 EXP Date - Aug / 2000 
Lot #205Z4721 EXP Date - Aug / 2000 
Lot #207Z4723 EXP Date - Aug / 2000 
Lot #208Z4724 EXP Date - Aug / 2000 
Lot #210Z4725 EXP Date - Aug / 2000 
Lot #213Z4726 EXP Date - Sep / 2000 
Lot #214Z5066 EXP Date - Sep / 2000 
Lot #215Z5067 EXP Date - Sep / 2000 
Lot #216Z5068 EXP Date - Sep / 2000 
Lot #323A6800 EXP Date - May / 2001 
Lot #323A6802 EXP Date - May / 2001 
Lot #323A6804 EXP Date - May / 2001 
Lot #323A6806 EXP Date - May / 2001 
Lot #323A6808 EXP Date - May / 2001 
Lot #323A6810 EXP Date - May / 2001 
Lot #324A6491 EXP Date - May / 2001 
Lot #324A6494 EXP Date - May / 2001 
Lot #324A6496 EXP Date - May / 2001 
Lot #324A6611 EXP Date - May / 2001 
Lot #324A6613 EXP Date - May / 2001 
This recall covers all of the firms manufactured product lots 
from 11/19/97 thru 05/20/99 identified under the same numbers NDC 
0078-0311-90), and Lots: (Miacalcin Nasal Spray 200 IU Carton of 
1's):  Lot #209Z2255 EXP Date - Aug / 2000 
Lot #324A6483 EXP Date - May / 2001  -- and  all of the firms 
manufactured product lots identified under 
NDC 0078-9149-01.
MANUFACTURER
Novartis Pharmaceuticals Corporation, Basel, Switzerland.
RECALLED BY
Novartis Pharmaceuticals Corporation, Suffern, New York, by 
letter on May 4, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
New Jersey, Tennessee, Indiana, Texas, Washington state, Oregon, 
California, Massachusetts, Illinois, Missouri, Florida, Puerto 
Rico, Vermont, North Dakota, New York, Michigan, Kentucky, 
Pennsylvania, New Mexico.
QUANTITY
131,837 cartons were distributed.
REASON
Discoloration, low pH, and subpotency potential due to embedded 
ferrous contamination in a portion of glass vials used in 
production.
________
PRODUCT
Fluocinolone Acetonide Topical Solution USP 0.01% in 60 mL 
bottles, Rx synthetic steroid used as an anti-inflammatory and 
anti-puritic agent, under the Zenith Goldline (NDC 0182-1564-68) 
and H.L. Moore (NDC 0839-6660-84). labels.
Recall #D-260-9.
CODE
Lot #K722 EXP 01/00.
MANUFACTURER
Thames Pharmacal Company, Inc., Ronkonkoma, New York.
RECALLED BY
Manufacturer, by letter sent on May 7, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Ohio, California, Connecticut.
QUANTITY
1,632 bottles were distributed; firm estimated that less than 10 
percent of the product remained on the market at time of recall 
initiation.
REASON
Subpotency (stability).
________
PRODUCT
a) Hygroton Tablets (chlorthalidone, USP), 50 mg, in 100 
tablet bottles, NDC 0075-0020-00; b) Hygroton Tablets 
(chlorthalidone, USP), 25 mg, in 100 tablet bottles NDC 
0075-0022-00.  Products are Rx oral diuretics.  Recall 
#D-262/263-9.
CODE
Lot Numbers: a) MN3117 EXP 6/30/00 and MN2528 EXP 
9/30/00; b) MN2523 EXP 8/31/99 and MN2428 EXP 8/31/99.
MANUFACTURER
Rhone Poulenc Rorer, Manati, Puerto Rico.
RECALLED BY
Rhone Poulenc Rorer, Collegeville, Pennsylvania, by 
letter dated April 16, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
Firm estimated that 3,000 units of the 50 mg tablets and 
approximately 3,000 units of the 25 mg tablets remained 
on market at time of recall initiation.
REASON
Dissolution failure.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS II
________
PRODUCT
Red Blood Cells.  Recall #B-791-9.
CODE
53T66727.
MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY
Manufacturer, by telephone on December 1, 1998, by fax dated 
December 3, 1998, and by letter dated December 4, 1998.  Firm-
initiated recall complete.
DISTRIBUTION
Maryland.
QUANTITY
1 unit was distributed.
REASON
Blood products may have been stored at unsuitable temperatures.
________
PRODUCT
Red Blood Cells.  Recall #B-846-9.
