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
09/28/1994
Recalls and Field Corrections: Foods -- Class I -- 09/28/1994
September 28, 1994 94-39
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Mexican Style Soft White Cheese, in 6 and 12 ounce plastic
packages. Recall #F-837-4.
CODE None. All lots manufactured and distributed prior to May
20, 1994.
MANUFACTURER R. Ramirez Cheese, San Benito, Texas.
RECALLED BY Manufacturer, by visit May 21-23, 1994. Firm-initiated
recall complete. Texas Department of Health issued press
release May 24, 1994.
DISTRIBUTION Texas.
QUANTITY Firm estimates none remains on the market.
REASON Product was contaminated with Listeria monocytogenes.
_______________
PRODUCT Mexican Style Soft White Cheese, in 6 and 12 ounce plastic
packages. Recall #F-838-4.
CODE None. All lots manufactured and distributed prior to May
23, 1994.
MANUFACTURER R. Salinas Cheese, Brownsville, Texas.
RECALLED BY Manufacturer, by visit May 23-24, 1994. Firm-initiated
recall complete. Texas Department of Health issued press
release June 7, 1994.
DISTRIBUTION Texas.
QUANTITY Firm estimates none remains on the market.
REASON Product was contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Vitamin and mineral dietary supplements:
(a) Canyon Ranch Anti-Oxidant Formula Vitamin and Mineral
Supplement in bulk and 120 tablet bottles;
(b) Canyon Ranch Multi-Vitamin and Mineral without iron in
bulk and 120 tablet bottles. Recall #F-832/833-4.
CODE All lots. Expiration dates range from August 1995 to
January 1997.
MANUFACTURER Naturally Vitamin Supplements, Inc., Scottsdale, Arizona.
RECALLED BY Canyon Ranch, Inc., Tucson, Arizona, by letter April 26,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY On May 13, 1994 the firm estimated that 2,189 bottles of
Multi-Vitamin tablets and 706 bottles of Anti-Oxidant
Formula tablets remained in commerce.
REASON Products contain selenium in excess of the amount stated on
the label.
_______________
PRODUCT Maling brand Imported Canned Mushroom Pieces and Stems, in
68 ounce cans. Recall #F-835-4.
CODE Can code #B1 2/9211 1/805 2.
MANUFACTURER Shanghai Yimin No. 1 Food Factory, Shanghai, People's
Republic of China.
RECALLED BY Edpeco International Ltd., New York, New York (importer), by
letter June 14, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Undetermined.
QUANTITY 703 cartons (6 cans per carton) were distributed.
REASON Product is contaminated with staphylococcal enterotoxin.
_______________
PRODUCT Lime Sherbet, in 3 gallon containers. Recall #F-845-4.
CODE Products manufactured from 3/6/94 through 9/6/94.
MANUFACTURER Schneider's Dairy, Pittsburgh, Pennsylvania.
RECALLED BY Manufacturer, by letter August 26, 1994. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY Firm estimates small quantities may remain in commerce.
REASON Product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Blue Mountain Non-Carbonated Natural Spring Water, in two
liter bottles. Recall #F-836-4.
CODE 0964 on bottle caps.
MANUFACTURER Cold Spring Brewing Company, Cold Spring, Minnesota.
RECALLED BY Manufacturer, by letter May 3, 1994. Firm-initiated recall
complete.
DISTRIBUTION Kansas, Louisiana, Minnesota, Mississippi, New Mexico,
Oklahoma, Texas, Wisconsin.
-2- QUANTITY 1,700 cases (8 bottles per case) were distributed.
REASON Product smelled like rotten eggs and as result of this was
determined to be unfit for human consumption.
_______________
PRODUCT Flat fillets of Sardines in 13 ounce cans labeled as
Santorini Flat Fillets of Anchovies or Krinos Flat Fillets
of Sardines Anchovied Style. Recall #F-842-4.
CODE Can code 67 NTJ.
MANUFACTURER Les Conserveries, Oujda, Morocco.
RECALLED BY Sirob Imports, Inc., Lindenhurst, New York, by letter August
19, 1994, followed by telephone. Firm-initiated recall
ongoing.
DISTRIBUTION New York, New Jersey, Pennsylvania, Rhode Island,
Connecticut, Maryland, Virginia, North Carolina, Florida,
Illinois, Indiana, Arizona, Washington, D.C.
