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
04/12/1995
Recalls and Field Corrections: Foods -- Class I -- 04/12/1995
April 12, 1995 95-15
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Portland Light brand Frozen Rock Crab Salad Crabmeat, in 5
pound boxes. Recall #F-518-5.
CODE None.
MANUFACTURER Portland Shellfish, Inc., Portland, Maine.
RECALLED BY Portland Shellfish Sales, Inc., Lynn, Massachusetts, by
telephone March 3, 1995. Firm-initiated recall complete.
DISTRIBUTION Massachusetts.
QUANTITY Firm estimates none remains on the market.
REASON Product is contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Osem brand Bamba Snacks, in 1.0 and 3.5 ounce packages.
Recall #F-527-5.
CODE All codes.
MANUFACTURER OSEM Food Industries Ltd., Petach-Tikva, Israel.
RECALLED BY OSEM USA, Inc., Englewood Cliffs, New Jersey, by telephone
February 23, 1995, followed by letter February 24, 1995.
Firm issued press release on February 24, 1995. See also
FDA statement dated February 10, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION California, Florida, Illinois, Louisiana, Massachusetts,
Maryland, Michigan, Minnesota, North Carolina, New Jersey,
New York, Pennsylvania, Texas.
QUANTITY Approximately 1,175 cases were distributed.
REASON Product is contaminated with Salmonella agona.
_______________
PRODUCT Zetov brand Bamba Snakcs, in 1.0 and 3.5 ounce packages,
product of Israel. Recall #F-528-5.
CODE All codes.
MANUFACTURER OSEM Food Industries, Ltd., Petach-Tikva, Israel.
RECALLED BY Zetov, Inc., Brooklyn, New York, by telephone February 22,
1995, followed by letter and press release March 1, 1995.
See also FDA statement dated February 10, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 2,954 cases (48 1-ounce packages) and 495 cases (24 3.5-
ounce packages) were distributed; firm estimates none
remains on the market.
REASON Product is contaminated with Salmonella agona.
_______________
PRODUCT Wild Fruit Candy, sugar free, salt free, 3.85 ounces.
Recall #F-604-5.
CODE 4138.
MANUFACTURER Sorbee International, Philadelphia, Pennsylvania.
RECALLED BY King Nut Company, Solon, Ohio (repacker), by relabeling
product September 15, 1994. Firm-initiated field correction
complete.
DISTRIBUTION New York.
QUANTITY 10 cases (24 bags per case) were distributed.
REASON Product contained undeclared FD&C Yellow No. 5.
_______________
PRODUCT Rolets Real Cotton Candy, in 1 ounce plastic bags.
Recall #F-605-5.
CODE All 1 ounce size bags shipped prior to 2/21/95 and coded
5/01 and older.
MANUFACTURER Rolet Food Products Company, Brooklyn, New York.
RECALLED BY Manufacturer, by letters of February 21, 1995, and March 17,
1995. Firm-initiated field correction (relabeling) ongoing.
DISTRIBUTION Connecticut, Massachusetts, Maryland, Maine, New Hampshire,
New Jersey, New York, Pennsylvania, Rhode Island, Virginia,
Vermont.
QUANTITY 500,000 1-ounce packages were distributed; firm estimates
none remains on the market.
REASON Product contains undeclared FD&C Yellow No. 5, Red No. 3 and
Red No. 40.
-2- RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Quaker Sweet Crunch, crisps of corn cereal, packaged in 16
ounce cellophane-type bags. Recall #F-523-5.
CODE Best before dates of 9/14/95-11/4/95
MANUFACTURER Quaker Oats Company, Cedar Rapids, Iowa.
RECALLED BY Quaker Oats Company, Chicago, Illinois, by fax and E-mail
February 1, 1995, followed by visit. Firm-initiated recall
complete.
DISTRIBUTION Tennessee, Illinois, Florida, Missouri, Texas, Pennsylvania,
Iowa, California.
QUANTITY Approximately 30,000 cases (12 bags per case) were
distributed.
REASON The product has an off odor.
_______________
PRODUCT Van Camp's Red Beans, in 15-1/2 ounce cans.
Recall #F-602-5.
CODE Can code: MRB07/07I4A **** (where *** indicates the
military time);
Case Code: SEP 07 94 MA and SEP 07 94 MB.
MANUFACTURER Morgan Foods, Inc., Austin, Indiana.
RECALLED BY The Quaker Oats Company, Chicago, Illinois, by telephone
March 9, 1995, followed by fax March 10, 1995. Firm-
initiated field correction (relabeling) ongoing.
DISTRIBUTION Missouri, Nebraska.
