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
01/20/1993
Recalls and Field Corrections: Foods -- Class II -- 01/20/1993
JANUARY 20, 1993 93-3
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
PRODUCT Tutti-Frutti Dessert Pasta, in 8 ounce cello bags, and in bulk
10 pound boxes. Recall #F-122-3.
CODE All lots.
MANUFACTURER Oak Creek Farms, Edgar, Nebraska.
RECALLED BY Manufacturer, by telephone November 30, 1992, followed by
letter December 3, 1992. Firm-initiated recall ongoing.
DISTRIBUTION New York, California, Nebraska, Illinois, Texas.
QUANTITY 200 10-pound boxes and 308 8-ounce bags were distributed.
REASON Product contains undeclared FD&C Yellow No. 5 and 6.
PRODUCT Northeast brand Mushrooms Pieces and Stems, in 68 ounce cans.
Recall #F-123-3.
CODE MSP FCY 2302.
MANUFACTURER Product of China.
RECALLED BY Northeast Marketing Company, New Bedford, Massachusetts, by
letter on or about December 23, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Massachusetts, Rhode Island.
QUANTITY 948 cases (5 cans per case) were distributed.
REASON Product was processed and packed under unsanitary conditions
which may cause it to be adulterated with Staphylococcus
Enterotoxin.
PRODUCT Fruit syrup products under the following labels:
Borinquen brand: Passion Fruit, Coconut, Raspberry, Tamarind,
Sugar Cane; Sesame Seed, Egg Nog, Grape;
Poly brand: Passion Fruit, Coconut, Sour Sop, Guava, Sesame
Seed, Tamarind. Recall #F-166/175-3.
CODE None.
MANUFACTURER Halcon Bakers, Inc., Caguas, Puerto Rico.
RECALLED BY Manufacturer, by telephone followed by letter September 15,
1992. Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 1,118 cases (12 24.5-ounce) and 1,052 cases (12 24.5-ounce)
were distributed; firm estimates none remains on the market.
REASON Product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
PRODUCT Food Lion Unsweetened Pineapple Juice, in 46 ounce metal cans.
Recall #F-124-3.
CODE All product with the letters "ZM" in the coding.
MANUFACTURER Seneca Foods, Mountain Home, North Carolina.
RECALLED BY Food Lion, Inc., Salisbury, North Carolina, by memorandum
September 28-29, 1992. Firm-initiated recall complete.
DISTRIBUTION North Carolina, South Carolina, Virginia, Florida,
Pennsylvania, Tennessee, Texas.
QUANTITY 6,653 cases were distributed.
REASON North Carolina Department of Agriculture, Food and Drug
Protection Division found the product is unfit for human
consumption due to foreign particles in cans of food, detinning
and deenameling.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
UPDATE Bulk Neomycin Sulfate, USP, Powder, Recall #D-479-2,
manufactured by Upjohn Company, which appeared in the September
9, 1992 Enforcement Report should read:
CODE: 430HR, 073HT, 177FU, 178FU. Lot #765FY should not be
included in recall
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Fentanyl Citrate and Droperidol Injections, in 2 ml vials, Rx
drugs indicated to produce tranquilization and analgesia for
surgical and diagnostic procedures. Recall #D-100-3.
CODE Lot numbers 210092 EXP 4/94, 211050 EXP 5/94 (10 ampules);
211114 EXP 5/94 (10 single dose vials).
MANUFACTURER Astra Pharmaceutical Products, Inc., Westborough,
Massachusetts.
RECALLED BY Manufacturer, by letter December 28, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,800 units of lot 210092, 200 units of lot 211050 and 4,300
units of lot 211114 were distributed.
REASON Supplier of bulk Fentanyl citrate ingredient used a
manufacturing method not currently approved.
PRODUCT Mallinckrodt T1-201 Thallous Chloride, in 10 ml vials, 1
mCi/ml, 8 mCi, A radioactive parenteral. Recall #D-101-3.
CODE All vials in this recall bore the correct lot #1202351.
MANUFACTURER Mallinckrodt Medical, Inc., Maryland Heights, Missouri.
RECALLED BY Manufacturer, by telephone December 22, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Pennsylvania, Florida.
QUANTITY 2 units were distributed.
REASON Two units (vial, can and insert) declare incorrect lot number
on can and insert. Vial declares correct lot number.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT Recovered Plasma. Recall #B-115-3.
CODE Unit #SV0501982.
MANUFACTURER Personal Blood Storage of America, Inc., Columbia, South
Carolina.
