FDA

Enforcement Report

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

CODE
M19114TK xxxx 8161 (where xxxx = military time).

MANUFACTURER
Wells Dairy, Inc., LeMars, Iowa.

RECALLED BY
Manufacturer, by press release and by telephone on September 4, 1998. Firm-initiated recall complete.

DISTRIBUTION
a) Minnesota, North Dakota, Wisconsin, Michigan; b) Iowa, Minnesota, South Dakota.

QUANTITY
a) 1,440 square half gallon containers; b) 1,628 square half gallon containers were distributed.

REASON
EASON Product contains undeclared peanuts.

CODE
None.

MANUFACTURER
Zenith AGRI - Industry, Ltd., Thailand.

RECALLED BY
Summit Import Corporation, New York, New York, by letter dated September 5, 1997. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
New York, New Jersey, Ohio, Florida, Pennsylvania, Tennessee.

QUANTITY
Firm estimates none remains on the market.

REASON
Product contained undeclared FD&C Yellow No. 5 and sodium benzoate.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

CODE
Can Code:

J7L245 xx:xx
           3323F, (Manufactured 10/24/97).

MANUFACTURER
Curtis Burns Food, Oakfield, New York.

RECALLED BY
Stop & Shop Supermarkets Company, Quincy, Massachusetts, by telephone followed by E-mail on August 20, 1998. Firm-initiated recall complete.

DISTRIBUTION
Connecticut, Massachusetts, Rhode Island, New York.

QUANTITY
Approximately 8,000 were distributed.

REASON
Product is contaminated with rodent parts.

CODE
Unit numbers: a) KF21280, KF20551, KQ20957, KQ15799, KQ10656, KQ11783; b) KF20551, KQ20957, KQ15799, KQ10656, KQ11783; c) KF20551, KQ15799, KQ10656, KQ11783; d) KF21280; e) KQ20957.

MANUFACTURER
Virginia Blood Services, Richmond, Virginia.

RECALLED BY
Manufacturer, by letter dated December 9, 1997. Firm-initiated recall complete.

DISTRIBUTION
Virginia, Illinois, California.

QUANTITY
a) 6 units; b) 5 units; c) 4 units; d) 1 unit; e) 1 unit.

REASON
Blood products were collected from a donor whose spouse has hepatitis C.

PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-739/741-8.

CODE
Unit numbers: a) 03FW43712, 03FW43713, 03FW43715, 03FW43718, 03FW43719; b) 03FW43713, 03FW43714; c) 03FW43714, 03FW43715, 03FW43719.

MANUFACTURER
American Red Cross Blood Services, Atlanta, Georgia.

RECALLED BY
Manufacturer, by telephone on August 30, 1997, and by letter dated September 11, 1996. Firm-initiated recall complete.

DISTRIBUTION
Georgia.

QUANTITY
a) 5 units; b) 2 units; c) 3 units were distributed.

REASON
Blood products were collected from donors whose body temperatures and blood pressure were not determined.

PRODUCT
Source Plasma. Recall #B-1534-8.

CODE
180R5753, 180R6003, 180R8158, 180R8242, 180R8312, 180R8370, 180R8440, 180R8540, 180R8599, 180R8697, 180R8918, 180R8959, 180R9082, 180R9140, 180R9311, 180R9346, 180R9481, 180R9567, 180R9653, 180R9743, 180R9884, 180SC170, 180SC359, 180SC479, 180SC644, 180SC760, 180SC843, 180SB714, 180SB884, 180SB942, 180SD313, 1840P085, 1840P232, 1840P450, 1840P540, 1840P725, 1840P805.

MANUFACTURER
Centeon Bio-Services, Charlotte, North Carolina.

RECALLED BY
Centeon Bio-Services, King of Prussia, Pennsylvania, by letter dated March 3, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
37 units were distributed.

REASON
Blood products were drawn from an unsuitable donor.

PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Plasma, Liquid. Recall #B-001/004-9.

CODE
Unit numbers: a) 04KM31896, 34KK29129, 34FH06140; b) 04KM31896; c) 04KM31896, 34FH19464; 34FH06140, 34KK29129; d) 04KK70691, 04KK53628. Recall #B-001/004-9.

MANUFACTURER
American Red Cross, New England Region, Dedham, Massachusetts.

RECALLED BY
Manufacturer, by letter dated August 13, 1997, or by fax on August 12, or telephone August 8, 1997. Firm-initiated recall complete.

