FDA

Enforcement Report

November 10, 1999                                             99-45

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS I
_______
PRODUCT
Vanilla Swiss Almond Rice Dream Non-Dairy Dessert, packaged in 
pint containers.  Recall #F-013-0.
CODE
6-11877541 9147 BH.
MANUFACTURER
Humboldt Creamery Association, Fernbridge, California.
RECALLED BY
Imagine Foods, Inc., Palo Alto, California, by letter faxed on 
September 22, 1999, and by press release on September 23, 1999.  
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
6,050 cases (12 packages per case) were distributed.
REASON
Product may be contaminated with peanut residue.
________
PRODUCT
Ice Cream as follows:
a) Chocolate Chip Cookie Dough Ice Cream in 1/2 gallon and
2 1/2 gallon size containers 
b) Pistachio Nut Ice Cream in 1/2 gallon and 2 1/2 gallon 
containers
c) Rocky Road Ice Cream in 1/2 gallon and 2 1/2 gallon containers 
d) Tin Roof Ice Cream in 2 1/2 gallon size containers 
e) Caramel Cashew Ice Cream in 2 1/2 gallon size containers 
f) Turtle Sundae Ice Cream in 1/2 gallon and 2 1/2 gallon size 
containers 
g) Butter Pecan Ice Cream in 2 1/2 gallon size containers 
h) Chocolate Butter Pecan Ice Cream in 2 1/2 gallon size  
containers 
i) Maple Nut Ice Cream in 1/2 gallon and 2 1/2 gallon size 
containers 
j) Peanut Butter Cup Ice Cream in 2 1/2 gallon size containers 
k) Peanut Butter Ripple Ice Cream in 2 1/2 gallon size containers 
l) Chocolate Peanut Butter Ripple Ice Cream in 2 1/2 gallon size 
containers.  Recall #F-015/026-0.
CODE
Products are not coded.  All products distributed on or before 
July 22, 1999.
MANUFACTURER
Steese's Ice Cream Company, Grove City, Pennsylvania.
RECALLED BY
Manufacturer, by telephone on July 23, 1999, by press release on 
July 24, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Pennsylvania.
QUANTITY
Undetermined.
REASON
Products do not bear complete ingredient statements and contain 
the following undeclared ingredients:  a) eggs and wheat; b-e) 
cashews; f-h) pecans; i) walnuts; j-l) peanuts.

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS II
________
PRODUCT
OVA brand Orange Peach Drink, in 473 ml glass bottles, a non-
carbonated beverage.  Recall #F-010-0.
CODE
All codes.
MANUFACTURER
Grayco Sales, Ltd., Ontario, Canada.
RECALLED BY
Consolidated Stores Corporation, Columbus, Ohio, by E-mail on 
August 25, 1999. Completed recall resulted from sample analysis 
and follow-up by the New York State Department of Agriculture and 
Markets.
DISTRIBUTION
Nationwide.
QUANTITY
37,536 bottles were distributed.
REASON
Product contains the uncertified color additives tartrazine 
(certifiable as FD&C Yellow No. 5) and sunset yellow (certifiable 
as FD&C Yellow No. 6).
________
PRODUCT
Life Savers Candy, in 5.2 ounce (150g) plastic bags.  
Recall #F-011-0.
CODE
All codes.
MANUFACTURER
Beta Brands Ltd., Ontario, Canada.
RECALLED BY
Consolidated Stores Corporation, Columbus, Ohio, by E-mail, on 
August 25, 1999. Completed recall resulted from sample analysis 
and follow-up by the New York State Department of Agriculture and 
Markets.
DISTRIBUTION
Nationwide.
QUANTITY
72,000 bags were distributed.
REASON
The product contains the uncertified color additives
tartrazine (certifiable as FD&C Yellow No. 5), sunset yellow
(certifiable as FD&C Yellow No. 6), and brilliant blue FCF
(certifiable as FD&C Blue No. 1).  It also contains an unapproved 
color formerly certifiable as FD&C Red. No. 2.
________
PRODUCT
Ice Cream and Sherbet as follows:
a) Butter Almond Ice Cream, in 2 1/2 gallon size containers 
b) Coconut Cream Ice Cream in 1/2 gallon and 2 1/2 gallon size 
containers
c) Butterscotch Ice Cream in 1/2 gallon and 2 1/2 gallon size 
containers 
d) Banana Cream Ice Cream in 2 1/2 gallon size containers 
e) Bubble Gum Ice Cream in 2 1/2 gallon size containers 
f) Cookies and Cream Ice Cream in 1/2 gallon and 2 1/2 gallon 
size containers 
g) Graham Cracker Ice Cream in 2 1/2 gallon size containers 
h) Peppermint Stick Ice Cream in 1/2 gallon and 2 1/2 gallon size 
containers 
i) Sunrise (Orange Sherbet and Vanilla Ice Cream) in 2 1/2 gallon 
size containers 
j) Orange Sherbet in 1/2 gallon and 2 1/2 gallon size containers
k) Orange Pineapple Ice Cream in 1/2 gallon size containers.  
