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
03/24/1993
Recalls and Field Corrections: Foods -- Class II -- 03/24/1993
March 24, 1993 93-12
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
PRODUCT Non-dairy coffee creamer in 6 ounce, 11 ounce and 35.3 ounce (1
kg) brown plastic jars, 12 jars per case, and 11 ounce, 12
ounce and 16 ounce shaker top canisters, 24 (12 for the 16
ounce) containers per case, the product was distributed under
multiple labels. Recall #F-246-3.
CODE All retail product produced on or before December 16, 1992, in
16 ounce, 11 ounce and 35 ounce (1) kg plastic jars, as well as
22 ounce plastic jars with code 254Z2H only. All food service
product produced on or before January 7, 1993 in 11 ounce, 12
ounce, and 16 ounce shaker canisters.
MANUFACTURER Kraft Food Ingredients, Champaign, Illinois.
RECALLED BY Kraft Food Ingredients, Memphis, Tennessee, by telephone
January 22, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 1,025,054 cases were distributed; firm estimates 25 percent
remains on the market.
REASON Product is contaminated with aluminum metal fragments.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
PRODUCT Various Welch's fruit juices and drinks, packaged in 11.5 fluid
ounce aluminum cans:
(a) Welch 100% Pure Apple Juice;
(b) Welch's Juice Cocktail Apple Cranberry;
(c) Welch's Grape Juice From Concentrate;
(d) Welch's Juice Cocktail Grape Apple;
(e) Welch's Artificially Flavored Strawberry Drink;
(f) Welch's Juice Cocktail Grape;
(g) Welch's Juice Cocktail Fruit Punch Blended Fruit Drink;
(h) Welch's 100% Pure Orange Juice From Concentrate;
(i) Welch's Fruit Juice Orange Blend;
(j) Welch's Juice Cocktail Apple Orange Pineapple;
(k) Welch's Juice Cocktail Tropical Blended Juice Drink.
Recall #F-233/243-3.
CODE Lot numbers: (a) 2K12J; (b) 2K12J, 2K26J, 2K07L; (c) 2K21J;
(d) 2K21J; (e) 2K21J; (f) 2K23J; (g) 2K23J; (h) 2K26J;
(i) 2K17K; (j) 2K26J; (k) 2K17K.
MANUFACTURER Welch Foods, Inc., Kennewick, Washington;
RECALLED BY Welch, Inc., Westfield, New York, by letter January 7, 1993.
Firm-initiated recall complete.
DISTRIBUTION Arizona, California, Washington, Idaho, Montana, South Dakota,
Oregon, Alaska, Hong Kong.
QUANTITY (a) 2,741 cases (24 cans per case);
(b) 4,548 cases; (c) 804 cases; (d) 1,549 cases;
(e) 2,852 cases; (f) 2,600 cases; (g) 4,075 cases;
(h) 887 cases; (i) 2,101 cases; (j) 724 cases;
(k) 1,800 cases were distributed.
REASON Product is contaminated with mold.
PRODUCT Hawaiian Punch Fruit Punch, Fruit Juicy Red, in 16 ounce
bottles. Recall #F-244-3.
CODE Lot numbers: L182DE0600 through L182DE0713.
MANUFACTURER Pepsi Cola East, Mckees Rocks, Pennsylvania.
RECALLED BY Manufacturer by visit January 22, 1993. Firm-initiated recall
complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1,525 cases were distributed; firm estimates 10 cases remain on
the market.
REASON Product is contaminated with yeast.
PRODUCT Bristol Court brand Pewter Hip Flasks, 5 ounce size.
Recall #F-259-3.
CODE None.
MANUFACTURER Kings Pewter Thailand.
RECALLED BY Things Remembered, Inc., Highland Heights, Ohio, by letter
January 22, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,000 flasks were distributed.
-2-
REASON The Product contains lead but is labeled as lead-free.
PRODUCT Minute Maid 100% Pure Apple Juice From Concentrate, in 64 fluid
ounce plastic bottles. Recall #F-261-3.