DISTRIBUTION
Massachusetts, Maine, New Hampshire, Vermont.

QUANTITY
a) 3 units; b) 1 unit; c) 4 units; d) 2 units were distributed.

REASON
Blood products were collected from a donor with a history of hepatitis.

PRODUCT
Platelets, Pheresis. Recall #B-005-9.

CODE
Unit numbers: 04LM56513A, 04LM56513B, 04LP31411A, 04LP31411B, 04LM56210B, 04KC04478A, 04KC04478B, 04LP31867A, 04LP31867B, 04LP31668, 04KC04546A, 04KC04546B, 04KC04506A, 04KC04506B.

MANUFACTURER
American Red Cross, New England Region, Dedham, Massachusetts.

RECALLED BY
Manufacturer, by letter dated December 19, 1997. Firm-initiated recall complete.

DISTRIBUTION
Massachusetts, New Hampshire, Maine.

QUANTITY
14 units were distributed.

REASON
Blood products had unacceptable platelet counts.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-006/007-9.

CODE
Unit numbers: Q09307, Q09580, M44969.

MANUFACTURER
Central California Blood Center, Fresno, California.

RECALLED BY
Manufacturer, by letter dated November 20, 1997. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
3 units of each component were distributed .

REASON
Blood products were not tested for syphilis.

PRODUCT
Platelets, Pheresis. Recall #B-008-9.

CODE
Unit numbers: 01P35015 and 01P34485.

MANUFACTURER
American Red Cross Blood Services, Rochester, New York.

RECALLED BY
Manufacturer, by letter dated either December 9, 1996 or February 24, 1997, and by telephone on December 9, 1996. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
2 units were distributed.

REASON
Blood products had high platelet counts.

PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-009/010-9.

CODE
Unit numbers: a) 01KW03173, 01KG11478, 01X71575, 01W43313, 01Q12731; b) 01KW03173, 01X71575, 01W43313, 01Q12731.

MANUFACTURER
American Red Cross Blood Services, Rochester, New York.

RECALLED BY
Manufacturer, by letter dated November 13, 1997. Firm-initiated recall complete.

DISTRIBUTION
New York and Pennsylvania.

QUANTITY
a) 5 units; b) 4 units were distributed.

REASON
Blood products were collected from a donor taking the drug Zovirax.

PRODUCT
Allergenic Extracts, Sterile Injectable 8 ml/vial dilutions of 1:40,000, 1:4,000, 1:400, 1:40, distributed by BioProducts for Medicine, Inc., (BMI), Phoenix, Arizona. Recall #B-013-9.

CODE
Lot Numbers: 1427, 1430, 1435, 1452, 1457, 1462. EXP Date: 8/14/99.

MANUFACTURER
Allergy Laboratories of Ohio, Inc., Columbus, Ohio.

RECALLED BY
Manufacturer, by fax on August 31, 1998. The distributor issued letter dated September 1, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Texas, Mississippi, Alabama, Louisiana, New Mexico, Missouri.

QUANTITY
19 patient treatment vials were distributed.

REASON
Unlicenced injectable allergenic extracts were distributed in interstate commerce.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-017/018-9.

CODE
Unit #Q07845.

MANUFACTURER
Central California Blood Center, Fresno, California.

RECALLED BY
Manufacturer, by letter dated November 19, 1997. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products tested RPR reactive for syphilis.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

CODE
Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.

MANUFACTURER
Central Kentucky Blood Center, Lexington, Kentucky.

RECALLED BY
Manufacturer, by letter dated February 20 or 21, 1997. Firm-initiated recall complete.

DISTRIBUTION
Kentucky, Florida, Texas, New Jersey, Illinois, North Carolina, Massachusetts, Connecticut, Maine, Arkansas, Maryland, California.

QUANTITY
a) --- units; b) 55 units were distributed.

REASON
Blood products were collected from donors whose medical history screening was incomplete.

PRODUCT
Red Blood Cells. Recall #B-608-8.

CODE
Unit #16LH15365.

MANUFACTURER
American Red Cross Blood Services, Columbus, Ohio.

RECALLED BY
Manufacturer, by telephone on September 9, 1997. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit was distributed.

REASON
Autologous blood product tested repeatedly reactive for the hepatitis B surface antigen (HBsAg), was not quarantined as required by the firm's standard operating procedures (SOP).

