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
05/31/1995
ENFORCEMENT REPORT FOR 05 31 95
May 31, 1995 95-22
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Bi-Lo Orchard Harvest Tomato Juice, in 46 ounce cans.
Recall #F-665-5.
CODE Lot #94092OR1.
MANUFACTURER Redwing Company, Geneva, Indiana.
RECALLED BY Bi-Lo, Inc., Mauldin, South Carolina, by computer mail
system on January 25, 1995, followed by hard copy of letter.
Firm-initiated recall complete.
DISTRIBUTION North Carolina, South Carolina, Georgia.
QUANTITY 582 cases were distributed.
REASON The label declares sodium content as zero "0" when it
actually contains 760 mg of sodium.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT G.R. Diamond New York Icicle, 10 Assorted Freeze Pops,
artificial flavors, net weight 28 fluid ounces, and 24 fluid
ounces in poly bags. Recall #F-659-5.
CODE None.
MANUFACTURER Great Rich Trading Company, Inc., Thailand.
RECALLED BY Great Rich Trading Company, Inc., Brooklyn, New York, by
letter January 12, 1995. Firm-initiated recall complete.
DISTRIBUTION Undetermined.
QUANTITY Undetermined.
REASON Product contained undeclared colors.
_______________
PRODUCT Ultra Slim-Fast Fat Free Breakfast Bars, sold in packages of
six in the following flavors: (a) Apple Fruit Bars;
(b) Fig Fruit Bars; (c) Blueberry Fruit Bars; (d) Strawberry
Fruit Bars. Recall #F-660/663-5.
CODE (a) FFSA 4326 through 5070; (b) FFSF 4326 through 5070;
(c) FFSB 4326 through 5070; (d) FFSS 4326 through 5070.
MANUFACTURER Fleetwood Snacks, Inc., Fleetwood, Pennsylvania.
RECALLED BY Slim-Fast Foods Company, West Palm Beach, Florida, by
telephone beginning on April 25, 1995, followed by letter.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 10,596,168 breakfast bars were produced; firm estimated that
3,000,000 to 5,000,000 bars remained on market at time of
recall initiation.
REASON Product is contaminated with plastic pieces.
_______________
PRODUCT Bumble Bee brand Solid White Tuna in water, in 6-1/8 ounce
cans. Recall #F-664-5.
CODE Lot numbers: SWP3J 67HD1 on can and 67HD1 23021 on case.
MANUFACTURER Bumble Bee International, Inc., Mayaquez, Puerto Rico.
RECALLED BY Winn Dixie Distribution Center, Hammond, Louisiana, by
visit. Firm-initiated recall complete.
DISTRIBUTION Louisiana, Mississippi.
QUANTITY 480 cases (per cans per case) were distributed; firm
estimates none remains on the market.
REASON Product was adulterated due to a petroleum distillate odor
which renders it unfit for human consumption.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Recovered Plasm. Recall #B-336-5.
CODE C13094, C13196, C13228, C13283, C13669.
MANUFACTURER Sewickley Valley Hospital Blood Bank, Sewickley,
Pennsylvania.
RECALLED BY Manufacturer, by letter February 28, 1995, and by fax March
1, 1995 complete.
DISTRIBUTION Pennsylvania.
QUANTITY 5 units.
REASON Blood products, which were collected from autologous donors
who did not meet the criteria for homologous donation, were
distributed.
_______________
PRODUCT Platelets. Recall #B-348-5.
CODE Unit #R71508.
MANUFACTURER Heartland Blood Center, Aurora, Illinois.
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RECALLED BY Manufacturer, by telephone February 14, 1995. Firm-
initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product, which tested negative for antibody to human
immunodeficiency virus type 1 (anti-HIV-1), but was
collected from a donor who previously tested repeatedly
reactive for anti-HIV-1, was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Recovered Plasma. Recall #B-337-5.
