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.

March 19, 1997 97-12

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Honey Roasted Cashews, in 4.5 ounce foil
packages, contained in various gift baskets:
Christmas catalog:
1) Grand Fruit Basket aka Royal Bistro Basket,
item 8V, Net weight 14 pounds
2) 9-Star All-Occasion Basket, item 4202, Net
weight 9 pounds
3) 6-Star All-Occasion Basket, item 4205, Net
weight 6 pounds
4) 4-Star All-Occasion Basket, item 4559, Net
weight 4 pounds
January - March 1997 catalog
5) Super Deluxe Fruit Basket, item 8V, Net
weight 14 pounds Recall #F-266-7.
CODE AUG 14 972C and AUG 14 972D.
MANUFACTURER Georgia Nut Company, Skokie, Illinois (nut
packer).
RECALLED BY Harry and David, Medford, Oregon
(distributor), by mailgram sent on or about
January 16, 1997, and by letter on January 24,
1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 12,100 bags were distributed.
REASON Product may contain undeclared peanuts.

_______________
PRODUCT Ice cream: (a) AMERICAN FARE Heavenly Hash
Premium Ice Cream labeled made for "Kmart
Corporation, Troy, Michigan", in half gallon
round plastic containers
(b) AMERICAN FARE Pralines 'N Cream Ice Cream
labeled made for "Kmart Corporation, Troy,
Michigan", in half gallon round plastic
containers. Recall #F-268/269-7.
CODE Lot numbers: (a) 635926-875B;
(b) 635826-875B.
MANUFACTURER Michigan Dairy, Livonia, Michigan.
RECALLED BY Manufacturer, by telephone, followed by letter
on January 14, 1997, and by press release
issued by Kmart Corporation and The Kroger
Company on January 14, 1997. Firm-initiated
recall complete.
DISTRIBUTION Texas, Florida, Ohio, Georgia, North Carolina,
South Carolina.
QUANTITY (a) 1,712 cartons; (b) 1,597 cartons were
distributed.
REASON (a) The product contains undeclared peanuts.
(b) The product contains undeclared pecans.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Stoneware Dinner Sets with Christmas Tree
Design, 16 piece sets, service for four.
Recall #F-262-7.
CODE Item #94605 on outer box.
MANUFACTURER Fei Na Te Ceramic Company, Ltd., Hebei, China.
RECALLED BY C.R. Seasons Ltd., Farmingdale, New York, by
telephone, followed by letter dated January 9,
1997. Firm-initiated recall ongoing.
DISTRIBUTION New York, South Carolina, Pennsylvania,
Massachusetts, Vermont, Connecticut, Florida.
QUANTITY 12,430 cartons (37,290 sets) were distributed.
REASON The dinner set contains excessive levels of
leachable lead.

_______________
PRODUCT Carnival Pink Lemon Fruit Drink, in 1 gallon
plastic jugs. Recall #F-265-7.
CODE All codes.
MANUFACTURER Superior Dairy, Inc., Canton, Ohio.
RECALLED BY Manufacturer, by telephone beginning on
February 21, 1997. Firm-initiated recall
ongoing.

-2-DISTRIBUTION Ohio, West Virginia, Pennsylvania, Michigan.
QUANTITY Undetermined.
REASON Product contains undeclared FD&C Yellow No. 5.

_______________
PRODUCT Pasteurized Liquid Whole Eggs, packed in 30
pound/5 gallon buckets. Recall #F-267-7.
CODE Lot #3236.
MANUFACTURER Quaker State Farms, Inc., Klingerstown,
Pennsylvania.
RECALLED BY Manufacturer, by telephone on November 26,
1996. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania and New Jersey.
QUANTITY Firm estimates none remains on the market.
REASON Product was contaminated with salmonella.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Sun Dried Tomatoes, in 3 ounce plastic
containers with a snap on lid.
Recall #F-261-7.
CODE None. All product in distribution.
MANUFACTURER South Mill Mushroom Sales, Inc., Kennett
Square, Pennsylvania (repacker/responsible
firm).
RECALLED BY Repacker, by telephone, followed by letter
dated January 24, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION New York, Massachusetts, Iowa, Texas,
California, Bermuda.
QUANTITY 78 cases (12 containers per case) were
distributed.
REASON Product contains undeclared sulfites.

