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.

April 23, 1997 97-17

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Frozen strawberries:
13.5 Kg pails, labeled in part: "frozen
sliced strawberries 4+1***ingredients
strawberries, sugar***13.5 kg***prepared
for***Pacific Coast Fruit Products,
Ltd.***Abbotsford, BC***"
30 lb pails, labeled in part: "AW Frozen
sliced strawberries with sugar added net wt.
30 lbs. dist. by Andrew & Williamson
Sales Co. San Diego, California***"
420 lb barrels, labeled in part: "***frozen
whole chandler strawberries 20+1 net wt. 420
lbs. Packed by Andrew & Williamson Sales San
Diego, CA***"
400 lb barrels, labeled in part: "***frozen
juice stock strawberries net wt. 400 lbs.
Packed by Andrew & Williamson Sales San Diego
CA***"
425 lb barrels, labeled in part: "***frozen
whole strawberries 4+1 sugar added net. wt.
425 lbs. packed by Andrew & Williamson Sales
San Diego, CA***"
6 1/2 lb tubs, labeled in part: "***AW brand
frozen sliced strawberries***with sugar added
net wt. 6 1/2 lbs.*** packed by Andrew &
Williamson Sales Co San Diego, CA***"
six tubs are packed per shipping box.
Recall #F-371-7.
CODE Lot numbers: 4141961, 6541963, 6541964,
7741962, 7741963, 31507612, 3150862, 3150863,
31508612, 7750862, 7750863, 7750864, 7750865.
MANUFACTURER Andrew & Williamson Sales Company, Inc., San
Diego, California.
RECALLED BY Manufacturer, by letter on March 29, 1997, and
April 1, 1997, and by press release on April
1, 1997. Firm-initiated recall ongoing. See
also FDA statement dated April 3, 1997.
DISTRIBUTION California, Colorado, Georgia, Massachusetts,
Michigan, New York, Oklahoma, Oregon.
QUANTITY Undetermined.
REASON The product was associated with a March 1997
illness outbreak of hepatitis A in Michigan.

_______________
PRODUCT Celebration Fat Free Cookies with rainbow
sprinkles in 2 ounce cellophane packages.
Recall #F-378-7.
CODE None.
MANUFACTURER Slim Waist Foods, Inc., Brooklyn, New York.
RECALLED BY Manufacturer, by visit on October 11, 1996.
Completed recall resulted from inspection and
follow-up by New York State Department of
Agriculture and Markets.
DISTRIBUTION New York.
QUANTITY 10 cases (24 packages per case) were
distributed.
REASON Product contained undeclared certified colors,
Yellow No. 5, Yellow No. 6, Blue No. 1, Red
No. 3, and Red No. 40.

_______________
PRODUCT Kemps Spumoni Ice Cream in one-half gallon
paper cartons. Recall #F-379-7.
CODE 35564 (new design label only) and 01774.
MANUFACTURER Marigold Foods, Inc., Rochester, Minnesota.
RECALLED BY Marigold Foods, Minneapolis, Minnesota, by
letter on February 25, 1997. Firm-initiated
recall complete.
DISTRIBUTION Minnesota, Wisconsin, Illinois, Iowa, South
Dakota, Michigan.
QUANTITY 4,400 units were distributed.
REASON Product contains undeclared almonds.

-2-RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Infants' Tylenol Acetaminophen Drops USP, 80
mg/ml, oral solution in 15 ml bottles, product
was labeled in French and English. Recall #D-
154-7.
CODE Lot #(L) E362.
MANUFACTURER McNeil La Compagnie De Produits, Aux
Consommateurs McNeil, Guelph, Canada.
RECALLED BY Edreiss Trading Co., Inc., Bohemia, New York,
by letter on March 25, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION New York.
QUANTITY 4,584 bottles were distributed.
REASON Product contains unapproved sweetener, sodium
cyclamate.