CODE C13110, C13199, C13212, C13299, C13395, C13397, C13399,
C13473, C13474, C13506, C13576, C13584, C13620, C14284.
MANUFACTURER Sewickley Valley Hospital Blood Bank, Sewickley,
Pennsylvania.
RECALLED BY Manufacturer, by letter February 28, 1995, and by fax March
1, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania.
QUANTITY 14 units.
REASON Blood products, collected from autologous donors who have a
medical history of cancer, were distributed.
_______________
PRODUCT Spectrogen-Duo Reagent Red Blood Cells. Recall #B-338-5.
CODE Lot #95005 and G95005.
MANUFACTURER Organon Teknika Corporation, West Chester, Pennsylvania.
RECALLED BY Organon Teknika Corporation, Durham, North Carolina, by
facsimile on December 29, 1994. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 619 units of lot 95005 and 74 units of lot G95005.
REASON Reagent Red Blood Cells, which were found to be hemolyzed,
were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-339/341-5.
CODE Unit #29116-6626.
MANUFACTURER United Blood Services Blood Systems, Inc., Chicago,
Illinois.
RECALLED BY Manufacturer, by letters of January 13 and 20, 1995. Firm-
initiated recall complete.
DISTRIBUTION Illinois, Switzerland.
QUANTITY 1 unit of each component.
REASON Blood products, which were improperly tested for syphilis,
were distributed.
-3-
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma;
(d) Recovered Plasma. Recall #B-342/345-5.
CODE Unit numbers: (a) 1043764, 1064205, 1101529, 1116407,
1140764, 4059997, 2092488, 1137624, 1159943, 1165709,
2053666, 1115610, 1137619, 1144439, 1151296, 1159997;
(b) 1116407, 1140764, 2053666, 1115610, 1137619, 1144439,
1151296, 1159997; (c) 1140764, 1165709; (d) 1043764,
1064205, 1101529, 1116407, 4059997, 2092488, 1137624,
1159943, 2053666, 1115610,1137619, 1144439, 1151296,
1159997.
MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City,
Missouri.
RECALLED BY Manufacturer, by letters of January 16, 1995, February 16,
1995, May 12 and 13, 1994. Firm-initiated recall complete.
DISTRIBUTION Kansas, Missouri, Tennessee.
QUANTITY (a) 16 units; (b) 8 units; (c) 2 units; (d) 14 units.
REASON Blood products, which tested negative for hepatitis B
surface antigen (HBsAg) and antibody to hepatitis B core
antigen (anti-HBc), but were collected from donors who
previously tested repeatedly reactive for HBsAg and anti-
HBc, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-346/347-5.
CODE Unit #3249668.
MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis,
Indiana.
RECALLED BY Manufacturer, by telephone December 23, 1992. Firm-
initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit of each component.
REASON Blood products, collected from a donor who had been
immunized one week prior to donation with Rubella vaccine,
were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Groshong Central Venous Catheters (8 Fr.) and Port Kits;
(a) Model No. 60283 Davol MRI Subcutaneous Port with
Attachable 1.5 mm I.D. Groshong Venous Catheter and 8 Fr.
Introducer Kit;
(b) Model No. 60312 Davol Specialty Access Products CV
Catheter 8 Fr. with Groshong Valve Long Term, Single Lumen
Intro-eze Percutaneous Introducer System;
(c) Model No. 60316 Davol Dome Implanted Port with
Attachable 1.5 I.D. Groshong Venous Catheter and Intro-eze
Percutaneous Introducer System;
-4-
(d) Model No. 60453 Davol MRI Hard Base Implanted Port with
Attachable 8 Fr. Groshong Single Lumen Venous Catheter and
Intro-Eze Percutaneous Introducer System;
(e) Model No. 1180 Cath-tech CV Catheter with Groshong Valve
Long Term Single Lumen Percutaneous Placement Procedure
Tray;
(f) Model No. 7711802 Davol CV Catheter 8 Fr. with Groshong
Valve and VitaCuff Antimicrobial Cuff Long Term Single Lumen
Percutaneous Placement Procedure Tray. Recall #Z-721/726-5.
