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
03/31/1993
Recalls and Field Corrections: Foods -- Class II -- 03/31/1993
March 31, 1993 93-13
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
PRODUCT Assorted Sour Balls Hard Candy, red, yellow, green,
and orange, packaged approximately 14-15 balls per
clear plastic bag. Recall #F-262-3.
CODE None.
MANUFACTURER Royal Candy Company, Inc., Brooklyn, New York.
RECALLED BY Manufacturer, by letter February 12, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 40 dozen 3-ounce bags were distributed; firm estimates
3 dozen bags remain on the market.
REASON Product contains undeclared FD&C Yellow No. 5.
PRODUCT Pepsi Cola, in 16 ounce glass bottles, sold
individually, in 6-packs, or in cases of 24 bottles.
Recall #F-263-3.
CODE B023CE2 DE5(cent symbol) 2236, B023CE2 DE5 (cent
symbol) 2237, B023CE2 (cent symbol) 2238.
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MANUFACTURER Pepsi-Cola Metropolitan Bottling Company, Inc., of
Philadelphia, Philadelphia, Pennsylvania.
RECALLED BY Manufacturer, by driver pick-up February 25, 1993.
Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 93 cases were distributed.
REASON Product is contaminated with glass.
PRODUCT Imported HP brand English Mustard Piccalilli Chow Chow
9.5 fluid ounces, for use as a relish.
Recall #F-265-3.
CODE None.
MANUFACTURER Lea & Perrins International, Worchester, England.
RECALLED BY Haddon House Food Products, Inc., Medford, New Jersey,
by letter December 30, 1992. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 212 cases (24 units per case) were distributed.
REASON Product contains undeclared FD&C Yellow No. 5.
PRODUCT Vineland Syrup brand flavored syrup products, in 1
gallon plastic containers:
(a) Lemon Syrup; (b) Banana Syrup; (c) Pineapple
Syrup; (d) Lime Syrup. Recall #F-266/269-3.
CODE None.
MANUFACTURER Vineland Syrup, Vineland, New Jersey.
RECALLED BY Manufacturer, by visit beginning November 20, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION New Jersey, Maryland, Delaware.
QUANTITY Approximately 138 gallons of product were distributed.
REASON Product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II
PRODUCT Fragrance Free Lubriderm Lotion for dry skin care, in
8 ounce plastic bottles. Recall #F-264-3.
CODE Lot #911N1VA.
MANUFACTURER Warner Lambert Company, Vega Baja, Puerto Rico.
RECALLED BY Warner Lambert Company, Morris Plains, New Jersey, by
letter dated September 1, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 61,384 bottles were distributed.
REASON Product is contaminated with Pseudomonas Aeruginosa.
-2-
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RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Sulfasalazine Tablets, 500 mg, a Rx anti-bacterial, in
500 tablet bottles. Recall #D-183-3.
CODE Lot #3960-31 EXP 4/94.
MANUFACTURER Lederle Laboratories, Pearl River, New York.
RECALLED BY Manufacturer, by letter January 27, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,160 bottles were distributed.
REASON Product does not meet dissolution specification
through expiration date.
PRODUCT Nystatin Tablets, USP 500,000 units, in bottles of
100, for the treatment of intestinal candidiasis.
Recall #D-182-3.
CODE Lot #H733-01 EXP 12/93.
MANUFACTURER Pharmaceutical Basics, Inc., Denver, Colorado,
California.
RECALLED BY Manufacturer, by letter March 3, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Washington state, Louisiana, Minnesota, Alabama, New
Mexico, California, Florida, Ohio, Oregon.
QUANTITY 1,105 bottles were distributed.
REASON Potency not assured through expiration date.
PRODUCT Povidone-Iodine 5% Surgical Scrub, packaged in bottles
of 16 oz., and 1 gallon sizes, used as a topical
antiseptic under the following labels: Thames, Rugby,
IDE, Bioline, Goldline, Schein, Qualitest.
Recall #D-184-3.
CODE All lots within their expiration date.
MANUFACTURER Thames Pharmacal Co. Inc., Ronkonkoma, New York.