_______________
PRODUCT Gaseous Oxygen USP packed in 415 liter or 628
liter aluminum cylinders. Recall #D-155-7.
CODE All units (lot or serial numbers not used).
MANUFACTURER Air Care, Inc., McRae, Georgia.
RECALLED BY Manufacturer, by telephone on or about January
7, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Georgia.
QUANTITY 32 to 42 cylinders were distributed.
REASON Current good manufacturing practice
deficiencies.

_______________
PRODUCT Clindamycin Phosphate Topical Solution 1% in
30 and 60 ml bottles, used in the treatment of
acne vulgaris. Recall #D-160-7.
CODE Lot nos. RP4721, RB5079, RA5014, RA5063,
RF5259, RJ5411, RN5631, RS5827, RB6051,
RD6217, RH6349, RJ6417, RK6521, RL6617,
RN6706.
MANUFACTURER Alpharma, U.S. Pharmaceuticals Division,
formerly Barre-National, Inc., Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated March 26, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Maryland.
QUANTITY 247,364 units were produced; firm estimates
that 10,541 units remained in commerce at time
of recall initiation.
REASON Bulk Clindamycin was recalled by Roussel
Corporation (parent firm of Biochimica Opos)
due to AADA discrepancies regarding the
manufacturing process; AADA was withdrawn.

-3-_______________
PRODUCT Clindamycin Phosphate Topical Solution, USP 1%
in 30 ml and 60 ml bottles, under the Copley,
Goldline, Major and Qualitest labels.
Recall #D-161-7.
CODE: 30 Ml 60 Ml
Copley 628P30 Exp 5/97 628P31 Exp 5/97
628D01 Exp 7/97 628P35 Exp 5/97
628D04 Exp 11/97 628D01 Exp 7/97
628D05 Exp 1/98 628D04 Exp 11/97
628D06 Exp 1/98 628D05 Exp 1/98
628D07 Exp 4/98 628D07 Exp 1/98
Major 628P29 Exp 5/97 628P33 Exp 5/97
628D06 Exp 1/98 628D01 Exp 7/97
628D07 Exp 4/98 628D06 Exp 1/98
628D07 Exp 4/98
Goldline 628P28 Exp 5/97 628P32 Exp 5/97
628D06 Exp 1/98 628D01 Exp 7/97
628D06 Exp 1/98
Qualitest 628D06 Exp 1/98 628P34 Exp 5/97
628D06 Exp 1/98.
MANUFACTURER Copley Pharmaceutical, Inc., Canton,
Massachusetts.
RECALLED BY Manufacturer, by letter dated March 26, 1997,
followed by fax on April 2, 1997. Firm-
initiated recall ongoing.
DISTRIBUTION Florida, California, Alabama.
QUANTITY 22,257 30-ml vials and 87,738 60-ml vials were
distributed.
REASON Bulk Clindamycin was recalled by Roussel
Corporation (parent firm of Biochimica Opos)
due to AADA discrepancies regarding the
manufacturing process; AADA was withdrawn.

