FDA

Enforcement Report

July 14, 1999                                              99-28

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS I
________
PRODUCT
Spiced Dry Tofu in 8 ounce plastic containers.
Recall #F-540-9.
CODE
None.
MANUFACTURER
Water Lilies Food, Inc., Brooklyn, New York.
RECALLED BY
Manufacturer, by visit on March 11, 1999, and by press release.  
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
10 cartons (36 containers per carton) were distributed.
REASON
Product contained undeclared peanuts.
________
PRODUCT
DawnMist Mouth Rinse, packaged in 2 ounce and 4 ounce white 
plastic containers.  Recall #F-543-9.
CODE
All lots labeled as "Made in Malaysia".
MANUFACTURER
HI-CITY Manufacturing, Penang, Malaysia.
RECALLED BY
Donovan Industries, Inc., Tampa, Florida, by letters on March 29, 
1999, and April 19, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
Approximately 1,200 cases (60 bottles per case) were distributed 
over the past six months in the United States.
REASON
Product may be contaminated with Burkholderia cepacia.
________
PRODUCT
Morningland Dairy Raw Milk Mild Cheddar Cheese, packaged in 
random sizes ranging in weight from .50 pounds to 20 pounds.  
Recall #F-544-9.
CODE
C179.
MANUFACTURER
Moringland Farm, Inc., Mountain View, Missouri.
RECALLED BY
Manufacturer, by telephone on June 11, 1999, and by press 
release.  Firm-initiated recall complete.
DISTRIBUTION
Michigan, Pennsylvania, Georgia, North Carolina, Washington 
state, Arkansas, Missouri, Alabama, Florida, Tennessee.
QUANTITY
228 pounds were distributed.
REASON
Product is contaminated with Listeria monocytogenes.
________
PRODUCT
"Sunshine Sprouts" Clover Sprouts, in 4-6 ounce cardboard 
containers.  Recall #F-545-9.
CODE
None.
MANUFACTURER
Sunshine Sprouts (sprout grower), West Palm Beach, Florida.
RECALLED BY
Manufacturer, by letter sent on June 7, 1999, and by telephone 
June 8, 1999, and by press release.  Firm-initiated recall 
complete.
DISTRIBUTION
Florida.
QUANTITY
Firm estimates none remains on the market.
REASON
The sprouts may have been contaminated with Salmonella s. 
Typhimurium.  The seeds used to manufacture these sprouts were 
from the same lot of seeds that was implicated in a Salmonella s. 
Typhimurium outbreak in Colorado.

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS III
________
PRODUCT
30 Different baked goods:
a) Honey Maid Graham Pie Crust;72 pkgs/case; Net Wt 6 oz.
b) Old Fashioned Ginger Snaps;6 pkgs/case; Net Wt.16 oz;
c) Family Favorite Oatmeal Cookies; 12 pkgs/case; 
    Net Wt.14 oz
d) Flavor Crisp Snack Cracker Entertainment Pack; 
   6 pkgs/case; Net Wt. 24 oz. 
e) Reduced Fat Triscuit Baked Whole Wheat Wafers:
   12    pkgs/case; Net Wt. 8.5 oz
f) Honey Maid Honey Grahams; 12 pkgs/case; Net Wt.16 oz.and
   6 pkgs/case; Net Wt.32 oz.  
g) Triscuit Baked Whole Wheat Wafers; 12 pkgs/case; Net
   Wt. 9.5 oz and 12 pkgs/case; Net Wt.13 oz.
h) Low Sodium Triscuit Baked Whole Wheat Wafers; 12
   pkgs/case; Net Wt. 9.5 oz.
i) Premium Soup and Oyster Crackers; 12 pkgs/case;
   Net Wt. 10 oz.
k) Nabisco Grahams; 12 pkgs/case; Net Wt. 16 oz.
l) Low Fat Honey Maid Cinnamon Graham; 12 pkgs/case; 
   Net Wt. 16 oz.
m) Barnum's Animal Crackers; 24 pkgs/case; Net Wt. 2.125 oz.
n) Original Premium Saltine Crackers; 12 pkgs/case;
   Net Wt 8 oz.
o) Sweet Crisper Chocolate Crispy Baked Snacks; 
   6 pkgs/case; Net Wt. 7 oz.
p) Sweet Crisper Honey Crispy Baked Snacks; 6 pkgs/case;
   Net Wt. 7 oz.
q) Holiday Oreo Chocolate Sandwich Cookies; 6 pkgs/case;
   Net Wt. 40 oz.
r) Ritz Value Pack; 6 pkgs/case; Net Wt. 40 oz.
s) Oreo Chocolate Sandwich Cookies; 12 pkgs/case; 
   Net Wt. 16 oz.
t) Triscuit Thin Crisps Baked Whole Wheat Snacks Original;
   12 pkgs/case; Net Wt. 8.5 oz.
u) Triscuit Thin Crisps Whole Wheat Snacks French Onion
   Flavor; 12 pkgs/case; Net Wt. 8.5 oz.
v) Chips Ahoy! Real Chocolate Chip Cookies; 12 pkgs/case;
   Net Wt. 12 oz. and 12 pkgs/case; Net Wt. 18 oz.
