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
11/13/1996
Enforcement Report for 11/13/1996
November 13, 1996 96-46
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Prune juice from concentrate, in 4 ounce
plastic single serve containers, under the
Fruit Bud and Harvest Value labels.
Recall #F-036-7.
CODE All product produced this year. Cases coded
00261 through 24363.
MANUFACTURER Quality Kitchen Corporation, Wyoming,
Delaware.
RECALLED BY Quality Kitchen, Inc., Danbury, Connecticut,
by fax on October 10, 1996. Firm-initiated
recall complete.
DISTRIBUTION Delaware, Illinois, Maryland, New Jersey, New
York, Pennsylvania.
QUANTITY Firm estimates little product remains on the
market.
REASON Product contains lead in excess of the level
of concern of 80 ppb (parts per billion).
_______________
PRODUCT Candied Chick Peas, in 16 ounce clear plastic
bags. Recall #F-037-7.
CODE None. All misbranded product is under recall.
MANUFACTURER Domian Roasting Company, Beirut, Lebanon.
RECALLED BY Baroody Imports, Clifton, New Jersey, by
notifying customers during its regular
distribution schedule. Firm-initiated recall
complete.
DISTRIBUTION New Jersey, New York, Pennsylvania,
Connecticut, Rhode Island, Massachusetts,
Maryland.
QUANTITY 1,500 pounds were distributed.
REASON The product contains undeclared FD&C Yellow
No. 6, FD&C Blue No. 1, and an unidentified
red color.
_______________
PRODUCT Bubble Gum Ice Cream, in 3 gallon cardboard
boxes. Recall #F-040-7.
CODE All misbranded product.
MANUFACTURER Gifford's Dairy, Inc., Skowhegan, Maine.
RECALLED BY Manufacturer, by telephone on October 21,
1996, followed by visit on October 23, 1996.
Firm-initiated recall complete.
DISTRIBUTION Maine, Connecticut.
QUANTITY Undetermined.
REASON The product bears a partial ingredient
statement and contains undeclared FD&C Yellow
No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Citrus Delight Florida Style Orange Beverage,
in 64 ounce, 8 ounce, 16 ounce and 1-gallon
containers. Recall #F-038-7.
CODE Item # Size Exp. Dates
56759 8/64 oz 7/29 through 12/18/96
56751 6/8-8 oz 7/29 through 12/18/96
56763 6/1 gal 7/29 through 12/18/96
56755 24/16 oz 7/29 through 12/18/96
56749 48/8 oz 7/29 through 12/18/96
56760-24 24/8 oz 7/29 through 12/18/96
56755-12 12/16 oz 7/29 through 12/18/96.
MANUFACTURER Heritage Family Specialty Foods, Inc.,
Grand Prairie, Texas.
RECALLED BY Manufacturer, by letter on July 15, 1996.
Firm-initiated recall complete.
DISTRIBUTION Texas, Oklahoma, Mississippi, Louisiana,
Kansas, Illinois, Missouri, Georgia.
QUANTITY Product shipped from January 4, 1996 to
July 5, 1996:
Size Total Cases
8 / 64 oz 18546.5
6 /8-8 oz 1093
6 / 1 gal 1666
24 / 16 oz 14
-2- 12 / 16 oz 110
48 / 8 oz 28.5.
REASON Product contains less than the labeled 100%
RDA Vitamin C.
_______________
PRODUCT Swordfish Loins, no label, wrapped in plastic
and butcher paper. Recall #F-039-7.
CODE None.
MANUFACTURER Tropic Fish & Vegetable Center, Inc.,
Honolulu, Hawaii.
RECALLED BY Manufacturer, by telephone September 25, 1996,
followed by letter September 27, 1996. Firm-
initiated recall complete.
DISTRIBUTION Hawaii.
QUANTITY 76.6 pounds were distributed.
REASON Product is decomposed.
_______________
PRODUCT Frisch's brand Tarter Sauce packaged in 16
fluid ounce retail glass jars.
Recall #F-041-7.