CODE
Unit numbers: 19GT22898 and 19GS24783.
MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY
Manufacturer, by letter dated December 18, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Tennessee.
QUANTITY
2 units were distributed.
REASON
Blood products were collected from a donor who traveled to an 
area considered endemic for malaria.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
Recall #B-857/859-9.
CODE
Unit #19GF15563.
MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY
Manufacturer, by letter dated February 8, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Tennessee, Kentucky, California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor with a history of 
having tested positive for hepatitis.
________
PRODUCT
CryoGraft Allograft (Meniscus with Bone), CryoGraft
Allograft (Achilles Tendon) and CryoGraft Allograft (Patellar 
Tendon).  Recall #B-869-9.
CODE
Meniscus with Bone Model M010:
Serial Number 4168402, Model M030,
Serial Number 4168437, Model M040,
Serial Number 4168445; 
Achilles Tendon Model T010:
Serial Numbers 4168453, 4168461;
Patellar Tendon Model T030: 
Serial Numbers 4168526, 4168496, 4168518, 4168488
MANUFACTURER
CryoLife, Inc., Kennesaw, Georgia.
RECALLED BY
Manufacturer, by letter dated February 5, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
California, Florida, Kentucky, Massachusetts, Minnesota, 
Tennessee, Texas.
QUANTITY
9 tissues.
REASON
Various tissues for transplant were collected from a donor who 
had not been properly evaluated.
________
PRODUCT
CryoVein Allograft (Saphenous Vein), and CryoVein
Allograft (Femoral Vein).  Recall #B-870-9.
CODE
Saphenous Vein 
Model V010; Serial Number 6314945
Model V010; Serial Number 6314937
Femoral Vein
Model V061; Serial Number 6314953.
MANUFACTURER
CryoLife, Inc., Kennesaw, Gaeoriga.
RECALLED BY
Manufacturer, by letter on either March 9, 10, 1999, or April 1, 
1999.  Firm-initiated recall complete.
DISTRIBUTION
Arizona, California, Mississippi.
QUANTITY
3 tissues were distributed.
REASON
Various tissues for transplant were collected from a donor who 
had not been properly evaluated.
________
PRODUCT
CryoVein Allograft (Saphenous Vein), Model V011.
Recall #B-871-9.
CODE
Serial #6088643.
MANUFACTURER
CryoLife, Inc., Kennesaw, Georgia.
RECALLED BY
Manufacturer, by letter on March 19, 1999.  Firm-initiated recall 
complete.
DISTRIBUTION
Arizona.
QUANTITY
1 tissue.
REASON
Tissues for transplant were collected from a donor who had not 
been properly evaluated.
________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced; b) Platelets.
Recall #B-872/873-9.
CODE
Unit #9899922.
MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, 
Cincinnati, Ohio.
RECALLED BY
Manufacturer, by letter dated December 16, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Ohio.
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-874-9.
CODE
Unit #4762326.
MANUFACTURER
New York Blood Services, New York, New York.
RECALLED BY
Manufacturer, by letter dated April 8, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
New York.
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
Platelets Pheresis, Leukocytes Reduced.  Recall #B-875-9.
CODE
Unit numbers: 8793200, 8785359, 8795619.
MANUFACTURER
New York Blood Center, Inc., New York Blood Services, 
New York, New York.
RECALLED BY
Manufacturer, by letter dated April 8, 1999, followed by 
telephone on April 30, 1999.  Firm-initiated recall complete.
DISTRIBUTION
New York.
QUANTITY
3 units were distributed.
REASON
Blood products had unacceptable platelet counts and not labeled 
correctly.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
Recall #B-876/877-9.
CODE
Unit Numbers: a) 24KK83716; b) 24KK83716, 24KK81955.
MANUFACTURER
American Red Cross Blood Services, Louisville, Kentucky.
RECALLED BY
Manufacturer, by telephone on December 11, 1998, and by letter 
dated December 11, 17, or 18, 1998.  Firm-initiated recall 
complete.
DISTRIBUTION
Indiana, Massachusetts, Switzerland.
QUANTITY
a) 1 unit; b) 2 units were distributed.
REASON
Blood products were collected from a donor with a history of 
hepatitis.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
Recall #B-878/880-9.
CODE
Unit #42S64144.
MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.
RECALLED BY
Manufacturer, by letter dated October 13, 1998, or October 20, 
1998.  Firm-initiated recall complete.
DISTRIBUTION
Ohio and California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products tested negative for the antibody to the human 
immunodeficiency virus type 1 (anti-HIV-1), but were collected 
from a donor who previously tested repeatedly reactive for anti-
HIV-1, Western blot negative.
