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
04/20/1994
Recalls and Field Corrections: Foods -- Class II -- 04/20/1994
April 20, 1994 94-16
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Barber's 100% Pure Orange Juice from Concentrate, in 4 fluid
ounce cartons. Recall #F-380-4.
CODE All 4 ounce cartons bearing pull dates of FEB 10.
MANUFACTURER Barber's Pure Milk Company, Mobile, Alabama.
RECALLED BY Manufacturer, by visits beginning January 31, 1994. Firm-
initiated recall complete.
DISTRIBUTION Alabama.
QUANTITY 2,004 cases (75 cartons per case) were distributed; firm
estimates none remains on the market.
REASON Orange juice contaminated with yeast and Bacilus Cereus and
associated with an outbreak of foodborne illness.
_______________
PRODUCT Diet Coca Cola Low Calorie Cola, cola flavored carbonated
beverage sweetened with Nutrasweet brand aspartame, in 2
liter PET plastic bottles, 8 bottles per case; 16 ounce PET
plastic bottles, 4 bottles per pack, 6 packs per case; 12
ounce cans, 6 cans per pack, 4 packs per case.
Recall #F-383-4.
CODE 061394MDA, 061394MDB, 061394MDC (followed by a 4 digit
military time code).
MANUFACTURER Coca-Cola Bottling Company, Niles, Illinois.
RECALLED BY Manufacturer, by issuing press release March 21, 1994.
Firm-initiated recall complete.
DISTRIBUTION Illinois, Indiana.
QUANTITY 3,200 cases of 2 liter bottles, 360 cases of 16 ounce
bottles and 3,150 cases of 12 ounce cans were distributed;
firm estimates that 75 percent of the product remains on the
market.
REASON Product contains undeclared sugar.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT All strengths and package sizes, including 5 ml physician
samples of the following products:
Eli Lilly brand Ceclor (Cefaclor, USP), for oral suspension;
M-5130, 187mg/5ml, 50ml; M-5130, 187mg/5ml, 100ml
M-5132, 375mg/5ml, 50ml; M-5132, 375mg/5ml, 100ml
M-5057, 125mg/5ml, 75ml; M-5057, 125mg/5ml, 150ml
M-5058, 250mg/5ml, 75ml; M-5058, 250mg/5ml, 150ml
Eli Lilly brand Lorabid (Loracarbef) for oral suspension:
M-5135, 100mg/5ml, 50ml; M-5135, 100mg/5ml, 100ml
M-5136, 200mg/5ml, 50ml; M-5136, 200mg/5ml, 100ml
Dista brand Keflex (Cephalexin, USP) for suspension:
M-201, 125mg/5ml, 100ml; M-201, 125mg/5ml, 200ml
M-202, 250mg/5ml, 5ml; M-202, 250mg/5ml, 100ml
M-202, 250mg/5ml, 200ml. Recall #D-238/245-4.
CODE All lots on the market within expiration date.
MANUFACTURER Eli Lilly Industries, Inc., Carolina, Puerto Rico.
RECALLED BY Eli Lilly and Company, Indianapolis, Indiana, by press
release and by letter March 31, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1.2 million bottles plus an equivalent number of physician
samples.
REASON Several bottles contained a small plastic cap.
_______________
PRODUCT Normodyne brand of Labetalol Hydrochloride, USP Tablets, 200
mg, in 1000 tablet bottles, indicated in the management of
hypertension. Recall #D-246-4.
CODE Lot #93888 EXP 9/96.
MANUFACTURER Schering Plough Products, Inc., Las Piedras Operations, Las
Piedras, Puerto Rico.
RECALLED BY Manufacturer, by telephone beginning March 16, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Texas, Missouri, Oregon, Wisconsin, Illinois, Alabama,
Kentucky, Michigan.
QUANTITY 5,663 bottles were distributed; firm estimates 2,420 bottles
remain on the market.
REASON Subpotency.
-2- _______________
PRODUCT Procainamide Hydrochloride Extended Release, USP 250 mg, Rx,
in bottles of 100 and unit dose packages (10 x 10),
indicated for the treatment of ventricular arrhythmias,
under the Danbury and Schein labels. Recall #D-247-4.
CODE Lot numbers: 41543D, 41544D (Danbury); 41543D, 44125D,
44343D, 44344D, 44392D, 44494D 44495D (Schein); 41543D,
44391D Schein unit dose).