CODE FEB-12-97 and FEB-13-97.
MANUFACTURER Food Specialties Company, Cincinnati, Ohio.
RECALLED BY Manufacturer, by telephone on September 30,
1996, followed by visit. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 1,722 cases (12 jars per case) were
distributed; firm estimates none remains on
the market.
REASON Product is contaminated with mold and/or
yeast.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Single
Donor Plasma; (d) Recovered Plasma; (e) Red
Blood Cells for further manufacture.
Recall #B-041/045-7.
CODE Unit numbers: (a-c) 53Y44151; (d&e) 53R31414.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated February 19,
1996. Firm-initiated recall complete.
DISTRIBUTION Maryland, New Jersey, California, District of
Columbia.
QUANTITY 2 units were distributed.
-3- REASON Blood products were collected from a donor who
reported a history of testing positive for
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1).
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Recovered Plasma; (e)
Platelets, for further manufacture.
Recall #B-051/055-7.
CODE Unit numbers: (a) 9200590, 9201468, 9302776,
9304340, 9316793, 9416652, 9422240, 9427415,
9508380, 9506839, 9505867, 9215295, 9216574,
9526768; (b) 9200590, 9201468, 9302776,
9304340, 9316793, 9416652, 9422240, 9427415,
9508380, 9506839, 9505867, 9526768;
(c) 9216574, 9427415, 9508380, 9505867;
(d) 9200590, 9201468, 9215295, 9302776,
9304340, 9316793, 9416652, 9422240, 9506839,
9526768; (e) 9215295, 9216574.
MANUFACTURER Lorain County Blood Bank, Elyria, Ohio.
RECALLED BY Manufacturer, by letter dated December 22,
1995. Firm-initiated recall complete.
DISTRIBUTION Ohio, Florida.
QUANTITY (a) 14 units; (b) 12 units; (c) 4 units; (d)
10 units; (e) 2 units were distributed.
REASON Blood products tested negative for 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 Western blot negative.
_______________
PRODUCT Platelets. Recall #B-056-7.
CODE Unit #1604434.
MANUFACTURER Evans Army Community Hospital Blood Bank, Fort
Carson, Colorado.
RECALLED BY Manufacturer, by telephone on September 29,
1995. Firm-initiated recall complete.
DISTRIBUTION Colorado.
QUANTITY 1 unit was distributed.
REASON Blood product tested repeatedly reactive for
antibody to the hepatitis B core antigen
(anti-HBc).
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Platelets, Pheresis. Recall #B-031-7.
CODE Unit #00 06383.
MANUFACTURER Community Blood Center, Inc., Appleton,
Wisconsin.
-4- RECALLED BY Manufacturer, by letter dated June 2, 1995.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
provided incomplete medical history.
_______________
PRODUCT (a) Red Blood Cells: (b) Platelets; (c) Fresh
Frozen Plasma; (d) Cryoprecipitated AHF; (e)
Plasma, Cryo-Poor. Recall #B-036/040-7.
CODE Unit numbers: KC42660, KC42826, KC43177,
KC43377, KC43696, KC43950, KC44181, KC44348,
KC44514, KC44694, KC44852.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by letter dated May 29, 1996.
Firm-initiated recall complete.
DISTRIBUTION Virginia, Maryland, Illinois.
QUANTITY (a) 11 units; (b) 9 units; (c) 9 units; (d) 2
units; (e) 2 units.
REASON Blood products, collected from a donor with
hemochromatosis, were distributed for
allogeneic transfusion.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-046/047-7.
CODE Unit #96 1092.
MANUFACTURER Merced County Blood Bank, Merced, California.
RECALLED BY Manufacturer, by letter dated July 18, 1996.
Firm-initiated recall complete.
DISTRIBUTION California and New York.
QUANTITY 1 unit of each component.
REASON Blood products were incorrectly tested for the
antibody to the human T-lymphotropic virus
type 1 (anti-HTLV-1).
_______________
PRODUCT Platelets. Recall #B-050-7.