PRODUCT
Red Blood Cells for Further Manufacture. Recall #B-617-8.

CODE
Unit #38-13496.

MANUFACTURER
Michigan Community Blood Centers, Bay City, Michigan.

RECALLED BY
Manufacturer, by letter on May 5, 1997. Firm-initiated recall complete.

DISTRIBUTION
Michigan.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor with Graves disease.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-011/012-9.

CODE
Unit numbers: 38FC33530 and 38FC33550.

MANUFACTURER
American Red Cross Great Lakes Region, Fort Wayne, Indiana.

RECALLED BY
Manufacturer, by telephone on May 18 or 21, 1998. Firm-initiated recall complete.

DISTRIBUTION
Indiana, California, Switzerland.

QUANTITY
2 units of each component were distributed.

REASON
Blood products were collected in expired blood collection bags.

CODE
All serial numbers.

MANUFACTURER
GE Medical Systems Europe SA, Buc Cedex, France.

RECALLED BY
GE Medical Systems, Waukesha, Wisconsin, by field modification instruction dated September 24, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
8,588 units were distributed.

REASON
The mounting hardware loosened, allowing the collimators to fall.

PRODUCT
Veridose Diodes Model No. 30-474, packaged under the Nuclear Associates label, used to provide dose verification and quality assurance for patients undergoing radiation therapy. Recall #Z-034-9.

CODE
Serial number 110 to 134, manufactured prior to September 26, 1997.

MANUFACTURER
Victoreen, Inc., Cleveland, Ohio.

RECALLED BY
Manufacturer, by telephone on or about August 31, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Florida, Virginia, Georgia, California, New York.

QUANTITY
8 diodes were distributed.

REASON
Devices were manufactured with a serial tag that did not correspond to the manufacturer's specifications. The serial tags indicate a prescribed energy use of 6 to 25 MeV electron radiation; however, the diodes are properly color coded and intended for use for 18 to 25 MV photon radiation.

PRODUCT
Storz Tanne Disposable Trephine Blades, sterile, single use, packaged 1 blade per package, Rx involving the following catalog numbers:

a) Catalog No. E3050 6.0;
b) Catalog No. E3050 6.25;
c) Catalog No. E3050 6.50;
d) Catalog No. E3050 6.75;
e) Catalog No. E3050 7.0;
f) Catalog No. E3050 7.25
g) Catalog No. E3050 7.50
h) Catalog No. E3050 7.75
i) Catalog No. E3050 8.0
j) Catalog No. E3050 8.25
k) Catalog No. E3050 8.50
l) Catalog No. E3050 8.75
m) Catalog No. E3050 9.0
n) Catalog No. E3050 9.25
o) Catalog No. E3050 9.50.  Recall #Z-037/051-9.

CODE

Lot numbers:  a) E3050 6.0, Lot Nos. S0974, S1046, S1211;
b) S1128, S1343;
c) S1129, S1344;
d) S0967, S1047, S1212;
e) S0987, S1112, S1066, S1213;
f) S0968, S0975, S1051, S1120, S1214;
g) S1052, S1130, S1152, S1215, S1468;
h) S0976, S1142, S1216, S1345, S1434;
i) S0966, S1057, S1143, S1346, S1435;
j) S0977, S1053, S1121, S1217, S1469;
k) S0978, S1067, S1218, S1436;
l) S0969, S1122, S1145, S1219;
m) S1113, S1161;
n) S1131, S1347;
o) S1114, S1398, S1532.

MANUFACTURER
Bausch & Lomb Surgical, St. Louis, Missouri.

RECALLED BY
Manufacturer, by letter on August 10, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
1,114 blades were distributed.

REASON
The blade may be brittle and break during corneal transplant procedures.

PRODUCT
a) Model SC9000 MULTIGAS Module (PN 5189407E536U) b) Model SC9015 MULTIGAS+ Module(PN 5189415E536U), used to measure inspiratory and expiratory carbon dioxide, oxygen and nitrous oxide and anesthetic agents. Recall #Z-052/053-9.

CODE
Serial numbers: 1201, 1018, 1025, 1052, 1057(German),1057 (France), 839, 857, 1013, 1107, 1185, 1205, 843, 849, 841, 844, 1051, 1053, 1106, 1027, 850, 842, 845, 846, 1021, 1029.

MANUFACTURER
ANDROS INC, Berkley, California.