QUANTITY Approximately 14,400 cans were distributed.
REASON Product is decomposed.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Pepcid Tablets (Famotidine) 20 mg, in 100 tablet bottles,
used for ulcer treatment. Recall #D-385-4.
CODE Lot numbers A6633 (NOV 96), A6634 (NOV 96), A6635 (NOV 96).
MANUFACTURER Merck & Company, Inc., Wilson, North Carolina.
RECALLED BY Manufacturer, by letter August 26, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 58,549 units were distributed; firm estimates none remains
on the market.
REASON Several bottles of Pepcid Tablets were found in unit cartons
labeled as Noroxin Tablets.
_______________
PRODUCT Prednisone 5 mg Tablets, in unit dose packages of 100 and in
dose-pack of 21, a corticosteroid. Recall #D-386-4.
CODE Lot numbers: 0536-029 EXP 11/94, 0536-030 EXP 11/94,
0536-031 EXP 11/94, 0536-032 EXP 7/95, 0536-033 EXP 7/95,
0536-034 EXP 2/96.
MANUFACTURER Purepac Pharmaceutical Company, Elizabeth, New Jersey.
RECALLED BY Vangard Labs, Inc., Glasgow, Kentucky (repacker), by letter
August 9, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 9,087 units were distributed.
REASON Product may not meet dissolution specifications through the
duration of its stated expiration date.
_______________
PRODUCT Transfilled Compressed Medical Oxygen, in E, D, and C size
cylinders. Recall #D-390-4.
CODE Not coded. All product subject to recall.
-3- MANUFACTURER Dillon Medical Oxygen Supply, Dillon, Montana.
RECALLED BY Manufacturer, by visit September 15, 1994. Firm-initiated
field correction ongoing.
DISTRIBUTION Montana.
QUANTITY 207 E size, 20 D size, and 6 C size cylinders were
distributed.
REASON Current good manufacturing practice deficiencies.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT 0.9% Sodium Chloride Injection USP, indicated as a source of
electrolytes and water for hydration in adults and children.
Recall #D-387-4.
CODE Lot #J4D487 EXP 10/96.
MANUFACTURER McGaw, Inc., Irvine, California.
RECALLED BY Manufacturer, by telephone April 24, 1994. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 46 cases were distributed; firm estimates none remains on
the market.
REASON Current good manufacturing practice deficiencies.
_______________
PRODUCT Phenobarbital w/Belladonna Tablets (Rexatal Tablets), in
bottles of 1000 and 5000, Rx drug used as adjunctive therapy
in treatment of irritable bowel syndrome. Recall #D-388-4.
CODE Lot #B3598 EXP 5/96 and 6/96.
MANUFACTURER Richwood Pharmaceutical Company, Inc., doing business as
Rexar Pharmacal, Valley Stream, New York.
RECALLED BY Manufacturer, by telephone September 7, 1994, followed by
letter September 8, 1994. Firm-initiated recall ongoing.
DISTRIBUTION California, Connecticut, Florida, Indiana, Kentucky, New
Jersey, New Mexico, New York, North Carolina, Pennsylvania,
Texas, Washington state.
QUANTITY 1,843 1000-tablet bottles and 272 5000-tablet bottles were
distributed.
REASON Subpotency of scopolamine HBr component.
_______________
PRODUCT Dopamine Hydrochloride Injection, USP, 80 mg/ml, Rx IV
infusion injectable for the correction of hemodynamic
imbalances. Recall #D-389-4.
CODE Lot #940724.
MANUFACTURER SoloPak Laboratories, Inc., Elk Grove Village, Illinois.
RECALLED BY Manufacturer, by letter September 6, 1994. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 957 trays of Dopamine HCl were distributed and 60 trays of
Multe-Pak-5 were distributed; firm estimated that 50% of the
product remained on market at time of recall.
-4- REASON Mislabeled carton -- A box of 25 properly labeled vials of
Dopamine HCl were packaged in a carton labeled Multe-Pak-5.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Red Blood Cells. Recall #B-469-4.
CODE Unit #4023468.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by telephone May 11, 1994. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product, which was collected from a donor who had
travelled to an area designated as endemic for malaria, was
distributed for transfusion.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma;
(d) Recovered Plasma. Recall #B-462/465-4.