RECALLED BY Manufacturer, by telephone February 3, 1993, followed
by letter February 11, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 8,000 16-ounce bottles and 1,500 1-
gallon bottles were distributed.
REASON Potency not assured through expiration date.
PRODUCT (a) Zenate, prenatal multivitamin/mineral supplement
tablets, in bottles of 100; (b) Creon, pancreatin USP,
Capsules, in bottles of 100. Recall #D-185/186-3.
CODE Lot 83774.
MANUFACTURER Solvay Pharmaceuticals, Marietta, Georgia.
RECALLED BY Manufacturer, by telephone January 8, 1993, followed
by letter January 14, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
-3-
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QUANTITY 6,245 bottles labeled as Zenate were distributed; firm
estimates that 10% of the product remains on the
market.
REASON Some units of Zenate Tablets are mislabeled as Creon
Capsules.
PRODUCT Buspar, (Buspirone HCl) 10 mg tablets, an antianxiety
agent, in 100 tablet bottles. Recall #D-188-3.
CODE Lot #HIJ91A EXP 10/94.
MANUFACTURER Bristol-Myers Squibb, Mayaguez Puerto Rico.
RECALLED BY Bristol-Myers Squibb Company, Pharmaceutical Group
Technical Operations, New Brunswick, New Jersey, by
letter December 10, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 29,490 bottles were distributed; firm
estimates 15,550 bottles remain on the market.
REASON Some tablets are superpotent.
PRODUCT Diprivan (Propofol) Injection, 10 mg/ml, in single-
patient infusion vials, used for intravenous
anesthesia. Recall #D-189-3.
CODE Lot numbers: 3049N, 3141N, 3145N, 3210N.
MANUFACTURER Kabi Pharmecia, Stockholm, Sweden.
RECALLED BY Zeneca Pharmaceutical Group, Wilmington, Delaware, by
fax and telephone on February 25, 1993, followed by
letter February 26, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 14,000 units were distributed; firm estimates 7,300
units remain on the market.
REASON Some vials have a potential for cracks which may
result in a lack of assurance of sterility.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Phenazopyridine Hydrochloride 100 mg sugar coated
tablets, in bottles of 100, indicated for the
symptomatic relief of pain, burning, urgency,
frequency and the discomforts arising from irritation
of the lower urinary tract mucosa. Recall #D-180-3.
CODE Lot #11201 which was later changed to AABM.
MANUFACTURER Manufacturing Chemists, Inc., Indianapolis, Indiana.
RECALLED BY Manufacturer, by telephone October 26, 1992, followed
by letters dated October 26 & 27, 1992. Firm-
initiated recall ongoing.
DISTRIBUTION New Jersey, Florida, New York, Michigan, California.
QUANTITY Approximately 800,000 tablets were distributed.
-4-
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REASON Product does not meet dissolution specifications.
PRODUCT Nalfon Tablets,Tablet #1900, Fenoprofen Calcium
Tablets, USP 600 mg, in bottles of 100 and 500, a Rx
drug used for relief of rheumatoid arthritis and
osteoarthritis. Recall #D-181-3.
CODE All lots.
MANUFACTURER Eli Lilly & Company, Indianapolis, Indiana.
RECALLED BY Manufacturer, by letter December 16, 1992. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, The Netherlands, Puerto Rico.
QUANTITY 904,192 bottles of 100 tablets and 164,000 bottles of
500 tablets were distributed in the United States
including Puerto Rico. 1,268 bottles of 100 were
distributed in the Netherlands. Firm estimates 10,000
bottles of 100 tablets and 700 bottles of 500 remain
on the market.
REASON Product does not meet dissolution specifications
through expiration date.
PRODUCT Extra Strength, Cold/Allergy/Flu Medicine Plus Fever
and Pain Reliever Tablets, in bottles of 20, an OTC
medication. Recall #D-187-3.
CODE Lot numbers and expiration dates: #Z411 EXP 7/93,
#Z412 EXP 7/93, #Z617 EXP 2/94, #Z618 EXP 2/94, #A453
EXP 8/94, #A454 EXP 8/94, #A689 EXP 3/95, and #A571
EXP 3/95.