________
PRODUCT
Platelets, Pheresis.  Recall #B-883-9.
CODE
Unit #NO2334.
MANUFACTURER
Central California Blood Center, Fresno, California.
RECALLED BY
Manufacturer, by telephone on May 12, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
________
PRODUCT
Red Blood Cells.  Recall #B-884-9.
CODE
Unit #FG69247.
MANUFACTURER
Sacramento Medical Foundation, Sacramento, California.
RECALLED BY
Manufacturer, by telephone on January 4, 1997.  Firm-initiated 
recall complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; 
d) Recovered Plasma.  Recall #B-885/887-9 and B-889-9.
CODE
Unit numbers:  a) 19GJ47299, 19GZ29710, 19GZ22941, 19GH13071; b) 
19GN41645, 19GZ29710, 19GH13071;
c) 19GJ47299, 19GH13071; d) 19GZ29710.
MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY
Manufacturer, by letters on November 9 and 30, 1998, December 15, 
1998, or by telephone on November 3, 1998.  Firm-initiated recall 
complete.
DISTRIBUTION
Tennessee, California, Massachusetts.
QUANTITY
a) 4 units; b) 3 units; c) 3 units; d) 1 unit.
REASON
Blood products were collected from a donor with a history of 
cancer.
________
PRODUCT
Platelets, Pheresis.  Recall #B-890-9.
CODE
Unit #FR16602 (A&B).
MANUFACTURER
Delta Blood Bank, Stockton, California.
RECALLED BY
Manufacturer, by telephone on March 24, 1998, and by letter dated 
September 1998.  Firm-initiated recall complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood products had high platelet counts.
________
PRODUCT
Red Blood Cells.  Recall #B-891-9.
CODE
Unit #FG72383.
MANUFACTURER
Sacramento Medical Foundation, Sacramento, California.
RECALLED BY
Manufacturer, by telephone on May 7, 1997.  Firm-initiated recall 
complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor whose suitability was 
not adequately determined.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS III
________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated.
Recall #B-882-9.
CODE
Unit #1226565.
MANUFACTURER
Houchin Community Blood Bank, Bakersfield, California.
RECALLED BY
Manufacturer, by letter dated November 3, 1997.  Firm-initiated 
recall complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
________
PRODUCT
Recovered Plasma for Manufacturing Non-Injectable Products.  
Recall #B-888-9.
CODE
Unit #19GZ22941.
MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY
Manufacturer, by fax on November 3, 1998.  Firm-initiated recall 
complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor with a history of 
cancer.

RECALLS AND FIELD CORRECTIONS:   DEVICES --CLASS II
________
PRODUCT
BVS 5000i Bi-Ventricular Support System, intended for use as a 
mechanical circulatory support system.  Recall #Z-944-9.
CODE
Serial Numbers: 1693, 1697, 1701, 1716, 1722-1725.
MANUFACTURER
Abiomed, Inc., Danvers, Massachusetts.
RECALLED BY
Manufacturer, by fax on April 30, 1999.  Firm-initiated field 
correction ongoing.
DISTRIBUTION
California, District of Columbia, Florida, Pennsylvania, New 
York, Tennessee, Texas, Washington state.
QUANTITY
8 units were distributed.
REASON
Solenoid valves do not provide adequate flow to the blood pump.
________
PRODUCT
Seraflo Q-Set Hemodialysis Tubing Set (common name is "Q-set 
Bloodlines", Catalog numbers 205-Q01, 205-Q02, 205-Q03, 205-Q04, 
205-Q05, 205-Q06, 205-Q07, 205-Q08, 205-Q09, 205-Q10, 205-Q11, 
205-Q13 AND 205-Q14.  Recall #Z-967/979-9.
CODE
All lot numbers and expiration dates.
MANUFACTURER
Nissho Nipro Corporation, Sena, Ayuhaya, Thailand.
RECALLED BY
Nipro Medical Corporation, Miami, Florida, by letter dated May 6, 
1999 and subrecalled by Althin Medical, Miami Lakes, Florida, by 
letter dated May 7, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
2,122,488 sets were distributed.
REASON
The dialysis machines which utilize the Seraflo bloodlilnes may 
become contaminated with blood due to blood backing up in the 
bloodlines.
________
PRODUCT
Shielded Trocar (obturator), Model: GT012, GT011, GT05,
GT-05-7, GSNT11.  Recall #Z-994/998-9.