w) Ritz Bits Sandwiches made with Real Cheese; 12
   pkgs/case; Net Wt. 10.5 oz.
x) Ritz Bits Sandwiches with Peanut Butter; 12 pkgs/case;
   Net Wt. 10.5 oz.
y) Ritz Crackers; 6 pkgs/case; Net Wt. 32 oz. 
z) Deli-Style Rye Triscuit Baked Whole Wheat Wafers; 
   12 pkgs/case; Net Wt. 9.5 oz.
aa) Snackwell's Fat Free Devil's Food Cookie Cakes;
    12 pkgs/case; Net Wt. 6.75 oz.
bb) Snackwell's Creme Sandwich Cookies; 12 pkgs/case;
    Net Wt. 7.75 oz..  Recall #F-509/535-9.
CODE
Old Fashioned Ginger Snaps, 9068AG,
Family Favorite Oatmeal Cookies, 9060AK, 9061AK
Flavor Crisps Snack Cracker Entertainment Pack, 9017RP, 9018RP, 
9019RP, 9020RP, 9027RP
Reduced Fat Triscuit Baked Whole Wheat Wafers, 9061AN, 9062AN
Honey Maid Honey Grahams, 9059AX, 9060AV, 9060AX, 9061AV, 9061AX, 
9062AV, 9062AX
Honey Maid Honey Grahams, 9053AV, 9072AV
Triscuit Baked Whole Wheat Wafers, 9060AN, 9062AN, 9080AN
Low Sodium Triscuit Baked Whole Wheat Wafers, 9058AN
Triscuit Baked Whole Wheat Wafers, 9066AN, 9068AN
Premium Soup and Oyster Crackers, 9069AX
Nabisco Grahams, 9070AG
Low Fat Honey Maid Cinnamon Graham, 9051AM, 9052AM, 9053AM
Barnum's Animals Crackers, 8360AP, 8364AP
Original Premium Saltine Crackers, 9045AP
Sweet Crisper Chocolate Crispy Baked Snacks, 9008AK, 9009AK, 
9013AK, 9014AK
Sweet Crisper Honey Crispy Baked Snacks, 9063AK
Holiday Oreo Chocolate Sandwich Cookies, 9045RP, 9046RP, 9047RP
Ritz Value Pack, 9045RP, 9053RP, 9055RP, 9057RP, 9059RP
Oreo Chocolate Sandwich Cookies, 9066AG, 9068AG
Triscuit Thin Crisps Baked Whole Wheat Snacks Original, 9062AN
Triscuit Thin Crisps Baked Whole Wheat Snacks French Onion 
Flavor, 9054AN, 9055AN
Chips Ahoy! Real Chocolate Chip Cookies, 9072AX
Chips Ahoy! Real Chocolate Chip Cookies, 9067AH, 9069AH, 9070AH, 
9071AH
Ritz Bits Sandwiches made with Real Cheese, 9067AW, 9068AW, 
9076BD, 9077BD, 9078BD
Ritz Bits Sandwiches with Peanut Butter, 9074AW, 9075AW, 9076AW, 
9080AW, 9081AW, 9081BD, 9082BD
Ritz Crackers, 9034AV, 9040AV
Deli -Style Rye Triscuit Baked Whole Wheat Wafers, 9062AN
Snackwell's Fat Free Devil's Food Cookie Cakes, 9011BG
Snackwell's Crème Sandwich Cookies, 9080KE
MANUFACTURER
Multiple sites.
RECALLED BY
Nabisco, Inc., East Hanover, New Jersey, by E-Mail on November 17 
and 23, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Nationwide 
QUANTITY
Approximately 183,300 cases (all products) were distributed; firm 
estimates none remains on the market.
REASON
Products were adulterated with organic volatile solvent rendering 
them unfit for food.
________
PRODUCT
Isomil, Ready-To-Feed Liquid Infant Formula, in 1 quart (32 fluid 
ounce) metal cans.  Recall #F-537-9.
CODE
The Batch Numbers: 52003RE and 52007RE, are ink-printed on the 
bottom of each can.  The shipping cases are identified with the 
Code numbers: 52003RE00 and 52007RE00, which are ink-jetted on 
the side panels of each case.
MANUFACTURER
Ross Products Division, Abbott Laboratories, Casa Grande, 
Arizona.
RECALLED BY
Ross Products Division, Abbott Laboratories, Columbus, Ohio, by 
telephone beginning April 28, 1999, followed by fax.  Firm-
initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
17,821 cases (106,926 cans) were distributed.
REASON
Product was held in cans with a low level of can lid defects 
allowing for post-processing contamination.

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS III
________
PRODUCT
Elizabeth's Candies Milk and Dark Chocolate Deluxe Assortment, in 
7 ounce boxes.  Recall #F-536-9.
CODE
All lots.
MANUFACTURER
Elizabeth's Candies, Kenmore, New York.
RECALLED BY
Manufacturer, by visit or by telephone beginning on May 6, 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
Approximately 300-400 boxes were distributed.
