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.

December 18, 1996 96-51

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Giglio brand Mascarpone Cheese, a soft cream
cheese used primarily in desserts, packed in
plastic tubs, net weight 17.5 ounces, 6 and 12
tubs per carton. Recall #F-078-7.
CODE The tub has a "Y" code followed by the
production time below, both are located on the
bottom of the tub.
MANUFACTURER Giglio Grana S.P.A., Reggio Emilio, Italy
(responsible firm).
RECALLED BY Battaglia & Company, Inc., Lyndhurst, New
Jersey, by telephone and by fax on September
9, 1996, followed by letter dated September
12, 1996. Firm-initiated recall complete.
See also FDA press release P96-14,
September 9, 1996.
DISTRIBUTION District of Columbia, Ohio, Illinois, New
Jersey, New York, Michigan.
QUANTITY Approximately 88 cartons containing 12 17.5-
ounce tubs and 153 cartons containing 6 17.5-
ounce tubs were distributed.
REASON The "Y" coded product was manufactured in the
same time frame as product associated with an
outbreak of botulism poisoning in Italy. In
the absence of information that the "Y" coded
product was produced under conditions that
would preclude the formation of botulinum
toxin, it also has the potential to be
contaminated.

_______________
PRODUCT Odwalla brand apple juice and products
containing apple juice as an ingredient, all
sizes:
(a) Apple Juice (100%)
(b) Apple Juice (5-15%)
(c) Blackberry Fruitshake
(d) Mango Tango
(e) Super Protein
(f) Strawberry Banana Smoothie
(g) Raspberry Smoothie
(h) C-Monster
(i) Mo'Beta
(j) Femme Vitale
(k) Strawberry C-Monster
(l) Superfood
(m) Serious Ginseng
(n) Deep in Peach. Recall #F-134/147-7.
CODE All product distributed prior to October 30,
1996.
MANUFACTURER Odwalla, Inc., Dinuba, California.
RECALLED BY Manufacturer, by issuing a press release on
October 30, 1996, followed by visits and E-
mail. Firm-initiated recall complete. See
also FDA press release P96-17, October 31,
1996.
DISTRIBUTION California, Colorado, Nevada, New Mexico,
Oregon, Texas, Washington state, Arizona,
Canada.
QUANTITY 1,000 units (all sizes) were distributed.
REASON Products may be contaminated with E. coli
O157:H7.

_______________
PRODUCT Lucia brand Dried Herring (Tunsoy), in 8 ounce
cellophane packages. Recall #F-133-7.
CODE None.
MANUFACTURER Pinili Commodities Corporation, Philippines.
RECALLED BY C.L. Imports Company, Inc., also known as
Great Rich Trading, and Great Year Import
Company, Inc.), Brooklyn, New York
(importer/distributor), by letter on August 5,
1996. Completed recall resulted from sample

-2- analysis and followup by the New York State
Department of Agriculture and Markets.
DISTRIBUTION New York and Venezuela.
QUANTITY 45 cases or 2,250 packages were distributed.
REASON Product, uneviscerated dried fish, has the
potential to support the growth of and toxin
production by Clostridium botulinum.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Barcelona brand Candyman Gummy Bears, net
weight 2.25 ounces. Recall #F-125-7.
CODE 032197, 092797, 100497, 101097, 102897.
MANUFACTURER Dae Julie, Des Plains, Illinois.
RECALLED BY Barcelona Nut Company, Baltimore, Maryland, by
telephone on or about November 15, 1996,
followed by letter. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 399 cases (72 packages per case) are involved.
REASON Product contains undeclared FD&C Yellow No. 5.

_______________
PRODUCT Lay's Regular Potato Chips, in 1.5 ounce
vending machine bags. Recall #F-127-7.
CODE Manufacturing code - 246242,
Lot number DEC 24 96.
MANUFACTURER Frito-Lay, Inc., Vancouver, Washington.
RECALLED BY Frito-Lay, Inc., Plano, Texas, by telephone
followed by letter on November 18, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Alaska, Idaho, Oregon, Washington state.
QUANTITY 10,044 bags were distributed.
REASON Some bags, labeled as regular, actually
contain sour cream and onion potato chips
whose complete ingredients are not declared on
the label. The sour cream and onion chips
contain dairy ingredients which could pose a
hazard to sensitive individuals.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Hi-C Cherry Flavored Drink in 10 packs of 8.45
ounce aseptic packages in cases containing 3
10-packs each. Recall #F-126-7.
CODE Case code: 10PK Cherry 0483 XXXX T
SEP0597 EF T35003B / Package code: SEP0597TE;
MANUFACTURER The Minute Maid Company, Paw Paw Plant, Paw
Paw, Michigan.