CODE 2290AAXX (bottle), 2205 over XXA101692 (case).
MANUFACTURER Whitfield Foods, Montgomery, Alabama.
RECALLED BY Coca-Cola Foods, Division of The Coca-Cola Company, Houston,
Texas, by telephone and letter on February 3, 1993.
Firm-initiated recall complete.
DISTRIBUTION Illinois, Michigan, Oklahoma.
QUANTITY 2,850 cases (8 bottles per case) were distributed. Firm
estimates none remains on the market.
REASON Product is contaminated with yeast.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Rimactane 300 mg capsules (rifampin USP), in 30, 60, and 100
capsule bottles, an orally administered antibiotic.
Recall #D-176-3.
CODE Lot numbers: 30 capsule bottles -- 1T122983 EXP 3/93, 1T139950
EXP 3/93, 2T139950 EXP 3/93, 1T142884 EXP 4/94;
60 capsule bottles -- 1T143940 EXP 10/94, 1T126600 EXP 5/93,
1T130678 EXP 6/93, 1T142876 EXP 3/94;
100 capsule bottles -- 1T119827 EXP 3/93, 1T130680 EXP 6/93,
1T143881 EXP 5/94, 1T143933 EXP 5/94, 1T002330 EXP 7/93,
1T143999 EXP 11/94, 1T142879 EXP 4/94.
MANUFACTURER Ciba-Geigy Pharmaceutical Corporation, Suffern, New York.
RECALLED BY Manufacturer, by letter sent February 28, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY Lot Number Bottles distributed
1T122983 3,614
*1T139950 2,648
*2T139950 1,656
1T143940 3,054
1T119827 1,754,
1T130680 1,666
1T143881 1,434
1T143933 11,030
1T002330 2,609
1T143999 48,156
1T142879 14,983
1T142884 6,856
1T126600 3,446
1T130678 1,228
1T142876 1,756.
REASON Product does not meet dissolution specifications through
expiration date.
-3-
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Polycitra LC, in 16 fluid ounce bottles, a Rx drug used for
long term maintenance of an alkaline urine and as a
neutralizing buffer. Recall #D-175-3.
CODE Lot #H103M.
MANUFACTURER Willen Drug Company, Baltimore, Maryland.
RECALLED BY Baker Norton Pharmaceuticals, Inc., Miami, Florida, by letter
on or about February 18, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,360 bottles were distributed.
REASON A color additive, FD&C Green #3, was omitted from this lot.
PRODUCT Dallergy Capsules (nasal decongestant, antihistaminic
antisecretory, a Rx drug packaged in bottles of 4 (physician
samples), 100 and 1,000 capsules. Recall #D-177-3.
CODE CER EXP 12/94.
MANUFACTURER Central Pharmaceuticals, Inc., Seymour, Indiana.
RECALLED BY Manufacturer, by telephone August 6, 1992, followed by letters
of August 7 and 14, 1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 19,442 bottles of 4 each, 8,628 bottles of 100 each, and 30
bottles of 1,000 each were distributed.
REASON Product does not meet content uniformity specifications.
PRODUCT Prozac Liquid, fluoxetine hydrochloride, oral solution, in 120
ml bottles, a mint flavored liquid antidepressant.
Recall #D-178-3.
CODE Lot numbers and expiration dates: 4PL60C 12/1/92, 4PL61C
12/1/92, 4PL62C EXP 12/1/92, 5AR23A 6/1/93, 5AR24A 9/1/93,
5AR24C 9/1/93, 6LA78A 7/1/94, 6LA78C 7/1/94.
MANUFACTURER Eli Lilly and Company, Indianapolis, Indiana.
RECALLED BY Manufacturer, by letter November 23, 1992. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY Lot No. Bottles Distributed
4PL60C 65,906
4PL61C 65,762
4PL62C 66,782
5AR23A 65,873
5AR24A 24,855
5AR24C 9,000
6LA78A 78
6LA78C 19,478.