REASON
Candy is misbranded because the labeling lists only "nuts" as an 
ingredient but does not specify which nuts are in the product.
________
PRODUCT
Crown brand:  a) Radix Dioscorea (Chinese Yam) in rigid plastic 
containers net weight 12 ounces (340 g); b) Dried Almond in 
flexible plastic packages, new weight 6 ounces (170 g).
Recall #F-538/539-9.
CODE
None.
MANUFACTURER
Wing Tak Fook Ltd., Sheung Wan, Hong Kong, China.
RECALLED BY
Murray International, Inc., Brooklyn, New York, 
(importer/distributor), by letter on February 23, 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
a) 32 cases (50 packages per case); b) 15 cases (100 packages per 
case) were distributed.
REASON
Products contained undeclared sulfites.

RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS II
________
PRODUCT
Medicap Pharmacy Peri-Colace Stool Softener With Laxative 
containing 100 mg of Docusate Sodium and 30 mg of Casanthranol 
per softgel, 100 softgels per bottle.  NDC number is 56050-254-
52.  Recall #D-280-9.
CODE
Lot #4985A EXP 7/00.
MANUFACTURER
Time-Cap Labs., Inc., Farmingdale, New York (Manufacturer of the 
bulk aspirin which was repacked and then mislabeled as Peri-
Colace).
RECALLED BY
Apothecary Products, Inc., Burnsville, Minnesota (repacker), by 
telephone and fax on June 8, 1999.  Firm-initiated recall 
complete.
DISTRIBUTION
Undetermined.
QUANTITY
12 bottles in 2 boxes of 6 bottles each were distributed.
REASON
Mislabeling - Bottles actually contain 325 mg aspirin tablets.


RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS III
________
PRODUCT
Calcionate Syrup, in 16 fluid ounce (pint) bottles, OTC calcium 
supplement.  Recall #D-281-9.
CODE
Lot #802921. EXP 7/00.
MANUFACTURER
Hi-Tech Pharmacal Company, Inc., Amityville, New York.
RECALLED BY
MANUFACTURER, by letter dated June 14, 1999.  
Firm-initiated recall ongoing.
DISTRIBUTION
Georgia.
QUANTITY
3,564 units were distributed.
REASON
Presence of white precipitate and cloudiness; calcium is 
precipitating out of formulation.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS II
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma;
d) Plasma, Cryoprecipitate Reduced; e) Cryoprecipitate AHF;
f) Cryoprecipitate AHF, Pooled; g) Platelets Pheresis;
h) Granulocytes Pheresis; i) Recovered Plasma For Manufacturing 
Non-injectable Use; j) Recovered Plasma.
Recall #B-905/914-9.
CODE
Unit numbers: a) 69715, 77277, 142284, 220419, 245114, 276682, 
294841, 314070, 238484, 344834, 434670, 444967, 478032, 486373, 
0577657;
b) 220419, 276682, 294841, 314070, 328484, 434670;
c) 294841, 344834; d) 0577657; e) 0577657; f) 9012582;
g) 352213, 357294, 363313, 368209, 374208, 376026, 393606, 
408547, 414029, 421271, 432676, 437417, 486501, 510584, 0526605, 
0579141, 442603, 447706, 465356, 470611, 481553, 498518, 502800, 
0533989, 0537182, 0545385, 0567818, 0587688, 0611765, 0559879 
(parts 1 and 2), 0549243 (parts 1 and 2), 0571891 (parts 1 and 
2); h) 0597507; i) 338981, 381491;
j) 444967, 478032, 486373, 69715, 77277, 142284, 148659, 220419, 
245114, 276682, 314070, 328484, 434670.
MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.
RECALLED BY
Manufacturer, by letters dated November 6, 20, 23, 24, 1998, 
December 9 and 17, 1998, January 11, 1999, and February 1, 1999. 
Firm-initiated recall complete.
DISTRIBUTION
California, Connecticut, Florida, Massachusetts, Minnesota, North 
Carolina, Pennsylvania, Switzerland.  Firm-initiated recall 
complete.
QUANTITY
a) 15 units; b) 6 units; c) 2 units; d) 1 unit; e) 1 unit;
f) 1 unit; g) 32 units; h) 1 unit; i) 2 units; j) 13 units were 
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 indeterminate.
________
PRODUCT
a) Red Blood Cells, Leukoreduced; b) Red Blood Cells.
Recall #B-927/928-9.
CODE
Unit numbers 03FL74884 and 03LG10030.
MANUFACTURER
American Red Cross, Gainesville, Georgia.
RECALLED BY
American Red Cross, Atlanta, Georgia, by telephone on October 16, 
1998, and by letter dated October 22, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Georgia.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who had traveled to an 
area designated as endemic for malaria.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
Recall #B-931/932-9.
CODE
Unit #12GZ01593.
MANUFACTURER
American Red Cross Blood Services, Durham, North Carolina.
RECALLED BY
American Red Cross Blood Services, Charlotte, North Carolina, by 
letter dated July 17, 1998.  Firm-initiated recall complete.