Recall #F-027/037-0.
CODE
Products are not coded.  All products distributed on or before 
July 22, 1999.
MANUFACTURER
Steese's Ice Cream Company, Grove City, Pennsylvania.
RECALLED BY
Manufacturer, by telephone on July 23, 1999, by press release on 
July 24, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Pennsylvania.
QUANTITY
Undetermined.
REASON
Products do not bear complete ingredient statements and contain 
the following undeclared ingredients:
a) almonds; b-e) FD&C Yellow No. 5, and FD&C Yellow No. 6;
f-g) FD&C Yellow No. 5 and wheat; h) FD&C Yellow No. 5;
i-k) FD&C Yellow No. 6.
________
PRODUCT
Prawn Crackers (Color) Banh Phong Tom Mau in 8 ounce boxes packed 
60 per case and 16 ounce boxes packed 50 per case.
Recall #F-043-0.
CODE
None.  All lots distributed in 1999.
MANUFACTURER
Packed for Guangdong Foods I & E Company, Ltd., Guangdong, China.
RECALLED BY
Great Union Wholesale, Inc., Houston, Texas, by letter dated 
September 23, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Texas and Florida.
QUANTITY
400 8-ounce boxes and 120 16-ounce boxes were distributed 
REASON
The product contains the unapproved color additives Ponceau 4R 
and azorubine.  In addition it contains the uncertified colors 
sunset yellow FCF (certifiable as FD&C Yellow No. 6), brilliant 
blue FCF (certifiable as FD&C Blue No. 1), and tartrazine 
(certifiable as FD&C Yellow No. 5). 

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS III
________
PRODUCT
Shaw's Tender Blue Lake French Style Green Beans, in 14.5 ounce 
cans.  Recall #F-014-0.
CODE
1307G 89161.
MANUFACTURER
Chiquita Brands (formerly KNA Friday Canning), Gillett, 
Wisconsin.
RECALLED BY
Shaw's Supermarkets, Inc., East Bridgewater, Massachusetts, by 
letter on August 26, 1999, October 16 and 18, 1999, and by press 
release on October 22, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Connecticut, Massachusetts, Maine, New Hampshire, Rhode Island, 
Vermont.
QUANTITY
1,326 cases (24 cans per case) were distributed.
REASON
Product may be contaminated with filth.
________
PRODUCT
Ice Cream as follows:
a) Black Walnut Ice Cream in 1/2 gallon size containers 
b) Butter Pecan Ice Cream in 1/2 gallon size containers 
c) Chocolate Peanut Butter Ripple Ice Cream in 1/2 gallon size 
containers 
d) Peanut Butter Ripple Ice Cream in 1/2 gallon size containers. 
 Recall #F-038/041-0.
CODE
Products are not coded.  All products distributed on or before 
July 22, 1999.
MANUFACTURER
Steese's Ice Cream Company, Grove City, Pennsylvania.
RECALLED BY
Manufacturer, by telephone on July 23, 1999, by press release on 
July 24, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Pennsylvania.
QUANTITY
Undetermined.
REASON
Products are misbranded because the labeling lists "nuts" as an 
ingredient but does not specify which nut is in the product.
________
PRODUCT
Hunt's Ketchup Plastic Squeeze Bottles, sizes 24 ounces, 32 
ounces and 50 ounces.  Recall #F-044-0.
CODE
The following codes and dates are affected:
CODE   DATE
R95A   05/10/99
R95B   05/11/99
R95C   05/12/99
R95D   05/13/99
R95E   05/14/99
R95F   05/15/99
R95H   05/16/99
R95J   05/17/99
R95K   05/18/99
R95L   05/19/99
R95M   05/20/99
R95N   05/21/99
R95O   05/22/99
R95P   05/23/99
R95R   05/24/99
R95S   05/25/99
R95T   05/26/99
R95U   05/27/99
R95W   05/28/99.
MANUFACTURER
ConAgra Grocery Products Cannery, Perrysburg, Ohio.
RECALLED BY
ConAgra Grocery Products Cannery, Fullerton, California, by 
telephone on June 11, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
294,419 cases were distributed.
REASON
Product is contaminated with Lactobacillus fermentum and 
Lactobacillus cellobiosus.

