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
09/27/1995
ENFORCEMENT REPORT FOR 09/27/95
September 27, 1995 95-39
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Cold Smoked Ready-To-Eat Salmon Fillets, in 30-40 pound
cases. Recall #F-579-5.
CODE Lot numbers: 0657 through 0667, 0669 through 0673.
MANUFACTURER Sorta Smoked Fish USA, Inc., Kingston, New York.
RECALLED BY Manufacturer, by telephone on August 21, 1995, followed by
letters mailed on August 22, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION New York, Colorado, North Carolina, California, Florida,
Louisiana, Washington, DC.
QUANTITY 3,440 pounds were distributed.
REASON Product is contaminated with Listeria monocytogenes.
_______________
PRODUCT Cake Decorating Candy Roses, under Cake Mate and Dec A Cake
labels, in 4 different colors (pink, yellow, red, and
white), on 8" x 12" cardboard cellophane wrapped strips, 6
roses per strip. Recall #F-590-5.
CODE UPC #5210015631 or 5210015632 (Cake Mate);
UPC #4156910097 (Dec A Cake).
MANUFACTURER Decko Products, Inc., Sandusky, Ohio.
RECALLED BY Manufacturer, by letters on July 26, 1995, and August 1,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Maryland, California.
QUANTITY Approximately 5,000 dozen strips were distributed.
REASON Product contains undeclared eggs.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Gatorade Thirst Quencher sports drink in 16 fluid ounce
glass bottles: (a) Lemon-Lime, UPC# 52000-00310 warehouse
club case UPC# 52000-32944;
(b) Orange, UPC# 52000-00320 warehouse club case UPC#
52000-32945;
(c) Fruit Punch, UPC# 52000-00330 warehouse club case UPC#
52000-32943;
(d) Lemon Ice, UPC# 52000-00340;
(e) Tropical Fruit, UPC# 52000-30614;
(f) Grape, UPC# 52000-32671;
(g) Citrus Cooler, UPC# 52000-33500. Recall #F-581/587-5.
CODE Bottle codes where "*" will be A, B, C, D, F, or H.
(a) 020D5*, 021D5*, 004E5*; (b) 021D5*, 005E5*;
(c) 020D5*, 004E5*, 005E5*; (d) 019D5; (e) 019D5*, 004E5*;
(f) 019D5*, 020D5*.
MANUFACTURER The Quaker Oats Company, Oakland, California.
RECALLED BY The Quaker Oats Company, Chicago, Illinois, by letters dated
August 29, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Arizona, California, Colorado, Guam, Hawaii, Idaho, Montana,
Nevada, Oregon, Texas, Utah, Washington state, Wyoming,
Japan, Mexico.
QUANTITY 129,193 cases (24 bottles per case) were distributed; firm
estimates 10-15% of product remains on the market.
REASON The products contain glass pieces.
_______________
PRODUCT Blueberries packaged in 1 pint plastic clam-shell
containers. Recall #F-588-5.
CODE None.
MANUFACTURER Dzen Farms, Inc., South Windsor, Connecticut.
RECALLED BY Manufacturer, by letter sent on or about August 18, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Massachusetts, Connecticut.
QUANTITY Approximately 1,000 to 1,500 pint sized containers were
distributed.
REASON The product is contaminated with Methiocarb and Dacthal
residue. There is no tolerance level for Methiocarb or
Dacthal residue in blueberries.
_______________
PRODUCT Symphony Petit Fours, fruit flavored dessert consisting of
heavy cream, almonds, chocolate, cherries, and other
ingredients, cut in 12"x4" strips, weighing approximately 24
ounces. Recall #F-592-5.
CODE All product on the market.
-2- MANUFACTURER Symphony, Inc., Cherry Hill, New Jersey.
RECALLED BY Manufacturer, by letters dated May 25, 1995, and June 2,
1995. Firm-initiated recall complete.
DISTRIBUTION New York, Georgia, Florida, Connecticut, Massachusetts, New
Jersey, Illinois, North Carolina, Texas, Pennsylvania, Ohio,
Missouri, Colorado, Washington, D.C.
QUANTITY 381 shippers were distributed (each shipper contains 4
Petits-Fours).
REASON Product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Formula 156 High B Complex 50 + Vitamin C Tablets, a non-
prescription vitamin tablet packed in bottles of 100.
Recall #F-580-5.
CODE Lot #2893921, List #SFC 2249, EXP 1/96.
MANUFACTURER Chase Laboratories, Inc., Newark, New Jersey.
RECALLED BY Manufacturer, by letter August 1, 1994. Firm-initiated
recall complete.
DISTRIBUTION Virginia.
QUANTITY 1,343 bottles were distributed; firm estimates none remains
on the market.
REASON The product's label represents it as containing vitamin B
complex at 50 mg and vitamin C at 500 mg when the product
was actually formulated to contain 12.5 mg and 125 mg of
these vitamins.