MANUFACTURER Danbury Pharmacal, Inc., Danbury, Connecticut.
RECALLED BY Danbury Pharmacal, Inc., Carmel, New York, by letter March
31, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 35,000 100-tablet bottles and 10,000 unit dose
packs of 100 tablets were distributed.
REASON Product does not meet dissolution specifications.
_______________
PRODUCT Theo-Dur Sprinkle Theophylline (anhydrous) Sustained Action
Oral Capsules, 50 mg, in 100 tablet bottles, for relief and
or prevention of symptoms from asthma and reversible
bronchospasm associated with chronic bronchitis and
emphysema (bronchodilator). Recall #D-249-4.
CODE Lot numbers: 93624 EXP 3/95, 93738 EXP 3/95.
MANUFACTURER Schering Plough Products, Inc., Las Piedras Operations, Las
Piedras, Puerto Rico.
RECALLED BY Manufacturer, by letter March 22, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 42,708 units were distributed; firm estimates 27,904 units
remain on the market.
REASON Marginally subpotent.
_______________
PRODUCT Bacitracin Ophthalmic Ointment, 500 units/gram, Rx
ophthalmic antibiotic used for the treatment of bacterial
infections of the eye, packaged in 3.5 gram tubes.
Recall #D-251-4.
CODE Lot numbers: 3026175, 3166059, 3137053.
MANUFACTURER Pharmafair, Inc., related to Bausch & Lomb), Hauppauge, New
York (responsible firm).
RECALLED BY Allscrips Pharmaceuticals, Inc., Vernon Hills, Illinois
(relabeler), by letter March 22, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION New Mexico, Florida, Illinois, California, Virginia,
Maryland, Indiana.
QUANTITY 133 tubes were distributed; firm estimates 15 percent of the
product remains on the market.
REASON Potency not assured through expiration date.
_______________
PRODUCT Primatene Tablets, 60 tablet size only, packaged in
thermoform blister/boxes, bronchodilator for relief and
control of attacks of bronchial asthma. Recall #D-252-4.
-3- CODE Lot Nos. and EXP Dates: 12B3 1/96, 08C3 2/96, 09C3 2/96,
10C3 2/96, 11C3 2/96, 12C3 2/96, 13C3 3/96, 14C3 3/96, 15C3
3/96, 28D3 4/96, 29D3 4/96, 30D3 4/96, 03E3 4/96, 07F3 5/96,
08F3 5/96, 09F3 5/96, 10F3 5/96, 11F3 5/96, 13F3 5/96, 14F3
5/96, 20H3 8/96, 22H3 8/96, 23H3 8/96, 24H3 8/96, 25H3 8/96,
26H3 8/96, 27H3 8/96, 12K3 8/96, 15K3 9/96, 16K3 9/96, 17K3
9/96, 18K3 10/96, 19K3 10/96.
MANUFACTURER Whitehall-Robins Labs, Guyama, Puerto Rico.
RECALLED BY Whitehall Laboratories, Madison, New Jersey (responsible
firm), by letter December 28, 1993. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 44,560 dozen 60-tablet blister packs were
distributed; firm estimates 20,000 dozen remains on the
market.
REASON Product label, by error, lacks pregnancy statement.
_______________
PRODUCT Loestrin FE 1.5/30 Tablets, Ethinyl Estradiol 30 mcg and
Norethindrone 1.5 mg, Rx oral contraceptive, packaged in
boxes 5 cards of 28 tablets each. Recall #D-253-4.
CODE Lot #3074048.
MANUFACTURER Parke-Davis, Division of Warner Lambert, Fajardo, Puerto
Rico (responsible firm).
RECALLED BY Allscrips Pharmaceuticals, Inc., Vernon Hills, Illinois
(repacker), by telephone February 14, 1994, followed by
letter March 18, 1994. Firm-initiated recall complete.
DISTRIBUTION Virginia, Ohio.
QUANTITY 8 boxes of 5 cards of 28 tablets were distributed; firm
estimates none remains on the market.
REASON Product may not meet content uniformity specifications.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Vitamin A Palmitate 15 mg (50,000 USP Units) Capsules,
packaged in bottles of 100 and 1000 soft-gel capsules, Rx,
effective for the treatment of Vitamin A deficiency, under
the following labels: Schein, URL, and Rugby.
Recall #D-248-4.
CODE Lot #55377 EXP 11/94.
MANUFACTURER Pharmacaps, Inc., Elizabeth, New Jersey.