MANUFACTURER The Reese Chemical Company, Cleveland, Ohio
RECALLED BY Manufacturer, by letter March 5, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 27,491 bottles were distributed; firm estimates 6,000
bottles remain on the market.
REASON Label declares FD&C Red #3, whereas the manufacturer's
formula states that the product contains Red #40
Aluminum Lake and Red #27 Aluminum Lake.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT (a) Red Blood Cells; (b) Red Blood Cells, Expired;
(c) Red Blood Cells, Leukocytes Removed;
(d) Red Blood Cells, Washed; (e) Platelets;
(f) Platelets, Expired; (g) Cryoprecipitated AHF;
(h) Fresh Frozen Plasma; (i) Source Leukocytes;
(j) Recovered Plasma. Recall #B-105/114-3.
CODE Unit numbers: (a) 1931999, 1964071, 1981891, 2617936,
2661980, 2679951, 2695001, 2702281, 2705007, 2705784,
-5-
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3364537, 5450031, 5451611, 5475781, 5479097, 6493253,
7210992, 8809899, 9271382, 9280641, 10013457,
10032079, 10032399, 10034740, 10035038, 10043861,
10103544, 10105390, 10127466, 10388036, 10761583,
10855351, 11076922, 11345199, 11587050, 11890885,
12261423, 12262455, 12400372, 12404234, 12496905,
12676810, 12942545, 12972551, 13812994, 14004660,
14025259, 14638445, 16129834, 16132863, 16139743,
17504242, 20067878, 21253392, 21253836, 21456491,
22597820, 40110747, 40122876, 51009023, 51013899,
51013942, 51016608, 51019486, 51030008, 51033674,
51045209, 51050813, 51052842, 51081071, 51084488,
51087603, 54216140, 72548909, 100192874, 101677201,
101749185, 101868134, 101971568, 103596713, 104072601,
104761318, 110258092, 110261089, 110277677, 110283208,
110318140, 111134056, 111239379, 111464745, 111772164,
115946698, 117388624, 117712004, 120330194, 120331920,
120346497, 120347798, 122734143, 130840971, 131248592,
131248810, 131993961, 132535597, 134773958, 141195212,
141707291, 142130154, 142130490, 142131931, 151476051,
151519447, 151628199, 151690355, 152037271, 152154396,
152710966, 152936191, 154308872, 155021190, 160224245,
160451691, 160452718, 160515391, 160529606, 160537919,
160538967, 160861762, 160861867, 161020289, 161023377,
161283504, 161284388, 161919227, 162066739, 162660620,
162895400, 163434303, 163987293, 164357283, 164816996,
164937463, 167228095, 167250077, 167765705, 170201078,
170210735, 170213320, 170563542, 170575222, 171018456,
171091311, 171179705, 171181113, 171316633, 171371785,
171753386, 171866078, 173576669, 174131770, 174257521,
174790489, 174791669, 175274886, 175508611, 180626210,
180630723, 180634757, 180637439, 180882571, 181174717,
181537720, 181540378, 181793490, 182287167, 184136909,
184284090, 184301091, 185519456, 187213397, 187616273,
190234154, 190308769, 190669821, 191718961, 191719587,
194156407, 194856358, 195425144, 200664640, 200710890,
204840800, 210693927, 211139364, 211425081, 212874133,
212962511, 220100152, 220101582, 220439449, 220591727,
220594164, 221065365, 221548013, 221695784, 221935635,
225237151, 225974423, 250444768, 250474842, 251190302,
251191907, 251312010, 252054107, 252160099, 252175273,
252664081, 252761218, 254544652, 260298807, 260299215,
260299266, 260299449, 260547376, 261068644, 262089766,
301305208, 306076041, 627745876, 807174479, and
808140409; (b) 160684294; (c) 77449564, 17351850, and
12620376; (d) 211142301;
(e) 2661980, 2695001, 2696862, 2702281, 2705007,
5450031, 5451611, 6493253, 8809899, 9280641, 10010621,
10032399, 10034740, 10035038, 10127466, 10761583,
12261423, 12496905, 12676810, 12942545, 12972551,
13812994, 16129834, 16132863, 17504242, 21456491,
51027428, 51033674, 51087603, 101868134, 103596713,
-6-
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104072601, 110261089, 110277677, 110283208, 110318140,
111239379, 115946698, 117388624, 117712004, 120331920,