QUANTITY 181 cases (24 cans per case) of mislabeled product were
distributed; firm estimated that 25 cases remained on market
at time of recall initiation.
REASON The product is mislabeled in that cans of chicken pasta soup
were labeled as containing red beans.
_______________
PRODUCT Powdered Non-Dairy Creamers, packaged in 6 ounce, 11 ounce,
16 ounce, 20 ounce, and 22 ounce retail containers. Also
packaged in 50 pound, 1,000 pound and 1,100 pound commercial
totes, distributed under the following labels: Cremora,
Cremora Lite, America's Choice, Astor, A & P, Bi-Lo, Laura
Lynn, Laura Lynn Lite, Piggly Wiggly, Rainbow, Shurfine,
Starflake, President's Choice, and Sun Spin.
Recall #F-603-5.
CODE z21may96, z23may96, z28may96, z20nov95 (on retail
containers); C4140, C4141, C4143-C4148 (on commercial
totes).
MANUFACTURER Borden, Inc., Chester, South Carolina.
RECALLED BY Borden, Inc., Columbus, Ohio, by letters dated September 23,
1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Canada, Costa Rica, Singapore.
QUANTITY Approximately 65,000 retail cases, and approximately 1,000
commercial totes were distributed.
REASON Product contains small thread-like pieces of metal.
-3- RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT A/B (Antipyrine/Benzocaine) Otic Drops, Rx, in 10 ml and 1/2
fluid ounce glass bottles, under the following labels:
Goldline, H.L. More, Aurodex, G PR, Rugby, Akorn, Clay Park.
Recall #D-106-5.
CODE For the 10ml:
Lot # EXP Lot # EXP
S412 4/95 U942 2/96
S678 5/95 V089 3/96
T178 7/95 V244 3/96
T199 7/95 V259 4/96
T450 8/95 V569 5/96
V575 5/96 X003 11/96
X012 11/96
For the 1/2 fluid ounce:
Lot # EXP Lot # EXP Lot # EXP
P007 4/95 S405 4/96 U704 11/97
P013 4/95 S412 4/96 U942 2/97
P274 5/95 S185 3/96 V089 3/97
P606 7/95 S688 5/96 V575 5/97
P806 8/95 S909 6/96 V259 4/97
R724 1/96 S917 6/96
R830 1/96 T178 7/96
S178 3/96 T966 10/96
MANUFACTURER Clay Park Laboratories, Inc., Bronx, New York.
RECALLED BY5 Manufacturer, by letter April 3, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Virgin Islands, West Indies, Guyana.
QUANTITY Approximately 534,183 10-ml bottles and 800,797 15-ml glass
bottles were distributed.
REASON Product does not meet pH and water content specifications.
_______________
PRODUCT Potassium Phosphates Injection, USP, in 5 ml and 50 ml
single dose vials, used as a source of phosphorus Recall #D-
107-5.
CODE Lot numbers: 4399 (5 ml) EXP 5/96, 4531 (50 ml) EXP 7/96.
MANUFACTURER Luitpold Pharmaceuticals, Inc., Shirley, New York.
RECALLED BY Manufacturer, by letter March 16, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 115,325 vials of lot 4399 and 26,450 vials of lot 4531.
REASON Presence of crystallization.
_______________
PRODUCT Rectacaine, and all other private labels of the firm's
Hemorrhoidal Suppositories containing "Live Yeast Cell
Derivatives" (LYCD). Recall #D-108-5.
CODE Lot #2120 EXP 1/96.
MANUFACTURER Dr. Rose, Inc., Madison, Connecticut.
-4- RECALLED BY The Reese Chemical Company, Cleveland, Ohio, by letter March
28, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 323 packages containing 12 suppositories each were
distributed.
REASON Product distributed after September 1994 ruling regarding
live yeast cell derivative (LYCD) content.
_______________
PRODUCT Bisacodyl Suppositories, 10 Mg, USP. Non-prescription
laxative, in aluminum foil packages of 8s, 12s, 50s, 100s,
500s and 1000s, marketed under firm's own label and the
following private labels:
-SUPERX - Bisacodyl Suppositories U.S.P., Distributed by
SUPERX DRUGS Cincinnati, Ohio 45246
-REVCO Bisacodyl U.S.P. LAXATIVE (bisacodyl suppositories)
Dist. by REVCO D.S., Inc. Twinsburg, Ohio 44087
-RUGBY Bisacodyl Suppositories, Dist. by Rugby Laboratories,
Inc., Rockville Centre, N.Y. 11570
-BIG B DISCOUNT DRUGS Gentle Laxative Suppositories
(Bisacodyl USP) Distributed By: BIG B DISCOUNT DRUGS,
Birmingham, AL. Recall #D-109-5.