_______________
PRODUCT Medford Farms Fat free vinaigrette dressing consisting of
sun dried tomatoes and other ingredients and bottled in 12
ounce bottles with metal caps. Recall #F-591-5.
CODE H0101J, H0201J, H0301J.
MANUFACTURER Haddon House Food Products, Inc., Medford, New Jersey.
RECALLED BY Manufacturer, by letter sent April 13, 1995. Firm-initiated
recall complete.
DISTRIBUTION Texas, Florida, South Carolina, Virginia, Louisiana, New
Mexico, Maryland, Connecticut, Ohio, California, Kentucky.
QUANTITY 5,386 bottles were distributed.
REASON Product is contaminated with Bacillus sphaericus, Bacillus
megaterium, and Bacillus thuringiensis.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Choledyl 100 mg Tablets, Oxytriphylline Delayed Release
Tablets USP Enteric coated, Rx bronchodilator.
Recall #D-246-5.
CODE Lot #26111D EXP 1/96.
MANUFACTURER Warner Lambert Company, Morris Plains, New Jersey.
RECALLED BY Manufacturer, by letter March 21, 1995. Firm-initiated
recall complete.
-3- DISTRIBUTION Nationwide.
QUANTITY 18,727 bottles of 100 tablets were distributed.
REASON Product does not meet disintegration specifications through
expiration date.
_______________
PRODUCT Biocraft brand Metoclopramide Tablets, USP, 5 mg, in bottles
of 100 and 500, Rx antiemetic. Recall #D-247-5.
CODE Lot #22552 EXP 10/1/96.
MANUFACTURER Biocraft Laboratories, Inc., Paterson, New Jersey.
RECALLED BY Biocraft Laboratories, Inc., Fair Lawn, New Jersey, by
letters of May 3, 1995, and June 1, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 8,731 bottles of 100 tablets were distributed.
REASON Product does not meet potency and content uniformity
specifications.
_______________
PRODUCT Sulfamethoxazole and Trimethoprim for Injection Concentrate,
USP, Rx, in 30 mL amber vials, used for urinary tract
infections. Recall #D-248-5.
CODE Lot numbers: P4N013 EXP 4/96, P4N014 EXP 4/96,
P4N015 EXP 4/96, P5B003 EXP 8/96, P5B004 EXP 8/96,
P5B017 EXP 8/96.
MANUFACTURER Gensia Laboratories, Ltd., Irvine, California.
RECALLED BY Manufacturer, by letter July 21, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimated that 2,000 vials remained on market at time
of recall initiation.
REASON Defect in glass vial may result in lack of assurance of
sterility.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-608/609-5.
CODE Red Blood Cells, units 26032-0495, 26032-0496, 26032-0497,
26032-0499, 26032-0597, 26032-0598, 26032-0599, 26032-0600,
26032-1016, 26032-1017, 26032-1019, 26032-1020, 26032-1022,
26032-1023, 26032-1024, 26032-1025, 26032-1026, 26032-1027,
26032-1028, 26032-5736, 26032-5737, 26032-5738, 26032-5739,
26032-5740, 26032-5741, 26032-5742, 26032-5743, 26032-5744,
26032-5745, 26032-6511, 26032-6512, 26032-6513, 26032-6514,
26032-6515, 26032-6516, 26032-6517, 26032-6518, 26032-6519,
26032-6520, 26032-6521, 26032-6522, 26032-6523, 26032-6525,
26032-6526, 26032-6665, 26032-6666, 26032-6667, 26032-6669,
26032-6670, 26033-6092, 26033-6093, 26033-6094, 26033-6095,
26033-6096, 26033-6097, 26033-6098, 26033-6099, 26033-6100,
26033-6102, 26033-6104, 26033-6105, 26033-6106, 26033-6107,
26033-6108, 26033-6109, 26033-6110, 26033-6111, 26033-6112,
-4- 26033-6188, 26033-6190, 26033-6191, 26033-6192, 26034-6001,
26034-6002, 26034-6003, 26034-6004, 26034-6005, 26034-6006,
26034-6007, 26034-6008, 26034-6009, 26034-6010, 26034-6011,
26034-6012, 26034-6013, 26034-6014, 26034-6015, 26034-6016,
26034-6017, 26034-6018, 26034-6019, 26034-6020, 26034-6021,
26034-6022, 26034-6023, 26034-6024, 27029-7322, 27029-7323,
27029-7324, 27029-7325, 27029-7327, 27029-7328, 27029-7329,
27029-7330, 27029-7331, 27029-7332, 27029-7333, 27029-7335,