122734143, 131993961, 132535597, 132799782, 134773958,
141707291, 142130154, 142130490, 151476051, 151519447,
152037271, 152154396, 152710966, 155021190, 160088921,
160451691, 160452718, 160515391, 160529606, 160861762,
160861867, 161020289, 161284388, 162066739, 163434303,
164357283, 164816996, 167765705, 170213320, 171018456,
171179705, 171181113, 171371785, 173576669, 174131770,
174257521, 174790489, 175274886, 175508611, 180626210,
180634757, 180882571, 181174717, 181793490, 184136909,
184301091, 185519456, 187213397, 187616273, 191718961,
194856358, 195425144, 200710890, 210693927, 220439449,
220591727, 220594164, 221695784, 251191907, 252054107,
252175273, 260299215, 260547376, and 808140409
(f) 1966717, 10043861, 11890885, 225974423, 12400372,
120347798, 160538967 and 190669821
(g) Units 1964071, 2679951, 5479097, 10031079,
10388036, 16139743, 101677201, 101971568, 103596713,
142131931, 151690355, 160537919, 161023377, 163987293,
164937463, 167228095, 167250077, 170210735, 171371785,
171753386, 174791669, 180630723, 181793490, 191719587,
194156407, 195425144, 200664640, 221065365, 221695784,
225237151, and 251312010;
(h) 2705007, 10105390, 11345199, 11890885, 12496905,
12676810, 13812994, 17351850, 51013899, 51030008,
51087603, 100192874, 110258092, 110261089, 110277677,
111239379, 115946698, 117388624, 117712004, 131248592,
131304797, 142130154, 155021190, 160515391, 160684294,
160861867, 167765705, 170201078, 171179705, 174790489,
175274886, 180634757, 181174717, 184136909, 185519456,
187616273, 190669821, 191718961, 220594164, 225974423,
260547376, 261068644, and 808140409;
(i) 10035038, 170213737, 204840800, 211095170, and
254544652;
(j) 1931999, 1964071, 1966717, 1981891, 2617936,
2661980, 2679951, 2695001, 2696862, 2702281, 2705784,
3364537, 5450031, 5451611, 5475781, 5479097, 6493253,
7190949, 7210992, 8809899, 9271382, 9280641, 10010621,
10013457, 10020278, 10032079, 10032399, 10034740,
10035038, 10043861, 10103544, 10127466, 10138953,
10388036, 10761583, 10855351, 11076922, 11573540,
11587050, 12262455, 12400372, 12404234, 12620376,
12942545, 12972551, 14004660, 14638445, 16129834,
16132863, 16139743, 17504242, 18018292, 20067878,
21253392, 21253836, 21456491, 22598811, 40110747,
40122876, 51009023, 51013942, 51016608, 51019486,
51033674, 51045209, 51050813, 51052842, 51081071,
51084488, 51089866, 51833190, 53945168, 54216140,
72548909, 77449564, 101677201, 101749185, 101868134,
101971568, 103596713, 104072601, 104761318, 110283208,
110285939, 110318140, 111464745, 111134056, 111772164,
120330194, 120331920, 120346497, 120347798, 122734143,
130840971, 131248810, 131993961, 132535597, 132799782,
134773958, 141195212, 141707291, 142131931, 142643481,
151476051, 151519447, 151628199, 151690355, 152037271,
152154396, 152710966, 152936191, 154308872, 160088921,
160451691, 160452718, 160529606, 160537919, 160538967,
160690777, 160861762, 161020289, 161023377, 161283504,
-7-
161284388, 161919227, 162066739, 162660620, 162895400,
163434303, 163987293, 164357283, 164816996, 164937463,
167228095, 167250077, 170210735, 170213320, 170563542,
170575222, 171018456, 171091311, 171181113, 171316633,
171371785, 171753386, 173576669, 174131770, 174257521,
174791669, 175508611, 180626210, 180630723, 180637439,
180882571, 181537720, 181540378, 181793490, 184284090,
184301091, 187213397, 190234154, 190308769, 190551230,
191719587, 192090118, 194156407, 194856358, 195425144,
200664640, 200710890, 204840800, 210693927, 211142301,
211425081, 212962511, 220100152, 220101582, 220439449,
220591727, 220945621, 221065365, 221548013, 221695784,
221935635, 225237151, 250444768, 251190302, 251191907,
251312010, 252054107, 252160099, 252175273, 252664081,
252761218, 254544652, 260298807, 260299215, 260299266,
260299449, 262089766, 301305208, 627745876, 807174479.