CODE Unit numbers: (a) 09G05146, 09G18593, 09G42804, 09G54344,
09G60784, 09G67283, 09GH31902, 09H60530, 09H86395, 09J25081,
09J37958, 09FG04133; (b) 09G05146, 09G18593, 09G54344,
09G67283, 09H86395, 09J25081, 09J37958, 09FG04133; (c)
09G54344, 09FG04133; (d) 09G05146, 09G18593, 09G42804,
09G60784, 09G67283, 09H31902, 09H60530, 09H86395, 09J25081,
09J37958.
MANUFACTURER The American National Red Cross, Omaha, Nebraska.
RECALLED BY Manufacturer, by letter July 7, 1994. Firm-initiated recall
complete.
DISTRIBUTION Nebraska, Iowa, South Dakota, Massachusetts, Florida,
California, Switzerland.
QUANTITY (a) 12 units; (b) 8 units; (c) 2 units; (d) 10 units.
REASON Blood products which were non-reactive for hepatitis B
surface antigen (HBsAg), but were collected from donors who
previously tested repeatedly reactive for HBsAg, were
distributed.
_______________
UPDATE Recall #B-428-4, Source Plasma, which appeared in the August
11, 1994 Enforcement report was incorrect in that Source
Plasma units XE23240, XE23522, XE24333 and XE24415 were
duplicated. In addition, this correction would reduce the
number of units recalled to 153 instead of 157 as previously
stated.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Instruction Manuals for the Hysterofiberscope, Models HYF-P
and HYF-1T for endoscopic observation and diagnosis and/or
treatment within the uterus. Recall #Z-1232/1233-4.
-5- CODE All codes of devices manufactured from 1989 to 1994.
MANUFACTURER Olympus Opti-Electronics Co., Ltd., Fukushima, Japan.
RECALLED BY Olympus America, Inc., Lake Success, New York, by letter
July 27, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Colombia, Canada.
QUANTITY 469 units were distributed.
REASON Devices labeling does not carry adequate directions for use
and fails to warn against unsafe application. Specifically,
their labeling fails to recommend testing patients for
pregnancy prior to use when warranted, and fails to warn
against using these devices in conjunction with laser or
electrosurgical devices.
_______________
PRODUCT Papoose Model 07P Power Add-On for Wheelchairs, designed to
convert any manual wheelchair with a high mount brake bar to
a power driven wheelchair. Recall #Z-1300-4.
CODE Serial numbers: 20990 22311 22712 22912
21694 22312 22714 22929 21697 22314
22849 22940 21942 22436 22860 22943
21992 22469 22870 23240 22209 22573 22893.
MANUFACTURER Redman, Inc., Tucson, Arizona.
RECALLED BY Manufacturer, by telephone July 15, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Arizona, California, Florida, Massachusetts, Minnesota,
Missouri, New Jersey, Nevada, New York, Tennessee, Texas.
QUANTITY 23 units were distributed.
REASON The device was installed on wheelchairs without anti-tippers
and the wheelchairs can tip over when ascending ramps.
_______________
PRODUCT IVAC Tympanic Thermometer, Model 2090B, indicated for the
measurement of core body temperature. Recall #Z-1325-4.
CODE All product is being recalled.
MANUFACTURER IVAC Corporation, San Diego, California.
RECALLED BY Manufacturer, by letter May 9, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 24,566 units were distributed. On July 21, 1994 the firm
reported that they had corrected 12,261 of the 24,566
distributed units.
REASON Device may display inaccurate temperature reading, due to a
faulty design.
_______________
PRODUCT Vingmed Diagnostic Ultrasound System CFM with 5 Mhz APAT
Probe, used for comprehensive evaluation of cardiac anatomy
and hemodynamics: (a) Vingmed Diagnostic Ultrasound System,
Model Nos. CFM 700, CFM 725, CFM 750, CFM 775 and CFM 800;
(b) Vingmed Diagnostic Ultrasound System, Model Nos. CFM
725II, CFM 750II, CFM 775 and CFM 800, Using Software V2.0
or V5.0. Recall #Z-1355/1356-4.
-6- CODE (a) All serial numbers; (b) 006, 13, 18, 33R, 34, 41, 42,
43, 46, 62R, 65, 66, 69R, 78, 102, 103, 104, 106, 133, 135,
136, 137, 138, 150, 155, 157, 158, 159, 161, 162, 163, 164,
165, 186, 223, 224, 229, 235, 567, 570, 571, 572, 573, 574,
575, 595, 597, 608, 609, 816, 895, 896.