CODE Unit #5002383.
MANUFACTURER Lorain County Blood Bank, Elyria, Ohio.
RECALLED BY Manufacturer, by telephone on April 15, 1996,
followed by letter dated April 29, 1996.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON Blood product, which tested reactive for
syphilis by RPR, FTA negative, was distributed
prior to testing.
-5- RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Clamping Adaptor, GammaMed 121 High Dose Rate
Afterloader, used with a bronchial catheter.
Recall #Z-059-7.
CODE Part #931012.
MANUFACTURER Isotopen-Technic Dr. Sauerwein GMBH, Haan,
Germany.
RECALLED BY Frank Barker Associates, Inc., Towaco, New
Jersey, by letter dated August 18, 1995.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 62 units were distributed.
REASON The clamping adaptor does not allow the
iridium-192 sealed source to return to its
fully shielded position if the catheter
becomes disconnected.
_______________
PRODUCT (a) Peri-Guard Pericardium
(b) Supple Peri-Guard Pericardium. Products
are prepared from bovine pericardium and are
patches used primarily for pericardial closure
and hernia repair.
(c) Peri-Strips Staple Line Reinforcement,
intended for use as a prosthesis for the
surgical repair of soft tissue deficiencies
using linear cutter surgical staplers.
Recall #Z-061/063-7.
CODE All lots.
MANUFACTURER Bio-Vascular, Inc., St. Paul, Minnesota.
RECALLED BY Manufacturer, through meetings and telephone
conference calls during the period from
approximately January 1996 to April 1996, and
by notification sent on September 23, 1996;
and by sending revision of indications for use
to customers who received the product. No
product was returned. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 1,783 units; (b) 832 units; (c) 166 units
were distributed.
REASON Devices have caused or contributed to
infections and/or foreign body reactions when
used as transvaginal urethral sling implants
for incontinence, as labeled.
_______________
PRODUCT Torcon NB Advantage Selective Angiographic
Catheters:
(a) Torcon NB Advantage Angiographic Catheter
H1 Headhunter Cerebral with Beacon Enhanced
Radiopaque Tip, French Size 4.1, Product
HNBR4.1-35-100-P-NS-H1;
-6- (b) Torcon NB Advantage Angiographic Catheter
H1 Headhunter Cerebral with Beacon Enhanced
Radiopaque Tip, French Size 5.0, Product
HNBR5.0-38-100-P-NS-H1;
(c) Torcon NB Advantage Angiographic Catheter
H1 Headhunter Cerebral with Beacon Enhanced
Radiopaque Tip, French Size 6.0, Product
HNBR6.0-38-100-P-NS-H1;
(d) Torcon NB Advantage Angiographic Catheter
H1 Headhunter Cerebral with Beacon Enhanced
Radiopaque Tip, French Size 7.0, Product
HNBR6.0-35-100-P-NS-H1;
(e) Judkins Coronary Catheter Set, Reorder No.
JCS-502;
(f) Judkins Coronary Catheter Set with Check
Flo Performer Introducer Set, Reorder No.
JCS-600-MM-090695;
(g) Judkins Coronary Catheter Set, Reorder No.
JCS-601-MM-072795;
(h) Judkins Coronary Catheter Set with
Micropuncture Check-Flo Performer Introducer
Set, Reorder No. JCS-600-SA-090695;
(i) Marx-Cope Pediatric Gastrojejunostomy Set,
Reorder No. GJS-1400-MCGJ;
(j) Gastrojejunostomy Set, Reorder No.
GJS-1400-HIETTE-022895;
(k) Gastrojejunostomy Set, Reorder No.
GJS-1400-HIETTE-072795;
(l) D'agostino Access Set, Reorder No.
NPAS-100-D'AGOSTINO-A-050393;
(m) Colapinto Transjugular
Cholangiography/Liver Biopsy Set, Reorder No.
TJC-101-UPSTATE-092094;
(n) Mewissen Transfemoral Liver Biopsy Set,
Reorder No. TLBS-100-MWSN.