MANUFACTURER J. K. and Susie L. Wadley Research Institute and Blood
Bank, Dallas, Texas.
RECALLED BY Manufacturer, by letters dated May 29, 1992, and July
13, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Texas, Louisiana, Ohio, Pennsylvania, Illinois,
Florida, California, New Jersey.
QUANTITY (a) 231 units; (b) 1 unit; (c) 3 units; (d) 1 unit;
(e) 105 units; (f) 8 units; (g) 31 units; (h) 43
units; (i) 5 units; (j) 203 units.
REASON Blood products which tested non-reactive for the
antibody to the human immunodeficiency virus type 1
(anti-HIV-1), but were collected from donors who
previously tested repeatedly reactive for anti-HIV-1,
were distributed.
PRODUCT Red Blood Cells, Deglycerolized. Recall #B-180-3.
CODE Unit #TM0101277.
MANUFACTURER Personal Blood Storage of America, Inc., Columbia,
South Carolina.
RECALLED BY Consignee notified firm by telephone November 24,
1992. Firm-initiated recall complete.
DISTRIBUTION South Carolina.
QUANTITY 1 unit.
REASON Blood product labeled with the incorrect expiration
date and time was distributed.
PRODUCT Red Blood Cells. Recall #B-223-3.
CODE Unit #R47748.
-8-
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MANUFACTURER Blood Bank of the Alameda-Contra Costa Medical
Association, Oakland, California.
RECALLED BY Manufacturer, by telephone April 2, 1992. Firm-
initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product, which tested repeatedly reactive for
the antibody to hepatitis B core antigen (anti-HBc),
was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT Platelets. Recall #B-183-3.
CODE Unit #53C44120.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter July 1, 1992. Firm-initiated
recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit.
REASON Blood product containing anti-E antibodies, but
labeled as negative for unexpected antibodies, was
distributed.
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-196/197-3.
CODE Unit #53FK01338.
MANUFACTURER American Red Cross Services, Baltimore, Maryland.
RECALLED BY Manufacturer, by telephone April 8, 1992, and by
letter April 29, 1992. Firm-initiated recall
complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit of each component.
REASON Blood products which tested negative for the antibody
to human immunodeficiency virus type 1 (anti-HIV-1),
but were collected from a donor who previously tested
repeatedly reactive for anti-HIV-1, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
PRODUCT (a) Model 2000W Heart/Respiration Monitors;
(b) Model 2000W Option H Heart/Respiration Monitors;
(c) Model 700 Recording Device (with monitor and pulse
oximeter). Recall #Z-314/316-3.