27029-7337, 27029-7340, 27029-7341, 27029-7342, 27029-7343,
27030-1799, 27030-1800, 27030-1801, 27030-1802, 27030-1803,
27030-1804, 27030-1805, 27030-1806, 27030-1807, 27030-1808,
27030-1809, 27030-1810, 27030-1811, 27030-1812, 27030-1813,
27030-1814, 27030-1815, 27030-1816, 27030-1817, 27030-1818,
27030-2904, 27030-2905, 27030-2906, 27030-2907, 27030-2909,
27030-2910, 27030-2911, 27030-2912, 27030-2913, 27030-2914,
27030-2915, 27030-2916, 27030-2917, 27030-2918, 27030-2919,
27030-2920, 27030-2921, 27030-6044, 27030-6048, 27030-6050,
27030-6051, 27030-6052, 27030-6053, 27030-6054, 27030-6055,
27030-6056, 27030-6057, 27030-6058, 27030-6059, 27030-6060,
27030-6061, 27030-6062, 27030-6063, 27030-6064, 27030-7464,
27030-7465, 27030-7466, 27030-7467, 27030-7469, 27030-7470,
27030-7471, 27030-7473, 27030-7474, 27030-7475, 27030-7476,
27030-7477, 27030-7478, 27030-7480, 27030-7481, 27030-7483,
27030-7484, 27030-7486, 27030-7488, 27030-7489, 27030-7490,
27030-8606, 27030-8608, 27030-8609, 27030-8610, 27030-8612,
27030-8613, 27030-8622, 27030-8624, 27031-2511, 27031-2568,
27031-2569, 27031-2570, 27031-2571, 27031-2572, 27031-2573,
27031-2574, 27031-2575, 27031-2576, 27031-2577, 27031-2578,
27031-2581, 27031-2582, 27031-2583, 27031-2584, 27031-2585,
27031-2586, 27031-2587, 27031-2588, 27031-2589, 27031-2590,
27031-2591, 27031-2592, 27031-2595, 27031-3670, 27031-3671,
27031-3672, 27031-3673, 27031-3674, 27031-3683, 27031-3685,
27031-3686, 27031-3687, 27031-3688, 27031-3689, 27031-3690,
27031-3691, 27031-3692, 27031-3694, 27031-3695, 27031-3696,
27031-6508, 27031-6509, 27031-6511, 27031-6512, 27031-6513,
27031-6514, 27031-6515, 27031-7400, 27031-7402, 27031-7403,
27031-7404, 27031-7405, 27031-7406, 27031-7407, 27031-7436,
27031-7437, 27031-7438, 27031-7440, 27031-8066, 27031-8067,
27031-8068, 27031-8070, 27031-8071, 27031-8072, 27031-8073,
27031-8074, 27031-8076, 27032-0058, 27032-0059, 27032-0060,
27032-0061, 27032-0063, 27032-0064, 27032-0065, 27032-0066,
27032-0068, 27032-0069, 27032-0070, 27032-0071, 27032-0072,
27032-0073, 27032-0074, and 27032-0075;
Platelets, Units 26032-0495, 26032-0496, 26032-0497,
26032-0499, 26032-0597, 26032-0598, 26032-0599, 26032-1016,
26032-1019, 26032-1020, 26032-1022, 26032-1023, 26032-1024,
26032-1025, 26032-1026, 26032-1027, 26032-1028, 26032-5737,
26032-5739, 26032-5740, 26032-5741, 26032-5742, 26032-5743,
26032-6511, 26032-6513, 26032-6514, 26032-6517, 26032-6518,
26032-6520, 26032-6521, 26032-6526, 26032-6665, 26032-6666,
26032-6667, 26032-6670, 26033-6092, 26033-6093, 26033-6094,
26033-6095, 26033-6096, 26033-6098, 26033-6099, 26033-6100,
-5- 26033-6104, 26033-6107, 26033-6108, 26033-6109, 26033-6111,
26033-6112, 26033-6188, 26033-6190, 26033-6191, 26033-6192,
26034-6001, 26034-6003, 26034-6004, 26034-6008, 26034-6012,
26034-6014, 26034-6016, 26034-6023, 27030-1799, 27030-1800,
27030-1801, 27030-1802, 27030-1803, 27030-1804, 27030-1805,
27030-1806, 27030-1807, 27030-1808, 27030-1809, 27030-1810,
27030-1811, 27030-1812, 27030-1814, 27030-1816, 27030-1817,
27030-1818, 27030-2904, 27030-2905, 27030-2906, 27030-2907,
27030-2909, 27030-2910, 27030-2911, 27030-2912, 27030-2913,
27030-2914, 27030-2915, 27030-2916, 27030-2917, 27030-2918,
27030-2919, 27030-2920, 27030-2921, 27031-2571, 27031-2574,
27031-2575, 27031-2576, 27031-2583, 27031-2584, 27031-2585,
27031-2586, 27031-2589, 27031-3688, 27031-3690, 27031-3695,
27031-6512, 27031-6514, 27031-7402, 27031-7403, 27031-7436,
27031-7438, 27031-8066, 27031-8068, 27031-8070, 27031-8071,
27031-8072, 27031-8073, 27031-8074, 27032-0060, 27032-0061,
27032-0062, 27032-0063, 27032-0064, 27032-0065, 27032-0066,
27032-0069, 27032-0070, 27032-0071, and 27032-0073.