Firm estimates 5 percent of the product
remains on the market.
REASON Leaking containers.
-4-
PRODUCT Ephedrine Hydrochloride (Mini Thin Bronchodilator), in 25 mg
tablets, in bottles and vials of 100, 250, 500.
Recall #D-179-3.
CODE Lot numbers 8844, 8855, 8922, 8925, 8926, 8928, 8929, 8900,
8907.
MANUFACTURER Ion Labs, Inc., Pinellas Park, Florida.
RECALLED BY BDI Pharmaceutical, Division of Body Dynamics, Inc.,
Indianapolis, Indiana, by telephone July 10, 1992.
Firm-initiated recall complete.
DISTRIBUTION Indiana, Texas.
QUANTITY Undetermined.
REASON The tablets did not contain the imprint provided in the label
TRP statement, i.e., Do not use if "Mini Thin and/or HR" is not
visible or is missing.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT Recovered Plasma. Recall #B-157-3.
CODE Unit numbers: 0227576, 0229146, 0229272, 0229490, 0230349,
0231071, 0231260, 0231463, 0231788, 0231854, 0231957.
MANUFACTURER Community Blood Bank of Erie County, Erie, Pennsylvania.
RECALLED BY Manufacturer, by letters dated September 10 and 14, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Delaware, New Jersey.
QUANTITY 11 units.
REASON Recovered Plasma, collected from autologous donors who either:
1) reported histories of hepatitis; 2) reported recent tattoos;
3) exhibited signs or symptoms of AIDS; or 4) were not asked
the Aids questions designed to illicit a history of high risk
behavior.
PRODUCT Source Plasma. Recall #B-193-3.
CODE Unit #SA543340.
MANUFACTURER Sera-Tec Biologicals, Inc., Pittsburgh, Pennsylvania.
RECALLED BY Sera-Tec Biologicals, Inc., North Brunswick, New Jersey, by
facsimile dated June 1, 1992. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Source Plasma, which tested repeatedly reactive for the
antibody to hepatitis C virus encoded antigen (anti-HCV), was
distributed.
PRODUCT Red Blood Cells. Recall #B-194-3.
CODE Unit numbers: 22LK15120, 22LK15123, 22LK15131.
MANUFACTURER American Red Cross Blood Services, Philadelphia, Pennsylvania.
RECALLED BY Manufacturer, by telephone February 7, 1992. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania.
-5-
QUANTITY 3 units.
REASON Red Blood Cells previously shipped under improper temperatures
were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT Recovered Plasma. Recall #B-158-3.
CODE Unit numbers: 0227453, 0227479, 0227481,
0227484, 0227500, 0227505, 0227508, 0227518, 0227524,
0227528, 0227538, 0227542, 0227544, 0227545, 0227552,
0227555, 0227558, 0227570, 0227575, 0227585, 0227621,
0227622, 0227623, 0227624, 0227633, 0227662, 0227663,
0227666, 0227682, 0227691, 0227697, 0227699, 0227702,
0227703, 0227712, 0227717, 0227721, 0227727, 0227728,
0227730, 0227736, 0227738, 0227741, 0227745, 0227746,
0227750, 0227772, 0227775, 0227777, 0227784, 0227786,
0227787, 0227804, 0227810, 0227813, 0227843, 0227847,
0227849, 0227852, 0227861, 0227869, 0227871, 0227880,
0227884, 0227908, 0227938, 0227947, 0227958, 0227960,
0227961, 0227966, 0227979, 0227982, 0227986, 0227995,
0228001, 0228005, 0228013, 0228016, 0228022, 0228028,
0228031, 0228038, 0228044, 0228054, 0228062, 0228069,
0228105, 0228110, 0228136, 0228149, 0228163, 0228169,
0228185, 0228192, 0228193, 0228199, 0228218, 0228237,