MANUFACTURER Vingmed Sound A/S, Horten, Norway.
RECALLED BY Diagnostics Ultrasound, Inc., Milpitas, California, (a) by
letter July 8, 1994; (b) by letter June 6, 1994. Firm-
initiated field correction ongoing.
DISTRIBUTION (a) Nationwide, Argentina, Canada; (b) Alabama, Arizona,
Colorado, Florida, Hawaii, Illinois, Massachusetts,
Maryland, Minnesota, Missouri, Nebraska, New York, Oregon,
Pennsylvania, Rhode Island, Texas, Utah.
QUANTITY (a) 386 units were distributed 1986-1994; (b) 55 units
distributed 1986-1994.
REASON (a) Some units may send electrical pulses from defibrillator
through the ultrasound machine to the ground, which may
result in current leakage and can cause arcing.
(b) The Maximum Acoustic Output (MAO) is nearly three times
the maximum value specified by FDA guidelines for diagnostic
ultrasound equipment.
_______________
PRODUCT Venous Bloodlines: (a) Multiple Arterial under NMC Label,
Catalog No. beginning with 03
(b) Multiple Arterial Bloodlines under Baxter Label, Catalog
No. beginning with 96;
(c) Multiple Venous Bloodlines under NMC Label, Catalog No.
beginning with 03;
(d) Multiple Venous Bloodlines under Baxter Label, Catalog
No. beginning with 96. Recall #Z-1371/1374-4.
CODE (a) Lot No. beginning with M9, M0, M1, M2A, M2B,
M2C, R9, R0, R1, R2A, R2B, R2C;
(b) Lot No. beginning with M9, M0, M1, M2A, M2B, M2C, R9,
R0, R1, R2A, R2B, R2C;
(c) Lot No. beginning with M9, M0, M1, M2A, M2B, M2C, R9,
R0, R1, R2A, R2B, R2C;
(d) Lot No. beginning with M9, M0, M1, M2A, M2B, M2C, R9,
R0, R1, R2A, R2B, R2C.
MANUFACTURER National Medical Care, McAllen, Texas.
RECALLED BY National Medical Care, Rockleigh, New Jersey, by letter
January 25, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Taiwan, India, Uruguay, Venezuela.
QUANTITY 3,860,326 units were distributed.
REASON Certain bloodlines exhibit "cloudy" (opaque) tube segments
which have been associated with bubble formation during use.
_______________
PRODUCT Infant monitors, computerized electronic instruments which
detect baby's heart beats and breathing effort:
(a) Infant Monitor, Model 500; (b) Infant Monitor, Model
500E; (c) Monitor, Model 502; (d) Remote Alarm for Infant
Monitor, Model 501. Recall #Z-1387/1390-4.
-7- CODE Lot numbers: (Model 500 with case) 0500AAA0170963,
0500AAA0195299, 0500AAA0281876, 0500AAA0281914,
0500AAA03212243, 050AAA0371191, 0500AAA0371242,
0500AAA0382097, 0500AAA05005269, 0500AAA05110884,
0500AAA0560268, 0500AAA0560284, 0500AAA0571341,
0500AAA06110942, 0500AAA06110962, 0500AAA0682560,
0500AAA07009526, 0500AAA07110992, 0500AAA07111026,
0500AAA07111042, 0500AAA07111045, 0500AAA0771430,
0500AAA0782576, 0500AAA0860626, 0500AAA0871456,
0500AAA0960668, 0500AAA09907083, 0500AAA1071618,
0500AAA1083353, 0500AAA11200644, 0500AAA1271752;
Model 500 w/o case -- 0500CAA0160161;
Model 500 German -- 0500CER01413980, 0500CER01413981,
0500CER01413982, 0500CER01413983, 0500CER01413985 through
0500CER0141390;
Model 500E: 0500EAA01007595, 0500EAA01007619,
0500EAA01007688, 0500EAA01008728, 0500EAA01008733,
0500EAA01008735, 0500EAA01008736, 0500EAA01008750,
0500EAA01008764, 0500EAA01008766, 0500EAA01110440,
0500EAA01212008, 0500EAA01212025, 0500EAA01212095,