RECALLED BY Manufacturer, by letter September 22, 1992. Firm-initiated
recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit.
REASON Recovered Plasma, which tested repeatedly reactive for the
antibody to hepatitis B core antigen (anti-HBc), was
distributed for further manufacture into non-injectable
products without labeling to reflect the anti-HBc reactive
results.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT (a) Platelets; (b) Recovered Plasma. Recall #B-116/117-3.
CODE Unit #616307.
MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, Colorado.
RECALLED BY Manufacturer, by telephone August 14, 1991. Firm-initiated
recall complete.
DISTRIBUTION Colorado, California.
QUANTITY 1 unit of each component.
REASON Blood products, corresponding to a unit of Red Blood Cells
which was found to be contaminated with Pseudomonas flourescens
and Pseudomonas picketti, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
PRODUCT Responder Series 1500 Defibrillator. Recall #Z-062-3.
CODE All serial numbers.
MANUFACTURER Marquette Electronics, Inc., Bangor, N. Ireland.
RECALLED BY Marquette Electronics, Inc., Milwaukee, Wisconsin, by letter
October 16, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 196 units.
REASON Potential for the device to fail to record patient ECG
tracings, without advising the user that the patient is not
connected.
PRODUCT Hystero-Flo Pump, Reorder #200346, a disposable, pneumatic
device designed to provide continuous, controlled, powered
irrigation during surgery and is intended for uterine
distention and irrigation during hysteroscopic procedures.
Recall #Z-118-3.
CODE All lots.
MANUFACTURER Davol, Inc., subsidiary of C.R. Bard, Inc., Lawrence, Kansas.
RECALLED BY Bard Reproductive Systems, C.R. Bard, Inc., Haverhill,
Massachusetts, by telephone October 26, 1992, followed by
letter. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 27,108 units were distributed.
REASON Failure of the pump's latex diaphragm could result in gas
introduction into the uterine cavity, causing an air embolism
and possible life-threatening complications.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT TEC 1410 Anatomical Programming Generator:
(a) TEC 1410 Anatomical Programming Generator, x-ray control,
Model T 1410-1;
(b) TEC 1410 Anatomical Programming Generator, high voltage
generator, Model T 1410-3. Recall #Z-119/120-3.
CODE Serial numbers: Undetermined.
MANUFACTURER Tecnomed USA, Bay Shore, New York.
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan
November 16, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION No units sold in the United States.
QUANTITY There is a single unit located in the Technomed USA facility
warehouse.
REASON Noncompliance with the performance standards for x-ray products
in that product lacked complete reports of quality assurance
test procedures, test data, accuracy specifications, and had
improperly placed certification labels.
PRODUCT Introducer kits, used in conjunction with candela urinary and
biliary scopes to provide an open channel into the surgical
site within the body cavity allowing the introduction of a
surgical endoscope:
Miniflex Introducer Kits, designed to be used in the urinary
tract:
(a) Catalog #7120-004770 contains 1 Miniflex Introducer kit;
(b) Catalog #7120-00-6120 contains 4 Miniflex Introducer Kits;
Reddick/Saye (RS) Introducer Kits, designed to be used in a
surgical incision through a trocar:
(c) Catalog #7120-00-4760 contains 1 Rs Introducer Kit;
(d) Catalog #7120-00-6110 contains 4 RS Introducer Kits.
Recall #Z-110/113-3.
CODE Lot numbers: (a) 7029201160036/92, 7039203720084/92,
7049202440103/92; (b) 7029201070036/92, 7039203950087/92,
7049202950108/92.
MANUFACTURER Cordis Corporation, Miami Lakes, Florida.
RECALLED BY Candela Laser Corporation, Wayland, Massachusetts, by letter
July 24, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,095 units were distributed.
REASON Sterility of the product may be compromised.
PRODUCT Reusable Techswitch Pencils, electrosurgical pencils:
(a) Model 9166; (b) Model 9167. Recall #Z-160/161-3.
CODE Lot numbers: (a) CA019257, CA039257, CA049257, CA069257,
CA089257, CB089257; (b) CA039258.
MANUFACTURER Aspen Labs, Inc., Englewood, Colorado.
RECALLED BY Manufacturer, by letter November 5, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION California, Colorado, Tennessee, Wisconsin, Pennsylvania,
Illinois, Washington state, New York, Alabama, Oregon,
Michigan, Texas, Maryland, Canada.
QUANTITY 13,900 pieces were distributed.