0228241, 0228242, 0228259, 0228268, 0228269, 0228271,
0228295, 0228304, 0228327, 0228336, 0228341, 0228362,
0228371, 0228372, 0228379, 0228412, 0228418, 0228431,
0228442, 0228447, 0228450, 0228464, 0228467, 0228469,
0228483, 0228488, 0228492, 0228500, 0228528, 0228530,
0228535, 0228553, 0228561, 0228562, 0228581, 0228587,
0228597, 0228605, 0228610, 0228614, 0228652, 0228655,
0228663, 0228690, 0228697, 0228701, 0228709, 0228718,
0228741, 0228746, 0228752, 0228776, 0228777, 0228780,
0228794, 0228796, 0228798, 0228817, 0228818, 0228821,
0228827, 0228839, 0228861, 0228880, 0228892, 0228893,
0228908, 0228910, 0228925, 0228961, 0228963, 0228969,
0228978, 0228990, 0228996, 0229001, 0229007, 0229009,
0229024, 0229026, 0229034, 0229050, 0229051, 0229052,
0229053, 0229056, 0229067, 0229079, 0229084, 0229087,
0229091, 0229100, 0229111, 0229114, 0229139, 0229176,
0229179, 0229182, 0229184, 0229207, 0229211, 0229219,
0229224, 0229237, 0229238, 0229249, 0229253, 0229259,
0229262, 0229264, 0229271, 0229292, 0229296, 0229299,
0229317, 0229321, 0229325, 0229340, 0229345, 0229347,
0229356, 0229365, 0229443, 0229445, 0229452, 0229464,
0229467, 0229472, 0229476, 0229477, 0229482, 0229501,
0229507, 0229508, 0229509, 0229528, 0229529, 0229546,
0229559, 0229577, 0229583, 0229604, 0229606, 0229612,
0229631, 0229635, 0229637, 0229638, 0229665, 0229669,
0229673, 0229682, 0229683, 0229691, 0229696, 0229698,
0229717, 0229727, 0229729, 0229737, 0229747, 0229750,
-6-
0229753, 0229756, 0229779, 0229783, 0229880, 0229899,
0230025, 0230282, 0230297, 0230396, 0230588, 0230594,
0230737, 0230744, 0230881, 0231106, 0231115, 0231127,
0231145, 0231305, 0231366, 0231635, 0231801, 0231855,
0231900, 0231984, 0232193, 0232309, 0232352, 0232376,
0232587, 0232720, 0232785, 0232790.
MANUFACTURER Community Blood Bank of Erie County, Erie, Pennsylvania.
RECALLED BY Manufacturer, by letters dated September 10 and 14,1992.
Firm-initiated recall complete.
DISTRIBUTION Delaware, New Jersey.
QUANTITY 295 units were distributed.
REASON Recovered Plasma, collected from autologous donors who either:
1) reported histories of hepatitis; 2) reported recent tattoos;
3) exhibited signs or symptoms of AIDS; 4) were not asked the
Aids questions designed to illicit a history of high risk
behavior or 5) did not or were presumed to not meet the
suitability criteria for allogenic use, were distributed.
PRODUCT Recovered Plasma. Recall #B-145-3.
CODE Unit numbers: KW08320, KW05113.
MANUFACTURER Rex Hospital, Inc., Raleigh, North Carolina.
RECALLED BY Manufacturer, by letter October 7, 1992. Firm-initiated recall
complete.
DISTRIBUTION Maryland.
QUANTITY 2 units.
REASON Blood products, which tested initially reactive for hepatitis B
surface antigen (HBsAg) or initially reactive for the antibody
to human T lymphotropic virus type I (anti-HTLV-I), were
distributed.
PRODUCT Platelets, Pheresis. Recall #B-182-3.
CODE Unit numbers: 11043-1358, 11043-6971.
MANUFACTURER United Blood Services, Blood Systems, Inc., El Paso, Texas.
RECALLED BY Manufacturer, by telephone August 3, 1992, and by letter August
20, 1992, for unit 11043-1358 and by telephone August 31, 1992,
for unit 11043-6971. Firm-initiated recall complete.