MANUFACTURER United Blood Services Blood Systems, Inc., Fort Smith,
Texas; United Blood Services Blood Systems, Inc., Texarkana,
Texas.
RECALLED BY United Blood Services Blood Systems, Inc., Scottsdale,
Arizona, by letters dated August 1, 1994, and September 2,
1994. Firm-initiated recall complete.
DISTRIBUTION Arkansas, Illinois, Oklahoma, Massachusetts, Texas,
Switzerland.
QUANTITY (a) 281 units; (b) 132 units.
REASON Blood products, which tested negative for the antibody to
the human immunodeficiency virus type 1 (anti-HIV-1), the
hepatitis B surface antigen (HBsAg), the antibody to the
hepatitis B core antigen (anti-HBc), the antibody to the
hepatitis C virus encoded antigen (anti HCV), the antibody
to the human T-lymphotropic virus type I (anti-HTLV-1), and
syphilis but were collected from donors in which donor
suitability was not adequately determined, were distributed.
_______________
PRODUCT Olympus PK7100 Cell Probes. Recall #B-614-5.
CODE Catalog #ZM046800, all lots manufactured from May 14, 1986
to March 1995.
MANUFACTURER Sanei-Seikai Company, Nitza-City Saitama Prefecture, Japan.
RECALLED BY Olympus America, Inc., Melville, New York, by letters dated
June 1, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, England, Australia, Canada.
QUANTITY 1,371 units.
REASON Olympus PK7100 Cell Probes, which contained a design defect
that could cause erratic cell sample dispensing, were
distributed.
-6- _______________
PRODUCT Platelets. Recall #B-620-5.
CODE Contact FDA, Center for Biologics Evaluation and Research,
Office of Compliance, (301) 594-1070, for individual unit
numbers recalled.
MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis,
Indiana.
RECALLED BY Manufacturer, by fax on April 27, 1994, followed by letter
dated June 6, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Indiana.
QUANTITY 2,375 units.
REASON Platelets which were labeled with the incorrect expiration
date were distributed.
_______________
PRODUCT Platelets. Recall #B-625-5.
CODE Unit #8119342.
MANUFACTURER Permian Basin Regional Blood Center, Midland, Texas.
RECALLED BY Manufacturer, by telephone October 27, 1993. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product, which tested repeatedly reactive for antibody
to the human T-lymphotropic virus type I (anti-HTLV-I), was
distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-627/628-5.
CODE Unit #32E33680.
MANUFACTURER American National Red Cross, Madison, Wisconsin.
RECALLED BY Manufacturer, by letters dated August 23 and 31, 1994.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin, Iowa.
QUANTITY 1 unit of each component.
REASON Blood products, which were not tested for syphilis, were
distributed.
_______________
PRODUCT (a) Red Blood Cells: (b) Fresh Frozen Plasma.
Recall #B-630/631-5.
CODE Unit numbers: (a) H19101, H19107, H19112, H19117, H19119,
H19120, H19123, H19125, H19126, H19130, S44240, S44242,
S44247, S44252, S44256, S44259; (b) H19107.
MANUFACTURER Mississippi Valley Regional Blood Center, Davenport, Iowa.
RECALLED BY Manufacturer, by letters dated March 17, 1995, and June 26,
1995. Firm-initiated recall complete.
DISTRIBUTION Illinois, Iowa, New York, Virginia.
QUANTITY 16 units; (b) 1 unit.
REASON Blood products, which were incorrectly tested for the
antibody to the human immunodeficiency virus type 1 (anti-
HIV-1), were distributed.
-7- RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT (a) Red Blood Cells For Further Manufacture; (b) Platelets
For Further Manufacture; (c) Recovered Plasma.
Recall #B-610/612-5.