RECALLS AND FIELD CORRECTIONS:  COSMETICS -- CLASS II
________
PRODUCT
Liquid Mouth Rinse/Mouth Wash, alcohol free, packed in 4 fluid 
ounce plastic bottles, under the BeFresh and MediFresh labels.  
Recall F-045-0.
CODE
Lot #08309-B.
MANUFACTURER
Chester Labs, Inc., Cincinnati, Ohio.
RECALLED BY
Manufacturer, by telephone on October 19, 1999, and by letter on 
October 26, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Florida, New York, Tennessee, Ohio, Illinois, Texas.
QUANTITY
444 cases (26,640 bottles) were distributed; firm estimated that 
170 cases remained on market at time of recall initiation.
REASON
Product is contaminated with Enterobacter gergoviae.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS II
________
PRODUCT
Red Blood Cells, Autologous.  Recall #B-038-0.
CODE
Unit #J43291.
MANUFACTURER
Blood Assurance, Inc., Chattanooga, Tennessee.
RECALLED BY
Manufacturer, by telephone on August 31, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Georgia.
QUANTITY
1 unit was distributed.
REASON
Blood product tested initially reactive for anti-HCV, and 
negative by a single repeat test.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma;
d) Cryoprecipitated AHF; e) Platelets for Use in Manufacturing 
Non-Injectable Products; f) Recovered Plasma Liquid For 
Manufacturing Non-Injectable Products;
g) Recovered Plasma.  Recall #B-065/071-0.
CODE
Unit Numbers:  a) 31507, 57170, 99944, 118635, 173081, 194857, 
285506, 292734, 314544, 354293, 462826, 507843, 0562387, 0594245, 
0645267
b) 57170, 99944, 118635, 173081, 194857, 292734, 354293, 0562387; 
c) 173081, 462826; d) 9005621
e) 507843, 0594245; f) 114331, 14425, 46007, 48744, 90708,
92982, 477357; g) 507843, 31507, 57170, 99944, 194857, 245265, 
247572, 285506, 292734, 314544, 354293, 0562387, 0594245, 
0645267, 9005621.
MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.
RECALLED BY
Manufacturer, by letters dated June 15, 22, or 28, 1999.  Firm-
initiated recall complete.
DISTRIBUTION
Minnesota, North Carolina, Ohio, Virginia, California, Florida, 
Texas, Pennsylvania, Switzerland.
QUANTITY
a) 15 units; b) 8 units; c) 2 units; d) 1 unit; e) 2 units; f) 7 
units; g) 15 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 donors who previously tested repeatedly reactive for anti-
HIV-1, Western blot indeterminate.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma;
d) Cryoprecipitated AHF; e) Recovered Plasma Liquid For 
Non-Injectable Products; f) Recovered Plasma, Pooled.
Recall #B-076/081-0.
CODE
Unit Numbers:  a) 74271, 163310, 268929, 399080, 92229, 107723; 
b) 74271, 163310, 268929, 92229, 107723;
c) 74271, 268929, 92229, 107723; d) 9007428; 
e) 399080; f) 9007428.
MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.
RECALLED BY
Manufacturer, by letters dated June 15, 21, or 28, 1999.  Firm-
initiated recall complete.
DISTRIBUTION
Minnesota, California, Florida.
QUANTITY
a) 6 units; b) 5 units; c) 4 units; d) 1 unit; e) 1 unit; f) 1 
unit distributed.
REASON
Blood products either tested initially reactive for the antibody 
to the human immunodeficiency virus type 1 (anti-HIV-1), or which 
tested negative for the antibody to the human immunodeficiency 
virus, but were collected from donors who previously tested 
repeatedly reactive for either anti-HIV-1 or anti HIV-1/2.
________
PRODUCT
Blood Collection Systems.  Recall #B-084-0.
CODE
50 lot numbers of products manufactured from May 04 through July 
05, 1999.
MANUFACTURER
Medsep Corporation, a subsidiary of Pall Corporation, Covina, 
California.
RECALLED BY
Manufacturer, by letter dated August 2, 1999, followed by 
telephone.  Firm-initiated recall complete.
DISTRIBUTION
Nationwide and England.
QUANTITY
390,076 units were distributed.
REASON
Blood collection bags contained low volumes of anticoagulant.
________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated; 
b) Recovered Plasma.  Recall #B-086/087-0.
CODE
Unit #40GE37390.
MANUFACTURER
American Red Cross Blood Services, Peoria, Illinois.
RECALLED BY
Manufacturer, by letter dated July 23, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Illinois and California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor taking the drug 
Proscar.
________
PRODUCT
Salvage Plasma.  Recall #B-089-0.