DISTRIBUTION Illinois and Texas.
QUANTITY 2 units.
REASON Unlicensed blood products were distributed interstate.
PRODUCT Red Blood Cells. Recall #B-195-3.
CODE Unit #22LN07275.
MANUFACTURER American Red Cross Blood Services, Philadelphia, Pennsylvania.
RECALLED BY Manufacturer, by telephone July 24, 1992, and by letter July
31, 1992. Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit.
REASON Red Blood Cells labeled with the incorrect expiration date were
distributed.
-7-
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Central Telemetry Systems, designed to detect arrhythmia:
(a) Accucore Model MPC1000;
(b) Accucore Model CCM-1000;
(c) Accucore Model RVS-1000;
(d) Datascope Visa;
(e) Quinton Instrument Q-Tel;
(f) Non-Invasive Monitoring Systems (NIMS) Central Telemetry
System. Recall #Z-359/364-3.
CODE Serial Nos. -- Accucore Models: MPC-100, CCM-1000 and RVS-1000:
110015 110004 202016 102007
110016 202001 202014 102006
201005 110013 202015 102009
201004 108001 202013 102005
201003 107006 202012 102002
201002 108002 202009 102003
201001 108004 202008 103001
201006 109002 202005 102001
201008 DP-002 202003 104007
201009 104002 202002 102004
201010 110011 202011 112002
201011 110008 202010 106005
201012 110009 202006 107001
104001 110010 202004
107005 108003 202007
204002 203004 110001
204001 106002 203003
203008 106001 104006
203006 105002 102010
203002 203001 102011
(d) 202002, 202003, 202006, 203007, 203010, 203011, 203012,
204002;
(e) 011001, 011002, 012001-0120010, 101001-101012,
102001-102015, 103001-103013, 104001-104011,105001-105010,
106001-106013, 107001-107003, 108001-108007, 109001-109013,
110001-110030, 110038, 111001-111024, 112001-112012,
201001-201015, 202001-202011,203001-203011, 204001-204007;
(f) 011001-011011, 101001-101008, 108001-108003, 109030-109043.
MANUFACTURER Pacific Communications, Inc., Santa Ana, California.
RECALLED BY Manufacturer, by telephone on or about April 9, 1992, followed
with a patient safety notice. On or about April 13, 1992, new
software was shipped to consignees. Firm-initiated field
correction ongoing.
DISTRIBUTION Alabama, Arizona, California, Delaware, Florida, Iowa,
Louisiana, Louisiana, Massachusetts, Maryland, Michigan, New
Hampshire, New Jersey, Oregon, Pennsylvania, Texas, Washington
state.
QUANTITY 336 units were distributed.
REASON Software defect may result in the telemetry system failing to
alarm during ventricular fibrillation or ventricular
tachycardia.
-8-
PRODUCT Olympus Flexible Sigmodioscope Examining Device, (a) Model OSF;
(b) OSF-35, used for examining the rectum and sigmoid for
colorectal cancer. Recall #Z-367/368-3.
CODE Serial numbers: (a) 0607679, 201490, 403737, 302834, 506996,
506113, 30365; (b) 0510782.
MANUFACTURER Olympus Opto - Electronics Company, Ltd., Fukushima, Japan.
RECALLED BY Olympus Corporation, Lake Success, New York, by letter December
7, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Georgia, Florida, South Carolina, Illinois, Michigan, New
Jersey, Washington state, Texas.
QUANTITY (a) 8 units; (b) 1 unit were distributed.
REASON Devices were incorrectly re-assembled during a repair
procedure. A missing part makes it possible for the angulation
mechanism to lock in the angulated position.
PRODUCT Ohmeda Modulus CD Anesthesia System, a computer-based
integrated anesthesia system with central display.