CODE Batch# Exp. Batch# Exp. Batch# Exp.
M250 4/95 N091 7/95 O084 11/95
M303 4/95 N140 7/95 O085 11/95
M304 4/95 N245 8/95 0086 11/95
M428 4/95 N246 8/95 O087 11/95
M429 4/95 N247 8/95 O093 11/95
M430 4/95 N308 8/95 O254 12/95
Batch# Exp. Batch# Exp. Batch# Exp.
M584 5/95 N309 8/95 O255 12/95
M585 5/95 N310 8/95 O256 12/95
M586 5/95 N366 8/95 O257 12/95
M588 5/95 N367 8/95 O258 12/95
M589 5/95 N368 8/95 O259 12/95
M687 5/95 N447 8/95 O304 1/96
M688 5/95 N448 8/95 O305 1/96
M689 5/95 N449 8/95 O306 1/96
M793 6/95 N521 9/95 O363 2/96
M794 6/95 N522 9/95 O364 2/96
M795 6/95 N523 9/95 O614 2/96
M856 6/95 N700 10/95 O619 3/96
M857 6/95 N701 10/95 O823 3/96
M858 6/95 N702 10/95 O824 3/96
M953 6/95 N703 10/95 O825 3/96
M954 6/95 N722 10/95 O826 3/96
M955 6/95 N723 10/95 O827 3/96
M956 6/95 N724 10/95 O931 3/96
M960 6/95 N725 10/95 O974 3/96
M961 7/95 N950 11/95 O975 3/96
N089 7/95 N951 11/95 O977 3/96
N090 7/95 N952 11/95 O978 3/96
-5- P315 5/96 R879 1/97 T476 8/97
P394 5/96 R880 1/97 T477 8/97
P588 6/96 R881 1/97 T478 9/97
P589 6/96 R882 1/97 T628 9/97
P590 6/96 R933 1/97 T629 9/97
P591 6/96 R934 1/97 T630 9/97
P592 7/96 R935 2/97 T631 10/97
P675 7/96 S333 4/97 T632 10/97
P676 7/96 S334 4/97 T950 10/97
P734 7/96 S335 4/97 T951 10/97
P735 7/96 S336 4/97 T952 10/97
P736 7/96 S337 4/97 T953 10/97
P867 8/96 S647 5/97 U370 11/97
P868 8/96 S648 5/97 U371 11/97
P869 8/96 S649 5/97 U375 11/97
R007 9/96 S650 5/97 U376 11/97
R008 9/96 S651 5/97 U585 12/97
R009 9/96 S764 5/97 U586 1/98
R010 9/96 S765 6/97 U587 1/98
R050 9/96 S766 6/97 U701 1/98
R052 9/96 S854 6/97 U702 1/98
R110 9/96 S855 6/97 U843 1/98
R111 9/96 S856 6/97 U844 2/98
R112 9/96 S951 6/97 U845 3/98
R350 10/96 S998 6/97 V080 3/98
R351 10/96 T043 6/97 V081 3/98
R352 10/96 T203 7/97 V401 4/98
R353 10/96 T204 7/97 V402 4/98
R521 11/96 T205 7/97 V506 5/98
R774 12/96 T270 7/97 V507 5/98
R775 12/96 T271 7/97 V508 5/98
R776 12/96 T272 7/97 V592 5/98
R777 1/97 T273 8/97 V593 5/98
R878 1/97 T475 8/97 V676 5/98
V677 5/98 V681 6/98 V800 6/98
V678 5/98 V682 6/98 V801 6/98
V679 5/98 V683 6/98 W054 7/98
V680 5/98 V684 6/98 W055 7/98
M689 5/95 O613 2/96 O364 2/96
P736 7/96
MANUFACTURER Clay Park Laboratories, Inc., Bronx, New York.
RECALLED BY Manufacturer, by letter to be mailed on April 17, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY A total of 758,339 labeled packages were distributed to date
(427,466/8s; 272,014/12s; 7,526/50s; 49,986/100s;
1,171/500s; 176/1000s). This product was also sold in bulk
to two customers (E-Z EM Inc., and P. F. Laboratories).
REASON Subpotency.
-6- _______________
PRODUCT Supac Analgesic Tablets, in 100 and 1000 count bottles, OTC
pain reliever. Recall #D-110-5.
CODE Lot 4J21 EXP 9/97.
MANUFACTURER Mission Pharmacal Company, San Antonio, Texas.
RECALLED BY Manufacturer, by letter March 23, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Sri Lanka.