CODE
Unit #7023525.
MANUFACTURER
Department of the Air Force, Keesler AFB, Mississippi.
RECALLED BY
Manufacturer, by telephone on September 12, 1997.  Firm-initiated 
recall complete.
DISTRIBUTION
Florida.
QUANTITY
1 unit was distributed.
REASON
Blood product was not tested for the antibodies to the human 
immunodeficiency virus type1/2, and Hepatitis B surface antigen 
(HBsAG), Hepatitis C virus encoded antigen (anti-HCV), Hepatitis 
B core antigen (anti-HBc), and syphilis.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Platelets, Pheresis;
d) Fresh Frozen Plasma; e) Recovered Plasma.  
Recall #B-100/104-0.
CODE
FDA, Center for Biologics Evaluation and Research, Contact Office 
of Compliance (301) 827-6220 for individual unit numbers 
recalled.
MANUFACTURER
Blood Systems, Inc., Tupelo, Mississippi.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on 
November 21 and 26, 1997, by letter and fax on January 30, 1998. 
 Firm-initiated recall complete.
DISTRIBUTION
Alabama, California, Illinois, Louisiana, Mississippi, New 
Jersey, New York, Tennessee.
QUANTITY
a) 111 units; b) 10 units; c) 14 units; d) 19 units; e) 82 units 
were distributed.
REASON
Blood products were collected from donors whose suitability was 
not adequately determined.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
Recall #B-105/106-0.
CODE
Unit #19233-2718.
MANUFACTURER
United Blood Services, Reno, Nevada.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone or letter 
on February 6, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Texas and Switzerland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who received weekly 
injections of gold salt.
________
PRODUCT
a) Red Blood Cells; b) Platelets.  Recall #B-120/121-0.
CODE
Unit Numbers: 22KV05788, 22GE46099.
MANUFACTURER
American National Red Cross, Philadelphia, Pennsylvania.
RECALLED BY
Manufacturer, by letters dated October 13 and 30, 1998, February 
3, 1998, and March 1, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Pennsylvania and New Jersey.
QUANTITY
2 unit of each component were distributed
REASON
Blood products were collected from donors who reported having 
lived or traveled in area designated as endemic for malaria.
________
PRODUCT
a) Red Blood Cells, Leukoreduced; b) Recovered Plasma.
Recall #B-123/124-0.
CODE
Unit #03GV11621.
MANUFACTURER
American Red Cross Blood Services, Atlanta, Georgia.
RECALLED BY
Manufacturer, by letter dated October 28, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Georgia and California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a unsuitable donor.
________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced, Irradiated.
Recall #B-125-0.
CODE
Unit #0328384-A2.
MANUFACTURER
Inland Northwest Blood Center, Spokane, Washington.
RECALLED BY
Manufacturer, by telephone on July 22, 1999, and by letter dated 
July 27, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Washington state.
QUANTITY
1 unit was distributed.
REASON
Blood product had incomplete documentation of irradiation.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS III
________
PRODUCT
Reverse Group 4TM, Pooled Cells for Serum Confirmation of ABO 
Group; b) Screening Cell PoolTM, for use in detection
of unexpected antibodies.  Recall #B-082/083-0.
CODE
a) Lot 0629 EXP 04 Aug 99; b) Lot 0629, EXP 04 Aug 99.
MANUFACTURER
Gamma Biologicals, Inc., Houston, Texas.
RECALLED BY
Manufacturer, by letter dated July 6, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Nationwide, Japan, Netherlands, Saudi Arabia.
QUANTITY
a) 198 vials; b) 226 vials were distributed.
REASON
In-vitro diagnostic products were contaminated with Serratia 
marcesans.
________
PRODUCT
Red Blood Cells, Irradiated, Leukocytes Reduced.
Recall #B-085-0.
CODE
Unit #X46547.
MANUFACTURER
Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY
Manufacturer, by telephone on August 19, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Illinois.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
________
PRODUCT
Sandoglobulin IV, Immune Globulin Intravenous (Human), in 12 gram 
vials, indicated for the maintenance treatment of patients with 
primary immunodeficiencies.  Recall #B-088-0.
CODE
Lot number on box (lot number on vial):  #561Z4409 (7.409.561.0), 
 029A6093 (8.409.208.0), 047A6478 (8.409.362.0), 053A6697 
(8.409.433.0), 053A6698 (8.409.433.0), 072A8945 (8.409.599.0), 
080B9812 (9.409.229.0), 085B9813 (9.401.255.0), 090B0161 
(9.401.292.0), 561Z4098 (7.409.561.0), 072A8946 (8.409.599.0).
MANUFACTURER
ZLB Central Laboratory, Bern, Switzerland.