_______________
PRODUCT Cefaclor Capsules USP, Rx: (a) 250mg Capsules;
(b) 500mg Capsules; Cefaclor Oral Suspensions
USP, Rx - (c) 125mg/5ml; (d) 187mg/5ml; (e)
(250mg/5ml; (f) 375mg/5ml, a semisynthetic
cephalosporin antibiotic for oral
administration, supplied by Zenith Goldline
Pharmaceuticals in 250mg capsules in bottles
of 15's, 100's, 500's, and 1000's, 500mg
capsules in bottles of 15's, 100's, and 500's.
Oral Suspensions are available in 125mg/5ml
and 250mg/5ml bottles, reconstituted to 75ml
and 150ml, and also 187mg/5ml and 375mg/5ml
bottles, reconstituted to 50ml and 100ml,
under the following labels: Zenith Goldline,
Major, Mova, Rugby, Schein, h.l. Moore, Warner
Chilcott, URL.
Recall #D-162/167-7.
-4-CODE All lots/all sizes.
MANUFACTURER Zenith Goldline Pharmaceuticals, Inc.,
Northvale, New Jersey.
RECALLED BY Manufacturer, by letter February 11, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Amount Manufactured/Amount Distributed/Amount
Quarantined (bottles)
250MG Capsules: Amount Distributed.
4760-40 15瑇 19,418
4760-60 100瑇 562,428
4760-70 500瑇 5,031
4760-80 1000瑇 3,185
500MG Capsules
4761-40 15瑇 44,086
4761-60 100瑇 121,801
4761-70 500瑇 3,040
125MG/5ML Supensions
4611-22 75ml 160,156
4611-23 150ml 497,442
187MG/5ML Supensions
4613-20 50ml 77,165
4613-21 100ml 233,740
250MG/5ml Supensions
4610-22 75ml 190,792
4610-23 150ml 798,419
375MG/ml Supensions
4612-20 50ml 90,481
4612-21 100ml 436,540.
Dates of Shipments: From 5/95 to 2/97.
Estimated amount of product remaining on
market: Approx. 25%
REASON Bulk Cefaclor was recalled by Roussel
Corporation (parent firm of Biochimica Opos)
due to AADA discrepancies regarding the
manufacturing process; AADA was withdrawn.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Bausch and Lomb Muro 128 5% Ophthalmic
Ointment (sodium chloride), OTC, in 1/8 ounce
tubes, for the temporary relief of corneal
edema. Recall #D-153-7.
CODE Lot #853571.
MANUFACTURER Bausch and Lomb Pharmaceuticals, Inc., Tampa,
Florida.
RECALLED BY Manufacturer, by letter dated March 24, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 18,240 tubes were distributed.

-5-REASON Labeling mix-up -- some tubes may be
mislabeled as containing erythromycin
ointment; the actual tube contents are Muro
128 and the unit carton label is correct.

_______________
PRODUCT Nycomed brand Hypaque (Diatrizoate Sodium)
Oral Powder and Liquid, and Oral Solution,
USP, used as an imaging agent, under the
Nycomed and Sanofi Winthrop labels.
Recall #D-156-7.
CODE All lots within expiration date.
MANUFACTURER Bayer Corporation, Myerstown, Pennsylvania.
RECALLED BY Nycomed, Inc., Princeton, New Jersey, by
letter dated March 4, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 1,231,572 bottles were distributed.
REASON Product lacks stability (free iodide exceeds
upper limit - spec is not more than 0.02% and
the product is as high as 0.05% as early as 24
months.

_______________
PRODUCT Zantac Injection Premixed (Ranitidine HCl), 50
mg/50ml, used in the treatment of ulcers.
Recall #D-157-7.
CODE Lot #20193FJ.
MANUFACTURER Glaxo Wellcome, Inc., Zebulon, North Carolina.
RECALLED BY Manufacturer, by letter sent on January 27,
1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 4,126 cases (24 prefilled flexible bags per
case) were distributed.
REASON Label mix-up (overwrap labeled as "Ciprol I.V.
(Ciprofloxacin)" may have been used on some
otherwise correctly labeled bags containing
Rantidine HCl).

_______________
PRODUCT Zaroxolyn Tablets (Metolazone, USP), 2.5 mg,
unit dose, Rx diuretic and anti-hypertensive.
Recall #D-158-7.
CODE Lot #60751 EXP 12/01.
MANUFACTURER Medeva Pharmaceuticals Manufacturing, Inc.,
Rochester, New York.
RECALLED BY Manufacturer, by telephone during the week of
March 31, 1997, and by letter dated April 3,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 956 cartons were distributed.

-6-REASON Unit carton label mix-up - 5 mg strength
cartons used in packaging this 2.5 mg lot
(immediate foil packaging and shipping cartons
bear the correct label).