CODE Red Blood Cells For Further Manufacture, unit 27030-8607
Platelets For Further Manufacture, units 27029-7322,
27029-7323, 27029-7324, 27029-7325, 27029-7327, 27029-7328,
27029-7329, 27029-7330, 27029-7331, 27029-7332, 27029-7333,
27029-7335, 27029-7337, 27029-7340, 27029-7341, 27029-7342,
27029-7343, 27030-1813, 27030-1815, 27030-6044, 27030-6048,
27030-6049, 27030-6050, 27030-6051, 27030-6052, 27030-6053,
27030-6054, 27030-6055, 27030-6056, 27030-6057, 27030-6058,
27030-6059, 27030-6060, 27030-6061, 27030-6062, 27030-6063,
27030-6064, 27031-2572, 27031-2573, 27031-2579, 27031-2581,
27031-2587, 27031-2588, 27031-2590, 27031-2591, 27031-2592,
27031-3671, 27031-3672, 27031-3673, 27031-3674, 27031-3683,
27031-3685, 27031-3686, 27031-3687, 27031-3689, 27031-3691,
27031-3692, 27031-3694, 27031-6508, 27031-6509, 27031-6511,
27031-6513, 27031-6515, 27031-7400, 27031-7437, 27031-8065,
and 27031-8067;
Recovered Plasma, units 26032-0495, 26032-0496, 26032-0497,
26032-0499, 26032-0597, 26032-0598, 26032-0599, 26032-0600,
26032-1016, 26032-1017, 26032-1019, 26032-1020, 26032-1022,
26032-1023, 26032-1024, 26032-1025, 26032-1026, 26032-1027,
26032-1028, 26032-5737, 26032-5738, 26032-5739, 26032-5740,
26032-5741, 26032-5742, 26032-5743, 26032-5744, 26032-5745,
26032-6511, 26032-6512, 26032-6513, 26032-6514, 26032-6515,
26032-6516, 26032-6517, 26032-6518, 26032-6519, 26032-6520,
26032-6521, 26032-6522, 26032-6523, 26032-6525, 26032-6526,
26032-6665, 26032-6666, 26032-6667, 26032-6669, 26032-6670,
26033-6092, 26033-6093, 26033-6094, 26033-6095, 26033-6096,
26033-6097, 26033-6098, 26033-6099, 26033-6100, 26033-6104,
26033-6105, 26033-6107, 26033-6108, 26033-6109, 26033-6111,
26033-6112, 26033-6188, 26033-6190, 26033-6191, 26033-6192,
26034-6001, 26034-6002, 26034-6003, 26034-6004, 26034-6005,
26034-6006, 26034-6007, 26034-6008, 26034-6009, 26034-6010,
26034-6011, 26034-6012, 26034-6013, 26034-6014, 26034-6015,
26034-6016, 26034-6017, 26034-6018, 26034-6019, 26034-6020,
26034-6021, 26034-6022, 26034-6023, 26034-6024, 27029-7322,
27029-7323, 27029-7324, 27029-7325, 27029-7327, 27029-7328,
27029-7329, 27029-7330, 27029-7331, 27029-7332, 27029-7333,
27029-7335, 27029-7337, 27029-7340, 27029-7341, 27029-7342,
27029-7343, 27030-1799, 27030-1800, 27030-1801, 27030-1802,
27030-1803, 27030-1804, 27030-1805, 27030-1806, 27030-1807,
27030-1808, 27030-1809, 27030-1810, 27030-1811, 27030-1812,
27030-1813, 27030-1814, 27030-1815, 27030-1816, 27030-1817,
27030-1818, 27030-2904, 27030-2905, 27030-2906, 27030-2907,
27030-2909, 27030-2910, 27030-2911, 27030-2912, 27030-2913,
27030-2914, 27030-2915, 27030-2916, 27030-2917, 27030-2918,
27030-2919, 27030-2920, 27030-2921, 27030-6044, 27030-6048,
27030-6049, 27030-6050, 27030-6051, 27030-6052, 27030-6053,
-8- 27030-6054, 27030-6055, 27030-6056, 27030-6057, 27030-6058,
27030-6059, 27030-6060, 27030-6061, 27030-6062, 27030-6063,
27030-6064, 27030-7464, 27030-7465, 27030-7467, 27030-7469,
27030-7470, 27030-7471, 27030-7473, 27030-7474, 27030-7475,
27030-7476, 27030-7477, 27030-7478, 27030-7479, 27030-7480,
27030-7481, 27030-7483, 27030-7484, 27030-7486, 27030-7488,
27030-7489, 27030-7490, 27030-8608, 27030-8610, 27030-8611,
27030-8612, 27030-8613, 27030-8622, 27030-8624, 27031-2511,
27031-2568, 27031-2569, 27031-2570, 27031-2571, 27031-2572,
27031-2573, 27031-2574, 27031-2575, 27031-2576, 27031-2579,
27031-2581, 27031-2583, 27031-2584, 27031-2585, 27031-2586,
27031-2587, 27031-2588, 27031-2589, 27031-2590, 27031-2591,
27031-2592, 27031-2595, 27031-3670, 27031-3671, 27031-3672,
27031-3673, 27031-3674, 27031-3683, 27031-3685, 27031-3686,
27031-3687, 27031-3688, 27031-3689, 27031-3690, 27031-3691,
27031-3692, 27031-3694, 27031-3695, 27031-3696, 27031-6508,
27031-6509, 27031-6511, 27031-6512, 27031-6513, 27031-6514,
27031-6515, 27031-7400, 27031-7402, 27031-7403, 27031-7435,
27031-7436, 27031-7437, 27031-7438, 27031-7440, 27031-8065,
27031-8066, 27031-8067, 27031-8068, 27031-8070, 27031-8071,
27031-8072, 27031-8073, 27031-8074, 27031-8076, 27032-0058,
27032-0059, 27032-0060, 27032-0061, 27032-0062, 27032-0063,
27032-0064, 27032-0065, 27032-0066, 27032-0068, 27032-0069,
27032-0070, 27032-0071, 27032-0072, 27032-0073, 27032-0074,
and 27032-0075.
MANUFACTURER United Blood Services Blood Systems, Inc., Fort Smith,
Texas; United Blood Services Blood Systems, Inc., Texarkana,
Texas.