REASON Control buttons were manufactured from an inappropriate
material. If this material is autoclaved, it may cause the
buttons to distort and/or fall off.
PRODUCT Bicarbolyte Bicarbonate Hemodialysis Concentrate Acidified
Portion (36.83X) 2DX, used with dual proportioning artificial
kidney machines. Recall #Z-186-3.
CODE Lot #JUN 93 JU 19.
MANUFACTURER Bicarbolyte Wisconsin, Oak Creek, Wisconsin.
RECALLED BY Bicarbolyte, Alexandria, Virginia, by telephone on or about
July 8, 1992. Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY Approximately 4 1-gallon drums were distributed.
REASON Product contains 3.9 mEq/L potassium instead of 2.0 mEq/L as
labeled.
PRODUCT (a) Mid Cross Brace; (b) End Cross Brace; (c) Support Rod
Components, used with the Selby 1 Spine Fixation Kit. The
Selby 1 system is intended for use in stabilizing and
supporting the spine during sacral/iliac/lamina attachment
procedures. Recall #Z-191/193-3.
CODE To include all lots for part numbers:
SS-1000-C.B.R.H. (Mid-High Profile); SS-1000-C.B.L.H. (Mid-High
Profile); SS-1000-C.B.R.H.-L.P. (Mid Low-Profile);
SS-1000-C.B.L.H.-L.P. (Mid Low-Profile); SS-1000-E.C.B.R.H.;
SS-1000-E.C.B.L.H.; SS-1000-6-4.0-175; SS-1000-6-3.5-175;
SS-1000-6-3.0-175; SS-1000-6-2.5-175.
MANUFACTURER Advance Spine Fixation Systems, Inc., Cypress, California.
RECALLED BY Manufacturer, by letter October 14, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Texas, Minnesota, Oregon, California, Georgia, Colorado.
QUANTITY 989 units were distributed.
REASON The device components were shipped prior to receiving 510(k).
PRODUCT Crib Monitor, breathing frequency device. Recall #Z-198-3.
CODE All lots.
MANUFACTURER Perinatronics, Inc., Palm Beach Gardens, Florida.
RECALLED BY Manufacturer, by letter September 17, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 245 units were distributed; firm estimates 103 units remain on
the market.
REASON Product was distributed without 510(k) approval.
PRODUCT Ortholoc Modular Total Condylar Femoral Prosthesis:
(a) Catalog #1880-0010, Medium/Left (Modular IV), porous
coated;
(b) Catalog #1880-0012, Medium/Right (Modular IV), porous
coated;
(c) Catalog #1885-0010, Medium/Left (Modular IV-C), non-porous.
Recall #Z-199/201-3.
CODE Lot numbers: (a) 092M781560; (b) 082M765020; (c) 082M57960,
092M774060.
MANUFACTURER Dow Corning Wright, Inc., Arlington, Tennessee.
RECALLED BY Manufacturer, by memorandum November 2, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Arizona, California, Colorado, Connecticut, Florida, Iowa,
Kansas, Kentucky, Louisiana, Michigan, Missouri, Nebraska, New
Jersey, Ohio, Oregon, Pennsylvania, Utah, Virginia, Washington
state, West Virginia.
QUANTITY 44 units were distributed.
REASON The outer carton labeling may not correspond with the outer and
inner sterile tyvek blister package labels.
-6-
PRODUCT Sterile medical devices:
(a) PCA/Syringe Pump V Set, Catalog #V3 GII;
(b) Pediatric V Set, Catalog #V4 GISL;
(c) Two Way V Set, Catalog #V2 VY;
(d) ICU V Set, Catalog #V4 GILL;
(e) General/Labor Ward V Set, Catalog #V3 GIS;
(f) Amnicots, Catalog #0-100. Recall #Z-208/213-3.
CODE All lots prior to 12/01/92.
MANUFACTURER Go Medical Industry Pty. Ltd., Subiaco 6008 Western Australia.
RECALLED BY Pacific Rim Medical, Inc., Nashville, Tennessee, by letter
December 16, 1992. Firm-initiated recall ongoing.
DISTRIBUTION (a-e) Arizona, California, Missouri, North Carolina, Ohio,
Pennsylvania, Tennessee, Wisconsin; (f) Nationwide and Canada.
QUANTITY (a-e) 19,104; (f) 94,000 units were distributed.
REASON Sterilization procedures has not been validated. Products were
also illegally imported in violation of an automatic detention
order.