_______________
PRODUCT Baclofen Tablets, 20 mg, USP, in bottles of
100, Rx muscle relaxant and antispastic.
Recall #D-159-7.
CODE Lot numbers: 24060 EXP 6/1/97 and 26221 EXP
6/1/98.
MANUFACTURER Biocraft Laboratories, Inc., (TEVA
Pharmaceuticals USA), Elmwood Park, New
Jersey.
RECALLED BY TEVA Pharmaceuticals USA, Sellersville,
Pennsylvania, by letter on March 28, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 9,413 bottles of 100 were distributed.
REASON Product lacks stability (fails potency assay
as early as 19 months -- spec is 90-110%LS;
actual is 89%).

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Venoglobulin-S 5% Solution Immune Globulin
Intravenous (Human): (a) 50 ml (2.5 grams in
50 ml); (b) 100 ml (5.0 grams in 100 ml); (c)
200 ml (10.0 grams in 200 ml).
Recall #B-560/562-7.
CODE Lot #GL7503A EXP1/16/99.
MANUFACTURER Alpha Therapeutic Corporation, Los Angeles,
California.
RECALLED BY Manufacturer, by letter on March 7, 1997.
firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Thailand.
QUANTITY 2,189 vials were distributed; firm estimated
that on March 17, 1997 1,200 vials remained in
commerce.
REASON Immune Globulin products with a higher than
expected rate of adverse reactions (urticaria)
from patients were distributed.

_______________
PRODUCT (a) Red Blood Cells: (b) Platelets; (c) Fresh
Frozen Plasma. Recall #B-571/573-7.
CODE (a) 13FC59982, 13Y93652, 13J11389,
13FT30212; (b) 13FC59982, 13Y93652, 13J11389,
13FT30212; (c) 13FC59982, 13Y93652, 13J11389.
MANUFACTURER American Red Cross Blood Services, Detroit,
Michigan.

-7-RECALLED BY Manufacturer, by letter dated June 14, 1996.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY (a) 4 units; (b) 4 units; (c) 3 units were
distributed.
REASON Blood products were collected from a donor who
reported a history of cancer.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-583/584-7.
CODE Unit #53LX01165.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by telephone on September 12,
1995, followed by letter dated September 1,
1995. Firm-initiated recall complete.
DISTRIBUTION Maryland and District of Columbia.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were prepared from a unit of
whole blood designated as overweight.

_______________
PRODUCT Platelets. Recall #B-589-7.
CODE Unit #2862289.
MANUFACTURER Central Indiana Regional Blood Center,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by telephone on July 23, 1995.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product was not tested for CMV antibody
but was labeled as negative for anti-CMV.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-587/588-7.
CODE Unit #29GY03329.
MANUFACTURER American Red Cross Blood Services, Norfolk,
Virginia.
RECALLED BY Manufacturer, by letter dated July 31, 1996.
Firm-initiated recall complete.
DISTRIBUTION Virginia and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
taking the drug Zovirax.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-590/591-7.
CODE Unit numbers: (a) 20264-4097, 20264-4100,
20264-4839;

-8- (b) 20264-4095, 20264-4096, 20264-4098, 20264-
4102, 20264-4829, 20264-4830, 20264-4832,
20264-4834, 20264-4835, 20264-4838,
20264-4839.
MANUFACTURER Blood Systems, Inc., Lafayette, Louisiana.
RECALLED BY Manufacturer, by telephone on June 18, 1996.
Firm-initiated recall complete.
DISTRIBUTION Louisiana.
QUANTITY (a) 3 units; (b) 11 units were distributed.
REASON Blood products were tested using pilot samples
that arrived at an unacceptable temperature.

_______________
PRODUCT Platelets, Pheresis. Recall #B-593-7.
CODE Unit #17180-3009.
MANUFACTURER United Blood Services, McAllen, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on November 15, 1996. Firm-
initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product had a platelet yield below the
acceptable limit.