RECALLED BY
Novartis, East Hanover, New Jersey, by fax or letter dated August 
27, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
24,585 vials were distributed.
REASON
Eleven lots of Immune Globulin Intravenous (Human) exceeded the 
residual moisture specification.
________
PRODUCT
Recovered Plasma.  Recall #B-131-0.
CODE
Unit #2549185.
MANUFACTURER
Department of Army, Armed Services Blood Bank Center, Tacoma, 
Washington.
RECALLED BY
Manufacturer, by letters dated February 10, 1999, and May 28, 
1999.  Firm-initiated recall complete.
DISTRIBUTION
Pennsylvania.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported taking the 
drug mesalamine.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS II
________
PRODUCT
RUBELLA IgG ELISA TEST KIT, diagnostic test kit used for 
detection of IgG antibody to rubella virus in human serum.
Recall #Z-085-0.
CODE
Catalog/Product Number:  RUE100-E, Lot #9DMGWW, EXP 4/30/00.
MANUFACTURER
Gull Laboratories, Salt Lake City, Utah.
RECALLED BY
Meridian Diagnostics, Inc., Cincinnati, Ohio, by telephone 
beginning August 24, 1999, and by fax between August 24 and 27, 
1999.  Firm-initiated recall complete.
DISTRIBUTION
California, Florida, Massachusetts, Michigan, Minnesota, 
Missouri, New York, Oklahoma, Pennsylvania, Texas.
QUANTITY
178 units.
REASON
Optical density (O.D.) values for the reference serum are outside 
of acceptable limits.
________
PRODUCT
LIFEPAK 500 Automated External Defibrillator designed to be used 
by first responders to cardiac emergencies.
Recall #Z-086-0.
CODE
Part Numbers: 3005400-000, 001, 002, 003, 004, 005, 009. 010, 
011, 012, 013, 014, 018, 020, 021, 022, 029, 030, 031, 064, 065, 
066, 067, 068, 070, 071, 074, 076, 078, 082, 083, 084 and 085.  
Serial Numbers: All devices distributed prior to 8/21/98.  The 
serial number range is for selected 8 digit serial numbers less 
than 10486696.
MANUFACTURER
Medtronic Physio-Control Corporation, Redmond, Washington.
RECALLED BY
Manufacturer, by visit on or about September 24, 1999.  Firm-
initiated field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
10,746 units were distributed.
REASON
Excessive electrical noise interfering with ECG analysis that, 
when present, may cause the shock advisory algorithm to render an 
incorrect decision.
________
PRODUCT
Blood Pressure Cuff for the BP 410 and 412 Monitor:
a) Part 17402-001: Blood pressure cuff, child
Part 17403-001: Blood pressure cuff, adult
Part 17403-003: Blood pressure cuff, large adult
b) Part 00304-001: 412 Blood pressure monitor (includes 71403-
001); Part 00304-002: 412 Blood pressure monitor 50hz (includes 
17403-001); Part 00304-B-001: 412 Blood pressure monitor 50hz 
(includes 17403-001).  Recall #Z-093/094-0.
CODE
None (n/a).
MANUFACTURER
Colin Medical Instruments Corporation, San Antonio, Texas.
RECALLED BY
Quinton Instrument Company, Bothell, Washington, by letter on or 
about October 15, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
630 units were distributed.
REASON
The bladder and air hose of the blood pressure cuff contain 
undeclared rubber latex.
________
PRODUCT
Portable Liquid Oxygen Units Models: AA-1000-EA, AA-1005-AA, AA-
1010-AA, AB-1001-EA, AB-1002-EC, AB-1005-AA, AB-1005-AE, AB-1005-
AG, AB-1005-EA, AB-1015-EA, AC-1005-AA, AD-1003-EA, AD-1005-AA, 
AD-1012-AA, AD-1017-EA, and AD-1014-EB.
Recall #Z-095/111-0.
CODE
No Lot Numbers.
MANUFACTURER
Penox Technologies, Inc., Pittston, Pennsylvania.
RECALLED BY
Manufacturer, by letter sent on August 12, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
1,144 units were distributed.
REASON
Portable liquid oxygen unit was distributed with unrestricted 
flow regulator.
________
PRODUCT
Schuhli Implant System, designed to lock a screw to a plate, 
independent of bony contact with the plate: Part numbers 219.401, 
219.401S, 219.402, 219.402S, 219.404, 219.404S, 219.411, 
219.411S, 219.412, 219.412S, 219.414, 219.414S, 419.401, 
419.401S, 419.402, 419.402S, 419.404, 419.404S, 419.411, 
419.411S, 419.412, 419.412S, 419.414, and 419.414S.   Recall #Z-
112/117-0.