RECALLED BY
Siemens Medical Systems, Inc., by Danvers, Massachusetts, by letter on August 25, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Arizona, California, Ohio, Germany, France, Italy, Sweden.

QUANTITY
26 units were distributed.

REASON
Monitor displays "Unidentified Contaminant" and multigas modules parameters are not updated.

PRODUCT

Lag Screws, implantable stainless steel devices used during
orthopedic procedures:
a) Standard Lag Screws - Catalogue No. (Length):
12-1100 (55 mm); 12-1101 (60 mm); 12-1102 (65 mm); 12-1103 (70
mm);
12-1104 (75 mm); 12-1105 (80 mm); 12-1106 (85 mm); 12-1107 (90
mm);
12-1108 (95 mm); 12-1109 (100 mm); 12-1110 (105 mm); 12-1111 (110
mm);
12-1112 (115 mm); 12-1113 (120 mm); 12-1114 (125 mm); 12-1176
(130 mm);
12-1177 (135 mm); and, 12-1178 (140 mm).
b)  Super Lag Screws - Catalogue No. (Length):
12-1180 (55 mm); 12-1181 (60 mm); 12-1182 (65 mm); 12-1183 (70
mm);
12-1184 (75 mm); 12-1185 (80 mm); 12-1186 (85 mm); 12-1187 (90
mm);
12-1188 (95 mm); 12-1189 (100 mm); 12-1190 (105 mm); 12-1191 (110
mm);
12-1192 (115 mm); 12-1193 (120 mm); 12-1194 (125 mm); 12-1195
(130 mm);
12-1196 (135 mm); and, 12-1197 (140 mm).  Recall #Z-054/
055-9.

CODE

A total of 1,036 lot numbers are subject to recall, representing
673 lots of the Standard Lag Screws and 363 lots of the Super Lag
Screws.  The following lots are subject to the recall:
Eight (8) digit lot number beginning with: "707" - representing
production in July 1997; "708" - representing production in
August 1997; "709" - representing production in September 1997;
"710" - representing production in October 1997; "711" -
representing production in November 1997; "712" - representing
production in December 1997;  "801" - representing production in
January 1998;
"802" - representing production in February 1998; and, "803" -
representing production in March 1998.
All Standard and Super Lag Screws bearing the above first three
(3) digits are subject to recall with the following EXCEPTIONS:
a)  Lot Nos. beginning with "707" through "803" that contain a
letter suffix [i.e. lot 80205715 would be subject to recall,
whereas lot 80205715A would not be subject to the recall] and
bearing a packaging date of April 1998 or later.
b)  All lots beginning with a "T" prefix do not possess the
problem which precipitated the recall action and are exempt from
the recall.

MANUFACTURER
Smith and Nephew, Inc., Orthopedic Division, Memphis, Tennessee.

RECALLED BY
Manufacturer, by voice mail message on May 5, 1997, and by letters on May 5 and 7, 1998, by fax on May 13, 1998, and letter dated September 2, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
28,457 screws were distributed.

REASON
Screws may not properly engage/disengage from surgical wrench during surgery.

CODE
Batch Nos. 6349, 6367, 6373, and 6380.

MANUFACTURER
Scientific Pharmaceuticals, Inc., Pomona, California.

RECALLED BY
Manufacturer, by letter dated March 31, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
California, New York, North Carolina, Florida, New Jersey, Pennsylvania, Washington state, Brazil, Korea, Taiwan, Italy.

QUANTITY
3,835 units were distributed.

REASON
Product does not set completely after curing at room temperature as labeled.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCT
S -- CLASS II

MANUFACTURER
/FEEDMILL: Purina Mills, Orrville, Ohio.

MEDICAL DEVICE SAFETY ALERT

CODE
Reorder or Catalog #3460 or 373460.

MANUFACTURER
Becton Dickinson Hancock, Hancock, New York.

ALERTED BY Becton Dickinson and Company, Becton Dickinson Division, Franklin Lakes, New Jersey, by letter on February 23, 1998.

DISTRIBUTION
Nationwide and international.

QUANTITY
100,000 units were distributed.

REASON
The firm's February 11, 1998 letter alerted all users to pay special attention to the "Directions for Use" printed on the package and "flow direction arrow" permanently molded on the transparent plastic chamber. This will prevent the device from being connected backwards, which could create a tension pneumothorax and can lead to death.

END OF ENFORCEMENT REPORT FOR OCTOBER 14, 1998. BLANK PAGES MAY FOLLOW.