PRODUCTS Angeflator Balloon Inflation Device, coronary angioplasty
balloon inflation pump, Model AFL-20. Recall #Z-214-3.
CODE Lot numbers: 2NBC59, 2QBC99, 2TBC16.
MANUFACTURER B. Braun Medical, Inc., Burron Cardiovascular Division,
Minneapolis, Minnesota.
RECALLED BY Manufacturer, by letter December 7, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Florida, Georgia, Kansas, Michigan, Minnesota, New Jersey, New
York, Oklahoma, Pennsylvania, Texas, and international.
QUANTITY 275 units were distributed.
REASON An incorrect bezel (glass covers) may interfere with the
pointer movement, which can cause the displayed pressure to be
significantly below the actual pressure.
PRODUCT Blood Glucose Test Strips, an in-vitro diagnostic used with a
supreme meter to determine blood glucose levels in diabetics.
Recall #Z-215-3.
CODE 100-289, 296-307, 310-492, 59101-95103.
MANUFACTURER Hypoguard (Exports), Inc., Suffolk, England, UK.
RECALLED BY British American Medical, Inc., Laguna Hills, California, by
letter December 17, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Maine, New Jersey, Washington, D.C., Georgia, Florida,
Michigan, Wisconsin, Minnesota, California.
QUANTITY 15,640 units were distributed; firm estimates that less than
200 bottles remain on the market.
REASON The strips may contain a manufacturing defect which causes the
strips to read blood glucose levels inaccurately.
PRODUCT Command2 Console Bracket, Part #2296-3-10. The product is a
bracket which attaches to an I.V. pole for placement of a
Command Microlectric Console. Recall #Z-216-3.
CODE None.
MANUFACTURER Stryker Corporation, Instruments Division, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter November 25, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 37 units were distributed.
REASON Inadequate fixation can cause the I.V. Console Plate to fall
off of an I.V. stand when loaded with weight.
PRODUCT ACS Hi-Torque Floppy II Exchange Wire Microglide Coating,
Catalog #22369MJ, intended to facilitate the placement of
balloon dilatation catheters during percutaneous transluminal
coronary angioplasty (PTCA), and/or percutaneous transluminal
angioplasty (PTA). Recall #Z-218-3.
CODE Lot numbers 2082751, 2090852, 2091651.
MANUFACTURER Advanced Cardiovascular Systems, Inc., Temecula, California.
RECALLED BY Manufacturer, by letter October 9, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Ohio, Tennessee, New York, Indiana, Minnesota, Michigan,
Florida, Canada, Italy.
QUANTITY 121 units were distributed.
REASON The labeling indicates that the guidewire has a 30 cm
radiopaque tip when the product actually has a 2 cm radiopaque
tip.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT Reciprocating Blade, 23.0 mm cut edge, Part # 1675-107, a
cutting accessory for orthopedic bone saw. Recall #Z-145-3.
CODE Lot #92060231.
MANUFACTURER Stryker Corporation, Instruments Division, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter September 28, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION New York, Pennsylvania, South Carolina, Virginia.
QUANTITY 4 boxes (3 units per box) were distributed.
REASON Each individual blade package may not have a part
identification label on it.
PRODUCT BBL Opticult. Product consists of 10 disposable plastic
containers with microbiological culture media, intended to be
used for subculturing of blood culture bottles.
Recall #Z-166-3.
CODE All lot numbers from June 1991 to November 1991.
MANUFACTURER Becton Dickinson Microbiology Systems, Cockeysville, Maryland.
RECALLED BY Manufacturer, by telephone on or about December 2, 1991, by fax
on or about December 19, 1991, followed by letter December 20,
1991. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 37,342 units were distributed.
REASON Portions of some lots exhibited leakage of blood/broth mixture
when inverted or opened during the subculturing process.
PRODUCT Invos 3100 Cerebral Oximeter, used as a monitor which when
connected to a sensor device, non-invasively measures the
approximate regional oxygen saturation (rSO2) of the hemoglobin
in the microvasculature of an adult's brain. Recall #Z-169-3.
CODE Serial numbers: 101004, 101028, 101029, 101035, 101072,
101095.
MANUFACTURER Somanetics Corporation, Troy, Michigan.
RECALLED BY Manufacturer, by Fax and letter January 20 and 30, 1992, and
March 39, 1992. Firm-initiated recall ongoing.
DISTRIBUTION New York, New Jersey, Massachusetts, UK, Japan.
QUANTITY 7 units were distributed; firm estimates none remains on the
market.