Stock numbers: 0397-2012-043, 0397-2080-000, 0397-2080-001,
0397-2080-002, 0397-2112-112, 1202-8173-000, 1202-9000-000,
1202-9001-000, 1202-9002-000, 1202-9003-000, 1202-9004-000,
1202-9005-000, 1202-9007-000, 1202-9008-000, 1202-9009-000,
1202-9016-000, 1202-9017-000, 1202-9018-000, 1202-9019-000,
1202-9021-000.
Recall #Z-383-3.
CODE ABZS00001 through ABZV00658.
MANUFACTURER Ohmeda, Madison, Wisconsin.
RECALLED BY Manufacturer, by letters of February 3 and 4, 1993, and by
Field Notification No. FN259-92; Modulus CD CRT Update, Modulus
CD CRT Update, dated 12/8/92. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,461 units were distributed.
REASON Certain display POD disturbances in pod operation have resulted
in an instability of displayed data, a loss of display, or, in
a few cases, an odor or presence of smoke emanating from the
display POD area.
PRODUCT Imager Torque Selective Angiographic Catheters, catalog Nos.
35-XXX, 90-XXX Special Order, used in angiography imaging
procedures. Recall #Z-384/385-3.
CODE Lots shipped from January 1, 1992 to December 22, 1992.
MANUFACTURER Boston Scientific Corporation, Milford, Massachusetts.
RECALLED BY Boston Scientific Corporation, Watertown, Massachusetts, by
letter January 18, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 153,000 units were distributed.
REASON Devices may leak at the hub at the proximal end of the catheter.
PRODUCT Ceiling Suspension Systems for one or two monitors for
fluoroscopic x-ray systems. Recall #Z-386/396-3.
-9-
CODE Models 9807 605 4009, -70001, -71001, 71009,
Models 9807 815 20009, -30009, -30109, -31109, -32109;
Models 9807 800 10001, -10109.
MANUFACTURER Philips Medical Systems Nederland B.V., Best Netherlands.
RECALLED BY Philips Medical Systems, Shelton, Connecticut, by sending a
mandatory action service information bulletin, publication
#4522 983 43931, dated January 1992, by visit, and by service
information bulletin #2496 N02, dated December 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 2,800.
REASON The rotary adapter between the arm and the u-shaped monitor
holder can break after a certain lifetime.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT Cards Hcg Urine Pregnancy (100 test) Kit, an in-vitro
diagnostic device used to detect human chorionic gonadotropin
(HCG) in urine. Recall #Z-297-3.
CODE Catalog #CR7502, lot Nos. 570277.1 and 580210.1.
MANUFACTURER Pacific Biotech, Inc., San Diego, California.
RECALLED BY Manufacturer, by letter dated December 30, 1992, and January 5,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Alaska, Alabama, Arkansas, California, Florida, Iowa, Illinois,
Indiana, Louisiana, Michigan, Minnesota, Maryland, North
Carolina, New Jersey, New York, Ohio, Pennsylvania, Texas,
Washington state, Canada.
QUANTITY 254 kits were distributed.
REASON Some Mono reaction units are mixed with the HCG reaction units.
PRODUCT (a) 3M Silux Plus Light Cure Restorative Material in Capsule
Assortment, product #5708E;
(b) 3M Silux Plus Light Cure Restorative Material in Capsules,
Product #5706SP;
(c) Silux Plus Gray Paste in Capsules, product #5706G, used for
tooth restorations. Recall #Z-338/340-3.
CODE Lot numbers: (a) P920304; (b) P920522;
(c) P910831, P910901, P910902, P910905, P910909,9910910.
MANUFACTURER 3M Dental Products Division, Irvine, California.
RECALLED BY 3M Dental Products Division, St. Paul, Minnesota, by letter
October 5, 1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY (a) 470 kits; (b) 30 boxes; (c) 2,151 boxes were distributed.
REASON The kits containing the batch Silux Plus Gray AD contain some
capsules that have been filled with an alternate shade believed
to be Light AD.
PRODUCT SysteMate Bicarbonate (BIC) R2 Reagent, an in-vitro
diagnostic. Recall #Z-374-3.