RECALLED BY Manufacturer, by telephone January 21, 1994, followed by
letters of January 21, 1994, and February 15, 1994. Firm-
initiated recall complete.
DISTRIBUTION New York, Pennsylvania.
QUANTITY 5,904 bottles of 100 capsules, and 168 bottles of 1000 were
distributed; firm estimates none remains on the market.
REASON Subpotency.
-4- _______________
PRODUCT Iodohippurate Sodium I-131 Injection, multi dose, a sterile,
non-pyrogenic intravenous solution for diagnostic use in
determining renal function, renal blood flow, urinary tract
obstruction and as a renal imaging agent. Recall #D-250-4.
CODE Lot #473, calibration date: March 22, 1993.
MANUFACTURER Sorin BioMedica, Saluggia, Italy.
RECALLED BY Cis-Us, Inc., Bedford, Massachusetts, by telephone and by
letter March 4, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 39 vials were distributed.
REASON Label bears incorrect calibration date of 3/22/93 instead of
3/22/94.
_______________
UPDATE The following are updates for E-Z-EM products which appeared
in the March 16, 1994, Enforcement Report:
Recall #D-190-4, Magnesium Citrate Effervescent Laxative,
should read: Manufacturer: E-Z-EM, Inc., Westbury, New
York.
_______________
UPDATE Recall #D-190-4, Magnesium Citrate Effervescent Laxative;
#D-191-4, E-Z-Gas II Effervescent Granules
Antiacid/Antiflatulent (citric acid formula); and #D-192-4,
E-Z-Gas Effervescent Granules Antacid/Antiflatulent
(Tartaric acid formula), should read:
CODE: All lots manufactured between January 1992 and
December 1993.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Source Plasma. Recall #B-195-4.
CODE Unit G-21457-073.
MANUFACTURER M.P.S., Inc., doing business as Leesville Plasma Center,
Leesville, Louisiana.
RECALLED BY M.P.S., Inc., Opelousas, Louisiana, by telephone December 28
or 29, 1993, and by letter January 4, 1994. Firm-initiated
recall complete.
DISTRIBUTION California, Kentucky, Germany.
QUANTITY 1 unit.
REASON Blood product, untested for viral markers, was distributed.
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Platelets; (d)
Platelets, Pheresis. Recall #B-196/199-4.
CODE Unit numbers: (a) 0165179, 0165182; (b) 0165175, 0165176,
0165177, 0165178, 0165181, 0165184, 0165187, 0165189,
1065191, 0165194, 0165195, 0165196, 0165198, 0165208,
0165210, 0165212, 0165218, 0165220, 0165225, 1158302,
1158303, 1158309, 1158315, 1158316, 1158319, 1158325,
-5- 1158333, 1158334, 1158338, 1158342, 1158343, 1158349,
1158351, 1158353, 1158355, 1158357, 1158358, 1158362,
2089885, 2089889, 2089890, 2089891, 2089898, 2089901,
2089911, 2089913, 8705885;
(c) 0165171, 0165175, 0165177, 0165178, 0165181, 0165184,
0165185, 0165187, 0165189, 0165194, 0165195, 0165196,
0165200, 0165201, 0165205, 0165206, 0165208, 0165210,
0165212, 0165214, 0165218, 0165220, 0165221, 0165223,
0165224, 1158296, 1158298, 1158301, 1158302, 1158303,
1158305, 1158309, 1158310, 1158311, 1158312, 1158313,
1158315, 1158316, 1158320, 1158321, 1158323, 1158324,
1158325, 1158326, 1158328, 1158329, 1158330, 1158333,
1158334, 1158338, 1158342, 1158343, 1158349, 1158351,
1158353, 1158355, 1158357, 1158358, 1158359, 1158361,
1158362, 2089890, 2089891, 2089895, 2089898, 2089901,
2089911, 2989913;
(d) 9016738, 9016739, 9016742.
MANUFACTURER The Community Blood Center of Greater Kansas City, Kansas
City, Missouri.
RECALLED BY Manufacturer, by telephone April 10, 1993. Firm-initiated
recall complete.
DISTRIBUTION Kansas, Missouri.
QUANTITY (a) 2 units; (b) 47 units; (c) 68 units; (d) 3 units.
REASON Blood products, incorrectly tested for the antibody to human
immunodeficiency virus type 1/2 (anti-HIV-1/2), were
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Battery packs with poor sonic weld seals, which seal the
battery pack assembly case of the LP-300 (LifePak 300
Defibrillator). Recall #Z-049-4.