_______________
PRODUCT Golden Maple Leaf brand Dried Sweet Potato, in
7 ounce and 14 ounce plastic bags.
Recall #F-263-7.
CODE None.
MANUFACTURER Taishin City Daxin Haufeng Food Co., Ltd.,
Taishin City Guangdong, China.
RECALLED BY Blooming Imports, Inc., Brooklyn, New York by
telephone and by letter dated October 7, 1996.
Ongoing recall resulted from sample analysis
and followup by the New York State Department
of Agriculture and Markets.
DISTRIBUTION New York and New Jersey.
QUANTITY 97 7-ounce cartons and 20-ounce cartons were
distributed.
REASON Product contains undeclared sulfites.

-3-_______________
PRODUCT Free Supreme Fat Free Ice Cream with
Nutrasweet, Chocolate Ripple Flavor, in half
gallon plastic rounds. Recall #F-264-7.
CODE The ice cream is identified with one of three
codes: "351 6", "015 7", and "041 7". The
ice cream branded with the code 051 6, was
manufactured on 12/16/96; the product
identified with the code 015 7, was
manufactured on 1/15/97; and the product coded
041 7, was manufactured on 2/10/97.
MANUFACTURER Superior Dairy, Inc., Canton, Ohio.
RECALLED BY Manufacturer, by telephone beginning on
February 25, 1997, followed by visit. Firm-
initiated recall ongoing.
DISTRIBUTION Ohio, West Virginia, Pennsylvania, Michigan,
New Jersey.
QUANTITY 1,137 cases (6,822 rounds) were distributed;
firm estimated that 80 percent of product
produced remained on market at time of recall
initiation.
REASON The product does not bear the warning
statement "PHENYLKETONURICS: CONTAINS
PHENYLALANINE" as required by 21CFR 172.804.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ==========
_______________
PRODUCT Oxygen, USP, Rx in portable aluminum
cylinders, sizes B, C, D, and E.
Recall #D-124-7.
CODE All codes distributed between November 13,
1996 and January 31, 1997.
MANUFACTURER Mersco Medical, Inc., Sioux Falls, South
Dakota.
RECALLED BY Eastern Dakota Health, doing business as
Mersco Medical, Inc., Sioux Falls, South
Dakota, by visits on or about February 3,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Minnesota, Iowa, South Dakota.
QUANTITY Undetermined. All product distributed from
11/13/96 to 1/31/97.
REASON Good manufacturing practice deficiencies.

_______________
PRODUCT Diltiazem Hydrochloride Extended Release
Capsules, USP, 60 mg, in bottles of 100,
Marketed under the Lemmon label, used for the
treatment of hypertension. Recall #D-125-7.
CODE Lots OB 6780 EXP 5/98 and OB 6781 EXP 6/98,
distributed between 12/9/96 and 1/28/97.

-4-MANUFACTURER Prographarm Laboratories S.A., France
(responsible firm).
RECALLED BY Teva Pharmaceuticals, Sellersville,
Pennsylvania, by letter dated January 28,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 25,000 bottles.
REASON Product fails to meet dissolution
specification (lot ob 6781 assays as low as
48% after 12 hours; spec is 55-80%).

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Cefadroxil Capsules, USP, 500 mg, in bottles
of 24, 50, 100, indicated for the treatment of
patients with infection caused by susceptible
strains of the designated organisms in the
following diseases: Urinary tract infections
caused by E. coli, and Klebsiella species.
Skin and skin structure infections caused by
staphylococci and/or streptococci.
Pharyngitis/tonsillitis caused by group A
beta-hemolytic streptococci.
Recall #D-126-7.
CODE Lot numbers: 4301-039 EXP 6/98, 4801-039 EXP
6/98, 6068-039 EXP 6/98.
MANUFACTURER Zenith Goldline Pharmaceuticals, Inc., Pralex
Corporation, Christiansted, Virgin Islands.
RECALLED BY Manufacturer, by letter dated February 24,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 8,410 bottles were distributed.
REASON Fails to meet dissolution specification at the
6-month stability testpoint (assay is 78% of
label strength; spec is not less than 85%
after 30 minutes).