CODE Serial numbers: (a) - Model 2000W
3911 20954 22563 23664 24661 26596
3934 20986 22660 23683 24687 26597
4005 21002 22776 23706 24799 26598
4024 21193 22819 23753 24810 26599
4061 21299 22916 23780 24812 26600
-9-
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4093 21382 22954 23811 24837 26601
4212 21385 23175 23867 25049 26602
4268 21399 23197 23928 25068 26603
4275 21626 23200 24079 25119 26604
4358 21957 23265 24090 26584 26605
4425 21964 23274 24102 26585 26606
4432 22036 23316 24110 26587 26607
4486 22078 23338 24125 26588 26608
4623 22240 23362 24129 26589 26609
20219 22299 23420 24210 26590 26610
20334 22312 23429 24249 26591 26611
20650 22391 23430 24421 26592 26612
20656 22462 23439 24540 26593 26628
20906 22466 23551 24541 26594 26629
20933 22492 23569 24617 26595 26630
26631 26797 26820 26847 26868 26889
26632 26798 26821 26848 26869 26890
26633 26799 26822 26849 26870 26891
26634 26800 26823 26850 26871 26892
26635 26801 26824 26851 26872 26893
26636 26802 26825 26852 26873 26894
26637 26803 26826 26853 26874 26895
26640 26804 26827 26854 26875 26898
26641 26805 26828 26855 26876 26899
26642 26806 26829 26856 26877 26900
26643 26807 26830 26857 26878 26901
26644 26808 26836 26858 26879 26902
26645 26809 26837 26859 26880 26903
26646 26810 26838 26860 26881 26904
26647 26813 26839 26861 26882 26905
26787 26814 26840 26862 26883 26906
26792 26815 26841 26863 26884 26907
26793 26816 26842 26864 26885 26908
26794 26817 26843 26865 26886 26909
26795 26818 26844 26866 26887 26910
26796 26819 26846 26867 26888 26911
26912 26933 26954 26677
26913 26934 26955
26914 26935 26956
26915 26936 26957
26916 26937 26958
26917 26938 26959
26918 26939 26960
26919 26940 26961
26920 26941 26962
26921 26942 26963
26922 26943 26964
26923 26944 26965
26924 26945 26966
26925 26946 26967
26926 26947 26968
-10-
26927 26948 26970
26928 26949 26971
26929 26950 26990
26930 26951 26992
26931 26952 27022
26932 26953 27023
The following additional Model 2000W units were
recalled on 2/8/93:
4070 23124 4118 23134 4122 23318 4369
23354 4392 23391 20577 23450 20612 23471
20891 23506 20924 23679 21069 23782 21072
23861 21379 24050 21664 24083 22095 24207
22314 24602 22390 24678 22648 22749 22784
22914 23060;
(b) Model 2000W Option H:
6084 6565 6721 6781 7032 7036 7110 7312 7316 7615 7616
7617 7618 7619 7620 7621 7622 7623 7624 7625 7626 7627
7628 7629 7630 7631 7632 7633 7634
(c) System 700: 70033 70066 70068 70073 70074.
MANUFACTURER EdenTec, A Nellcor Company, Eden Prairie, Minnesota.
RECALLED BY Manufacturer, by telephone January 18 and 19, 1993,
followed by letters of January 20, 1993, and February
8, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Germany.
QUANTITY 378 monitors and 5 recording devices were distributed.
REASON The devices fail to alarm (both visually and audibly)
during an apnea event due to defective capacitor(s).
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Quantum 250 Lightsource, for endoscopic surgery:
(a) Product #220-136-000 (120 volt model);
(b) Product #220-136-220 (220 volt model).
Recall #Z-377/378-3.
CODE Serial numbers: (a) Q891005, Q91201, Q91202, Q91302,
Q91204, 90013001Q2, 90013003Q2, 90013004Q2,
90013005Q2, 90013006Q2, 90013007Q, 90013008Q,
90013010Q, 90013011Q, 90013012Q, 90013013Q, 90013014Q,
90013007Q, 90013015Q, 90013016Q, 90013027Q, 90020014Q,
90020024Q, 90020034Q, 90020044Q, 90020045Q, 90030014Q,
90030024Q, 90030034Q, 90030044Q, 90030054Q, 90030064Q,
90030074Q, 90030084Q, 90030094Q, 90030104Q, 90030114Q,
90030124Q, 90030134Q, 90030144Q, 90120024Q, 90120034Q,
90120044Q, 90120054Q, 90120064Q, 90120074Q, 90120084Q,
90120094Q, 90120104Q, 90120114Q, 90120124Q, 90120134Q,
90120144Q, 90120154Q, 90120164Q, 90120174Q, 90120184Q,
90120194Q, 90120204Q, 91090024Q, 91090034Q, 91090044Q,
91090054Q, 91090064Q, 91090014Q, 91090024Q2,
91090034Q2, 91090044Q2, 91090012Q, 91100014Q2,
91100024Q2, 91100184Q, 91100174Q, 91100164Q,
91100154Q, 91100144Q, 91100134Q, 91100124Q,
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91100114Q, 91100104Q, 91100094Q, 91100084Q, 91100074Q,
91100064Q, 91100054Q, 91100044Q, 91100034Q, 91100024Q,
9110014Q.