CODE All battery packs manufactured between 4/1/91 and 5/4/93,
with non continuous serial numbers from 000021 through
13320. Part numbers: 804901-00, English; 804901-01, French;
804901-02, German; 804901-03, Spanish; 804901-04, Japanese.
MANUFACTURER Physio Control Corporation, Redmond, Washington.
RECALLED BY Manufacturer, by letter March 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 11,088 battery packs were distributed.
REASON The weld seals fail, resulting in damage to diodes on the
battery pak's charging circuity causing improper charging of
the battery.
_______________
PRODUCT Glucose 3 and Glucose V Test Strips under the following
labels: (a) Biocare M, 50 strip bottles;
(b) Biocare VT, 50 strip bottles;
(c) Biotel 3, 25 and 50 strip bottles
(d) Biotel V, 14, 25 and 50 strip bottles
-6- (e) Glucose 3, 50 strip bottles
(f) Glucose V, 50 strip bottles. Recall #Z-497/502-4.
CODE 90141192 90011292 90021293 90041292
90061292 90071292 90081292 90091292
90101292 90111292 90131292 90141292
90151292 90161292 90171292 90181292
90191292 90211292 90221292 90231292
90241292 90251292 90261292 90271292
90281292 90291292 90301292 90311292
90010193 90040193 90090193 90100193
90110193 90120193 90140193 90010293
90020293 90040293 90050293 90060293
90070293 90090393 90120493 90081092
90131192 90201292 90020193 90030193
90050193 90060193 90070193 90080193
90130193 90030293 90090293 90110293
90130293 90140293 90160293 90190293
90010393 90020393 90030393 90040393
90060393 90070393 90140393 90150393
90010493 90020493 90030493 90040493
90050493 90070493 90090493 90110493
90130493 90150493 90160493 90170493
90180493 90190493 90200493 90210493
90010593 90020593 90070593 90090593
90100593 90110593 90130593 90140593
90150593 90160593 90260593 90270593
90040693 90100693 90170693 90180693
90190693 90200693 90210693 90220693
90230693 90240693 90250693 90020993
90031292 90051292 90100293 90170293
90180293 90100393 90110393 90120393
90130393 90080693 90090693 90010893
90080293 90120293 90150293 90050393
90080393 90060493 90080493 90100493
90140493 90030593 90040593 90050593
90060593 90080593 90120593 90170593
90180593 90190593 90200593 90210593
90220593 90230593 90240593 90250593
90010693 90020693 90030693 90050693
90060693 90070693 90110693 90120693
90130693 90140693 90150693 90160693
90010793 90020893 90030893 90040893
90050893 90060893 90070893 90080893
90090893 90100893 90110893 90120893.
MANUFACTURER Caromed, Inc., Chester, South Carolina, by telephone October
6, 1993, followed by letters of October 8, 1993, and
November 23, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
-7- REASON Certain batches of CaroMed Glucose V and CaroMed Glucose 3
Blood Glucose Monitoring Strips have been marketed with
shelf-lives shorter than that indicated on the package.
This error could result in consumers receiving values lower
than their actual glucose levels.
_______________
PRODUCT Cards HCG-Serum/Urine Pregnancy Test Kits, an in-vitro
diagnostic device and its purpose is to detect Human
Chorionic Gonadotropin (HCG) in serum or urine to aid in the
diagnosis of pregnancy:
(a) Catalog #CR7503; (b) Catalog #CR7504; (c) Catalog
CR7506. Recall #Z-503/505-4.
CODE Lot numbers: 650213.1, 650214.1, 650215.1, 650215.2; (b)
650216.1, 650216.2; (c) 650217.1, 650217.2, 650217.3.
MANUFACTURER Pacific Biotech, Inc., San Diego, California.
RECALLED BY Manufacturer, by letter December 27, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 1,344 units; (b) 130 units; (c) 1,498 units.
REASON There is a loss of sensitivity which may result in failure
of the test to detect early pregnancy.