_______________
PRODUCT Platelets, Pheresis. Recall #B-594-7.
CODE Unit #11314-5383.
MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Manufacturer, by telephone on November 1,
1996, followed by letter dated December 2,
1996. Firm-initiated recall complete.
DISTRIBUTION New Mexico.
QUANTITY 1 unit was distributed.
REASON Blood product had a platelet yield below the
acceptable limit.

_______________
PRODUCT Red Blood Cells. Recall #B-595-7.
CODE Unit #21GH53169.
MANUFACTURER American Red Cross, Pacific Northwest Regional
Blood Services, Portland, Oregon.
RECALLED BY Manufacturer, by letter dated August 20, 1996.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to an area designated as endemic for
malaria.

_______________
PRODUCT Red Blood Cells. Recall #B-596-7.
CODE Unit #11K74574.

-9-MANUFACTURER American Red Cross Blood Services, St. Louis,
Missouri.
RECALLED BY Manufacturer, by telephone on March 7, 1996.
Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood product, positive for the S antigen, was
labeled as S negative.

_______________
PRODUCT Red Blood Cells. Recall #B-598-7.
CODE Unit numbers: 11FZ09724, 11S90102, 11S90120,
11Q52983.
MANUFACTURER American Red Cross Blood Services, St. Louis,
Missouri.
RECALLED BY Manufacturer, by telephone on or about August
7, 1996, followed by letter dated August 16,
1996. Firm-initiated recall complete.
DISTRIBUTION Missouri and Illinois.
QUANTITY 4 units were distributed.
REASON Blood products corresponded to a unit of
pooled platelets that was positive for
coagulase negative Staphylococcus.

_______________
PRODUCT Red Blood Cells. Recall #B-599-7.
CODE Unit numbers: 11R30905, 11J31566, 11R30834,
11R30947, 11R30870.
MANUFACTURER American Red Cross Blood Services, St. Louis,
Missouri.
RECALLED BY Manufacturer, by telephone on or about July
26, 1996. Firm-initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 5 units were distributed.
REASON Blood products which corresponded to a unit of
pooled platelets that was positive for
coagulase negative Staphylococcus.

_______________
PRODUCT Platelets. Recall #B-600-7.
CODE Unit #11V13271.
MANUFACTURER American Red Cross Blood Services, St. Louis,
Missouri.
RECALLED BY Manufacturer, by telephone, followed by letter
dated October 26, 1995. Firm-initiated recall
complete.
DISTRIBUTION Alabama.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
whole blood with an extended collection time.

_______________
PRODUCT Platelets, Pheresis. Recall #B-601-7.
-10-CODE Unit #11LP09178.
MANUFACTURER American Red Cross Blood Services, St. Louis,
Missouri.
RECALLED BY Manufacturer, by telephone, followed by letter
dated November 16, 1995. Firm-initiated
recall complete.
DISTRIBUTION Missouri.
QUANTITY 1 unit was distributed.
REASON Blood product was collected using a defective
apheresis collection kit.

_______________
PRODUCT Platelets, Pheresis. Recall #B-602-7.
CODE Unit #40P48940.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on September 25,
1996, followed by letter dated September 26,
1996. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product had a platelet yield above the
acceptable limit.

_______________
PRODUCT Platelets, Pheresis. Recall #B-603-7.
CODE Unit #40P50047 (split unit).
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois
RECALLED BY Manufacturer, by telephone on November 21,
1996, followed by letter dated November 25,
1996. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product had a platelet yield above the
acceptable limit.

_______________
PRODUCT Platelets. Recall #B-605-7.
CODE Unit #11G11373.
MANUFACTURER American Red Cross Blood Services, St. Louis,
Missouri.
RECALLED BY Manufacturer, by telephone on December 28,
1995, followed by letter dated January 9,
1996. Firm-initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose
medical history screening was inadequately
performed.