DISTRIBUTION
North Carolina Switzerland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products tested negative for anti-HCV but was collected 
from a donor who previously tested reactive for Hepatitis C.
_________
PRODUCT
Platelets, Pheresis.  Recall #B-933-9.
CODE
Unit #12GW16747 (split unit 1 and 2).
MANUFACTURER
American Red Cross Blood Services, Charlotte, North Carolina.
RECALLED BY
Manufacturer, by telephone on August 27, 1998, 
and by letter dated September 1, 1998.  Firm-initiated recall 
complete.
DISTRIBUTION
North Carolina.
QUANTITY
1 split unit was distributed.
REASON
Blood products had high platelet counts.
________
PRODUCT
Red Blood Cells.  Recall #B-934-9.
CODE
Unit #03LR53822.
MANUFACTURER
American Red Cross Blood Services, Atlanta, Georgia.
RECALLED BY
Manufacturer, by telephone on December 24, 1998, and by letter 
dated January 14, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Georgia.
QUANTITY
1 unit was distributed.
REASON
Blood product was exposed to unacceptable shipping temperatures.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma;
d) Recovered Plasma for Manufacturing Non-injectable; Products; 
e) Recovered Plasma.  Recall #B-938/942-9.
CODE
Unit numbers: a) 42FJ73931, 42FZ75158, 42FW43232, 42K89757, 
42S58161, 42FG52747; b) 42FJ73931, 42FW43232, 42K89757, 42S58161, 
42FG52747; c) 42K89757, 42S58161; d) 42FZ75158;
e) 42FJ73931, 42FG52747, 42FW43232.
MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.
RECALLED BY
Manufacturer, by letter dated December 7, 1998, and January 27, 
1999.  Firm-initiated recall complete.
DISTRIBUTION
Ohio and Massachusetts, California.
QUANTITY
a) 6 units; b) 5 units; c) 2 units; d) 1 unit; e) 3 units were 
distributed.
REASON
Blood products tested negative for anti-HCV, but was collected 
from a donor who previously tested reactive for anti-HCV.
________
PRODUCT
Allergenic Extract - GS Ragweed Mix.  Recall #B-943-9.
CODE
Lot #P1-235-5X3.
MANUFACTURER
Greer Laboratories, Inc., Lenoir, North Carolina.
RECALLED BY
Manufacturer, by telephone on April 6, 1999.  
Firm-initiated recall complete.
DISTRIBUTION
Florida.
QUANTITY
1 vial was distributed.
REASON
Allergenic extract labeled with the incorrect concentration.
________
PRODUCT
Platelets.  Recall #B-944-9.
CODE
Unit #1558773.
MANUFACTURER
Central Kentucky Blood Center (CKBC), Lexington, Kentucky.
RECALLED BY
Manufacturer, by telephone on April 27, 1999, and by letter dated 
June 8, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Kentucky.
QUANTITY
1 unit was distributed.
REASON
Platelets were prepared from a whole blood unit which was 
collected from a donor who had taken aspirin within three days of 
donation.
_________
PRODUCT
Red Blood Cells.  Recall #B-945-9.
CODE
Unit #22402-9453.
MANUFACTURER
Blood Services, Inc., Las Vegas, Nevada.
RECALLED BY
Blood Systems,Inc., Scottsdale, Arizona, by telephone on October 
3, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Nevada.
QUANTITY
1 unit was distributed.
REASON
Blood product was not quarantined after receiving information 
concerning a post donation illness.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
Recall #B-946/947-9.
CODE
Unit numbers: FK03851, FK03852, FK03853, FK03854, FK03856,
FK02983, FK02984, FK02985, FK02986, FK02987, FK02988, FK02989, 
FK02990, FK02991, FL01488, FL01489, FL01490, FL01491, FL01492, 
FL01493, FL01494, FL01495, FL01497, FL01498, FL01499, FL01500, 
FL01501, FK04657, FK04659, FK04660, FX00499, FX00451, FX00453, 
FX00454, FX00455, FX00456, FX00458, FX00459, FX00463, FX00469, 
FX00471, FX00472, FX00476, FX00484, FX00490, FX00491, FX00495, 
FX00497, FX00348, FX00349, FX00350, FX00351, FX00352, FX00353, 
FX00354, FX00356, FX00357, FX00358, FX00360, FX00057, FX00058, 
FX00059.
MANUFACTURER
Central Illinois Community Blood Bank, Springfield, Illinois.
RECALLED BY
Manufacturer, by telephone on May 25, 1999, and by letter and fax 
on May 27, 1999, and by fax on May 26, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Illinois, California, Switzerland.
QUANTITY
62 units were distributed.
REASON
Testing for syphilis not performed in accordance with 
MANUFACTURER's insert in that the age of the 
sample exceeded the 48 hour requirement.
________
PRODUCT
Red Blood Cells.  Recall #B-964-9.
CODE
Unit #40GT19792.
MANUFACTURER
American Red Cross Blood Services, Peoria, Illinois.
RECALLED BY
Manufacturer, by letter dated May 28, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Illinois.
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
Red Blood Cells.  Recall #B-965-9.
