FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contains
information
on actions taken in connection with agency regulatory activities.
ENFORCE
09/22/1993
Recalls and Field Corrections: Foods -- Class I -- 09/22/1993
September 22, 1993
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
=========================
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PRODUCT Braum's Premium Oatmeal Cookie Dough Ice Cream, in half
gallon containers. Recall #F-635-3.
CODE All lots.
MANUFACTURER Braum's Ice Cream and Dairy Stores, Tuttle, Oklahoma.
RECALLED BY Braum's Ice Cream and Dairy Stores, a division of W.H.
Braum, Inc., Oklahoma City, Oklahoma, by voice mail July 23,
1993, followed by letter dated July 26, 1993. Firm-
initiated recall complete.
DISTRIBUTION Arkansas, Kansas, Oklahoma, Missouri, Texas.
QUANTITY Firm estimates none remains on the market.
REASON The product contains peanuts or peanut containing
ingredients which are not declared on the label.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
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PRODUCT (a) Dorman's Lo-Chol Swiss Cheese Alternative Slices, 5
ounces;
(b) Dorman's Lo-Chol Swiss Cheese Alternatives, 12 pound
loaves. Recall #F-580/581-3.
CODE (a) A25 JUL 932M; (b) 7/22/93.
MANUFACTURER Dorman-Roth Foods, Inc., Monroe, Wisconsin.
RECALLED BY Dorman-Roth Foods, Inc., Hasbrouck Heights, New Jersey, by
telephone April 8, 1993, with follow-up letter on April 9,
1993. Firm-initiated recall complete.
DISTRIBUTION New Jersey, New York.
QUANTITY (a) 281 cases (12 units per case); (b) 25 loaves were
distributed; firm estimates none remains on the market.
REASON Product contains metal pieces.
_______________
UPDATE Recall #F-622-3, which appeared in the September 8, 1993
Enforcement Report should read:
PRODUCT: Himalayan Harvest Apricot Kernels, naturally
bitter, in 8 ounce bags. Firm-initiated recall complete.
RECALL AND FIELD CORRECTIONS: FOODS -- CLASS III
=========================
_______________
PRODUCT Various ethnic Indian relish products:
(a) Carrot Pickle; (b) Mint Chutney;
(c) Coriander Chutney; (d) Tamarind Chutney;
(e) Green Chili Chutney. Recall #F-624/628-3.
CODE All codes, all sizes.
MANUFACTURER Palace Foods, Inc., Bownamsville, Pennsylvania.
RECALLED BY Manufacturer, by telephone June 28, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION New York, New Jersey, Marylalnd, Illinois.
QUANTITY Undetermined.
REASON Acidified canned food products were produced without
adequate controls.
_______________
PRODUCT Isomil Soy Formula with Iron, (infant formula) Concentrated
Liquid, in 13 fluid ounce cans. Recall #F-623-3.
CODE DEC 94 I 77680 RC.
MANUFACTURER Ross Laboratories, Columbus, Ohio.
RECALLED BY Wegmans Food Markets, Inc., Rochester, New York, by
memorandum August 3, 1993. Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 324 cases (24 cans per case) were distributed by Wegmans.
REASON Product is in cans with peeling can liners.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
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PRODUCT SMX-TMP SS (sulfamethoxazole 400 mg/trimethoprim 80 mg
single strength tablets), Rx antibacterial, with indications
and usage for treatment of urinary tract infections, acute
otitis media, chronic bronchitis and others.
Recall #D-338-3.
CODE Lot No Exp. Date
OGO1O 10/93
OHO34 11/93
OKO69 2/94
-2- 1AO66 6/94
1C067 8/94
1F011 10/94
1KO22 1/95
1L041 2/95
2CO46 5/95
2EO49 8/95
2GO35 9/94
2JO1O 4/95
2MO14 4/95
3BO62 6/95
3CO2O 7/95
MANUFACTURER Eon Labs Manufacturing Inc., Laurelton, New York.
RECALLED BY Manufacturer, by letter on or about September 10, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 38,682 bottles were distributed.
REASON Overage of the trimethoprim ingredient.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Recovered Plasma. Recall #B-392-3.
CODE Unit #7020342.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by letter April 22, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION New York.
QUANTITY 1 unit.