_______________
PRODUCT ALP Respiratory Therapy Solution Transfer Sets, Sterile Rx
devices used to fill and feed sterile solutions to adult and
pediatric respiratory therapy humidifier and nebulizer
reservoirs from flexible solution containers, 48 sets per
case; Manufactured for: Automatic Liquid Packaging, Inc.,
Healthcare Products Division, Woodstock, Illinois:
(a) Catalog #AL5002: ALP Luer Tip Respiratory Transfer
Set, 97 cm (38" long), for use with humidifiers which
incorporate their own float feed liquid level control and
humidifiers requiring manual filling;
(b) Catalog #AL5003: ALP Respiratory Transfer Set, 97 cm
(38" long), for use with the Bird Micronebulizer (4144)
which does not contain a float feed liquid level control
device;
(c) Catalog #AL5003-A: ALP Respiratory Transfer Set, 97
cm (38" long), this set is similar to the AL5003, but has a
larger luer adapter tip;
(d) Catalog #AL5004: ALP Respiratory Transfer Set, 97
cm (38" long), for use with humidifiers and nebulizers which
incorporate their own float feed liquid level control
(e) Catalog #AL5008: ALP Respiratory Transfer Set, 97 cm
(38" long) (same configuration as the AL5003-A set);
(f) Catalog #AL5009: ALP Ventilator Transfer Set with 22 mm
elbow and spring to close clamp, 99 cm (39" long), for use
with heated humidifiers and nebulizers which do not contain
float feed liquid level control devices.
Recall #Z-506/511-4.
-8- CODE Lot numbers: (a) lot #7040675, 70401963, 70402162,
70402679, 70402679B, 70402679BR, 70402872R, 70402881,
70402881B, 70403037, 70403091, 70403202, 70403381, 70403683,
70403746, 70404248, 70404067;
(b) 7050676, 7050676B, 7050676R, 70502781R, 70502781BR,
70503144, 70503203, 70504096, 70504106, 7050676BR;
(c) 69903412; (d) 7060677, 70601964, 70602680B, 70602680,
70603204, 70604206; (e) 69904292;
(f) 7070678, 7070678B, 7070678C, 7070678D, 7070678ER,
7070678G, 7070678R, 7070678H, 7070678F, 70703892, 70704166,
70703972, 70703865.
MANUFACTURER The Mextrix Company, Dubuque, Iowa.
RECALLED BY Automatic Liquid Packaging, Inc., Woodstock, Illinois, by
letters of February 9 and 11, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, the Netherlands, Italy, Canada.
QUANTITY 5,686 cases were distributed; firm estimates 542 cases
remain on the market.
REASON Products fail to perform as intended in that the
clamp/delivery is in the "shut-off" position. Further, the
firm made significant changes to the devices, for which no
510(k) was submitted to FDA for clearance prior to
marketing, catalog numbers AL5003A and AL5008.
_______________
PRODUCT Aerosol Cloud Enhancer Component Accessories And Kits,
single-patient use prescription devices for use with metered
dose inhalers or other breathing devices:
(a) Ace Spacer Kits, Catalog #11-1020;
(b) Ace Adaptor Kits, Catalog #11-1030;
(c) Ace Hospital Evaluation Sampler Kit, Catalog 11-1099;
(d) Ace (Pharmacy/Homecare package), Catalog #11-2020;
(e) Ace/Coach Training System: Pediatric Model, Catalog #11-
0002. This kit contains an ACE 11-1020 and a 2000cc Coach
Jr. (22-20002);
(f) Ace/Coach Training System: Adult Model, Catalog #11-
0004. This kit contains an ACE 11-1020 and a 4000cc Coach
22-400; (g) Nif-Tee Kit, Inspiratory Force Monitoring Kit,
Catalog #55-4900; (h) Nif-Tee, Non-breathing T-Piece,
Catalog #33-3500; (i) Nif-Tee with Reducer and Extension
Tube, Catalog #33-3500. Recall #Z-520/528-4.
CODE Lot numbers: (a) 223606, 224581, 226407, 227406, 227417,
227447, 227486, 230219, 231078; (b) 224998; (c) 225000; (d)
223623 and 227448; (e) 227444; (f) 227443; (g) 227445; (h)
225111, 225115, 228045, 230555; (i) 225116, 231420.
MANUFACTURER DHD Diemolding Healthcare Division, Wampsville, New York.
RECALLED BY DHD Diemolding Healthcare Division, Canastota, New York, by
letter February 14, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Australia, Canada, England, Korea, Lebanon,
Netherlands, Singapore.
-9- QUANTITY Catalog No. Quantity Shipped
11-0002 23 units
11-0004 21 units
11-1020 64,950 units
11-1030 2,125 units
11-1099 64 units
11-2020 1,096 units
33-3500 21,144 units
33-3505 528 units
55-4900 3 units.