CODE Lot numbers: (a) 36JE2705; (b) 36KE2888; (c) 36JE2702;
(d) 36KE3048; (e) 36JE2689; (f) 36JE2426.
MANUFACTURER Bard Access System, Inc., Salt Lake City, Utah.
RECALLED BY Manufacturer, by telephone and by letter starting December
20, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Ireland.
QUANTITY 768 units were distributed.
REASON Particulates were found in the cannulae.
_______________
PRODUCT Collimator Cart (a) for all ADAC Argus and (b) some ADAC
Cirrus Nuclear Imaging Systems. The cart is used to
transport the collimator (lead shield) between imaging
applications. Recall #Z-753/754-5.
CODE (a) Model ADAC Part #2145-5453;
(b) Model ADAC Part #2145-5454.
MANUFACTURER ADAC Laboratories, Milpitas, California.
RECALLED BY Manufacturer, by memorandum March 3, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 88 carts; (b) 101 carts were distributed.
REASON The wheel attached to the base of the collimator transport
cart for the Argus and Cirrus nuclear imaging systems may
become dislodged, which may result in the collimator tipping
over and possibly causing injury to the operator of the
equipment.
_______________
PRODUCT Radiation Therapy Planning Systems (RTP): (a) RTP-5000; (b)
XL-PLAN-73; (c) CAD PLAN, used to calculate radiation
dosage. These systems are NOT used with any of ADAC's
nuclear imaging systems. Recall #Z-755/757-5.
CODE Software versions 3C.1, all revisions A through E.
MANUFACTURER ADAC Laboratories, Milpitas, California.
RECALLED BY Manufacturer, by sending Product Warning Bulletin dated May
19, 1994. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 128 systems were distributed.
-5-
REASON Under certain conditions a software calculation error could
occur, causing a possible bracytherapy plan which has the
incorrect number of sources, and therefore, the incorrect
dose rate and dose distribution.
_______________
PRODUCT Landmark Midline Catheter, a venous access device designed
for peripheral infusion of general IV therapy solutions and
blood sampling. Recall #Z-758-5.
CODE Lot numbers earlier/lower than 404011 or 404011M.
MANUFACTURER Menlo Care, Inc., Menlo Park, California.
RECALLED BY Manufacturer, by letter sent between March 6 and 10, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimated that 4,400 catheters to be in consignees'
inventory on or about March 20, 1995.
REASON Labeling is inadequate for intended use.
_______________
PRODUCT (a) Dual Head Genesys Nuclear Medicine Imaging Unit; (b)
Vertex Nuclear Medicine Imaging Unit. The item under recall
is the software which controls the detector heads (also
known as a gantry). Recall #Z-765/766-5.
CODE (a) Units with software version 2.55;
(b) Units with software version 2.16.
MANUFACTURER ADAC Laboratories, Milpitas, California.
RECALLED BY Manufacturer, by performing upgrades to software. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 205 units; (b) 90 units were distributed.
REASON An error in the software could cause an uncommanded movement
of the collimator and detectors prior to activating the
imaging units, which could result in potential injury to
patients.
_______________
PRODUCT Protective Plus I.V. Catheter Safety System.
Recall #Z-767-5.
CODE Product #3060. All individual package codes with letter G
as 5th character and shelf pack/shipping container lot codes
from L1670 up to and including L2560.
MANUFACTURER Critikon, Inc., Southington, Connecticut.
RECALLED BY Critikon, Inc., Tampa, Florida, by letter December 22, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 1 million systems were distributed.
REASON Due to a manufacturing condition, the catheter tubing may
separate from the catheter hub.