REASON Blood products collected from a donor with a history of
cancer were distributed.
_______________
PRODUCT Platelets. Recall #B-394-3.
CODE Unit #12J91560.
MANUFACTURER American Red Cross Blood Services, Charlotte, North
Carolina.
RECALLED BY Manufacturer, by letter January 11, 1993. Firm-initiated
recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit.
REASON Blood product, containing anti-C, anti-e, and anti-G
antibodies, but labeled negative for unexpected antibodies,
was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-426/428-3.
CODE Unit #03Z62627.
MANUFACTURER American Red Cross, Atlanta, Georgia.
RECALLED BY Manufacturer, by letters dated November 20, 1992, and
January 6, 1993. Firm-initiated recall ongoing.
-3- DISTRIBUTION Georgia, California.
QUANTITY 1 unit of each component.
REASON Blood products which tested non-reactive for the antibody to
the human immunodeficiency virus type 1 (anti-HIV-1), but
were collected from a donor who previously tested initially
reactive for anti-HIV-1, were distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-429-3.
CODE Unit #6702758.
MANUFACTURER Community Blood Centers of South Florida, Inc., Lauderhill,
Florida.
RECALLED BY Manufacturer, by telephone March 16, 1993. Firm-initiated
recall complete.
DISTRIBUTION Tennessee.
QUANTITY 1 unit.
REASON Blood product, which tested repeatedly reactive for the
antibody to the human immunodeficiency virus type 2 (anti-
HIV-2), was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Red Blood Cells, Expired. Recall #B-391-3.
CODE Unit #7020342.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by letter April 22, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Tennessee.
QUANTITY 1 unit.
REASON Blood products collected from a donor with a history of
cancer were distributed.
_______________
PRODUCT Sebra Tubing Sealers. Recall #B-424-3.
CODE Model 2100 with serial numbers 2100-0001 through 2100-0048,
and Model 2101 with serial numbers 2101-0100 through 2101-
0173.
MANUFACTURER Engineering and Research Associates, Inc., Tucson, Arizona.
RECALLED BY Manufacturer, by letter March 19 and 20, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 63 units.
REASON Blood collection tubing sealers, producing irregular or cut
seals, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
========================
______________
PRODUCT Matrx LifeDefense Plus (LDP) Portable
Defibrillator/Monitor/pacer, used to provide emergency
-4- electric (DC) defibrillation, ECG waveform monitoring and
both demand and fixed transcutaneous pacing functions.
Recall #Z-689-3.
CODE All serial numbers. (Some products are also cincluded in
Recall #Z-721-3 described below).
MANUFACTURER NEC Tochigi, Ltd., Tochigi Prefecture, Japan.
RECALLED BY Matrx Medical, Inc., Orchard Park, New York, by safety
letter dated April 21, 1993, and by recall letter dated July
16, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 1,385 units were distributed.
REASON The device will fail to operate in the defibrillation mode
if a certain component (the D8 diode located on the high
voltage PC board) fails. The D8 diode failure causes the
unit to produce an 001 error code which disables the
defibrillation function of the device.
______________
PRODUCT Matrx LifeDefense Plus (LPD) Portable
Defibrillator/Monitor/Pacer, used to provide emergency
electric (DC) defibrillation, ECG waveform monitoring and
both demand and fixed transcutaneous pacing functions.
Recall #Z-721-3.
CODE 0120640, 2081132, 2081134 through 2081137, 2081140, 2081141,
2081144, 2091146 through 2091258, 2111259, 2111333. (This
recall is a subset of Recall #Z-689-3 described above.)
MANUFACTURER NEC Tochigi, Ltd, Tochigi Prefecture, Japan.
RECALLED BY Matrx Medical, Inc., Orchard Park, New York, by letter July
23, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 194 units were distributed.
REASON The relay switch (K1) which turns the unit on could
malfunction resulting in the unit failing to turn on, or
requiring multiple depression of the on/off button before
the unit turns on.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT (a) Exam-Tex brand Medium/Large Gloves, product #7208
(b) Exam-Tex brand Small/Medium Gloves, product #7209
(c) VHA+Plus brand Small/Medium Gloves, product #V7266
(d) VHA+Plus brand Medium/Large Gloves, product #V7267.