REASON The one way valve sticks to the valve housing and requires a
pressure to open the valve that is higher than desired.
This would affect the function of the product in which the
valve is used, possibly resulting in less than adequate
performance.
_______________
PRODUCT Patient Transport Stretcher, Model 910. Recall #Z-570-4.
CODE All codes.
MANUFACTURER Basic American Metal Products, Fond DuLac, Wisconsin
(contract manufacturer).
RECALLED BY Hausted, Inc., Medina, Ohio, by letter sent on or about
September 11, 1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 279 units were distributed.
REASON The stretcher frame may break while carrying an injured
patient and the patient could suffer more injury, causing a
serious condition to become critical.
_______________
PRODUCT Vision Sciences Endosheath System (disposable) for use with
the VSI 2000 sigmoidoscope, 13.8 mm distal head, sterile,
provides a protective covering for the endoscope and
includes channels for air, water, and suction/biopsy.
Recall #Z-574-4.
CODE Catalog #06-2101-12, lot #0800077B.
MANUFACTURER Vision Sciences, Inc., Natick, Massachusetts.
RECALLED BY Manufacturer, by telephone between November 4, 1993 and
November 16, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Alabama, California, Florida, Georgia, Indiana,
Massachusetts, New York.
QUANTITY 120 units were distributed.
REASON There is a potential for leaks at the distal head cap of the
sheath.
_______________
PRODUCT Cascade I Series Humidifiers, designed to add heat and
moisture to inspired gases delivered to patients during
ventilation: (a) Model 1; (b) Model 1A.
Recall #Z-575/576-4.
CODE All serial numbers.
-10- MANUFACTURER Puritan-Bennett Corporation, Ventilator Systems Division,
Carlsbad, California.
RECALLED BY Manufacturer, by letter sent October 18, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 149,083 units were distributed.
REASON Devices may pose a fire hazard under certain conditions and
modes of operation; if the units are not properly
maintained, used, and monitored (for example, thermoswitch
not replaced per owners manual, no water in jar, no thermal
well, and no temperature alarm).
_______________
PRODUCT Ophthalmic microsurgical accessory vitrectomy packs:
(a) Deluxe Posterior Vitrectomy Packs, sterile/single
patient use, packaged 6 packs/box, Catalog #DP4800. The
pack provides instruments and accessories necessary to
perform a pars plana vitrectomy;
(b) Basic Posterior Vitrectomy Packs, sterile/single patient
use, packaged 6 packs/box, Catalog #DP4801. The pack
provides a vitrectomy cutter, tubing and cassette to
perform a pars plana vitrectomy;
(c) Anterior Vitrectomy Packs, sterile/single patient use,
packaged 2 packs/box, Catalog #DP4400. The pack provides
vitrectomy cutter and tubing to assist with vitreous
prolapses into the anterior chamber (anterior vitrectomy).
(d) Anterior Vitrectomy Packs with Variable Port Cutter,
sterile/single patient use, packaged 2 packs/box, Catalog
#DP4400VP. The pack provides a vitrectomy cutter and tubing
for the anterior chamber when vitreous prolapses into the
anterior chamber (anterior vitrectomy);
(e) Microvit Systems Vitrectomy Probe Pack, sterile/single
patient use, packaged 2 packs/box, Catalog #MVS-3201. The
pack is used to assist with vitreous prolapses into the
anterior chamber (anterior vitrectomy).
Recall #Z-581/585-4.
CODE (a) 1663AF 1723AF 1753AF 2093AF
2093BF 2103AF 2103BF 2143AF
2143BF 2443AF 2573BF 2653AF
2713BF 2773BF 2993BF 3063AF
3143AF 3093AF 3343AF 3363AF
3413BF 3473BF
(b) 2393BF 3333AF
(c) 3203AF 3233AF 3233BF 3233F
(d) 3223AF
(e) 2393BF 2743BF 3023AF
MANUFACTURER Storz Instrument Company, St. Louis, Missouri.
RECALLED BY Manufacturer, by Federal Express packages sent on December
30, 1993, and by letter January 3, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 3,280 packs; (b) 189 boxes; (c) 211 boxes; (d) 82 boxes;
(e) 44 boxes were distributed.
-11- REASON The actuation (air) and aspiration lines connected to the
vitrectomy probe may be reversed.
_______________
PRODUCT Chemcard Cholesterol Test, a screening device for
identification of elevated blood cholesterol levels.