0500EAA01212098, R500EAA01300927, R500EAA01302060,
0500EAA01313134, 0500EAA01413991 through 0500EAA01413997,
0500EAA01413999, 0500EAA01414000, 0500EAA0195144,
0500EAA0195230, 0500EAA0195305, 0500EAA0195408,
0500EAA0195414, 0500EAA0195419, 0500EAA0195463,
0500EAA0195489, 0500EAA02007842, 0500EAA02007846,
0500EAA02007851, 0500EAA02007854, 0500EAA02007860,
0500EAA02008941, 0500EAA02008944, 0500EAA0212170,
R500EAA02300666, R500EAA02905612, 0500EAA02905620,
R500EAA02905623, 0500EAA02905634, 0500EAA02905664,
0500EAA02905675, 0500EAA02905686, 0500EAA02905720,
0500EAA02905755, R500EAA0291727, 0500EAA0295520,
0500EAA0295544, 0500EAA0295590, 0500EAA03313327,
0500EAA0380048, 0500EAA0380187, 0500EAA0380442,
0500EAA0382152, 0500EAA0382170, 0500EAA0382193,
0500EAA03905817, 0500EAA03905857, 0500EAA03905899,
0500EAA03905903, R500EAA03905909, 0500EAA03905951,
0500EAA04212289, 0500EAA04212295, 0500EAA04212301,
0500EAA04212308, 0500EAA0482262, 0500EAA0482266,
0500EAA0482291, R500EAA0482313, 0500EAA0482323,
0500EAA04905973, 0500EAA04905987, 0500EAA04906045,
0500EAA04906087, 0500EAA04906092, 0500EAA05009173,
0500EAA05009178, 0500EAA05009184, 0500EAA05009194,
0500EAA05009201, 0500EAA05110792, 0500EAA05110800,
0500EAA05110807, 0500EAA05110843, 0500EAA05110855,
0500EAA05110865, 0500EAA05212447, 0500EAA05313450,
0500EAA05906161, 0500EAA05906170, 0500EAA05906200,
0500EAA05906407, 0500EAA06009313, 0500EAA06009317,
0500EAA06009323, R500EAA06207159, 0500EAA06212551,
0500EAA06212585, 0500EAA0682473, 0500EAA0682527,
0500EAA0682537, 0500EAA06901651, 0500EAA06906485,
-8- 0500EAA06906505, 0500EAA06906552, 0500EAA06906596,
0500EAA06906598, R500EAA0691551, 0500EAAO7111178,
0500EAAO7111220, 0500EAAO782591, 0500EAAO782625,
0500EAAO782643, 0500EAAO782659, 0500EAAO7782747,
0500EAAO7906640, 0500EAAO7906641, 0500EAAO7906648,
0500EAAO7906782, 0500EAAO8009617, 0500EAAO8111293,
0500EAAO8111320, 0500EAAO8111322, 0500EAAO8111333,
0500EAAO8111341, 0500EAAO8111357, 0500EAAO8111369,
0500EAAO8212713, 0500EAAO8212721, 0500EAAO8212732,
0500EAAO8301014, 0500EAAO882764, R500EAA0882810,
0500EAAO882885, R500EAA0882908, 0500EAAO882919,
0500EAAO882986, 0500EAAO8906878, 0500EAAO8906914,
0500EAAO8906939, 0500EAAO8906940, 0500EAAO8906941,
0500EAAO8906947, 0500EAAO8906948, 0500EAAO8906968,
0500EAAO8907004, 0500EAAO8907005, 0500EAAO909009743,
0500EAAO9009750, 0500EAAO9009758, 0500EAAO9009761,
0500EAAO9009764, R500EAA09009766, 0500EAA09009778,
0500EAA09009781, 0500EAA09009885, 0500EAA09009886,
0500EAA09009916, 0500EAA09009918, 0500EAA09009939,
0500EAA09009943, 0500EAA09212799, 0500EAA09212803,
0500EAA09212813, 0500EAA0983093, 0500EAA0983154,
0500EAA0983171, 0500EAA0983180, R500EAA0983214,
0500EAA0983262, 0500EAA0983265, 0500EAA0983267,
0500EAA0983270, 0500EAA10010025,
0500EAA10010026,0500EAA10111515, 0500EAA10111520,
0500EAA10111593, 0500EAA1083371, 0500EAA1083375,
0500EAA1083380, 0500EAA1083403, 0500EAA1083417,
R500EAA1083442, R500EAA1083467, R500EAA1083471,
0500EAA1083593, 0500EAA10907114, 0500EAA10907132,
0500EAA11111626, 0500EAA11111667, 0500EAA11111696,
0500EAA11111749, 0500EAA11111751, 0500EAA11212981,
0500EAA1183597, 0500EAA1183625, 0500EAA1183628,
0500EAA1183669, 0500EAA1183670, 0500EAA1183697,