Recall #Z-064/077-7.
CODE All lots.
MANUFACTURER Cook, Inc., Bloomington, Indiana.
RECALLED BY Manufacturer, by letter dated September 24,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 207,288 units were distributed.
REASON There has been an increased frequency of
catheter tip separation.
_______________
PRODUCT Coeur bulk non-sterile 10 cc Angiographic
Injection Syringes, Model #PCA-10, Part
#C305-1035, 100 units/carton.
Recall #Z-088-7.
CODE Lot #50196802.
-7- MANUFACTURER Coeur Laboratories, Inc., Raleigh, North
Carolina.
RECALLED BY Manufacturer, by letter dated July 25, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION International.
QUANTITY 2,000 units were distributed.
REASON Handheld syringes leaked air into the syringe
during aspiration, which may result in
patients being subjected to air emboli during
administration.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Guglielmi Detachable Coil (GDC), used to treat
aneurysms. Recall #Z-078-7.
CODE All codes.
MANUFACTURER Target Therapeutics, Inc., Fremont,
California.
RECALLED BY Manufacturer, by implementing a corrective
action plan on July 27, 1996. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 31,200 units were distributed.
REASON Markers were made of stainless steel rather
than platinum that resulted in reduced
fluoroscope visibility.
_______________
PRODUCT Cordis brand PTA Balloon Catheter, "Powerflex"
used for percutaneous transluminal angioplasty
procedures:
(a) Catalog No. 411-544T
(b) Catalog No. 411-552T
(c) Catalog No. 411-554T
(d) Catalog No. 411-562T
(e) Catalog No. 411-564T
(f) Catalog No. 411-572T
(g) Catalog No. 411-574T
(h) Catalog No. 411-582T
(i) Catalog No. 411-584T.
Recall #Z-079/087-7.
CODE Lot numbers: (a) S0196359
(b) R0396987, S0196448, S0196449, S0196450,
S0196618
(c) R0596272, S0496555, S0496757
(d) R0496487, S0196451, S0196549, S0396130,
S0496286, S0596258
(e) R0496656, R0596892, S0196554, S0396369,
S0496623, S0596589
(f) R0296133, R0396721, R0496939, S0396440,
W0196113
-8- (g) R0296327, R0396719, R0496377, R0696682,
S0596430, S0596718, S0596983, W0196089,
W0696202
(h) R0296282, S0296115
(i) R0296332, R0396472, R0396437, R0696229,
R0696427, R0696727, R0896371, S0196997,
S0596100, S0796451, S0796927.
MANUFACTURER Cordis Europa, Roden, Netherlands.
RECALLED BY Cordis Corporation, Miami Lakes, Florida, by
visit beginning on September 20, 1996 and
completed on October 4, 1996. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 512 catheters were distributed.
REASON The instructions for use contained the wrong
psi pressure readings.
MEDICAL DEVICE SAFETY ALERTS ================================
_______________
PRODUCT Atrial Bipolar Pacing Leads:
(a) Model No. 4504 Capsure, Bipolar,
Implantable, Tined, Atrial Transvenous Lead
(b) Model No. 4504M Capsure, Steroid Eluting,
Bipolar, Implantable, Atrial Transvenous Lead
(c) Model No. 4582 Bipolar Atrial Pacemaker
Lead. Safety Alert #N-001/003-7.
CODE All serial numbers.
MANUFACTURER Medtronic Puerto Rico, Villalba, Puerto Rico.
ALERTED BY Medtronic, Inc., Minneapolis, Minnesota, by
letter October 4, 1996.
DISTRIBUTION Nationwide and international.
QUANTITY 26,806 leads were distributed.
REASON The devices may fail sooner than expected due
to insulation degradation (metal induced
oxidation (MIO), causing intermittent over-
and undersensing and possible intermittent
loss of capture.
-9-
END OF ENFORCEMENT REPORT FOR NOVEMBER 13, 1996. BLANK PAGES MAY
FOLLOW.
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