REASON Good manufacturing practice deficiencies and lack of device
history records.
PRODUCT Deklene II 7-0 Polypropylene Cardiovascular Nonabsorbable
Surgical Suture with T-6 Needle USP (blue monofilament:
(a) Catalog #D-7004M4; (b) Catalog #D-7063M4.
Recall #Z-181/182-3.
CODE Lot numbers: (a) 02478, 02479A; (b) 02478, 02576P.
MANUFACTURER Deknatel, Inc., Fall River, Massachusetts.
RECALLED BY Manufacturer, by letter September 11, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3 boxes of 12 paks of lot 02576P, 5 boxes of 12 paks of lot
02479A, 52 boxes of 12 paks of lot 02478 were distributed.
REASON The devices were labeled as containing 7-0 Suture and t-6
Needle, but may contain 5-0 Suture and T-1 Needle instead.
PRODUCT (a) Storz Disposable Trephine Blade, 8.0 mm, Product #E3096;
(b) Castroviejo Corneal Transplant Trephine Kit with 2/8.0 mm
blades, Product #E3094, used to cut donor corneal tissue,
therefore, no patient contact is made. Recall #Z-183/184-3.
CODE Lot numbers (a) 19022C; (b) All lots.
MANUFACTURER Storz Instrument Company, St. Louis, Missouri.
RECALLED BY Manufacturer, by letter November 11, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 67 individually packaged blades and 29 blades which were put
into kits were distributed.
REASON 7.25 mm blades may be packaged as 8.0 mm blades.
PRODUCT (a) Dacroswab Type 1, general all purpose sterile disposable
specimen collection swabs on an aluminum shaft used for the
collection of non-microbial specimens and viral specimens from
the ear, nose, and urethral canal such as herpes simplex virus,
packaged 100 swabs, 10 boxes per case, 1 per envelope;
(b) Calgiswab Type 4, sterile alginate swabs on ultrafine
flexible aluminum shafts for use as sampling specimens for
infectious diseases of the ear, nose, and throat, and sexually
transmitted diseases, packaged 100 swabs (10 boxes per case, 1
swab per envelope. Recall #Z-194/195-3.
CODE Lot numbers: (a) Lot #8784, reorder 174135; (b) 8948, reorder
#174116.
MANUFACTURER Spectrum Laboratories, Inc., Houston, Texas.
RECALLED BY Manufacturer, (a) by letter dated October 14, 1992; (b) by
letter dated November 13, 1992. Firm-initiated recall ongoing.
DISTRIBUTION (a) Nationwide, Canada, China, Finland; (b) Nationwide, Puerto
Rico, Bermuda, Canada.
QUANTITY (a) 157,200 swabs were distributed; FDA estimates 20 percent of
the product remains on the market; (b) 60 cases (1,000 swabs
per case) were distributed; FDA estimates that 20 percent of
the product remains on the market.
REASON The products do not conform to the firm's quality control
standards.
UPDATE Stryker Instruments' Medium Narrow Blade, Recall #Z-152-3,
which appeared in the December 30, 1992 Enforcement Report
should have read Part #2296-3-114.
MEDICAL DEVICE SAFETY ALERTS:
PRODUCT Disposable low pressure gas/driven irrigating pumps used in
arthroscopic procedures:
(a) Davol Arthro-Flo Pump (K870915), Reorder #0037750;
(b) Davol Arthro-Flo Pump (K913028), Reorder #0015000.
Safety Alert #M-010/011-3.
CODE All lots.
MANUFACTURER Davol, Inc., Subsidiary of C.R. Bard, Inc., Lawrence, Kansas.
ALERTED BY Davol, Inc., Subsidiary of C.R. Bard, Inc., Cranston, Rhode
Island, by letter October 23, 1992.
DISTRIBUTION Nationwide and international.
QUANTITY 461,517 units were distributed.
REASON The device is contraindicated in hysteroscopy due to diaphragm
failure.
PRODUCT Omitron 2000, Hi-Dose Rate Remote Afterloader System with
Ir-192, for brachytherapy radiation. Safety Alert #M-012-3.
CODE All units.
MANUFACTURER Omnitron International, Inc., Houston Texas.
ALERTED BY Manufacturer, by letter December 17, 1992.
DISTRIBUTION Nationwide, Australia.
QUANTITY 33 units were distributed.
REASON Possibility of source separating from wire during treatment
procedures.
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END OF ENFORCEMENT REPORT FOR JANUARY 20, 1993. BLANK PAGES MAY
FOLLOW.