Recall #Z-589-4.
CODE All lots of modified version, distinguished by the test
color chart in strip form instead of color chart wheel.
MANUFACTURER Chem-Elec, Inc., North Webster, Indiana.
RECALLED BY Manufacturer, by letter December 9, 1992. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 127 boxes of 24 test cards were distributed.
REASON The firm has not demonstrated that their present product
using a pull out color chart is substantially equivalent to
the original color wheel chart.
_______________
PRODUCT Cobe CMS Hardshell Oxygenator, sold as stand-alone units.
Recall #Z-590-4.
CODE Catalog #050202-000, Lot 04Y6041.
MANUFACTURER Cobe Cardiovascular, Inc., Arvada, Colorado.
RECALLED BY Manufacturer, by telephone September 30, 1993. Firm-
initiated recall complete.
DISTRIBUTION Michigan, Indiana, Illinois.
QUANTITY 20 2-unit cases were distributed.
REASON A potential reversal of arterial and venous sample line
connections may exist, which could cause an embolism to be
created.
_______________
PRODUCT Sirecust 404 patient monitors with software version VJ1-BTH.
The monitor measures signals for EKG, Dual EKG + RESP, SP02,
NIBH/NP Ventilator, pCo2 or C+C02. Recall #Z-611-4.
CODE Software version VJ1-BTH.
MANUFACTURER Siemens Medical Systems, Inc., Danvers, Massachusetts.
RECALLED BY Manufacturer, by Customer Notification No. SME-CN-09-1292,
dated December 1992. Firm-initiated field correction
ongoing.
DISTRIBUTION California, Tennessee, Minnesota, Illinois, Wisconsin, North
Carolina, Georgia, Iowa, New York, Ohio, and international.
QUANTITY 1,240 copies of software version VJ1-BTH were distributed.
REASON When the device is used with software version VJ1-BTH, the
monitor does not alarm for asytole when an artifact alarm is
in effect for channel due to the presence of a cartridge in
the second cartridge slot of the monitor.
-12- _______________
PRODUCT Siredoc 60 recorders with software version VFO-GXX or VF1-
GXX, a two-channel recorder that prints timed or continuous
strip recordings that contain waveforms, alarm messages,
patient data, numerical parameter values and the date and
time. Recall #Z-612-4.
CODE Software version VFO-GXX and VF1-GXX.
MANUFACTURER Siemens Medical Systems, Inc., Danvers, Massachusetts.
RECALLED BY Manufacturer, by letter January 12, 1994. Firm-initiated
field corrections ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,731 units were distributed.
REASON When the recorder is used with either software version VFO-
GXX or VF1-GXX, the recorder output contains waveforms not
belonging to the patient currently being monitored due to
memory buffer interferes with real-time recording. The
occurrence of such a malfunction could lead to the
inappropriate assessment of a patient's cardiopulmonary
condition.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Asserchrom Anti-Phospholipid Antibodies (APA) kits, an
enzyme immunoassay of anti-phospholipid antibodies for in-
vitro diagnostic use. Recall #Z-546-4.
CODE Catalog #0443, lot numbers: 931205 and 931206.
MANUFACTURER Diagnostica Stago, Franconville, France.
RECALLED BY American Bioproducts Company, Parsippany, New Jersey, by
telephone September 15, 1993, followed by letter. Firm-
initiated recall complete.
DISTRIBUTION New Mexico, Massachusetts, Texas, Tennessee, Pennsylvania,
Maryland.
QUANTITY 29 kits were distributed.
REASON The device was found to have the negative control and the
cut-off control mislabeled.
_______________
PRODUCT DSA Coordinate Indicator Anterior Plate, Part #A0860-03,
included in the 11/15/90, 1/24/91, and 4/24/91 shipments.
Recall #Z-560-4.
CODE None.
MANUFACTURER Elekta Instruments, AB, Stockholm, Sweden.
RECALLED BY Elekta Instruments, Inc., Atlanta, Georgia, by telephone
November 12, 1991, and by letter July 13, 1993. Firm-
initiated recall complete.
DISTRIBUTION California, Connecticut, New York, Pennsylvania, Texas,
Virginia, Wisconsin, Michigan.
QUANTITY Firm estimates none remains on the market.
REASON Fiducial marking on some of the plates are improperly
placed.