______________
PRODUCT Mechanical Servants brand Regular Afrin Nasal
Decongestant 12 Hour Nasal Spray,
(Oxymetazoline HCl, USP), 0.05% in a 1/10
fluid ounce spray bottle. Recall #D-127-7.
CODE Lot #6-CFC-100 EXP 6/98.
MANUFACTURER Schering-Plough Healthcare Products, Memphis,
Tennessee.
RECALLED BY Mechanical Servants, Inc., Chicago, Illinois,
by letter dated March 3, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 14,405 units were distributed; firm estimated
that 25 percent of product remained on market
at time of recall initiation.
-5-REASONS Some outer packages are labeled with an
incorrect expiration date (the expiration date
may appear as "10/97" or "6/98"). The bottles
bear the correct expiration date.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Red Blood Cells. Recall #B-226-7.
CODE Unit #20LY04214.
MANUFACTURER American Red Cross Blood Services, Boise,
Idaho.
RECALLED BY Manufacturer, by telephone on July 2, 1996.
Firm-initiated recall complete.
DISTRIBUTION Idaho.
QUANTITY 1 unit was distributed.
REASON Blood product was collected in a manner which
compromises the sterility of the collection
system.

_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-324/325-7.
CODE Unit numbers: (a) 32GW36179, 32GW41876;
(b) 32GW41876.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by letter dated October 18,
1995. Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY (a) 2 units; (b) 1 unit was distributed.
REASON Blood products were collected from a donor who
had previously reported a history of cancer.

_______________
PRODUCT Red Blood Cells. Recall #B-407-7.
CODE Unit #21Q49876.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by letter June 6, 1996. Firm-
initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
reported a history of cancer.

_______________
PRODUCT Platelets. Recall #B-413-7.
CODE Unit #15286-4452.
MANUFACTURER United Blood Services, Lubbock, Texas.

-6-RECALLED BY Blood Services, Inc., Scottsdale, Arizona, by
letter on February 28, 1996. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Platelets were prepared from a unit collected
from a donor who had taken aspirin within
three days of donation.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Recovered Plasma.
Recall #B-437/440-7.
CODE Unit numbers: (a) 32H01431, 32H24383;
(b) 32H01431; (c) 32H24383; (d) 32H01431,
32J13749.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by letters dated March 13, 1996,
or May 28, 1996, and by Fax on March 13, 1996.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin and California.
QUANTITY (a) 2 units; (b) 1 unit; (c) 1 unit; (d) 2
units were distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1), but were collected from a
donor who previously tested repeatedly
reactive for anti-HIV-1.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-441/443-7.
CODE Unit #32F85453.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by letters dated August 18,
1995, September 7, 1995, or November 4, 1996,
and by fax on September 5, 1995. Firm-
initiated recall complete.
DISTRIBUTION Wisconsin, Illinois, New Jersey, California
Massachusetts, Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested initially reactive for
the hepatitis B surface antigen (HBsAg), and
were not retested as required; or were
collected from a donor who was previously
tested incorrectly for HBsAg.

_______________
PRODUCT Red Blood Cells. Recall #B-448-7.
CODE Unit #1382803.

-7-MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by telephone on August 10, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product tested initially reactive for
syphilis, but was not retested in accordance
with the manufacturer's test kit instructions.

_______________

PRODUCT Platelets, Pheresis. Recall #B-455-7.
CODE Unit #KZ37936 and KZ37595.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone on November 7,
1996. Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor who
had traveled to an area considered endemic for
malaria.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-460/461-7.
CODE Unit #29Y26767.
MANUFACTURER American Red Cross Blood Services, Norfolk,
Virginia.
RECALLED BY Manufacturer, by letters dated February 1,
1996, and March 7, 1996, and by memorandum
dated January 16, 1997. Firm-initiated recall
complete.
DISTRIBUTION Virginia and Pennsylvania.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested initially reactive for
the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1), and were not
retested in duplicate.

_______________
PRODUCT Red Blood Cells. Recall #B-462-7.
CODE Unit #T31202.
MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY Manufacturer, by telephone on October 4, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with
a history of ear piercing within 12 months of
donation.

-8-_______________
PRODUCT Platelets, Pooled. Recall #B-463-7.
CODE Unit #126.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by telephone on October 25,
1996. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration time.

_______________
PRODUCT (a) Red Blood Cells. Recall #B-464-7.
CODE Unit #40GJ11210.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on October 22,
1996, followed by letter dated October 23,
1996. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
reported a history of cancer.

_______________
PRODUCT Platelets. Recall #B-469-7.
CODE Unit #11313-8133.
MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Blood Services, Inc., Scottsdale, Arizona, by
letter on October 15, 1996. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a whole blood
unit with an extended collection time.