CODE
All lots are involved.
MANUFACTURER
Synthes (USA), Monument, Colorado.
RECALLED BY
Synthes (USA), Paoli, Pennsylvania, by E-mail on October 30, 
1997.  Firm-initiated recall complete.
DISTRIBUTION
Nationwide, Canada, Switzerland.
QUANTITY
3,827 units. 
REASON
In some instances the device may not lock securely into the 
plate.
________
PRODUCT
Quickie Power Wheelchairs P200 Series, a powered wheelchair; 
battery operated medical device with wheels that is intended for 
medical purpose to provide mobility to persons restricted to a 
sitting position:
a) Model P120; b) Model P200; c) Model P210; d) Model P300;
e) Model P320.  Recall #Z-118/122-0.
CODE
Model P120, Serial #s: P19-0290 to P19-6340
Model P200, Serial #s: P2-1006 to P2-13486
Model P210, Serial #s: P2-10010 to P2-13517
Model P300, Serial #s: P3-10500 to P3-12197
Model P320, Serial #s: P32-1000 to P32-4420.
MANUFACTURER
Sunrise Medical Quickie Designs, Inc., Fresno, California.
RECALLED BY
Manufacturer, by letter on October 26, 1999, followed by 
telephone.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
11,030 units.
REASON
The failure of the front two bolts-caster plate-can result in the 
caster assembly separating from the chair frame.
________
PRODUCT
Sterngold Black Era-RV (Reduced Vertical) Males Intended for the 
retention of partial dentures:
Product Numbers: a) 811105 Era RV Starter Kit
b) 811115   Era RV Attachment
c) 811125   Era RV Black Males
d) 811166   Assorted Era RV Males
e) 811168   Era RV Housing
f) 811203   Era Offset RV 4.5mm
g) 811204   Era Offset RV 2.5mm.  Recall #Z-123/129-0.
CODE
Lot Numbers:  a) W1579; b) W1262, W1263, W1305, W1293, W1413, 
W1305,W1340, W1452, W1475, W1476,W1508, W1565, W1608, W1639, 
W1655, W1780, W1795,  W1795, W1812, W1841, 990901-1, 990902-1; c) 
W1178, W1483; d) W1302, W1774 
e) W1176, W1214, W1458; f) W1277, W1283, W1319, W1705 
g) W1278, W1284, W1318, W1660, W1767.
MANUFACTURER
Spectrum Plastics, Assonia, Connecticut.
RECALLED BY
Sterngold, Attleboro, Massachusetts, by letter dated September 
28, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
8,037 units.
REASON
Incorrect height dimensions to the denture attachment.
________
PRODUCT
LSL Sterile Tracheotomy Care and Clean Set, sterile, single 
patient use tray.  Recall #Z-131-0.
CODE
Product #LSL5110, Lot #9G3020.
MANUFACTURER
LSL Industries, Inc., Chicago, Illinois (kit);
Jiang Su Jin Hong Corporation, Jintan City, Jiangsu, China 
(gauze).
RECALLED BY
LSL Industries, Inc., Chicago, Illinois, by letter dated 
September 23, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Maine, Illinois, Missouri, New Jersey, Puerto Rico.
QUANTITY
1,160 trays.
REASON
The kits may contain a contaminated gauze component.  The gauze 
may contain an ETO resistant mold.
________
PRODUCT
FreeHand Implantable Epimysial Electrodes for the NeuroControl 
FreeHand System, Part #1320-A and Model 200-19, all 
sizes/lengths.  The system uses electrical muscle stimulation 
which is intended to improve a patient's ability to grasp, hold, 
and release objects.  Recall #Z-132-0.
CODE
The affected serial numbers are:
243, 253, 259, 263, 289, 290, 368, 471, 493, 512, 800, 804, 820, 
842, 850, 852, 873, 885, 900, 914, 893, 955, 968, 971, 977, 980, 
983, 1077, 1127, 1151, 1153, 1172, 1217, 1221, 1241, 1250, 1255, 
1261, 1307, 1564, 1582, 1604, 1606, 1630, 1635, 1651, 1955, 1965, 
1966, 1976, 1981, 1999, 2001, 2006, 2044, 2045, 2046, 2055, 2325, 
2062, 2232, 2063, 2065, 2067, 2008, 2069, 2160, 2198, 2229, 2234, 
2235, 2236, 2237, 2249, 2253, 2276, 2291, 2293, 2294, 2295, 2299, 
2315, 2323, 2326, 2327, 2331, 2424, and 2425.
MANUFACTURER
NeuroControl Corporation, Valley View, Ohio (kits);
Bio-Control Technology, Inc., Indiana, Pennsylvania (electrodes).