CODE
Unit Numbers: 4615125, 4615134, 4615178, 4615179, 4615228, 
4615251, 4615329, 4615414, 4615447, 4615897, 4615919, 4616093, 
4616241, 4616433, 4616909, 4616937, 4617183, 4617245, 4617299, 
4617302, 4617535, 4617537, 4617575, 4617665, 4617994, 4618241, 
4618297, 4618316, 4618318, 4618322, 4618373, 4618493, 4618567.
MANUFACTURER
Department of the Navy, Naval Hospital Blood Bank, Great Lakes, 
Illinois.
RECALLED BY
Manufacturer, by letter dated June 7, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
New Jersey.
QUANTITY
33 units were distributed.
REASON
Blood products were collected from donors who had not been 
properly questioned regarding malarial risk.
________
PRODUCT
Platelets.  Recall #B-966-9.
CODE
Unit #32KQ04827,
MANUFACTURER
American Red Cross Blood Services, Madison, Wisconsin.
RECALLED BY
Manufacturer, by telephone on November 12, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Wisconsin.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who previously tested 
positive for human leukocyte antigen.
________
PRODUCT
a) Red Blood Cells; b) Plasma.  Recall #B-974/975-9.
CODE
Unit #11T49807.
MANUFACTURER
American Red Cross Blood Services, St. Louis, Missouri.
RECALLED BY
Manufacturer, by telephone on August 12 and 13, 1998, and by 
letter dated August 21, 1998.  Firm-initiated recall complete.
DISTRIBUTION
New Jersey and California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products tested positive for HbsAg, but were collected from 
a donor who previously tested reactive for Hepatitis B.
________
PRODUCT
a) Red Blood Cells; b) Plasma.  Recall #B-976/977-9.
CODE
Unit #11LY02861.
MANUFACTURER
American Red Cross Blood Services, St. Louis, Missouri.
RECALLED BY
Manufacturer, by telephone on December 31, 1997, and by letter 
dated January 6, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Missouri and California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products tested negative for the antibody to the human 
immunodeficiency virus type 1/2 (HIV-1/2), but were collected 
from a donor who previously tested reactive for the antibody.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
Recall #B-991/993-9.
CODE
Unit #1589203.
MANUFACTURER
LifeSource, Glenview, Illinois.
RECALLED BY
Manufacturer, by letter and telephone on March 11, 1999.  Firm-
initiated recall complete.
DISTRIBUTION
Illinois and Switzerland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor with a history of 
cancer.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS III
________
PRODUCT
Sterile Diluent for Allergenic Extract in 9.0 ml vials, Normal 
Saline with Phenol.  Recall #B-640-9.
CODE
Lot #5527C.
MANUFACTURER
Allergy Laboratories, Inc., Oklahoma City, Oklahoma.
RECALLED BY
Manufacturer, by telephone on March 2, 1999, and by letter dated 
March 15, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
2,800 vials were distributed.
REASON
Discoloration was observed in some vials of sterile diluent 
marketed for use with allergenic extracts.
________
PRODUCT
Red Blood Cells.  Recall #B-901-9.
CODE
RH24133, RH24135, RH24136, RH24137, RH24138, RH24139, RH24142, 
RH24143, RH24144, RH24145, RH24148, RH24149, RH24150, RH24151.
MANUFACTURER
Riverview Hospital Association, Wisconsin Rapids, Wisconsin.
RECALLED BY
Manufacturer, by telephone on April 28 and 29, 1998.  Firm-
initiated recall complete.
DISTRIBUTION
Wisconsin and California.
QUANTITY
14 units were distributed.
REASON
Blood products were labeled with extended expiration dates.
________
PRODUCT
Red Blood Cells and Fresh Frozen Plasma.
Recall #B-902/903-9.
CODE
Unit #32KJ41602.
MANUFACTURER
American Red Cross Blood Services, Madison, Wisconsin.
RECALLED BY
Manufacturer, by letters dated October 29, 1998 or November 6, 
1998.  Second notices were sent on either December 11 or 18, 
1998.  Firm-initiated recall complete.
DISTRIBUTION
Wisconsin.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor whose arm inspection 
and skin disease status had not been accurately documented.
________
PRODUCT
Allergenic Extract - Mold Mix.  Recall #B-915-9.
CODE
Lot M0145-83-1F1.
MANUFACTURER
Greer Laboratories, Inc., Lenoir, North Carolina.
RECALLED BY
Manufacturer, by telephone on April 6, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
New Jersey.
QUANTITY
3 vials were distributed.
REASON
Allergenic extracts were labeled with an extended expiration 
date.
________
PRODUCT
Platelets, Pheresis.  Recall #B-917-9.
CODE
Unit #0023932 (split product)
MANUFACTURER
American Red Cross Blood Services, Atlanta, Georgia.
RECALLED BY
Manufacturer, by telephone on October 9, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Georgia.
QUANTITY
1 split unit was distributed.
REASON
Blood products which were in transit greater than 24 hours were 
redistributed without swirl testing being performed.
________
PRODUCT
Platelets and Fresh Frozen Plasma.  Recall #B-929/930-9.
CODE
Unit #12FR54188.