_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-473/474-7.
CODE Unit #40GT45599.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on July 25, 1996,
followed by letter dated July 31, 1996. Firm-
initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested repeatedly reactive for
the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1), but were subjected
to additional retesting.

-9-RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
______________
PRODUCT Recovered Plasma. Recall #B-326-7.
CODE Unit #32GW36179.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by Fax on October 17, 1995.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who
had previously reported or a history of
cancer.

_______________
PRODUCT (a) Platelets. Recall #B-348-7.
CODE Unit numbers: 5570811 5570851 5570881
5825491 5570821 5570861 5570891 5738741
5570841 5570871 5825481.
MANUFACTURER Central Indiana Regional Blood Center,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by telephone on July 7, 1995.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 11 units were distributed.
REASON Blood products were distributed prior to
completion of testing for the antibody to the
hepatitis B core antigen (anti-HBc).

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-421/422-7.
CODE Unit #53K16896.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letters dated February 15 and
20, 1996. Firm-initiated recall complete.
DISTRIBUTION Maryland and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
had been immunized with Measles, Mumps, and
Rubella (MMR) vaccine.

_______________
PRODUCT Fresh Frozen Plasma. Recall #B-426-7.
CODE Unit #29135-4108.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on July 22, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.

-10-REASON Blood product was prepared from a unit of
whole blood designated as a difficult
collection.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Recovered Plasma.
Recall #B-444/447-7.
CODE Unit numbers: (a) 32H44790, 32H74393,
32F05171, 32H87632, 32H01007, 32K74428,
32GQ03590, 32K98221, 32LH18254, 32GW11991,
32FF20952, 32GW34796; (b) 32H74393, 32F05171,
32H87632, 32H01007, 32K98221, 32LH18254,
32GW11991; (c) 32H44790, 32F05171, 32H87632;
(d) 32H74393, 32H01007, 32K74428, 32K85116,
32GQ03590, 32K98221, 32LH18254, 32GW11991,
32FF20952, 32GW34796.
MANUFACTURER American Red Cross Blood Services, Madison,
Wisconsin.
RECALLED BY Manufacturer, by letter dated August 18, 1995,
September 7, 1995, or November 4, 1996, or by
Fax on September 5, 1995. Firm-initiated
recall complete.
DISTRIBUTION Wisconsin, Illinois, New Jersey,
Massachusetts, California, Switzerland.
QUANTITY (a) 12 units; (b) 7 units; (c) 3 units; (d) 10
units were distributed.
REASON Blood products tested initially reactive for
the hepatitis B surface antigen (HBsAg), and
were not retested as required, or were
collected from a donor who was previously
tested incorrectly for HBsAg.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-449/451-7.
CODE Unit #2706070.
MANUFACTURER Gulf Coast Regional Blood Center, Houston,
Texas.
RECALLED BY Manufacturer, by Fax followed by telephone on
March 16, 1995. Firm-initiated recall
complete.
DISTRIBUTION Texas and New York.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
whose spouse tested positive for the antibody
to the human T-lymphotropic virus type II
(anti-HTLV-II).

_______________
PRODUCT Red Blood Cells. Recall #B-452-7.
CODE Unit #30R27570.

-11-MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated November 7,
1995. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Unlicensed blood product was shipped
interstate.

_______________
PRODUCT Platelets, Pheresis. Recall #B-454-7.
CODE Unit #KZ38852.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone on October 2, 1996.
Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit was distributed.
REASON Unlicensed blood product was shipped
interstate.

_______________
PRODUCT Recovered Plasma. Recall #B-465-7.
CODE Unit #40GJ11210.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letter on October 24, 1996.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
reported a history of cancer.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Cobe Centrysystem HG Dialyzer, used in chronic
hemodialysis procedures to remove body wastes
and water from the blood: (a) 600 HG
Dialyzer; (b) 700 HG Dialyzer.
Recall #Z-295/296-7.
CODE Lot numbers: (a) G07B5291, G07B5292,
G07B5293, G07B5294, G08B5292, G09B5291,
G09B5293, G09B5294, G10B5291, G10B5292,
G10B5293, G11B5291;
(b) G10B5311, G10B5312, G10B5313, G11B5311,
G11B5313, G01C5311.
MANUFACTURER Secon GMBH, Dransfeld, Germany.
RECALLED BY Gambro Healthcare, Lakewood, Colorado, by
telephone followed by FedEx on January 31,
1997. Firm-initiated recall ongoing.