RECALLED BY
NeuroControl Corporation, Valley View, Ohio, by telephone 
beginning on November 13, 1998.  Firm-initiated recall ongoing.
DISTRIBUTION
New York, Pennsylvania, Indiana, Australia, United Kingdom, 
France.
QUANTITY
87 electrodes included in a total of 6 kits.
REASON
Lack of assurance that the electrodes were sterilized.
________
PRODUCT
a) Percutaneous Transluminal Angioplasty (PTA) Catheter, Catalog 
numbers: PTA-OS253, 303 and 403
b) Z-MED Dilation Catheter, Catalog Numbers: PDZ-S
c) Z-MED II Dilatation Catheter, Catalog Numbers: PDS-630, 643 
and 655
d) PTA-OS Balloon Catheter, Catalog Numbers: VSB-030 and 040
e) Ghost II Dilation Catheter, Catalog Numbers: GII-109, 113, 
121, 129, 130, 137, 138, 141.  Recall #Z-135/139-0.
CODE
a) OS-0013THRU OS-0014, AND OS-0022 THRU OS-0024
b) Z-0774
c) ZZ-0240 THRU ZZ-0242
d) OS-0025/0026 
e) GG0138 THRU GG0145.
MANUFACTURER
NUMED, Inc., Hopkinton, New York.
RECALLED BY
Manufacturer, by fax between January 29, 1999 and February 5, 
1999.  Firm-initiated recall complete.
DISTRIBUTION
Massachusetts, United Kingdom, South Africa, Argentina.
QUANTITY
302 catheters were distributed.
REASON
Non-sterility.
________
PRODUCT
Surface Smoothness Sensor, Model 4206.  Recall #Z-141-0.
CODE
Model #4206.
MANUFACTURER
Honeywell-Measurex Corporation, Cupertino, California.
RECALLED BY
Manufacturer.  FDA Approved the firm's corrective action plan on 
May 11, 1999.  Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
14 units.
REASON
The laser product failed to comply with the Federal laser product 
performance standard, 21 CFR 10 1040.10(d) in that the product 
permitted human access to laser radiation in excess of the product 
class, and 1040.10(f)(2) in that the product failed to incorporate 
a safety interlock that was fail safe or redundant.
________
PRODUCT
Abbott TestPack Plus H. pylori Reaction Discs, in vitro 
diagnostic, rapid, visually read, qualitative immunoassay for the 
detection of human IgG antibodies specific to Helicobacter pylori 
in serum, plasma and whole blood:
List 1D04-05 - 5 test kit (whole blood);
List 1D04-16 - 20 test kit (whole blood);
List 6C71-16 - 20 test kit (whole blood, plasma or serum). Recall 
#Z-144/145-0.
CODE
List number 1D04-05:  Lot numbers 54412M300, 56628M200
List number 1D04-16:  Lot numbers 54334M300, 56629M200
List number 6C71-16:  Lot numbers 54417M300, 55211M300, 
56631M200.
MANUFACTURER
Abbott Laboratories, Inc., North Chicago, Illinois.
RECALLED BY
Abbott Laboratories, Inc., Abbott Park, Illinois, by letter dated 
October 22, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
5,003 kits were distributed.
REASON
False positive results with some negative samples.
________
PRODUCT
Abbott Gonozyme Diagnostic Kit, an EIA for detection of Neisseria 
gonorrhoeae antigens in urethral and endocervical swab specimens 
from humans; 100 test kit:
List 6502-24 - Kit with female swabs
List 6502-25 - Kit with male swabs
List 6502-62 - Reagent Kit with no swabs.
Recall #Z-148/150-0.
CODE
Lot number 49762M300.
MANUFACTURER
Abbott Laboratories, Inc., Abbott Park, Illinois.
RECALLED BY
Manufacturer, by letter dated October 19, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Texas, Germany, Italy, Japan, Singapore, Taiwan.
QUANTITY
136 kits were distributed.
REASON
Stability failure.
________
PRODUCT
Ameda Disposable Vacuum Assist Cup, a sterile, single use device 
for use with electric or hand-held vacuum pumps to facilitate 
vaginal delivery of term or near term infants exhibiting fetal 
distress.  Recall #Z-151-0.
CODE
Sotck #17420, Lot #9E10.
MANUFACTURER
Hollister, Inc., Cary, Illinois.
RECALLED BY
Hollister, Inc., Libertyville, Illinois, by letter dated October 
22, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
1,780 units were distributed.
REASON
Some of the tubing adapters do not have the black "O-rings" in 
place.