MANUFACTURER
American Red Cross Blood Services, Durham, North Carolina.
RECALLED BY
American Red Cross Blood Services, Charlotte, North Carolina, by 
letters on January 30, 1999, and March 2, 1999, and by telephone 
on January 25, 1999.  Firm-initiated recall complete.
DISTRIBUTION
North Carolina and Puerto Rico.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor taking the drug 
Propecia.
________
PRODUCT
a) Platelets; b) Platelets, Pheresis.  Recall #B-935/936-9.
CODE
Contact FDA, Center for Biologics Evaluation and Research, Office 
of Compliance (301) 827-6220 for individual unit numbers 
recalled. PRIVATE  
MANUFACTURER
American Red Cross Blood Services, Madison, Wisconsin.
RECALLED BY
Manufacturer, by letter dated May 13, 1998, or June 12, 1998, or 
July 10, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Illinois.
QUANTITY
a) 28 units; b) 27 units were distributed.
REASON
Blood products were stored at unacceptable temperatures.
________
PRODUCT
Platelets, Pheresis.  Recall #B-937-9.
CODE
Unit #03FK17429.
MANUFACTURER
American Red Cross Blood Services, Atlanta, Georgia.
RECALLED BY
Manufacturer, by telephone on February 5, 1999, and by letter 
dated February 9, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Georgia.
QUANTITY
1 unit was distributed.
REASON
Blood product was distributed without having performed a platelet 
count.
________
PRODUCT
Red Blood Cells and Recovered Plasma.  Recall #B-948/949-9.
CODE
Unit Numbers:  FK04658, FX00500, FX00457, FX00461, FX00465,
FX00466, FX00467, FX00470, FX00473, FX00474, FX00477, FX00478, 
FX00480, FX00481, FX00482, FX00483, FX00485, FX00486, FX00487, 
FX00488, FX00492, FX00493, FX00494, FX00496, FX00498, FX00355.
MANUFACTURER
Central Illinois Community Blood Bank, Springfield, Illinois.
RECALLED BY
Manufacturer, by telephone on May 25, 1999.  Follow-up letter 
were mailed and faxed on May 27, 1999.  Firm-initiated recall 
complete.
DISTRIBUTION
Illinois, California, Switzerland.
QUANTITY
26 units were distributed.
REASON
Blood products were incorrectly tested for syphilis.
________
PRODUCT
Red Blood Cells, Leukocytes Reduced.  Recall #B-963-9.
CODE
Unit numbers: 11GQ04972, 11FE32552, 11FG35193, 11FG35190, 
11FG35192, 11FG40607, 11LY18691, 11GJ00819, 11GW04886, 11GW04891, 
11GY01388, 11FM38222, 11LV23710.
MANUFACTURER
American Red Cross Blood Services, St. Louis, Missouri.
RECALLED BY
Manufacturer, by telephone on August 14, 1998, and by letter 
dated August 28, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Missouri.
QUANTITY
13 units were distributed.
REASON
Red Blood Cells, leukoreduced by filtration greater than five 
days past the time of collection, were distributed for 
transfusion.
________
PRODUCT
a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced;
c) Platelets; d) Platelets, Pooled; e) Fresh Frozen Plasma;
f) Recovered Plasma for Manufacturing Injectables 
g) Recovered Plasma for Manufacturing Non-Injectables.
Recall #B-967/973-9.
CODE
Unit numbers:  a) 6605080, 6605083, 6605084, 	6605085, 
6605086, 6605088, 6605090, 6605093, 6605095, 	6605099, 
6605109, 6605110, 6605111, 6605115
b) 6605112, 6605116 
c) 6605080, 6605083, 6605084, 6605085, 6605086, 6605088, 6605092, 
6605095, 6605098, 6605099, 6605104, 6605106 
d) P65682, P65687, P65685, P65690 
e) 6605080 
f) 6605085, 6605086, 6605088, 6605099, 6605104, 6605105, 6605106, 
6605115, 6605116, 6605117
g) 6605093.
MANUFACTURER
Carter Blood Center, Fort Worth, Texas.
RECALLED BY
Manufacturer, by telephone on December 3, 1998, followed by 
letter dated December 16, 1998, and by fax on December 7, 1998.  
Firm-initiated recall complete.
DISTRIBUTION
Texas, California, Switzerland.
QUANTITY
a) 14 units; b) 2 units; c) 12 units; d) 4 units; e) 1 unit; f) 
10 units; g) 1 unit.
REASON
Blood products were collected from donors who were offered 
monetary payment for donating and were mislabeled as volunteer 
donations.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma.
Recall #B-988/990-9.
CODE
Unit #4303896.
MANUFACTURER
LifeSource, Glenview, Illinois.
RECALLED BY
Manufacturer, by telephone on January 14, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Illinois.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who received a tissue 
transplant (surgery) within 1 year of donation.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- 
CLASS II
________
PRODUCT
CVIS Insight Imaging Catheter for intraluminal coronary 
interventional procedures; 2.6French/30 MHz and 2.6French/40 MHz, 
Model C3020 and C3005, indicated for ultrasound examination of 
the coronary intravascular pathology only.  Intravascular 
ultrasound is indicated in-patients who are candidates for 
transluminal coronary interventional procedures.  