RECALLED BY United Blood Services Blood Systems, Inc., Scottsdale,
Arizona, by letters dated August 1, 1994, and September 2,
1994. Firm-initiated recall complete.
DISTRIBUTION Arkansas, Illinois, Oklahoma, Massachusetts, Texas,
Switzerland.
QUANTITY (a) 1 unit; (b) 67 units; (c) 274 units.
REASON Blood products, which tested negative for the antibody to
the human immunodeficiency virus type 1 (anti-HIV-1), the
hepatitis B surface antigen (HBsAg), the antibody to the
hepatitis B core antigen (anti-HBc), the antibody to the
hepatitis C virus encoded antigen (anti HCV), the antibody
to the human T-lymphotropic virus type I (anti-HTLV-1), and
syphilis but were collected from donors in which donor
suitability was not adequately determined, were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-621-5.
CODE Unit numbers: 33LM36497, 33LT38645, 33LJ37528, 33LS29840.
MANUFACTURER American Red Cross Blood Services, Farmington, Connecticut.
RECALLED BY Manufacturer, by letters dated March 28, 1995. Firm-
initiated recall complete.
DISTRIBUTION Connecticut.
QUANTITY 4 units.
-9- REASON Red Blood Cells which were stored at an unacceptable
temperature, were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-622-5.
CODE Unit #4101732.
MANUFACTURER Central Texas Regional Blood & Tissue Center (CTRBTC),
Austin, Texas.
RECALLED BY Manufacturer, by telephone on March 23, 1995. Firm-
initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product which was untested for the antibody to the
human immunodeficiency virus type 1/2 (anti-HIV-1/2) was
distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-626-5.
CODE Unit #09T37375.
MANUFACTURER American Red Cross Blood Services, North Platte, Nebraska.
RECALLED BY American Red Cross Blood Services, Omaha, Nebraska, by
telephone on August 11, 1993. Firm-initiated recall
complete.
DISTRIBUTION Nebraska.
QUANTITY 1 unit.
REASON Blood product, which was untested for the antibody to the
human immunodeficiency virus types 1 and 2 (anti-HIV-1/2),
was distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-629-5.
CODE Unit #32E33680.
MANUFACTURER American National Red Cross, Madison, Wisconsin.
RECALLED BY Manufacturer, by letters dated August 23 and 31, 1994.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product, which was not tested for syphilis, was
distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-632-5.
CODE Unit #42T09970.
MANUFACTURER American National Red Cross, Cleveland, Ohio.
RECALLED BY Manufacturer, by letter dated May 31, 1994. Firm-initiated
recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON Blood product, which contained anti-E alloantibodies but was
incorrectly labeled as containing anti-Kell, was
distributed.
-10- RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Infusion Sets,used for subcutaneous injections of
maintenance therapies:
(a) Subcutaneous Infusion Set, 24", 27 ga., 90 degree Angle
Needle, Catalog numbers: 1M8472Y (domestic), 1M8472
(foreign; (b) Subcutaneous Infusion Set, 42", 27 ga., 90
degree Angle Needle, Catalog numbers: 1M8463Y (foreign),
1M8463 (domestic); (c) Micro-Volume Infusion Set, 24", 27
ga, Needle, Catalog #1M8450; (d) Micro-Volume Infusion Set,
42", 27 ga, Needle, Catalog #1M8451. Recall #Z-882/885-5.
CODE Lots manufactured from January 1, 1994 through March 1995.
Lot numbers: (a) GD444166, GD444174, GD444562, GD444570,
GD449330, GD457085, GD457093, GD457101, GD460162, GD460170,
GD460188, GD463844, GD464354, GD464362, GD467308, GD467316,
GD467324, GD471490, GD471490X, GD471896, GD471904,
GD475855***, GD475863***, GD475871***, GD479238***,
GD479717***, GD480954, GD480962, GD483909, GD483917,
GD483925, GD488155, GD488163; (b) GD444992, GD445007,
GD445015, GD446047, GD446054, GD446062, GD446559, GD446567,
GD450247, GD452086, GD452094, GD452102, GD452896, GD452904,
GD453373, GD453381, GD455766, GD455774, GD455782, GD458778,
GD458786, GD458794, GD459347, GD459354, GD462085, GD462093,
GD462101, GD462861, GD462879, GD463778, GD465203, GD465211,
GD465484, GD465492, GD466094, GD466102, GD467837, GD467845,
GD467852, GD467860, GD468868, GD468876, GD468884, GD470302,
GD470542, GD470559, GD470567, GD470575, GD473728, GD473736,
GD473744, GD474791, GD474809, GD474817A, GD477281, GD477299,
GD477307, GD478271, GD478289, GD478297, GD481523, GD481531,
GD481549, GD482406, GD482414, GD482422, GD484964, GD484972,
GD484980, GD486142***, GD486159, GD488858, GD488874; (c)
GD451294R, GD457705R, GD463471R, GD466441R, GD469403R,
GD472712R, GD476481R, GD483214R, GD486829R, GD487728R; (d)
GD445064R, GD454231R, GD457713R, GD460733R, GD463489R,
GD466458R, GD469411R, GD47272OR, GD476499R, GD483222R,
GD486837R, GD487736R. (*** intact lots).