-12-DISTRIBUTION Colorado, District of Columbia, Florida,
Illinois, Kentucky, Missouri, New York,
Tennessee, Virginia, Washington state,
Wisconsin, Canada.
QUANTITY (a) 11,740 units; (b) 13,980 units were
distributed.
REASON The blood in the dialyzers was leaking from
the blood side into the dialysate.

_______________
PRODUCT SPUR Infant/Child Resuscitator, single use.
Recall #Z-309-7.
CODE Catalog Nos. (Old Catalog Nos.)
430013000 (243004000)
430013001 (243004000001)
430014000 (2430050NIT)
430015000 (243001000004)
430015002 (n/a)
430017000 (n/a)
430613000 (243004600)
430613001 (2430046000001)
430613002 (243004600002)
430613003 (n/a)
430614000 (2430056NIT)
430614004 (n/a)
430814000 (243006000NIT)
431813000 (243014000)
431813002 (243014000002)
431814000 (243009800 &243015000NIT)
431815000 (243014000IT)
431817000 (n/a)
Discontinued Catalog Nos.
430013002 (243004000002)
430014002 (2430050NIT002)
430014004 (n/a).
MANUFACTURER Ambu, Inc., Linthicum, Maryland.
RECALLED BY Manufacturer, by letter dated June 21, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 48,315 units were distributed; firm estimates
none remains on the market.
REASON The patient mask connector can cause
deformation of the resuscitator connector,
resulting in inability to connect an
endotracheal tube for a patient to be
intubated.

_______________
PRODUCT Medtronic Synchromed Programmable Pumps:
(a) Model #8617-18; (b) 8617L-18.
Recall #Z-310/311-7.
CODE None.

-13-MANUFACTURER Medtronic, Inc., Neurological Division,
Columbia Heights, Minnesota.
RECALLED BY Manufacturer, by letter on January 31, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 97 pumps were distributed.
REASON The infusion pump could leak, resulting in
corrosion of the components, causing a motor
stall condition.

_______________
PRODUCT Angio-Seal Hemostatic Puncture Closure Device,
8 French, indicated for use in closing and in
reducing time to hemostasis at the femoral
arterial puncture site in patients who have
undergone diagnostic angiography or
percutaneous transluminal coronary angioplasty
procedures using an 8F or smaller procedural
sheath: (a) Catalog No. 8888-610089;
(b) Catalog No. 1180-580050.
Recall #Z-312/313-7.
CODE Lot Numbers: (a) 879905, 880245, 880445,
880446, 881486, 881700; (b) 881474, 96I041E,
96I201E.
MANUFACTURER Quinton Instrument Company, Bothell,
Washington.
RECALLED BY Sherwood Davis & Geck, St. Louis, Missouri, by
letter dated January 27, 1997, and by
telephone on January 28, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Between 9/30/96-1/21/97, 2,090 devices in the
U.S. and 2,272 devices internationally were
distributed.
REASON During deployment, the devices anchor may
become detached from the remainder of the
device, remaining within the femoral artery of
the patient.

_______________
PRODUCT Kendall Sheridan JETTX Jet
Ventilation/Tracheal Tube Exchanger, used as a
airway management system. Recall #Z-314-7.
CODE Product #5-24205, Lot #051472.
MANUFACTURER Kendall Healthcare, Argyle, New York.
RECALLED BY Kendall Healthcare Products Company,
Mansfield, Massachusetts, by overnight mail on
January 31, 1997, and February 3, 1997. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.

-14-QUANTITY 470 units were distributed.
REASON The Luer Lock Adapter may be missing,
preventing attachment of conventional jet
ventilation devices to the tracheal tube
exchanger.

_______________
PRODUCT Aero-Mist Nebulizer/Compressor System, Reorder
#HCS 1200, a disposable home use nebulizer
used to atomize liquid medications for
inhalation, normally used by asthmatics.
Recall #Z-315-7.
CODE Lot numbers 601 and 604, Serial numbers 13003-
22000.
MANUFACTURER Medel Italiana S.R.L., Polo Di Torrile (PR),
Italy.
RECALLED BY Medline Industries, Inc., Mundelein, Illinois,
by letter dated February 18, 1997. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 6,100 units were distributed.
REASON The units may experience a drop in air
pressure over time during use, causing
difficulty in administering the recommended
dosage of medication.