-3-RECALLED BY The Minute Maid Company (MMC), Houston, Texas,
by telephone for pick up on or before November
18, 1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 2,377 cases were distributed.
REASON Product is in leaking containers and thus
unfit for food.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT UDL brand Albuterol Sulfate Syrup:
(a) Albuterol Sulfate Syrup 1 mg/2.5 mL, Oral
Syringe; (b) Albuterol Sulfate Syrup 2 mg/5
mL, Oral Syringe; (c) Albuterol Sulfate Syrup
2 mg/5mL, UD50. Recall #D-048/050-7.
CODE Lot numbers: (a) 506004; (b) 506005; (c)
508023.
MANUFACTURER Mova Laboratories, Caguas, Puerto Rico
(responsible firm).
RECALLED BY UDL Laboratories, Inc., Largo, Florida, by
letter on October 15, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 355 cases of Lot #508023, 54 cases of Lot
#506004 and 47 cases of Lot #506005 were
distributed.
REASON Microbial contamination.

_______________
PRODUCT Abbott brand Ultane (sevoflurane) Inhalation
Anesthetic, Rx halogenated general inhalation
anesthetic drug, in 250 ml bottles.
Recall #D-054-7.
CODE Lot #10-590-DK EXP 10/97.
MANUFACTURER Maruishi Pharmaceutical Company, Ltd., Osaka,
Japan.
RECALLED BY Abbott Laboratories, Hospital Products
Division, Abbott Park, Illinois, by letter
dated November 18, 1996, followed by
telephone. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 7,700 bottles were distributed; firm estimated
that 500 bottles remained on market at time of
recall initiation.
REASON Product is degrading into hydrogen fluoride
and failing pH specification (pH of 1 or
below; SPEC is 5.5-6).

-4-RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Quinine Sulfate Tablets, used for the
prophylaxis and treatment of patients with
malaria: (a) 200 mg; (b) 260 mg;
(c) 325 mg. Recall #D-051/053-7.
CODE USP 260 MG Tablets:
LOT NUMBER: 3001-86OV, EXP DATE 01/97
3001-861V, EXP DATE 01/97
3001-862V, EXP DATE 01/97
USP 200MG & 325 MG Tablets:
LOT NUMBER: 2184-055162V, EXP DATE 12/96
2184-065122V, EXP DATE 02/97
2359-761, EXP DATE 10/97.
MANUFACTURER Zenith laboratories Caribe, Inc., Cidra,
Puerto Rico.
RECALLED BY Manufacturer, by letter September 1996. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 260 mg -- 9,251 bottles of 100, 1,092 bottles
of; 200 mg -- 4,651 bottles of 100, 1,092
bottles of 500; 325 mg -- 5,241 bottles of 100
and 600 bottles of 1,000 were distributed.
REASON Product fails USP purity test (more than 2% of
Cinchonidine Sulfate).

_______________
PRODUCT Coly-Mycin S Otic with Neomycin and
Hydrocortisone (Colistin Sulfate-Neomycin
Sulfate-Thonzonium Bromide-Hydrocortisone
Acetate Otic Suspension, Sterile), Rx drug
intended for use in the treatment of
superficial bacterial infections of the
external auditory canal and for the treatment
of infections of mastoidectomy and
fenestration cavities caused by organisms
susceptible to the antibiotics.
Recall #D-056-7.
CODE Lot 02885P (10mL vials) EXP 12/96, and
lot 028D5P (5mL vials) EXP 4/97.
MANUFACTURER Warner-Lambert Company, Parke-Davis Sterile
Products Division, Rochester, Michigan.
RECALLED BY The Parke-Davis Division of Warner-Lambert Co.
Morris Plains, New Jersey, by letter dated
October 31, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 31,392 vials of lot 02885P were distributed
between September 1995 and December 1995.
60,108 vials of lot 028D5P were distributed
between January 1996 and June 1996.