0500EAA1183707, 0500EAA1183710, 0500EAA1183804,
0500EAA1183805, 0500EAA1183852, 0500EAA11907218,
0500EAA11907220, 0500EAA11907285, 0500EAA11907329,
0500EAA11907348, 0500EAA11907354, 0500EAA12010374,
0500EAA12010384, 0500EAA12010390, 0500EAA12111787,
0500EAA12111823, 0500EAA12313955 through 0500EAA12313979,
0500EAA1285056, 0500EAA12907423, 0500EAA12907428,
0500EAA12907430, 0500EAA12907432, 0500EAA12907456,
0500EAA12907460, 0500EAA12907504;
Model 500E German -- 00500EER01413984;
Model 501 Remote Alarm -- 051AAY02402677, 0501AAY0240268,
0501AAY02402679, 0501AAY02402680, 0501AAY02402681,
0501AAY02402682;
Model 502 French -- 0502ADR01404589, 0502ADR01404590;
Model 502 -- 0502AAA01404591 through 0502AAA01404600,
0502AAA01404602 through 0502AAA01404610, 0502AAA0280687,
0502AAA0881026, 0502AAA09002455, 0502AAA11203911,
0502AAA1281252;
-9- Model 502 German -- 0502AAR01404576, 0502AAR01404577,
0502AAR01404578, 0502AAR02404626;
Model 502 German -- 0502AER01404579, 0502AER01404580,
0502AER01404501, 0502AER01404582 through 0502AER01404588.
MANUFACTURER Corometrics Medical Systems, Inc., Wallingford, Connecticut.
RECALLED BY Manufacturer, by telephone July 29, 1994, followed by letter
August 3, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 348 units were distributed.
REASON There is a failure of the audible alarm which has been
attributed to a faulty audio transducer/indicator.
_______________
PRODUCT Puritan-Bennett Series D Pressure Compensated Oxygen
Flowmeter, Flowmeter w/Regulator, and Flowmeter Replacement
Cartridge, prescription devices used to control and
indicate the flow of oxygen to the patient in liters per
minute increments:
(a) Flowmeter, Part Numbers: 124500, 124501, 124502, 124504,
124505, 124531, 124532, 124534;
(b) Flowmeter w/Regulator, Part Numbers: 128411, 128413;
(c) Flowmeter Replacement Cartridge, Part Number 290346.
Recall #Z-1402/1404-4.
CODE (a) Part #124500; Lot numbers: 401B, 402B, and 404B;
124501/401A, 402B, and 404A; Part #124502; Lot numbers: 402A
and 404A; Part #124504, Lot numbers: 401A, 402A, and 404A;
Part #124505, Lot numbers: 402A and 405A; Part #124531, Lot
numbers: 402A and 410A; Part #124532, Lot numbers: 401A,
402A, and 404A; Part #124534, Lot numbers: 402A and 404A;
(b) Part #128411, lot numbers: 402 and Part #128413,
Lot #402; (c) Part #290346, Lot #409A.
MANUFACTURER Puritan-Bennett, Lenexa Division, Lenexa, Kansas.
RECALLED BY Manufacturer, by letter July 11, 1994. Firm-initiated field
correction recall ongoing.
DISTRIBUTION Nationwide, England, Canada, Japan.
QUANTITY 1,711 Flowmeters, 223 regulators, and 122 replacement
cartridges that may have the incorrect scale were
distributed during the months of January through July 1994.
REASON Some of the flowmeter scales (cartridges) have the word
"Air" instead of the word "Oxygen" printed at the bottom of
the scale and the scale is approximately 1/10 of an inch
shorter than required.
_______________
PRODUCT Laser Marking Systems, used to mark and identify parts etc:
(a) Model Signature Laser Marking; (b) Model Script Laser
Marking System. Recall #Z-1406/1407-4.
CODE None.
MANUFACTURER Excel Control Laser, Inc., Orlando, Florida.