MANUFACTURER Baxter Healthcare Corporation, Cleveland, Mississippi.
RECALLED BY Manufacturer, by letter dated May 8, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 544,206 units were distributed.
REASON Infusion sets may leak at the solvent bond where the tubing
is joined to the interior.
_______________
PRODUCT Model BLF-75A Beam Limiting Device. Recall #Z-1169-5.
CODE None.
MANUFACTURER Toshiba America Medical Systems, Inc., Tustin, California.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan September 15, 1995. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
-11- QUANTITY 21 units.
REASON Noncompliance with the performance standards for x-ray
products. When operated in photofluorography (or photospot)
mode, x-ray exposure can be initiated when the manual switch
on the beam limiting device is selected and the field size
is made larger than the image receptor (the sum of the
excess length and width is >4% of the SID).
_______________
PRODUCT Pacing leads: (a) Encor Atrial J-Wire Passive Fixation
Pacing Leads, Models 330-854, 330-755, 033-757, 033-856; (b)
EnGuard PFX Endocardial Defibrillation Leads, Models 040-
069/069C, 040-022/022C. Recall #Z-1171/1172-5.
CODE All serial numbers.
MANUFACTURER Telectronics Pacing Systems, Miami Lakes, Florida.
RECALLED BY Telectronics Pacing Systems, Englewood, Colorado, by letter
September 11, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 38,925 units were distributed .
REASON The "J" retention wires can fracture, protrude through the
polyurethane insulation, through the right atrial appendage,
and perforate the aorta.
_______________
PRODUCT Kinair TransportAir Battery Pack, used to provide temporary
emergency power for air inflated critical care beds during
periods of electrical power outages and when the beds are
moved from one location to another. Recall #Z-1205-5.
CODE Serial numbers: 055120 through 055953.
MANUFACTURER Kinetic Concepts, Inc., (KCI), San Antonio, Texas.
RECALLED BY Manufacturer, by memorandum sent November 9, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 7,628 units were distributed.
REASON Device can emit smoke and fumes if the batteries become
overcharged, due to either a broken trace on the circuit
board or to re-setting the voltage of the charger.
_______________
PRODUCT Stryker CBC II Constavac Blood Conservation System,
Part #225-28, used for post-operative auto-transfusion.
Recall #Z-1208-5.
CODE Lot #450763, all products distributed from 3/28/94 through
3/29/94.
MANUFACTURER Stryker Instruments, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by telephone March 30, 1994. Firm-initiated
recall complete.
DISTRIBUTION Arizona, Illinois, Louisiana, Mississippi.
QUANTITY 24 units were distributed.
REASON The blood conservation system did not receive the full
irradiation dose, thereby compromising the sterility of the
system.
-12- _______________
PRODUCT Custom Packs, hospital towel and drape products, packaged in
sterile plastic pouches (dust covers) and heat sealed:
(a) Open Heart Drape Pack, Pack #1856;
(b) 4-Towel Pack, Pack #2104;
(c) Lap Basin Pack, Pack #5266. Recall #Z-1213/1215-5.
CODE Sterilizer Lot #142972841.
MANUFACTURER Sterile Recoveries, Westland, Michigan.
RECALLED BY Manufacturer, by visit and by telephone on October 28, 1994,
and by product recall update November 4-7, 1994. Firm-
initiated recall complete.
DISTRIBUTION Illinois and Michigan.
QUANTITY (a) 4 units; (b) 100 units; (c) 34 units were distributed.
REASON The sterility of the devices have been compromised due to
failure to follow good manufacturing practices with regard
to record keeping.
_______________
PRODUCT Various sterile electrosurgical (ES) products which are
packaged using shrink-wrap surrounding 5 unit trays:
Valleylab Handswitching ES Pencils
(a) Catalog No. E2515; (b) Catalog No. E2515H;
(c) Catalog No. E2515H-DB; (d) Catalog No. E2516;
(e) Catalog No. E2516H;
Valleylab ES Footswitching Pencils
(e) Catalog No. E2504;
Valleylab ES Cords:
(f) Catalog No. E0503; (g) Catalog No. E0509;
(g) Catalog No. E0510;
Valleylab ES Holster:
(h) Catalog No. E2400. Recall #Z-1220/1229-5.
CODE Lot numbers 21944 to 22000, 22107 to 23025.
MANUFACTURER Valleylab, Inc., Boulder, Colorado.
RECALLED BY Manufacturer, by letter August 31, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 39,932 cases were distributed.
REASON Devices sterility may be compromised due to breaks or holes
in the plastic tray.