-5- At the time of the recall, there was no
remaining inventory at the distribution
centers.
REASON Product fails potency for hydrocortisone
acetate (stability samples stored at 30
degrees C inverted, assayed as high as 133%).

_______________
PRODUCT Prednisone Tablets, USP, 10 mg, in bottles of
1000, Rx corticosteroid, under the Schein
label.
Recall #D-057-7.
CODE Lot #CBA114 EXP 11/30/96.
MANUFACTURER Danbury Pharmacal, Inc., Carmel, New York.
RECALLED BY Danbury Pharmacal, Inc., Brewster, New York,
by letter dated November 6, 1996. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 4,871 bottles were distributed; firm estimated
that little product remained on market at time
of recall initiation.
REASON Product failed content assay on stability at
22 months (114%; limit is 110%).

_______________
PRODUCT Cefotan (Cefotetan Disodium), 1 gm/10 ml vial,
sterile injectable antibiotic.
Recall #D-058-7.
CODE Lot #3256W EXP 2/98.
MANUFACTURER Smith Kline Beecham, Conshohocken,
Pennsylvania (responsible firm).
RECALLED BY Zeneca Pharmaceuticals, Inc., Wilmington,
Delaware, by letter dated November 20, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimated that 150,000 vials remained on
market at time of recall initiation.
REASON Product fails moisture specification at the
six month stability timepoint (1.65%; limit is
1.5%).

_______________
PRODUCT Guaifenesin/Codeine Phosphate Cough Syrup,
100 mg/10 mg per 5 ml; an OTC schedule V
narcotic expectorant cough suppressant: (a)
Regular Formula, Product Code 8023, packaged
in 4 ounce and 1 pint bottles, labeled under
the following labels:
i) MGP Mytussin AC Cough Syrup, Manufactured
by: Morton Grove Pharmaceuticals, Inc., Morton
Grove, Illinois

-6- ii) GG Glydeine Cough Syrup, Distributed by
Geneva Pharmaceuticals, Inc., Broomfield,
Colorado
iii) Robafen AC Cough Syrup, Distributed by
Major Pharmaceuticals, Inc., Chicago, Illinois
(b) Sugar Free Formula, Product Code 8045,
packaged in 1 pint and 1 gallon bottles,
labeled under the following labels:
i) MGP Mytussin AC Cough Syrup, Sugar Free,
Manufactured by: Morton Grove Pharmaceuticals,
Inc., Morton Grove, Illinois
ii) GG Glydeine Cough Syrup, Sugar Free,
Distributed by Geneva Pharmaceuticals, Inc.,
Broomfield, Colorado
iii) Robafen AC Cough Syrup, Sugar Free,
Distributed by Major Pharmaceuticals, Inc.,
Chicago, Illinois. Recall #D-059/060-7.
CODE Lot 20547, EXP 07/31/97 and 20643, EXP
10/31/97.
MANUFACTURER Morton Grove Pharmaceuticals, Inc., Morton
Grove, Illinois.
RECALLED BY Manufacturer, by letters dated November 20 and
21, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,741 - 40 oz. and 5,615 pints of regular
formula and 12,596 pints and 296 gallons of
sugar free formula were distributed, firm
estimated that 25% of the product remained on
the market at time of recall initiation.
REASON Potency of codeine phosphate cannot be assured
through the expiration date due to content
assay failures of routine stability samples
(87%; SPEC is 90-110%).

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-068/070-7.
CODE Unit #93-57588.
MANUFACTURER Medic Regional Blood Center, Knoxville,
Tennessee.
RECALLED BY Manufacturer, by letters dated March 28 and
30, 1995, and May 31, 1996. Firm-initiated
recall complete.
DISTRIBUTION California and Tennessee.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type I (anti-HIV-1) were collected from a
donor who previously tested repeatedly
reactive for anti-HIV-1, Western blot
negative.
-7-
_______________
PRODUCT Platelets. Recall #B-071-7.
CODE Unit #92-27391.
MANUFACTURER Medic Regional Blood Center, Knoxville,
Tennessee.
RECALLED BY Manufacturer, by letter March 29, 1994. Firm-
initiated recall complete.
DISTRIBUTION Tennessee.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
whole blood which was air contaminated during
collection.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma. Recall #B-122/124-7.
CODE Unit numbers: (a) 42Y14904, 42X63886,
42K47903, 42R05054, 42L37882; (b) 42Y14904,
42L37882, 42K47903, 42X63886; (c) 42Y14904,
42L37882, 42X63886, 42K47903.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letters on April 21 through
27, 1995. Firm-initiated recall complete.
DISTRIBUTION Ohio, California.
QUANTITY (a) 5 units; (b) 4 units; (c) 4 units were
distributed.
REASON Blood products were collected from a donor who
reported a history of cancer.