Recall #Z-1051/1052-9.
CODE
UPN/Material #H749C30200, Catalog #C3020, Lots: All Lots
UPN/Material #H749C30050, Catalog #C3005, Lots: All Lots.
MANUFACTURER
Boston Scientific Corporation, San Jose, California.
RECALLED BY
Manufacturer, by letter on June 15, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
44,841 units were distributed.
REASON
The product may separate from the proximal segment.
________
PRODUCT
Midmark 73018 Attachment Accessories for the Midmark Magnum 
General Table, hydraulic, sold as kits and are designed for use 
in the support of patients during orthopedic surgery procedures.
Recall #Z-1053-9.

CODE
Serial Numbers:  TFY1010 through TFY1025.
MANUFACTURER
Midmark Corporation, Versailles, Ohio.
RECALLED BY
Manufacturer, by telephone on June 14-15, 1999, and by letter 
mailed on June 24, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
New Jersey, Florida, Michigan, Louisiana, Minnesota, Texas, 
Missouri, District of Columbia.
QUANTITY
14 units.
REASON
Defects of table accessories cause unintended motion during 
orthopedic surgery.
________
PRODUCT
Henley Healthcare Fluidotherapy Unit, air-fluidized beds 
employing dry heat that is intended to treat local pain, range of 
motion and blood flow insufficiency in the body extremities:  
a) Henley Healthcare Fluidotherapy, Model 110D;
b) Henley Healthcare Fluidotherapy, Model 110DE, 
Recall #Z-1054/1055-9.
CODE
a) Serial Numbers 2-00001 - 2-00369
b) Serial Numbers 2-00001 - 2-00006.
MANUFACTURER
Henley Healthcare, Inc., Sugarland, Texas.
RECALLED BY
Manufacturer, by letter dated January 15, 1998.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
a) 369 units; b) 6 units were distributed.
REASON
Excessively long metal bolts securing metal legs to the wooden 
base of the device protruded too far into the housing, contacting 
the electrical connection to the heater after collapsing a metal 
heater schroud, causing 13 amps of electrical current to be 
delivered to the metal legs.
________
PRODUCT
Doctors Review System, OBLink software releases prior to 9.0.
Recall #Z-1056-9.
CODE
All units.
MANUFACTURER
Digisonics, Inc., Houston, Texas.
RECALLED BY
Manufacturer, by telephone, fax, and letter on March 29, 1999.  
Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
39 units were distributed.
REASON
Y2K software error may produce an incorrect estimated delivery 
date (EDD).
________
PRODUCT
QTEST(R) STREP, an IVD kit for P.O.C. testing to detect Group A 
streptococcus, using a sample throat swab, Catalog 494776 - 40 
tests/kit; 494780 - 80 tests/kit.  Recall #Z-1058-9.
CODE
SERIAL NOS. 5648, 5663, 5664, 5673, 5665.
MANUFACTURER
Becton Dickinson Microbiology Systems, Cockeysville, Marland.
RECALLED BY
Manufacturer, by letter on June 10, 1999, and by letter on June 
22, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
1,044 kits were distributed.
REASON
The Vol-pak pouch sealer failed to provide an adequate seal, and 
the Quali-pak leak tester failed to detect the inadequate seal. 
________
PRODUCT
DIRECTIGEN 1-2-3 GROUP A STREP TEST, DEVICE LISTING 702228, an 
IVD kit used by hospitals for detection of Group A streptococcus 
using a sample of throat swabs or bacterial colonies.
Recall #Z-1059-9.
CODE
CATALOG # 852540, Serial Nos. 5638, 5662, 5670.
MANUFACTURER
Becton Dickinson Microbiology Systems, Cockeysville, Maryland.
RECALLED BY
Manufacturer, by letter on June 10, 1999, and by letters 
beginning June 22, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Washington state, Tennessee, Florida, Georgia, Connecticut, Utah, 
Kentucky, New Jersey, Pennsylvania, Indiana, Alaska, Illinois, 
Minnesota, Arkansas, California, Virginia, District of Columbia.
QUANTITY
1,230 kits were distributed.
REASON
The VolPak pouch sealer failed to provide an adequate seal, and 
the QualiPak leak tester failed to detect the inadequate seal. An 
inadequate seal may lead to false negative results.
________
PRODUCT
Quest Myocardial Protection System (MPS), a sterile, single-use, 
prescription device:
a) Model No. 5001101; b) Model No. 5001101 NE;
c) Model No. 5001102.  Recall #Z-1061/1063-9.
CODE
a) Lot No. 9306.05K; b) Lot No. 9373.08K;
c) Lot Nos. 9267.08J, 290.03K, 9340.01L, 9357.03L, 9394-03L, 
9403.04L, 404.07L, 9405.09L, 9415.03M, 9434.05M.
MANUFACTURER
Quest Medical, Inc., (QMI), an Atrion company, Allen, Texas.
RECALLED BY
Manufacturer, by telephone on May 6, 1999, followed by letter.  