RECALLED BY Manufacturer. FDA approved the firm's correction action
plan August 8, 1994. Firm-initiated field correction
complete.
-10- DISTRIBUTION Nationwide.
QUANTITY 9 units.
REASON Laser products failed to comply with the Federal laser
product performance standard regarding protective housing
requirements.
_______________
PRODUCT Ophthalmic Laser System, used in ophthalmic surgery -
posterior capsulotomies. Recall #Z-1412-4.
CODE Model Q10 Plus.
MANUFACTURER HGM Medical Lasers, Inc., Salt Lake City, Utah.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 19 units.
REASON The device was found to have a defective design in that the
joystick aiming beam control was poorly seated causing
internal electrical wires to become prematurely worn and
broken.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Spli-Prest (FDF Serum) Kits, used for detection and
semiquantitation of fibrine/fibrinogen degradation products
(FDP) by agglutination of latex particles coated with
specific antibodies: (a) Spli-Prest (FDF Serum) Kit Catalog
#0538; (b) Spli-Prest Latex, Catalog #0538A;
(c) Spli-Prest Bulk Latex and Buffer, Catalog #0549.
Recall #Z-1391/1393-4.
CODE Lot numbers: (a) 932077A and 934187; (b) 935187;
(c) 935187.
MANUFACTURER Diagnostica Stago, Franconville, France.
RECALLED BY American Bioproducts, Parsippany, New Jersey, by letters of
January 20, 21, and 31, 1994, and February 28, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,175 units were distributed.
REASON The Spli-Prest kit and two components (Latex & Bulk Latex
and Buffer) will give an inaccurate test results when used
with the enclosed buffer dropper caps.
_______________
PRODUCT Cell Dyn 3000/3500 Hematology Analyzer Sample Loader,
automatically advances blood samples for testing by the
analyzers:
(a) CELL-DYN 3000/3500 Hematology Analyzer Sample Loader,
List #91384-01;
(b) CELL-DYN 3000/3500 Hematology Analyzer Sample Loader,
List #91384-03;
(c) CELL-DYN 3000/3500 Hematology Analyzer Sample Loader
List No. 91387-01;
-11- (d) CELL-DYN 3000/3500 Hematology Analyzer Sample Loader
List No. 91387-03;
(e) CELL-DYN 3000/3500 Hematology Analyzer Sample Loader
List No. 91381-01;
(f) CELL-DYN 3000/3500 Hematology Analyzer Sample Loader
List No. 91380-01;
(g) CELL-DYN 3000/3500 Hematology Analyzer Sample Loader
List No. 91103-81. Recall #Z-1395/1401-4.
CODE List numbers: (a) 91384-01; (b) 91384-03; (c) 91387-01;
(d) 91387-03; (e) 91381-01; (f) 91380-01; (g) 91103-81.
MANUFACTURER Abbott Laboratories, Inc., Diagnostic Division, Santa Clara,
California.
RECALLED BY Manufacturer, by letter March 10, 1994. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 706 units were distributed between 1989 and January 1994.
REASON The sample loader rack fails to advance, resulting in
multiple aspirations of a single tube.
SEIZURES:
=================================================================
_______________
PRODUCTS Farm Cream and Anhydrous Milk Fat (94-710-925 et al).
CHARGES Adulterated - A valuable constituent of the articles, milk
fat, has been, in whole or in part, omitted or abstracted
from the articles; and a substance, soybean oil, has been
substituted wholly or in part for milk fat.
LOCATIONS Danish Maid Butter Company, Hammond Cold Storage, and
Berkshire Foods, Inc., Chicago, Illinois.
FILED September 19, 1994; U.S. District Court for the Northern
District of Illinois, Eastern Division; Civ. #94C 5695;
FDC #67015.
SEIZED September 20, 1994 - goods valued at approximately $545,000.
_______________
PRODUCT Oxygen, USP (94-628-683/4).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the articles' manufacture, processing,
packing, and holding do not conform to, and are not operated
and administered in, conformity with current good manufac-
turing practice requirements.
LOCATIONS Maag Prescription & Medical Supply, Inc., Pocatello, Idaho.
FILED August 5, 1994; U.S. District Court for the District
of Idaho; Civ. #94-0340-E-HLR; FDC #66933.
SEIZED August 25, 1994 - goods valued at approximately $14,625.
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