-13- _______________
PRODUCT Abbott IMx CK-MB Calibrators, Controls, Mode 1 Calibrator:
(a) Abbott IMx CK-MB Calibrators, for calibration of IMx
Analyzer when used for the determination of human CK-MB, in
4 ml bottles, list #2207-01;
(b) Abbott IMx CK-MB Controls, for verification of the
calibration of the IMx Analyzer when used for the
determination of human CK-MB, in 8 ml bottles, list #2207-
10; (c) Abbott IMx CK-MB Mode 1 Calibrator, for in-vitro
diagnostic use with IMx CK-MB, in 4 ml bottles, list #2207-
40. Recall #Z-578/580-4.
CODE Lot numbers: (a) 71138Q100 EXP 8/4/93; (b) 70649Q100 EXP
8/17/93; (c) 70695Q100 EXP 8/4/93.
MANUFACTURER Abbott Laboratories, Diagnostics Division, Abbott Park,
Illinois.
RECALLED BY Manufacturer, by telephone beginning April 5, 1993. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 1,624 calibrator packs, 5,348 control packs and 3,534 Mode 1
calibrators were distributed.
REASON The device was found to have lost potency over time, which
may result in controls reading outside specifications and
thus giving invalid assay results.
_______________
PRODUCT Axiom Knee Tibial Punch/Alignment Guide Handle, sizes 70-90,
used to prepare the tibia for implant of the Axiom Knee
Prosthesis. Recall #Z-591-4.
CODE Catalog #2275-PG01, Lot #017540001.
MANUFACTURER Orthomet, Inc., Minneapolis, Minnesota.
RECALLED BY Manufacturer, by telephone and by letter December 22, 1993.
Firm-initiated recall complete.
DISTRIBUTION Kentucky, Maine, Louisiana.
QUANTITY 3 units.
REASON A "dovetail" area was machined onto the wrong side of the
instrument which resulted in the slope being oriented in the
wrong direction.
_______________
PRODUCT Abbott IMx MEIA #2 Diluent Buffer, an in-vitro diagnostic
reagent for use with the IMx test kits, in 1000 ml bottles,
list #8374. Recall #Z-620-4.
CODE Lot #61061M401 EXP 1/16/93.
MANUFACTURER Abbott Laboratories, Diagnostics Division, Abbott Park,
Illinois.
RECALLED BY Manufacturer, by telephone April 17-27, 1992. Firm-
initiated recall complete.
DISTRIBUTION Nationwide, Mexico, Taiwan, Korea, France, Italy.
QUANTITY 860 boxes (4 bottles per box) were distributed.
REASON The buffer was found to inappropriately contain phosphate
which could cause decreased rates with IMx assays.
-14- MEDICAL DEVICE SAFETY ALERTS:
============================================
_______________
PRODUCT Optima Hollow Fiber Oxygenators:
(a) Catalog #050-212-000 Optima Open System with Integral
Filter;
(b) Catalog No. 050-214-000 Optima Open System;
(c) Catalog No. 050-255-000 Optima Open Adult Hollow Fiber
Oxygenator. Safety Alert #N-044/046-4.
CODE All lots manufactured prior to lot #10Y7000.
MANUFACTURER Cobe Cardiovascular, Inc., Arvada, Colorado.
ALERTED BY Manufacturer, by letter October 27, 1993.
DISTRIBUTION Nationwide and international.
QUANTITY 3,656 units were distributed.
REASON Reports of air being drawn across the microporous membrane
into the blood side of the membrane sections have been
received by the firm.
SEIZURES:
=================================================================
_______________
PRODUCT Ground Cinnamon (94-314-743).
CHARGES Adulterated - The article is unfit for food by reason of
the presence therein of a gritty substance resembling sand;
and a gritty substance resembling sand has been substituted
in part for ground cinnamon.
LOCATION T. J. Harkins Basic Commodity Brokers, Inc., Addison,
Illinois.
FILED April 5, 1994; U.S. District Court for the Northern District
of Illinois, Eastern Division; Civil #94C 2100; FDC #66951.
SEIZED April 5, 1994 - goods valued at approximately $1,692.
_______________
PRODUCT Prune Culls (93-673-113).
CHARGE Adulterated - The article consists in part of a filthy
substance.
LOCATION Allied Frozen Storage, Inc., Cheektowaga, New York.
FILED March 2, 1994; U.S. District Court for the Western
District of New York; Civil #94-CV-144; FDC #66908.
SEIZED March 31, 1994 - goods valued at approximately $79,000.
-15-
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