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
3,430 units were distributed.
REASON
The delivery sets may develop a leak in the main pump cassette 
during use.
________
PRODUCT
Ampilcor HBV Monitor(tm) Kit, an IVD test that utilizes PCR 
nucleic acid amplification and DNA hybridization for the 
detection and quantitative measurement for Hepatitis B viral DNA 
in human serum or plasma:  a) Catalog No. 87521/0757160 
(Domestic), Amplicor HBV Monitor(tm) Test "For Research Use 
Only"; b) Catalog No. 83271/0757152 (International), Amplicor HBV 
Monitor(tm) Test "For In Vitro Diagnostic Use".
Recall #Z-1064/1065-9.
CODE
Lot numbers:  a) Lot No. 9803, EXP 5/99; b) Lot No. 9804,
EXP 5/99.
MANUFACTURER
AB Sangtec Medical, Bromma, Sweden.
RECALLED BY
Roche Molecular Systems, Inc., Somerville, New Jersey, by field 
correction dated February 8, 1999.  Firm-initiated recall 
complete.
DISTRIBUTION
New Jersey, Pennsylvania, Maryland, North Carolina, Indiana, 
Michigan, Texas, California.
QUANTITY
91 kits were distributed.
REASON
The IS values for the standards are low which results in HBV/IS 
OD ratios which are high and outside of the kit-specified 
acceptance criteria causing invalid runs.


RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS III
________
PRODUCT
Steris Process Biological Indicator; the kit includes 20 
biological indicators (B.stearothermophilus), 20 vials filled 
with growth medium, and a Certificate of Performance and 
Instruction Card, to be used in conjunction with STERIS Chemical 
Monitoring Strips.  The product is shipped frozen.
Recall #Z-1048-9.
CODE
Catalog Numbers:  S3032, S3036, and S3036-2.  The lot number is a 
6-digit number.  All lots which end with '613', '815', or '816' 
are subject to this recall.  The expiration dates and ending lot 
numbers are as follows:  '613'/exp 7/99; '815'/exp 8/99; and 
'816'/exp 3/99. 
MANUFACTURER
Steris Corporation, Mentor, Ohio.
RECALLED BY
Manufacturer, by memorandum dated August 26, 1998.  Firm-
initiated recall complete.
DISTRIBUTION
Nationwide and international.
QUANTITY
8,553 kits were distributed.
REASON
Product failed stability testing at three (3) months.  The spore 
counts dropped below labeled specification.
________
PRODUCT
Kodak Digital Science Medical Film EIR-11 Laser Imaging Film, 
intended for secondary imaging of radiographs, packed 150 sheets 
per box.  Recall #Z-1057-9 
CODE
Lot/Serial Nos. 4597-0128-003-11/-12/-13/-14/-15.
MANUFACTURER
Eastman Kodak Company, Health Imaging Division, Rochester,
New York.
RECALLED BY
Manufacturer, by telephone on April 26 and 27, 1999.  Firm-
initiated recall ongoing.
DISTRIBUTION
Arizona, Kansas, North Carolina, Nebraska, Ohio, Pennsylvania.
QUANTITY
32 cases (450 sheets per case) were distributed.
REASON
The film was exposed to light during the rewind process, and has 
an elevated background fog.  The normal level of fog has a Dmin of 
0.18, while the identified product has a Dmin of 0.30.

________
PRODUCT
ARCHITECT Estradiol Reagent Kit, list 6C22-20 - 4 x 100 tests 
and list 6C22-25 - 1 x 100 tests; an in-vitro diagnostic 
Chemiluminescent Microparitcle Immunoassay (CMIA) for the 
quantitative determination of estradiol in human serum and 
plasma.  Recall #Z-1060-9.
CODE
List 6C22-20, lot 49994M100 and List 6C22-25, lot 49994M101.
MANUFACTURER
Abbott Laboratories, Abbott Park, Illinois.
RECALLED BY
Manufacturer, by letter dated June 29, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
245 400-test kits and 68 100-test kits were distributed.
REASON
The Architect Estradiol Reagents may show under-recovery of 
estradiol with undiluted patient specimens.

ALLS AND FIELD CORRECTIONS:  VETERINARY PRODUCTS -- CLASS 
II
________
PRODUCT
Agri-Cillin, Penicillin G Procaine Injectable Suspension, USP, 
Injectable Antibiotic in Aqueous Suspension 300,000 units per mL, 
OTC.  Recall #V-070-9.
CODE
Lot #8501-02 EXP 12/00.
MANUFACTURER
Norbrook Laboratories Ltd., Newry, Northern Ireland.
RECALLED BY
Agri Laboratories, Ltd., St. Joseph, Missouri, by letter dated 
May 26, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nebraska, South Dakota, California, Idaho, Oklahoma, Ohio, Texas, 
Louisiana, Kansas, New York, Colorado.
QUANTITY
3,618 bottles were distributed.
REASON
Product contains glass, unidentified foreign material fiber 
clumps and hair.

END OF ENFORCEMENT REPORT FOR JULY 14, 1999.  BLANK PAGES MAY 
FOLLOW.