-11-_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-606/607-7.
CODE Unit #49R74451.
MANUFACTURER American National Red Cross, Tulsa, Oklahoma.
RECALLED BY Manufacturer, by letter dated January 30,
1996. Firm-initiated recall complete.
DISTRIBUTION Texas and Oklahoma.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
traveled to a malarial endemic area.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-608/609-7.
CODE Unit #42Q47962.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letter dated January 15,
1997. Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
traveled to an area endemic for malaria.

_______________
PRODUCT Platelets, Pheresis. Recall #B-610-7.
CODE Unit numbers: 10518-4806, 10518-4808,
10518-7836.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on October 4, 1996. Firm-initiated
recall complete.
DISTRIBUTION Wyoming.
QUANTITY 3 units were distributed
REASON Blood products were pooled incorrectly.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-611/612-7.
CODE Unit #18Q75951.
MANUFACTURER American Red Cross Blood Services, Lansing,
Michigan.
RECALLED BY Manufacturer, by letter dated October 3, 1996.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
was taking the drug Prednisone.

_______________
PRODUCT Red Blood Cells. Recall #B-614-7.
CODE Unit #12GL31066 and 12LJ20505.
-12-MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by telephone on February 10,
1997. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor who
traveled in an area considered endemic for
malaria.

_______________
PRODUCT Cryoprecipitated AHF. Recall #B-616-7.
CODE Unit #03GZ00980.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by telephone on November 14,
1996. Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit.
REASON Blood product, corresponding to a unit of Red
Blood Cells that was reported as clotted, was
distributed.

_______________
PRODUCT Platelets. Recall #B-624-7.
CODE Unit numbers: 3292210, 3292211, 3292213,
3292214, 1608046, 1608047.
MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by telephone on December 3,
1996, followed by letter dated December 18,
1996. Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 6 units were distributed.
REASON Blood products were prepared from units of
whole blood which were shipped at unacceptable
temperatures.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Recovered Plasma. Recall #B-574-7.
CODE Unit #13FT30212.
MANUFACTURER American Red Cross Blood Services, Detroit,
Michigan.
RECALLED BY Manufacturer, by letter dated June 14, 1996.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
reported a history of cancer.

-13-_______________
UPDATE Recall #B-555-7, Gamma Reagent Red Blood
Cells, 3-4%, which appeared in the April 9,
1997 Enforcement Report was incorrectly
lettered. The product listing should read as
follows:
(a) Duet Reagent Red Blood Cells
(b) Trio 1, 2, and 3 Reagent Red Blood Cells
(c) Panel One Reagent Red Blood Cells
(d) Panel Two Reagent Red Blood Cells
(e) Panel 15 Reagent Red Blood Cells
(f) Panel 20 Reagent Red Blood Cells.

RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II =========
_______________
PRODUCT HeartStart Rechargeable Lead Acid Battery,
used in HeartStart Semi-Automatic External
Defibrillators, Model numbers HS 2000, HS 3000
QR, HS 3000ATS, and HS 911.
Recall #Z-429-7.
CODE Battery lot numbers 960212 through 960319.
MANUFACTURER Panasonic, Secaucus, New Jersey.
RECALLED BY Laerdal Medical Corporation, Wappingers Falls,
New York, by letter dated March 11, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Chile, Brazil, Colombia.
QUANTITY 885 batteries were distributed.
REASON The batteries are subject to pre-mature and
undetectable depletion of charge, which can
result in failure to deliver defibrillation
therapy to sudden cardiac arrest patients
power-up can lead to failure to defibrillate
the patient.