CODE Catalog #65412/R2, lot #2005.
-10-
MANUFACTURER EM Diagnostic Systems, Inc., Gibbstown, New Jersey.
RECALLED BY Manufacturer, by letters sent between December 7 and 12, 1992.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 725 units were distributed.
REASON The reagent can become turbid with a precipitate, causing
unrealistic, out-of-range data.
PRODUCT Clinistat Uric Acid Reagent Discs. Recall #Z-375-3.
CODE Product #3450, lot #1111103 EXP 5/93.
MANUFACTURER Konica Corporation, Tokyo, Japan.
RECALLED BY Miles, Inc., Diagnostics Division, Mishawaka, Indiana, by
letter September 3, 1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 47 cartons (24 tests per carton) were distributed; firm
estimates none remains on the market.
REASON The "B" calibration values printed on the product carton were
incorrect.
PRODUCT Space Labs Medical Supplies Anesthesia Calibration Gas.
Recall #Z-376-3.
CODE Lot numbers: 222321 EXP 2/93, 113261 EXP 6/93, 102552 EXP 3/94.
MANUFACTURER Scott Specialty Gases, Inc., Scott Medical Products Division,
Plumsteadville, Pennsylvania.
RECALLED BY Manufacturer, by telephone November 6, 1992. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 54 units were distributed.
REASON The lots failed to meet the product specification due to high
oxygen concentration.
PRODUCT Synchron Uric Acid Reagent, intended for use on Synchron CX
Systems for quantitative determination of uric acid in serum or
plasma. Recall #Z-382-3.
CODE Part #442785, lot #M208253.
MANUFACTURER Beckman Instruments, Inc., Diagnostic Systems Group, Carlsbad,
California.
RECALLED BY Beckman Instruments, Brea, California, by letter January 25,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 2,246 units were distributed.
REASON The reagent is exhibiting some discoloration of enzyme
component, resulting in falsely elevated results most
noticeable at the lower end of the measuring range.
PRODUCT Ames Multistix brand Reagent Strips for Urinalysis.
Recall #Z-353-3.
CODE Lot #A436022 EXP 8/93.
MANUFACTURER Miles, Inc., Diagnostics Division, Elkhart, Indiana.
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RECALLED BY Miles, Inc., Diagnostics Division, Mishawaka, Indiana, by June
26, 1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 7,956 units were distributed; firm estimates none remains on
the market.
REASON Some bottles of the product were mislabeled as another product,
Multistix 10SG.
SEIZURES:
PRODUCT Glutinous and sweet rice (93-667-726, et al).
CHARGE Adulterated - The articles have been held under insanitary
conditions whereby they may have become contaminated with filth.
FIRM Jinthay Trading Company, Portland, Oregon.
FILED February 18, 1993; U.S. District Court for the District of
Oregon; Civil #93-173-BE, FDC #66658.
SEIZED February 26, 1993 - goods valued at approximately $4,790.
PRODUCT Frozen cod fillets (92-591-732, et al).
CHARGE Adulterated - The articles consist in whole or in part of a
decomposed or filthy substance, or are otherwise unfit for food.
FIRM Point Adams Packing Company, Portland, Oregon.
FILED December 8, 1992; U.S. District Court for the District of
Oregon; Civil #92-1554-BE, FDC #66636.
SEIZED December 16, 1992 - goods valued at approximately $12,705.
PRODUCT Frozen whole, cooked Dungeness crab (92-667-723).
CHARGE Adulterated - The article consists in whole or in part of a
decomposed substance or is otherwise unfit for food because it
is rancid.
FIRM Point Adams Packing Company, Portland, Oregon.
FILED January 25, 1993; U.S. District Court for the District of
Oregon; Civil #93-95-BE, FDC #66652.
SEIZED February 10, 1993 - goods valued at $57,964.
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END OF ENFORCEMENT REPORT FOR MARCH 24, 1993. BLANK PAGES MAY
FOLLOW.