_______________
PRODUCT Red Blood Cells. Recall #B-126-7.
CODE Unit #42FX38159.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letter dated July 18, 1995.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled in an area considered endemic for
malaria.

_______________
PRODUCT Platelets. Recall #B-128-7.
CODE Unit #1972501.
MANUFACTURER Department of the Army, The Blood Bank Center,
Fort Hood, Texas.
RECALLED BY Manufacturer, by telephone on April 15, 1996.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.

-8-REASON Blood product was collected from a donor who
received a tattoo within 12 months of
donation.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-132/133-7.
CODE Unit numbers: (a) 42LO8562; (b) 42LO8562,
42FT12330.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letters dated December 27 and
28, 1995. Firm-initiated recall complete.
DISTRIBUTION Ohio, California, Switzerland.
QUANTITY (a) 1 unit; (b) 2 units were distributed.
REASON Blood products tested negative for the
hepatitis B surface antigen (HBsAg), were
collected from a donor who was previously
confirmed positive for HBsAg.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-134/135-7.
CODE Unit #49LG17427.
MANUFACTURER American Red Cross Blood Services, Waco,
Texas.
RECALLED BY Manufacturer, by telephone on May 2, 1996.
Firm-initiated recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
was taking the drug Proscar at the time of
donation.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-136/138-7.
CODE Unit #42FH37627.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, (a) by letters dated May 11,
1995, and June 30, 1995; (b) by telephone on
May 26, 1995. Firm-initiated recall complete.
DISTRIBUTION Ohio and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
was taking the drug Proscar at time of
donation.

_______________
PRODUCT Red Blood Cells. Recall B-139-7.
CODE Unit #42T41139.

-9-MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letter on April 2, 1996.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was associated with a unit of
Platelets that cultured positive for
Staphylococcus epidermidis.

_______________
PRODUCT Platelets, Pheresis. Recall #B-142-7.
CODE Unit #16LZ03006.
MANUFACTURER American Red Cross Blood Services, Columbus,
Ohio.
RECALLED BY Manufacturer, by telephone on September 5,
1996, followed by letter dated September 9,
1996. Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was stored in an insufficient
volume of plasma.

_______________
PRODUCT (a) Red Blood Cells; (b) Cryoprecipitated AHF;
(c) Recovered Plasma. Recall #B-151/153-7.
CODE Unit #53F06965.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letters dated September 23,
1996, and by fax on September 23, 1996. Firm-
initiated recall complete.
DISTRIBUTION Maryland, North Carolina, Switzerland.
QUANTITY 1 unit of each component.
REASON Blood products were collected from a donor
with a history of jaundice.

_______________
PRODUCT Platelets, Pheresis. Recall #B-155-7.
CODE Unit #40P47089.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on June 25, 1996,
followed by letter dated July 1, 1996. Firm-
initiated recall compete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.