(b) 900900940, 90090104, 9009074, 9009084, 90090054,
9009034Q, 900100024, 900100054, 9001300102, 90070014,
90070024, 90070034, 90070044, 90070054, 90070064,
90070074, 90070084, 90070094, 90070104, 90070114,
90070124, 90070134, 90070144, 90070154, 90070164,
90070714, 90070184, 90070194, 90070204.
MANUFACTURER Stryker Endoscopy, San Jose, California.
RECALLED BY Manufacturer, by letter July 3, 1992.
Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 126 units were distributed.
REASON The unit may turn off prematurely due to defective
switch, and the light adjustment feature may fail,
keeping the light output at a constant level.
PRODUCT Adult and Child Bageasy Disposable Manual
Resuscitators, single use units. Recall #Z-369/370-3.
CODE Lot numbers: B326, B327, B328, B329, B330.
MANUFACTURER Respironics, Inc., Murrysville, Pennsylvania.
RECALLED BY Manufacturer, by letter between November 5 and 16,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 2,257 units were distributed.
REASON Devices may exhibit higher than normal exhalation
resistance characteristics.
PRODUCT FACS Vantage Cell Sorter. Recall #Z-371-3.
CODE None.
MANUFACTURER Becton-Dickinson Immunocytometry Systems, San Jose,
California.
RECALLED BY Manufacturer. FDA approved the firm's corrective
action plan February 19, 1993. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 28 units were distributed.
REASON Noncompliance with the performance standards for laser
products in that in one position of the camera
subsystem there was a gap in the protective housing
allowing unnecessary human access to laser radiation.
PRODUCT Cardiotronics Adult Multi-Pad Disposable External
Pacing/External Defibrillation/ECG Monitoring
Electrodes. Recall #Z-373-3.
CODE Lot numbers (used before date): November 17, 1993,
November 24, 1993, December 08, 1993, December 20,
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1993, December 27, 1993, January 10, 1994, January 24,
1994, January 31, 1994, February 28, 1994.
MANUFACTURER Cariotronics, Inc., Carlsbad, California.
RECALLED BY Manufacturer, by letters dated August 25, 1992. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, New Zealand, Canada.
QUANTITY Approximately 150 boxes (10 units per box) were
distributed; firm estimates 45 boxes remain on the
market.
REASON A recent modification to the electrode has caused
unsuitable electrical characteristics, which may
result in the lose of the ECG signal.
PRODUCT Bovie Specialist Electrosurgery Units.
Recall #Z-380-3.
CODE CM2001, CM2002, CM2003, CM2004, CM2005, CM2006,
CM2007, CM2008, CM2009, CM2010, CM2011, CM2012,
CM2013, CM2014, CM2015, CM2016, CM2017, CM2018,
CM2019, CM2020, CM2021, CM2022, CM2023, CM2024
MANUFACTURER MDT Diagnostic Company, N. Charleston, South Carolina.
RECALLED BY Manufacturer, by telephone the first week of June
1992. Firm-initiated recall complete.
DISTRIBUTION California, Florida, Illinois, Iowa, Massachusetts,
Maryland, North Carolina, Nevada, New York, Tennessee,
Texas, Virginia.
QUANTITY 24 units were distributed.
REASON The device may contain an assembled wiring harness
which will not allow the circuit to sentry red lamp to
go off when the dispersive electrode is properly
connected to the unit.
PRODUCT Remstar Choice Nasal CPAP System, used by sufferers of
obstructive sleep apnea, to deliver constant air
pressure to the patient through a mask that fits over
the nose. Recall #Z-397-3.
CODE Serial number range 97131-97215 and 68161-68233.
MANUFACTURER Respironics, Inc., Murrysville, Pennsylvania.
RECALLED BY Manufacturer, by letter February 15, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION California, Alabama, North Dakota, Oklahoma,
Connecticut, Texas, Utah, Michigan, Georgia, Iowa,
Missouri, Ohio, Minnesota, Colorado, Idaho, Canada.