_______________
PRODUCT Model 531-30 (software) Rx2000 Program Module,
an electronic memory cartridge containing
instructions needed by the Model 522-06
Rx2000 graphics programmer to program and
obtain data from Intermedics Res-Q Arrhythmia
Control, life support devices.
Recall #Z-316-7.
CODE All lots. Serial numbers involved range
within #1330-1657 and #101680-102337.
Manufactured from August 24, 1990 to current.
MANUFACTURER Intermedics, Inc., Angleton, Texas.
RECALLED BY Manufacturer, by letter sent on February 3,
1997. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide and Lebanon.
QUANTITY 280 units were distributed.
REASON A software condition can cause inappropriate
programming of parameter data that can result
in undersensing, oversensing, and loss of
capture.

_______________
PRODUCT Toshiba Digital Gamma Cameras, used to perform
a wide range of nuclear medicine examinations:
(a) Model No. GCA-7100A

-15- (b) Model No. GCA-7200A
(c) Model No. GCA-7100A/DI
(d) Model No. GCA-7200A/DI.
Recall #Z-317/320-7.
CODE All serial numbers.
MANUFACTURER Toshiba Corporation, Tochigi, Japan.
RECALLED BY Toshiba America Medical Systems, Inc., Tustin,
California, by letter on November 18, 1996.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 76 units are installed.
REASON Allen head bolts located in the rotating
assembly drive train section had been sheered
off, allowing the single head assembly to
rotate freely between 90 to 270 degrees
beneath the patient.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Nellcor-Equipped MicroDigitrapper-S/Oxy-
Holter, used in the diagnosis of sleep
disorders. Recall #Z-301-7.
CODE Various serial numbers.
MANUFACTURER Synectics Medical, Inc., Irving, Texas.
RECALLED BY Manufacturer, by letter on November 2, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 103 units were distributed.
REASON The device experiences loss of pulse-oximetry
data from high artifact levels due to a design
problem.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III ==========
__________________
PRODUCT Master Mix P-S-Y Lax PAC 7926, nonmedicated
feed for the relief of constipation of sows.
Recall #V-029-7.
CODE Lot #478106.
MANUFACTURER ADM Animal Health and Nutrition Division, Des
Moines, Iowa.
RECALLED BY Manufacturer, by letter on November 7, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nebraska.
QUANTITY 299 20-pound bags were distributed; firm
estimates none remains on the market.
REASON The product was manufactured following the
manufacture of an experimental batch of Type B
medicated feed which contained the new animal
drug tilmicosin. No clean-out occurred
between production.

-16-__________________
PRODUCT SCNS Pig Charger 500 Xtra, nonmedicated feed.
Recall #V-030-7.
CODE Lot #593086.
MANUFACTURER ADM Animal Health and Nutrition Division, Des
Moines, Iowa.
RECALLED BY Manufacturer, by telephone on October 25,
1996, followed by letter on November 7, 1996.
Firm-initiated recall complete.
DISTRIBUTION Minnesota.
QUANTITY 41 50-pound bags were distributed.
REASON The product was manufactured following the
manufacture of an experimental batch of Type B
medicated feed which contained the new animal
drug tilmicosin. No clean-out occurred
between production.

_______________
PRODUCT "Go Dry" Dry Cow Mastitis Treatment,
Penicillin G Procaine in Sesame Oil, (10 mL
syringe) for the treatment of bovine mastitis
in dry cows. Recall #V-031-7.
CODE H 5430 - Exp. February 1999.
MANUFACTURER G C Hanford Manufacturing Company, Syracuse,
New York.
RECALLED BY Manufacturer, by telephone on February 19,
1997, followed by letter on February 20, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Alabama, California, Iowa, Kentucky,
Massachusetts, Mississippi, Missouri,
Nebraska, New Mexico, New York, Pennsylvania,
Wisconsin, West Virginia.
QUANTITY 76,116 syringes were distributed.
REASON Product is packaged in cartons labeled for
lactating cow mastitis treatment "Hanford's
Penicillin Lactating Cow Mastitis Treatment."

-17-

END OF ENFORCEMENT REPORT FOR MARCH 19, 1997. BLANK PAGES MAY FOLLOW.

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End of Enforcement Report for