_______________
UPDATE Chest Drain In-Line Connector used in 5 models of the
Atrium-Water Seal Chest Drain, which appeared in August 9,
1995 Enforcement Report, should read:
Recall #Z-1059/1063-5.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Imp Pin, Steinman Pin, Kirschner Wire, Threaded Steinman
Pin, and K-Wire, distributed under the Onxy Medial and Komet
Medical labels:
-13- (a) Imp Pin, 7/64" x 9", Style 4, SS STNMN, Catalog No.
103562, Onyx Medical Corporation
(b) Steinman Pin, Trocar Point Both Ends, 9/64" x 9",
Catalog No. 3711-5-090, Onyx Medical Corporation
(c) Steinman Pin, Trocar Point Both Ends, 5/32" x 9",
Catalog No. 3711-6-090, Onyx Medical Corporation
(d) Kirshner Wire, Diamond Point Both Ends, 0.035 x 9",
Catalog No. 3713-4-090, Onyx Medical Corporation
(e) Threaded Steinman Pin, 3/32" diameter, Style I, Catalog
No. 8169-19-33, Onyx Medical Corporation
(f) Plain Steinman Pin, 9/64" diameter, Style 1, Catalog No.
KM168-19-96, Komet Medical
(g) Threaded Steinman Pin, 3/32" diameter, Style 4, Catalog
No. KM169-49-33, Komet Medical
(h) K-Wire, 0.045 x 4", Style 1, Catalog No. KM172-14-45,
Komet Medical
(i) K-Wire, 0.054 x 4", Style 2, Catalog No. KM172-24-54,
Komet Medical
(j) K-Wire, 0.028 x 5", Style 2, Catalog No. KM172-25-28,
Komet Medical
(k) Plain Steinman Pin, 5/32" diameter, Style 3, Catalog No.
KM172-155-54, Komet Medical. Recall #Z-1157/1167-5.
CODE (a) 409, (b) BUXO; (c) BUXL; (d) BWGY; (e) 501; (f) 412; (g)
411; (h) 409; (i)409; (j) 409; (k) 409.
MANUFACTURER Onyx Medical Corp., Memphis, Tennessee.
RECALLED BY Manufacturer. Firm-initiated recall complete.
DISTRIBUTION California, Georgia, New Jersey, Tennessee.
QUANTITY Firm estimates none remains on the market.
REASON The devices were found to be mislabeled.
_______________
PRODUCT Abbott TDxFLx Vancomycin Wedge Reagent Pack, used with the
Abbott TDxFLx System for the quantitative measurement of
vancomycin, an antibiotic drug, in serum or plasma.
Recall #Z-1204-5.
CODE List #9523-85, Lot #05026Q200 EXP 6/17/96.
MANUFACTURER Abbott Health Products, Inc., Barceloneta, Puerto Rico.
RECALLED BY Abbott Laboratories, Abbott Park, Illinois, by telephone
followed by letter on August 22, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,132 kits were distributed.
REASON There is a potential for a "NET I TOO SMALL" or "P O TOO
SMALL" error message to be generated, resulting in the
inability to generate a numeric concentration result.
MEDICAL DEVICE SAFETY ALERTS:
============================================
_______________
PRODUCT PPV Anesthesia Vaporizer, used in conjunction with an
Anaesthesia Gas Machine to provide controlled amounts of
anaesthesia drug to a patient in an operating arena:
-14- (a) Catalog #53401 Halothane, Pin Safety - Cagemount;
(b) Catalog #53403 Halothane, Pin Safety - Back Entry;
(c) Catalog #53419 Enflurane, Pin Safety - Cagemount;
(d) Catalog #53421 Enflurane, Pin Safety - Back Entry;
(e) Catalog #53413 Isoflurane, Pin Safety - Cagemount;
(f) Catalog #53415 Isoflurane, Pin Safety - Back Entry.
Safety Alert #N-032/037-5.
CODE Devices distributed prior to 1992.
MANUFACTURER Penlon Limited, Abington, England.
ALERTED BY Manufacturer, by letter in May 1992.
DISTRIBUTION Ohio, New York, Arizona, California, Iowa, Washington state,
New Hampshire, Missouri, New Jersey, Puerto Rico,
Mississippi, Illinois, Kansas.
QUANTITY 58 units were distributed.
REASON There is a potential for overfilling vaporizer.
_______________
PRODUCT Electrode Lead Wires, unprotected lead wires used with the
portable battery powered TENS device.
Safety Alert #N-042-5.
CODE All units with unprotected electrode lead wires.
MANUFACTURER Uni-Patch Medical Supplies, Wabash, Minnesota.
ALERTED BY Manufacturer, by letter August 5, 1994.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Device labeling fails to provide adequate directions for use
and the devices pose an warranted risk of injury to
patients, because the products are not labeled to warn
against the hazards of unprotected electrode lead wires
being connected to electrical power sources.
-15-
END OF ENFORCEMENT REPORT FOR SEPTEMBER 27, 1995. BLANK PAGES MAY
FOLLOW.
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