QUANTITY Undetermined.
REASON The units were indirectly exposed to dust generated
during construction.
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MEDICAL DEVICE SAFETY ALERTS:
PRODUCT (a) CA 72-4 RIA Test Kits; (b) CA 72-2 RIA Standards,
in-vitro diagnostic kits used to aid in the management
of patients with diagnosed gastric cancer and other
malignancies. Safety Alert #N-033/034-3.
CODE Kit lots which contain an implicated set of standards:
10K0011 10K0112 10K0261 10K0481 10K0420
10K0012 10K0121 10K0271 10K0491 10K0430
10K0021 10K0122 10K0281 10K0501 10K0440
10K0022 10K0131 10K0291 10K0511 10K0450
10K0031 10K0132 10K0301 10K0521 10K0460
10K0032 10K0141 10K0311 10K0531 10K0470
10K0041 10K0142 10K0321 10K0541 10K0480
10K0042 10K0151 10K0331 10K0551 10K0490
10K0051 10K0152 10K0341 10K0561 10K0500
10K0061 10K0161 10K0351 10K0571 10K0510
10K0062 10K0162 10K0371 10K0581 10K0520
10K0071 10K0181 10K0411 10K0591 10K0530
10K0072 10K0191 10K0421 10K0601 10K0540
10K0082 10K0201 10K0431 10K0621 10K0550
10K0091 10K0221 10K0451 10K0631 10K0560
10K0092 10K0231 10K0461 10K0641 10K0570
10K0102 10K0251 10K0471 10K0651
Standard Reagent lots:
10H0020 10H0021 10H0020/2 10L0020 10L0020/2
10L00210 10S0020 10S0020/1 10S0021 10S0040
10S0040/1 14L0030 14S0030.
MANUFACTURER Centocor, Inc., Malvern, Pennsylvania
ALERTED BY Manufacturer, by letter June 16, 1992.
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON The antigen standards used were found to have tested
positive for antibodies to HIV. Users are reminded to
adhere to the warning precautions specified in the
product labeling.
INJUNCTION:
PRODUCT Sandwiches (93-689-981).
CHARGE The complaint was filed to enjoin defendants from the
preparation and holding for sale of sandwiches after
the components of such sandwiches have been shipped in
interstate commerce, which preparation and holding
resulted in the sandwiches becoming adulterated, in
that they contained Listeria monocytogenes, a
poisonous or deleterious substance which may render
the food injurious to health, and in that the
sandwiches have been prepared, packed or held under
insanitary conditions whereby they may have become
contaminated with filth or whereby they may have been
rendered injurious to health.
-14-
DEFENDANTS Finest Foods, Inc., doing business as Mrs. Drake's
Sandwiches, a corporation, and James W. Ganus, James
W. Ganus, Jr., Robert W. Ganus, and Ronald P.
Blanchard, individuals, New Orleans, Louisiana.
FILED March 5, 1993; U.S. District Court for the Eastern
District of Louisiana; Civil #93-0746; INJ 1317.
SEIZURES:
PRODUCT Canned fruit cocktail, canned pears, and canned
peaches(92-271-336).
CHARGE Adulterated - The canned peaches consisted in part of
a filthy substance because they contained Geotrichum
mold. Misbranded - All of the articles had product
labels that expressed net quantity of contents in
terms of fluid measure rather than the required
avoirdupois pound and ounce. In addition, the labels
of the canned fruit cocktail and canned pears failed
to include the packing medium as part of the name as
required; the canned fruit cocktail contained only
two of the five ingredients required by the standard;
and, the quality of the canned peaches and canned
pears fell below identified standards of quality
because the peaches contained excess pieces of pit and
the pears did not conform to the uniformity of size
requirement and neither product bore the required
label statement that they fell below the standards.
FIRM Econocaribe Consolidators Warehouse, Miami, Florida.
FILED February 15, 1993; U.S. District Court for the
Southern District of Florida; Civil #92 2840; FDC
#66621.
SEIZED February 17, 1993 - goods valued at approximately
$9,100.
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END OF ENFORCEMENT REPORT FOR MARCH 31, 1993. BLANK PAGES MAY
FOLLOW.