-10-_______________
PRODUCT Source Plasma. Recall #B-157-7.
CODE Unit numbers: XQ 11 308, XQ 11 588,
XQ 17 044, XQ 17 294, XQ 17 577, XQ 24 875,
XQ 26 766, XQ 26 922, XQ 27 561, XQ 27 903,
XQ 28 945, XQ 37 429, XQ 37 786, XQ 40 017,
XQ 44 550, XQ 52 102, XQ 52 734, XQ 53 359,
XQ 53 719, XQ 55 166, XQ 55 579, XQ 56 099,
XQ 56 229, XQ 56 900, XQ 57 190, XQ 58 519,
XQ 58 891, XQ 59 427, XQ 59 806, XQ 60 084,
XQ 60 483, XQ 60 992, XQ 61 320, XQ 61 835,
XQ 62 324, XQ 62 956, XQ 63 281, XQ 64 222,
XQ 64 640, XQ 66 952, XQ 76 329.
MANUFACTURER Community Bio Resources, Inc., Birmingham,
Alabama.
RECALLED BY Manufacturer, by letter dated August 11, 1994.
Firm-initiated recall complete.
DISTRIBUTION Michigan and Austria.
QUANTITY 41 units were distributed.
REASON Blood products tested negative for antibody to
the human immunodeficiency virus type 1 (anti-
HIV-1) were collected from a donor who
previously tested repeatedly reactive for
anti-HIV-1.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Red Blood Cells. Recall #B-067-7.
CODE Unit numbers: 90-79602, 91-50538, 91-50560,
91-50561, 91-50575, 91-50600, 91-50613,
91-50618, 93-06813, 93-06814, 93-09896,
94-30727, 94-30733, 94-30734, 94-30735,
94-30768, 94-30798, 92-37224, 93-06567.
MANUFACTURER Medic Regional Blood Center, Knoxville,
Tennessee.
RECALLED BY Manufacturer, by telephone on December 1,
1995, followed by letter dated December 27,
1995, by telephone on November 29, 1995,
followed by letter dated December 19, 1995, by
telephone on September 14, 1995, followed by
letter dated December 19, 1995. Firm-
initiated recall complete.
DISTRIBUTION Tennessee.
QUANTITY 19 units were distributed.
REASON Blood products were stored under unmonitored
or unsuitable temperatures.

_______________
PRODUCT (a) Red Blood Cells; (b) Irradiated Red Blood
Cells; (c) Platelets. Recall #B-072/074-6.

-11-CODE Unit numbers: (a) 90-52981, 92-38383;
(b) 93-91870, 90-60980, 90-61249, 90-61015,
93-92053, 91-41204; (c) 90-52981.
MANUFACTURER Medic Regional Blood Center, Knoxville,
Tennessee.
RECALLED BY Manufacturer, by (a) letter dated February 22,
1994; (b) by telephone on August 17, 1994,
followed by letter dated August 29, 1994; (c)
by letter dated February 2, 1994. Firm-
initiated recall complete.
DISTRIBUTION Tennessee.
QUANTITY (a) 2 units; (b) 6 units; (c) 1 unit.
REASON Blood products labeled with extended
expirations were distributed for transfusion.

_______________
PRODUCT Red Blood Cells. Recall #B-121-7.
CODE Unit #20KH03272.
MANUFACTURER American Red Cross Blood Services, Boise,
Idaho.
RECALLED BY Manufacturer, by telephone on February 21,
1995. Firm-initiated recall complete.
DISTRIBUTION Montana.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.

_______________
PRODUCT Recovered Plasma. Recall #B-125-7.
CODE Unit #42R05054.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by telephone on April 27, 1995.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who
reported a history of cancer.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-140/141-7.
CODE Unit #53L73475.
MANUFACTURER American Red Cross, Baltimore, Maryland.
RECALLED BY Manufacturer, by letter dated April 21, 1996.
Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
provided incomplete medical history.

-12-_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-143/145-7.
CODE Unit numbers: (a&c) 42G01163, 42T30834,
42FW10645, 42H76744, 42H75031; (b) 42T30834
and 42H76744; 42H75031 (Expired Platelets).
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letters on January 17 and 18,
1996. Firm-initiated recall complete.
DISTRIBUTION Ohio, Florida, California.
QUANTITY 5 units of Red Blood Cells and Recovered
Plasma; 2 units of Platelets; and 1 unit of
Expired Platelets were distribution .
REASON Blood products were collected from a donor
with hemochromatosis.

_______________
PRODUCT Red Blood Cells. Recall #B-158-7.
CODE Unit numbers: 1221517, 1224395, 1254915.
MANUFACTURER South Texas Blood and Tissue Center, San
Antonio, Texas.
RECALLED BY Manufacturer, by telephone on September 17,
1995. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 3 units were distributed.
REASON Blood products containing either anti-E, e, or
JK antibodies were labeled as negative for the
unexpected antibodies.