Recall #Z-460/463-3.
CODE Lot Numbers: 204----05, 205----05, 206----05, 207----05.
MANUFACTURER Ansell Lanka (PVT) Ltd., Byagama, Sri Lanka.
RECALLED BY Ansell, Inc., Dothan, Alabama, by letter March 2, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 100 million gloves were distributed; firm
estimated that 10 million gloves remained on the market at
the time of recall.
-5- REASON Product failed FDA leak test.
_______________
PRODUCT Mevatron Linear Accelerator, digital controlled x-ray and
electron beam therapy. Recall #Z-646-3.
CODE Model type is designated by the first group of
letters/numbers and the serial number is specified by the
last 4 numbers:
KD 2001 KD2 2043 KD2 2082 KD2 2123 MXE2 2156
MD 2004 KD 2044 KDS2 2084 MXE 2124 MD 2157
MD 2006 MD2 2045 MD2 2086 MD2 2125 KDS2 2158
KDS 2007 KD2 2048 KD2 2088 MD 2126 KDS 2159
MD 2008 MD 2051 MD 2089 KD2 2127 MXE2 2161
MD 2009 KD 2052 KD 2094 KD2 2128 MXE 2162
MD 2013 MD2 2053 KDS2 2097 KDS 2129 MD2 2163
KD2 2014 KD 2054 KDS 2098 KD2 2131 MXE2 2164
MD 2015 KDS2 2055 KD 2099 KD 2132 MD 2165
MD 2017 MD2 2057 KDS 2104 KD2 2133 MD2 2166
KDS 2018 MD 2058 MD 2105 KD2 2135 KD 2167
KD 2019 KD 2061 KDS2 2106 MD 2138 KDS2 2168
KD 2021 MD2 2063 KDS2 2108 MD2 2139 MD 2169
KDS2 2023 KD 2064 MD 2109 MD 2141 MXE2 2171
KD 2026 KD2 2065 KDS2 2111 KD2 2142 KD 2172
KD 2028 MD2 2067 MD 2112 KD2 2143 KD2 2173
KD2 2031 KDS 2069 MD2 2113 MD 2144 MXE 2174
MD 2034 MD 2072 MD 2114 KD2 2145 KD2 2175
KDS2 2035 KD2 2074 KDS2 2115 MXE 2146 KD 2176
MD 2037 KD 2075 MXE 2116 KDS 2148 MXE2 2177
KD2 2038 KD2 2076 MD2 2117 KD2 2149 KD 2178
KDS 2039 KDS2 2078 MD2 2118 KDS 2151 KD2 2179
KD2 2041 MD 2079 MXE 2119 MD2 2152 MD 2181
KDS 2042 MD 2081 KDS2 2122 KD2 2154 MD2 2182
KDS2 2183 MXE 2204 MXE2 2227 MXE 2248
MD 2184 MD2 2205 KD2 2228 MD2 2249
MXE 2185 KD 2206 KDS2 2229 KDS2 2251
MXE2 2186 KDS2 2207 MD2 2231 MD2 2252
MXE 2188 KDS2 2208 KDS 2232 MXE2 2254
MD2 2189 MD 2209 MD2 2233 KDS2 2255
MXE 2191 MXE2 2211 MD2 2234 MD 2256
MXE2 2192 KD2 2213 MD2 2235 MXE2 2257
KDS 2193 KDS2 2214 MXE 2236 KD2 2258
KD 2194 MXE 2215 MD 2137 MD2 2261
MD 2195 KD2 2216 MD2 2238 MD2 2262
KDS2 2196 MD2 2217 MD2 2241 KDS2 2263
MDS 2197 KD2 2218 KDS2 2242 KDS2 2264
MXE 2198 KDS 2221 MXE 2243 KD2 2265
MD2 2199 KDS2 2222 KDS2 2244 MXE 2266
MD 2201 KD2 2224 KDS2 2245 MXE2 2267
KD2 2202 MXE 2225 KD2 2246 MD 2274
MXE 2203 MD 2226 MXE2 2247.
MANUFACTURER Siemens Medical Laboratories, Inc., Concord, California.
-6- RECALLED BY Manufacturer, by upgrading units during the next scheduled
performance maintenance. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 331 units were distributed.