-6-
PRODUCT Huber Needles Butterfly Sets, used for infusing fluids or
withdrawing blood:
(a) Catalog #IP-1001 Huber Needle Butterfly Set;
(b) Catalog #IP-2001 Huber Needle Butterfly Set;
(c) Catalog #IP-3001 Huber Needle Butterfly Set;
(d) Catalog #IP-4001 Huber Needle Butterfly Set;
(e) Catalog #IP-2000 Huber Needle Butterfly Set;
(f) Catalog #IP-3000 Huber Needle Butterfly Set;
(g) Catalog #IP-4000 Huber Needle Butterfly Set.
Recall #Z-781/787-5.
CODE Huber Needle Infusion Sets involved have Harmac lot numbers
7125-01 and 7239-01. The Ideas for Medicine kit lot numbers
that contain the recalled component made by Harmac
Industries as follows: (a) D091594-11, D111794-11, D111894-
11, D120194-11, D111594-11, D090294-11, D111694-11, D111894-
31; (b) D092394-21, D092494-21, D110194-21, D091494-21,
D101294-21, D092194-21, D092394-21, D100494-21, D101094-21,
D090894-21, D091094-21, D100394-21, D102794-21, D121394-21,
D122194-21, D091294-21; (c) T110494-31, T111894-31, T120894-
31; (d) T091694-41, T101094-41, T100594-41, T110994-41,
T091294-41, T110294-41, T120594-41, T092294-41, T110994-41;
(e) D090794-20R; (f) T102494-30; (g) T092794-40, T111194-40.
MANUFACTURER Harmac Medical Products, Inc., Buffalo, New York.
RECALLED BY Ideas for Medicine, Clearwater, Florida, by letter April 5,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,346 kits were distributed.
REASON Incidents have been reported of a possible functional
problem due to needle occlusion caused by a manufacturing
defect.
_______________
PRODUCT Uroview X-ray Imaging Systems with fixed tables:
(a) Model 2000; (b) Model 2500. Recall #Z-788/789-5.
CODE Various serial numbers.
MANUFACTURER OEC Medical Systems, Inc., Salt Lake City, Utah.
RECALLED BY Manufacturer, by letter dated November 15, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 494 units were distributed.
REASON In certain situations when the table is vertical, a pin
could re-position, causing the head to swivel down
uncontrolled.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Centry System 3 Dialysis Control Units manufactured between
03/23/95 and 04/06/95:
(a) Part #333103001; (b) Part #333100011;
(c) Part #333100012; (d) Part #333100013;
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(e) Part #333100017; (f) Part #333100101;
(g) Part #333103111; (h) Part #333104111;
(i) Part #333100111. Recall #Z-768/776-5.
CODE Nine part numbers involving 136 individually serial numbered
units.
MANUFACTURER Cobe Renal Care, Inc., Lakewood, Colorado.
RECALLED BY Manufacturer, by memorandum April 20, 1995. Firm-initiated
field correction ongoing.
DISTRIBUTION California, North Carolina, Indiana, Illinois, Georgia,
Thailand, Hong Kong, Israel, Greece.
QUANTITY 34 units were distributed.
REASON The incorrect operator warning label was placed on the cover
of the balance chamber subassembly.
_______________
PRODUCT AOA brand Instant Cold Compress, single use only,
disposable. Recall #Z-794-5.
CODE Catalog #4299.1AOA; Lot #950316B.
MANUFACTURER Consolidated Products & Services, Inc., Braintree,
Massachusetts.
RECALLED BY Manufacturer, by letter May 5, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Florida, Georgia, Indiana, Kentucky, Maryland, Ohio,
Oklahoma, Pennsylvania, Texas.
QUANTITY 31 cases (24 units per case) were distributed.
REASON The product is labeled as an instant cold pack, however, the
chemical in the pack was calcium chloride which is the raw
material used to make chemical hot packs. The cold packs
turned hot instead of cold.
-8-
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END OF ENFORCEMENT REPORT FOR MAY 31, 1995. BLANK PAGES MAY FOLLOW.