_______________
PRODUCT InstaTrak Straight and Frontal Aspirators:
(a) InstaTrak Straight Aspirator, Catalog No.
ENT-100AS-01,
(b) InstaTrak Frontal Aspirator, Catalog No.
ENT-101AF-01. Recall #Z-431/432-7.
CODE Lot Numbers: (a) JAZ6263-1; (b) JAZ626-2.
MANUFACTURER Visualization Technology, Inc., Woburn,
Massachusetts.
RECALLED BY Manufacturer, by telephone on January 13,
1997, and by issuing a Dear Doctor letter on
January 13, 1997. Firm-initiated recall
complete.
DISTRIBUTION Alabama, California, Georgia, Illinois,
Massachusetts, Minnesota, New York, Ohio,
Tennessee.
QUANTITY (a) 36 boxes (10 units per box); (b) 35 boxes
(10 units per box) were distributed.
-14-REASON The aspirating instruments may be stressed
beyond their design limits when used for
prying and dissecting. The excessive side
forces generated by these applications may
degrade the devices' accuracy.

_______________
PRODUCT RX5000 Software Operating System 2.01.02 and
lower for Marathon SR and DR Pacemakers.
Recall #Z-433-7.
CODE Serial Numbers 01000 through 06093 (not
inclusive).
MANUFACTURER Sulzer Intermedics, Inc., Angleton, Texas.
RECALLED BY Manufacturer, by letter March 13, 1997. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 3,300 units were distributed.
REASON A software condition caused the parameters of
the two pacemakers to become reversed. That
is, the software cannot distinguish Marathon
DR (dual-chamber) from Marathon SR
(single-chamber) USER PRESET values; whichever
values were most recently stored will be
recalled.

_______________
PRODUCT Zeus Laser Cutting Systems, used for cutting
or engraving material: (a) Model Z100;
(b) Model Z250. Recall #Z-438/439-7.
CODE Model numbers Z100 and Z250.
MANUFACTURER Cad Cam Technology, Inc., U.S.A., Alphretta,
Georgia.
RECALLED BY Manufacturer. FDA approved the firm's
corrective program on April 14, 1997. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 24 units were distributed.
REASON Noncompliance with the following provisions of
the Federal laser product performance
standard: identification; protective housing
labels; protective housing; and safety
interlocks.

_______________
UPDATE Recall Z-064/077-7 reported in the 11/13/96
Enforcement Report contained incorrect
identifications of devices listed. The
correct identifications are as follows:
Z-064-7 - Angiographic Catheters bearing the
catalog product prefix HNBR4.1;
Z-065-7 - Angiographic Catheters bearing the
catalog product prefix HNBR5.0;

-15- Z-066-7 - Angiographic Catheters bearing the
catalog product prefix HNBR6.0;
Z-067-7 - Angiographic Catheters bearing the
catalog product prefix HNBR7.0;
Z-075-7 - D'AGOSTINO ACCESS SET; Reorder #
NPAS-100-D'AGOSTINO-A-050393 and
NPAS-100-D'AGOSTINO-B-050393.
Recall Z-274/281-7 reported in the 2/26/97
Enforcement Report contained a mistyped
catalog number and should read:
Z-279-7 - COOK BRAND ROYAL FLUSH PLUG
ANGIOGRAPHIC SET WITH BEACON TIP 4 FR PIGTAIL.
SET INCLUDES 1/4.0 FRENCH 70CM PIGTAIL
CATHETER WITH 10 SIDEPORTS, 1/.035 IN. 145CM
TFE COATED WIRE GUIDE WITH 3MM J, 1/19UT GAUGE
NEEDLE. REORDER # HNRS-405-70.PIG-SH-012795;
QUICK REORDER # 234728.
In addition, the recall included catheters
that were sold individually that were
inadvertently omitted from the list.
These devices are as followed with their
assigned recall numbers:
Z-440-7 - ROYAL FLUSH PLUG ANGIOGRAPHIC
CATHETERS WITH BEACON ENHANCED RADIOPAQUE
TIPS, CATALOG PREFIX HNR4.0;
Z-441-7 - ROYAL FLUSH PLUG ANGIOGRAPHIC
CATHETERS WITH BEACON ENHANCED RADIOPAQUE
TIPS, CATALOG PREFIX HNR5.0.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT SickleScreen Sickling Hemoglobin Screening
Test. Recall #Z-422-7.
CODE Catalog No. 251-050, Lot No. 250A03, Catalog
No. 262-375, Lot No. 258A04.
MANUFACTURER Pacific Hemostasis, Huntersville, North
Carolina.
RECALLED BY Manufacturer, by telephone beginning November
4, 1996, followed by letter on or about
November 6, 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and Greece.
QUANTITY 501 kits of lot 250A03 and 208 kits of lot
258A04 were distributed.
REASON Device can produce false negative results with
known positive patient samples and positive
controls.