________
PRODUCT
Alpha IQ Mammographic X-Ray Units:  a) Model IQ; 
b) Model RT.  Recall #Z-152/153-0.
CODE
Serial numbers 8140-8268, except 8251, 8189, 8254, 8257, 8219, 
and 8238.
MANUFACTURER
Instrumentarium Corporation, Imaging Division, Tuusula, Finland.
RECALLED BY
Instrumentarium Imaging, Inc., Milwaukee, Wisconsin, by field 
modification instructions dated October 28, 1999.  Firm-initiated 
field correction ongoing.
Nationwide.
QUANTITY
62 units were distributed.
REASON
There can be unintended motion of the C-arms of the X-ray 
units due to insufficient switch insulation.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS III
________
PRODUCT
Immunocard Toxin A, a diagnostic test kit.  Recall #Z-133-0.
CODE
Catalog # 711050, Lot Numbers:  #711050.112 and #711050.113.  
Both lots expire on 5/29/00.
MANUFACTURER
Meridian Diagnostics, Inc., Cincinnati, Ohio.
RECALLED BY
Manufacturer, by telephone on beginning on August 8, 1999, and by 
letters mailed on August 8, 1999, and September 17, 1999.  Firm-
initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
291 kits were distributed.
REASON
Kits contain an improper sample transfer pipet (50ul instead of 
25 ul).
________
PRODUCT
Premier Giardia, a diagnostic test kit.  Recall #Z-134-0.
CODE
Catalog #614096, Lot Numbers:  614096.010 EXP 9/8/99 and 
614096.011 EXP 11/10/99.
MANUFACTURER
Meridian Diagnostics, Inc., Cincinnati, Ohio.
RECALLED BY
Manufacturer, by letter dated October 13, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
601 kits were distributed.
REASON
Weak positive test samples may be reported as false negative.
________
PRODUCT
Abbott TestPack Chlamydia 20T-CE Kit, in-vitro diagnostic enzyme 
immunoassay for the detection of Chlamydia trachomatis antigen 
from endocervical swab specimens; 20 tests per kit.  Recall #Z-
140-0.
STRONG>CODE
List 03436-18; Kit lot #56934M200; Swab lot #170.
MANUFACTURER
Abbott Laboratories, Inc., North Chicago, Illinois.
RECALLED BY
Abbott Laboratories, Inc., Abbott Park, Illinois, by letter dated 
October 19, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
48 kits were distributed.
REASON
Swab component expires prior to the kit expiration date.
________
PRODUCT
ARCHITECT Estradiol Reagent Kit: List 6C22-20 and List 6C22-25, 
in-vitro diagnostic Chemiluminescent Microparticle Immunoassay 
(CMIA) for the quantitative determination of estradiol in human 
serum and plasma.  Z-142/143-0.
CODE
List 6C22-20 (400 tests): lots 47955M300, 54859M100, 
54859M103, 54965M300, 55686M200; 
List 6C22-25 (100 tests): lots 47955M301, 54859M101, 54965M301, 
55686M201.
MANUFACTURER 
Abbott Laboratories, Inc., Abbott Park, Illinois.
RECALLED BY
MANUFACTURER, by telephone on October 20, 1999, 
and by letters dated October 19, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
825 400-test kits; 463 100-test kits were distributed.
REASON
Under recovery of estradiol with undiluted patient specimens. 
________
PRODUCT
Abbott Test Pack Plus hCG Combo with on Board Controls (OBC) 
Reaction Disc, a self-performing immunoassay designed for the 
qualitative detection of human chorionic gonadotropin (hCG) in 
serum and urine for early detection of pregnancy.  Recall #Z-146-
0.
CODE
List 7B34, Lot Numbers 52412M200, 52414M200, 53867M100, 
55058M200.
MANUFACTURER
Abbott Laboratories, Inc., North Chicago, Illinois.
RECALLED BY
Abbott Laboratories, Inc., Abbott Park, Illinois, by letter dated 
October 22, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
32,036 kits were distributed.
REASON
Lots may produce false positive results.
________
PRODUCT
Abbott Vision Chem Controls, multianalyte controls used for 
verifying the performance of specific chemistry tests on the 
Abbott Vision System.  Recall #Z-147-0.
CODE<
List 1433-02, Lot Numbers 51719M405, 51719M406, 51719M407.
MANUFACTURER
Abbott Laboratories, Inc. North Chicago, Illinois.
RECALLED BY
Abbott Laboratories, Inc., Abbott Park, Illinois, by letter dated 
October 19, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
2,589 kits were distributed.
REASON
Chem Control II running below specification range when used with 
SGPT assay.

END OF ENFORCEMENT REPORT FOR NOVEMBER 10, 1999.