REASON A defective connection link between the target and the
target drive assembly.
_______________
PRODUCT Respiration/Heart Rate Monitor, used in the care of patients
at risk from central apnea, fast heart rate or slow heart
rate, and are intended to warn the care giver when breathing
effort, heart rate or both are outside limits specified by
the physician: (a) Model 9500; (b) Model 9550.
Recall #Z-654/655-3.
CODE 6-digit code numbers beginning with 432xxx or 462xxx.
MANUFACTURER Aequitron Medical, Inc., Plymouth, Minnesota.
RECALLED BY Aequitron Medical, Inc., Plymouth, Minnesota, by letter June
18, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Germany.
QUANTITY 178 units were distributed.
REASON Vibration could cause the alarm to malfunction.
_______________
PRODUCT Auto Suture Endo Gage 30 disposable instrument, Reorder
#173025, a sterile device used during laparotomy procedures,
sold separately or in kits:
(a) Auto Suture Endo-Gauge 30 Disposable Instrument, reorder
#173025; (b) Endoscopic Cholecystectomy;
(c) Endoscopic Bowel; (d) Endoscopic Hernia;
(e) LAVH (Laparoscopically Assisted Vaginal Hysterectomy).
Recall #Z-696\700-3.
CODE Lot numbers begin with prefixes: N2L, N2M, N3A, N3B, N3C,
N3D, and include all lots in tyvek pouches manufactured
beginning November 1992 and extending through April 1993.
MANUFACTURER United States Surgical Corporation, Norwalk, Connecticut.
RECALLED BY U.S. Surgical Corporation, North Haven, Connecticut, by
letters dated June 15 and 17, 1993. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 43,538 units were distributed.
REASON Some of the Tyvek pouches containing the Endo Gauge 30
instrument were found to be unsealed, which could compromise
the sterility of the device.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________
PRODUCT CK-MB Flurometric Enzyme Immuno Assay. Recall #Z-782-3.
CODE Kit lot #KXMB-1423M and #KXMB-1425M.
MANUFACTURER Baxter Healthcare Corporation, Miami, Florida.
-7- RECALLED BY Manufacturer, by telephone May 26, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 10 kits were distributed and all are accounted for.
REASON Phenobarbital conjugate was packed into 10 kits instead of
K-MB conjugate. If controls are not run to flag an invalid
assay, a sample may be reported as having a very low
concentration of CK-MB when it actually contains a higher
level.
MEDICAL DEVICE SAFETY ALERT:
=============================================
_______________
PRODUCT Theratronics linear accelerator and Cobalt 60 teletherapy
radiation devices for cancer therapy with treatment tables
T60, T73, and T73M:
(a) Model T20; (b) Model T25; (c) T1000.
Safety Alert #N-081/083-3.
CODE Serial numbers: (a) 043, 813; (b) 022, 024, 025;
(c) 001, 002, 007, 010, 011, 012.
MANUFACTURER Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL Medical), Carrollton, Texas;
Theratronics International, Ltd., formerly Atomic Energy of
Canada, Ltd. (AECL Medical), Ontario, Canada.
ALERTED BY Manufacturer, by User Bulletin (a & b) AUB 93-01;
(c) CUB 93-02.
DISTRIBUTION California, Georgia, Florida, Illinois, Kansas,
Pennsylvania, Texas, Washington state.
QUANTITY 11 units were distributed.
REASON The output shaft support bearing and vertical drive gearbox
may be improperly aligned after servicing and could result
in a sudden descent of the treatment table.
SEIZURE:
==================================================================
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PRODUCT Mung beans (93-665-574/6).
CHARGES Adulterated - One of the articles consists in whole or in
part of a filthy substance because it contains rodent
excreta, rodent hair, and rodent-gnawed product; and, all of
the articles have been held under insanitary conditions
whereby they may have become contaminated with filth.
FIRM China Noodle Company, Oakland, California.
FILED July 21, 1993; U.S. District Court for the Northern
District of California; Civil #C93-2739 TEH; FDC #66756.
SEIZED August 13, 1993 - goods valued at approximately $15,000.
-8-
END OF ENFORCEMENT REPORT FOR SEPTEMBER 22, 1993. BLANK PAGES MAY
FOLLOW.
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