_______________
PRODUCT Staphylase Test Kit, a slide identification
for Staphyloccus aureus. Recall #Z-434-7.
CODE Catalog #DR595A, Lot #102614.
-16-MANUFACTURER Oxoid, Inc. (formerly Unipath), Basingstoke,
England.
RECALLED BY Oxoid, Inc., (formerly Unipath), Ogdensburg,
New York, by letter issued dated January 1997.
Firm-initiated recall complete.
DISTRIBUTION Tennessee.
QUANTITY 1 kit was distributed.
REASON There are stability problems with the
sensitized sheep red blood cells used as
positive quality controls.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III ==========
_______________
PRODUCT SmithKline Beecham OXTC-50 brand of
Oxytetracycline 50 Type A medicated article
packaged in a 50-lb. bag. Recall #V-034-7.
CODES 104 premix lot numbers manufactured during the
period of 8/10/93 through 7/5/96:
025026 116076 092015 391015 002025
447025 448025 616025 617025 618025
619025 620025 621025 622025 623025
624025 625025 506035 500055 016075
417075 147085 387095 430105 533014
534014 535014 536014 537014 080024
081024 082024 083024 084024 085024
129024 130024 131024 132024 323024
220054 221054 222054 239064 266074
267074 268074 269074 270074 337084
338084 339084 340084 341084 342084
343084 344084 345084 346084 347084
483084 484084 485084 486084 487084
488084 489084 490084 491084 492084
552084 717084 718084 719084 720084
721084 722084 723084 190094 191094
192094 127104 128104 538104 167114
114124 276124 187093 188093 189093
305103 306103 382103 383103 486103
487103 488103 741103 815103 816103
829103 074113 075113 378113.
MANUFACTURER ADM Animal Health & Nutrition Division, Des
Moines, Iowa.
RECALLED BY Manufacturer, by letter dated November 6,
1996. Firm-initiated recall complete.
DISTRIBUTION Kansas, Iowa, Washington state, Nebraska,
South Dakota, Minnesota, Missouri, Vermont,
Colorado, Wisconsin, North Dakota, Arizona,
California, Illinois.
QUANTITY 104 lots to 66 animal feed manufacturers were
distributed. The size of each lot is
undetermined.

-17-REASON There was a misinterpretation of the procedure
approved for calculating the expiration date.
Product could be subpotent.

MEDICAL DEVICE SAFETY ALERTS: ==============================
_______________
PRODUCT InstaTrack Headset, patient headset used with
the InstaTrak device. Safety Alert #N-013-7.
CODE Catalog #ENT 400-01, Part #1000408, All Lots.
MANUFACTURER Visualization Technology, Inc., Woburn,
Massachusetts.
RECALLED BY Manufacturer, by telephone, followed by letter
dated February 18, 1997.
DISTRIBUTION Nationwide.
QUANTITY 635 headsets were distributed.
REASON Inform users that headset is not to be used on
patients below the age of 14 years.

-18-

END OF ENFORCEMENT REPORT FOR APRIL 23, 1997. BLANK PAGES MAY FOLLOW.

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End of Enforcement Report for