CODE
All 50 lots of 5 sizes of Trocars manufactured between 1/1/98 and 
4/1/99
MANUFACTURER
Gibbons Surgical Corporation, Virginia Beach, Virginia.
RECALLED BY
Manufacturer, by fax on May 17, 1999, followed by telephone.  
Firm-initiated recall ongoing.
DISTRIBUTION
Alabama, California, Pennsylvania, Texas, Michigan, 
Massachusetts, Missouri, Austria, Germany.
QUANTITY
51,080 units were distributed.
REASON
Gamma sterilization was not validated.  Devices were dosed at a 
different level than that provided for in validataion study.
________
PRODUCT
Apex Universal Irrigation Console, pumps intended to provide 
necessary pressure ranges during arthroscopy from 20 to 150 mmHg. 
They also provide flow rates of up to 2000ml/min. for 
proper and safe joint distension and visualization:
a) Model C7100; b) Model C7100A.  Recall #Z-1001/1002-9.
CODE
Models C7100 or C7100A Apex Irrigation Pumps with screened 
power supplies.
Serial Numbers:  a) 1124, 1144, 1191, 1360, 
1370, 1501, 1589, 1621, 1625, 1684, 1702, 1768, 1816, 1845, 
1859, 2027, 2120
b) 1006, 1050, 1052, 1056, 1103, 1114. 1137, 1197, 1198, 1249, 
1266, 1328, 1355, 1405, 1447, 1449, 1454, 1461, 1505, 1519, 1541, 
1543, 1544, 1616, 1628, 1654, 1691, 1693, 1709, 1799, 1802, 1833, 
1841, 1842, 1881, 1931, 1985, 2008, 2052, 2066, 2125, 10026, 
10036, 10046, 10070, 10088, 10162, 10175, 10188, 10209, 10213, 
10231,10256, 10262, 10263, 10342, 10381, 10384, 10387, 10414, 
10418, 10429, 10434, 10436, 10438, 10445-10447, 10455, 10504, 
10507, 10512, 10529, 10531, 10536, 10539, 10554, 10560, 10588, 
10600, 10647, 10707, 10756, 10763, 10775, 10789, 10799, 10804, 
10807, 10838, 10848, 10861, 10872, 10873, 10876, 10880, 10884, 
10889, 10895, 10898, 10899, 10900, 10901, 10905-10907, 10909-
10912, 10914-10916, 10918, 10919, 10922, 10925, 10927, 10928, 
10930, 10933, 10938, 10939, 10941, 10943, 10944,  10949, 10951.
MANUFACTURER
Linvatec Corporation, Largo, Florida.
RECALLED BY
Manufacturer, by letter on June 2, 1999, followed by visit.  
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
145 units were distributed.
REASON
Pump may only operate intermittently.
________
PRODUCT
IMMUNOCARD(TM) C. DIFFICILE, diagnostic test kit used for the 
detection of C. difficile Common Antigen.
Recall #Z-1007-9.
CODE
Lot Numbers: #706050.125 EXP 8/9/98; #706050.126, EXP 11/11/99.  
Product Number: 706050.
MANUFACTURER
Meridian Diagnostics, Inc., Cincinnati, Ohio.
RECALLED BY
Manufacturer, by telephone beginning April 27, 1999, or by 
letter.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide, Italy, Canada.
QUANTITY
A total of 304 kits (161 - lot #706050.125) and (143 - lot 
#706050.126).
REASON
Negative color reactions may result in invalid or false negative 
test results.
________
PRODUCT
Patil Emergency Cricothyrotomy Catheters:  
a) Cook Citical Care Brand Patil Emergency Cricothyrotomy 
Catheter Set with 6 French Airway Catheter, Reorder No. C-DTJV-
6.0-6.0-PATIL;
b) Cook Critical Care Brand Patil Emergency Cricothyrotomy 
Catheter Set with 9 French Airway Catheter, Reorder No.
C-DTJV-9.0-6.0-PATIL.  Recall #Z-1009/1010-9.
CODE
All Lot Numbers.
MANUFACTURER
Cook Incorporated, Bloomington, Indiana.
RECALLED BY
Manufacturer, by letter sent on April 29, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
535 units were distributed.
REASON
The 6 cc syringe will not connect to the cricothyrotomy catheter, 
thus not allowing aspiration to verify correct final placement of 
the catheter within the trachea as per the instructions for use.

END OF ENFORCEMENT REPORT FOR May 23, 1999.

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