_______________
PRODUCT Platelets, Pheresis. Recall #B-159-7.
CODE Unit numbers: 042FR36617, 042FR36618,
042FR36619, 042FR36620, 042FR36621,
042FR36622, 042FR36623, 042FR36624,
042FR36625, 042FR36626, 042FR36628,
042FR40225.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by telephone on June 27, 1995.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 12 units were distributed.
REASON Blood products were incorrectly tested for the
antibody to the human immunodeficiency virus
types 1 and 2 (anti-HIV-1/2).

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT VivaLink AED, automated external defibrillator
semi-automatic external defibrillator used to
rescue patients who have sudden cardiac
-13- arrest. Model numbers 9001 and 9004.
Recall #Z-160/161-7.
CODE All serviced units which came for upgrade
August 14 through October 3, 1996 may have had
wrong parts installed. These units include
the following serial numbers:
Model Number Serial Numbers
9001 200696
9004 200076, 200087, 200093, 200100,
200103, 200109, 200120, 200138,
200164, 200170, 200187, 200189,
200204, 200217, 200219, 200388,
200390, 200423, 200908, 200923,
201023, 201055, 201059, 201071,
201095, 201118, 201120, 201121,
201303, 201306, 201307, 206618.
MANUFACTURER SurVivaLink Corporation, Minneapolis,
Minnesota.
RECALLED BY Manufacturer, by telephone on October 16 and
17, 1996, followed by letter. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY Approximately 33 units.
REASON An incorrect part installed in the units may
cause the units to malfunctions and may not
deliver any defibrillation shocks.

_______________
PRODUCT Software used in Diagnostic Ultrasound
Systems, Model numbers 5200B, Performa, and
5200S. Recall #Z-164-7.
CODE All Model 5200B, 5200S and Performa Ultrasound
Systems.
MANUFACTURER Acoustic Imaging, Phoenix, Arizona.
RECALLED BY Manufacturer, by notification for Model 5200B,
Model 5200s and Model Performa, sent on June
10, 1996, and by sending corrective software
for Model 5200s and Model Performa on July 30,
1996. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 635 units of Model 5200B, 672 units of
Performa, and 536 units of Model 5200S.
REASON An error in the software trace function used
to measure the circumference of a 2D
structure, may under certain circumstance
cause perimeter measurements to be inaccurate.

_______________
PRODUCT Intertech/SIMS single use resuscitator (Adult)
With Mask, Filter, and One-Way Valve, Catalog
No. 008010, a portable, single patient use,

-14- mouth-to-mouth device for treatment of adult
victims suffering from respiratory failure.
Recall #Z-167-7.
CODE Lot Numbers 6H0257 and 6H0258.
MANUFACTURER Sims Medical System (also known as Intertech)
Fort Myers, Florida.
RECALLED BY Manufacturer, by letter on October 29, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 283 cases (10 units per case) were
distributed.
REASON Resuscitators may be assembled with the flex
tube on the patient end of the valve housing
which makes the device inoperable.

_______________
PRODUCT 3M Sarns Disposable Centrifugal Pumps,
indicated for use as an extracorporeal blood
pump: (a) Part No. 98-0702-0266-2, Delphin
7850 Centrifugal Pump Heads 8 Pack;
(b) Part No. 98-0702-1027-7, Delphin 7850
Disposable Pump Bulk Pkg.
Recall #Z-168/169-7.
CODE (a) Catalog # 164275, Lot Numbers: W347844,
W347845, W346707, W347211, W346708, W347209,
W347210; (b) Lot Number: W346816.
MANUFACTURER 3M Health Care, Ann Arbor, Michigan.
RECALLED BY Manufacturer, by telephone, fax, and letter on
November 8, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 6,500 pumps.
REASON Products may contain plastic particulate
levels that exceed the firm's particulate
specification.

_______________
PRODUCT Centrifugal Battery Pack with Battery Cables
and Battery Cable Assembly:
(a) Catalog # 9490, Part No. 98-0702-0485-8,
110/115 Volt Centrifugal Battery Pack with
Battery Cables;
(b) Catalog #9491, Part No. 98-0702-0486-6,
220/224 Volt Centrifugal Battery Pack with
Battery Cables;
(c) Part No. 78-7066-9180-0, Battery Cable
Assembly. Recall #Z-170/172-7.
CODE Includes all units distributed between March
1995 and October 18, 1996.
MANUFACTURER 3M Health Care, Ann Arbor, Michigan.
RECALLED BY Manufacturer, by letter on November 8, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
-15-QUANTITY Approximaely 240 cables were distributed.
REASON The battery cables used with the 3M Sarns
Delphin I and II Control modules were
incorrectly assembled.

_______________
PRODUCT Valves for oxygen cylinders tapped to accept
CGA 870 valves in cartons labeled with either
"ATI U.S.A." or "ATI MADE IN POLAND."
Recall #Z-175-7.
CODE All ATI OXM CGA 870 Valves Unless They are
also Stamped with "Laing International" on the
Body of the Valve.
MANUFACTURER Mr. Andrew Niemczyk, also known as Armo
Trading, Troy, Michigan (importer).
RECALLED BY Laing International, Ft. Lauderdale, Florida,
by letter on July 1, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Michigan, Florida.
QUANTITY 47,050 valves were distributed.
REASON The valves may break off with little or no
external force with the potential of causing
serious patient or health professional injury.

_______________
PRODUCT Liquid Sodium Bicarbonate-Chloride Concentrate
for Hemodialysis Item No. OLB-1-01, Not For
Parenteral Use Non pyrogenic 1 US Gal./ 4 Gal.
per case, labeled as distributed by Fresenius
USA Walnut Creek, California, Manufactured
for: BDH Inc. Toronto, Canada.
Recall #Z-176-7.
CODE Lot numbers: 6046, 6052, 6057, 6050, 6051,
6067, 6073, 6074, 6080, 6079, 6079A, 6081,
6099, 6100, 6101, 6102, 6086, 6087, 6107,
6108, 6108A, 6109, 6131, 6134, 6135, 6137,
6121, 6138, 6150, 6151, 6152, 6144, 6156,
6162, 6163, 6169, 6170, 6171, 6177, 6178,
6184. These lots have EXP dates ranging from
8/24/96 to 1/3/97.
MANUFACTURER EM Science a Division of EM Industries, Inc.,
Gibbstown, New Jersey.
RECALLED BY Manufacturer, by telephone and letter on
August 22, 23, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 47,928 cases were distributed.
REASON The device is contaminated with
microbiological growth.

-16-RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Software Versions 4.0 and 4.6, Part Nos.
469800, 471005, 471177, 471009, Used in
Synctron CX7 and CX3/CX7 Delta
Clinical Systems, in-vitro diagnostic
analyzer. Recall #Z-163-7.
CODE No codes. All Synchron CX Quantum IV Version
4.0 and 4.6 software.
MANUFACTURER Beckman Instruments, Brea, California.
RECALLED BY Manufacturer, by letter on September 25, 1996.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 2,071 units were distributed.
REASON The device has a software malfunction that can
cause false low test results for glucose and
BUN.

_______________
PRODUCT Storz Tanne Disposable Trephine Blades:
(a) E3050[Size]NS - Tanne Disposable Trephine
Blades - Sizes: 6.ONS, 6.25NS, 6.5NS, 6.75NS,
7.ONS, 7.25NS, 7.5NS, 7.75NS, 8.ONS, 8.25NS,
8.5NS, 8.75NS, 9.ONS, 9.25NS, 9.5NS;
(b) E3096[Size]NS - Disposable Trephine Blades
- Sizes: 6.OLNS, 6.25LNS, 6.5LNS, 6.75LNS,
7.0LNS, 7.25LNS, 7.5LNS, 7.75LNS, 8.OLNS,
8.25LNS, 8.5LNS, 8.75LNS, 9.OLNS, 9.25LNS,
9.5LNS. Recall #Z-165/166-7.
CODE All lot numbers except those beginning with
"CW".
MANUFACTURER Storz Instrument Company, Manchester, Missouri
(blades).
RECALLED BY Storz Instrument Company, St. Louis, Missouri,
by letter dated October 11, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 8,712 blades were distributed.
REASON Some of the packages may contain trephine
blades of the wrong size or style.

-17-

END OF ENFORCEMENT REPORT FOR DECEMBER 18, 1996. BLANK PAGES MAY FOLLOW.

####

End of Enforcement Report for