QUANTITY 2,964 100-tablet and 299 1000-tablet bottles were
distributed; firm estimated that 20-30 percent of product
remained on market at time of recall.
REASON Product does not meet uniformity specifications for the
caffeine ingredient.
_______________
PRODUCT Hemorrhoidal A Suppositories, 2.08 grams, packed in 12s,
24s, 100s, and 1000s aluminum foil blister packages under
the Clay Park Labs and Eckerd Drug labels, a
non-prescription drug. Recall #D-111-5.
CODE Lot # EXP Lot # EXP
S704 06/95 U746 01/96
T004 06/95 U847 01/96
T133 07/95 U984 02/96
T775 09/95 V319 04/96
T949 10/95 V591 05/96
U232 10/95 V996 07/96
U409 11/95 W267 08/96
U410 11/95 W515 09/96
U584 12/95 W993 11/96
U699 01/96 X133 12/96
U700 01/96.
MANUFACTURER Clay Park Laboratories, Inc., Bronx, New York.
RECALLED BY Manufacturer, by letter March 30, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION New York, New Jersey, California, Ohio, Florida, Georgia,
Texas, Pennsylvania, Mississippi, Tennessee, Massachusetts,
Arkansas, Alabama, Indiana, Ohio, Puerto Rico, Hong Kong.
QUANTITY Approximately 75,185 units were distributed.
REASON Stability data does not support expiration date.
HUMAN TISSUE MANDATORY
RECALLS:============================================
_______________
PRODUCT Human Tissue From Cadaveric Donors, indicated for human
transplant. Recall #B-198-5.
CODE Donor numbers:
AK9408002, BA9303001, BA9303002, BA9304001, BA9304003,
BA9305004, BA9305006, BA9306001, BA9306003, BA9306004,
BA9306005, BA9306006, BA9307008, BA9307010, BA9307011,
BA9308007, BA9308008, BA9308009, BA9308010, BA9309002,
BA9309003, BA9309004, BA9309005, BA9309006, BA9309008,
BA9309009, BA9310009, BA9310012, BA9310013, BA9310014,
-7- BA9310015, BA9310016, BA9310017, BA9310018, BA9311001,
BA9311002, BA9311003, BA9311005, BA9311006, BA9311007,
BA9311008, BA9311009, BA9312001, BA9312003, BA9312004,
BA9312005, BA9312006, BA9312007, BA9312008, BA9312009,
BA9312010, BA9312011, BA9312013, BA9401002, BA9401005,
BA9401006, BA9401008, BA9401009, BA9402003, BA9402004,
BA9402005, BA9402007, BA9402008, BA9402009, BA9402010,
BA9402011, BA9402012, BA9402013, BA9403002, BA9404001,
BA9406007, BA9406008, BA9406008, BA9406009, BA9406009,
BA9406010, BA9406011, BA9406012, BA9406013, BA9408004,
BA9408005, BA9408006, BA9408008, BA9408010, BA9408012,
BA9408013, BA9408014, BA9408015, BA9409001, BA9409002,
BA9409003, BA9409004, BA9409006, BA9409007, CA9104098,
CA9108099, CA9201043, CA9203102, CA9204093, CA9208081,
CA9209013, CA9209021, CA9209072, CA9304043, CA9304085,
CA9305097, CA9306011, CA9306074, CA9308061, CA9309110,
CA9309115, CA9310150, CA9312012, CA9312016, CA9401054,
CA9401082, CA9401110, CA9402006, CA9402091, CA9403063,
CA9403075, CA9403109, CA9406110, CA9407057, CA9408047,
CA9409017, CA9409108.
MANUFACTURER Lions Doheny Eye and Tissue Bank, Los Angeles, California.
RECALLED BY Manufacturer, by letters dated November 1, 1994, and
December 5, 1994. FDA ordered recall ongoing.
DISTRIBUTION California, Florida, Indiana, New Jersey, New York, Georgia,
Washington, D.C., Argentina, Canada, Egypt, France, Greece,
Israel, Italy.
QUANTITY All lots involved.
REASON Human tissue from cadaveric donors was distributed which:
(1) lacked adequate documentation about the donors' relevant
medical history related to risk factors for, or clinical
evidence of, hepatitis B, hepatitis C, or human
immunodeficiency virus (HIV) infection; or (2) the donor
tested repeatedly reactive for hepatitis B surface antigen
(HBsAg).
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-195/196-5.
CODE Unit #2982243.
MANUFACTURER Central Florida Blood Bank, Inc., Orlando, Florida.
RECALLED BY Manufacturer, by letter July 1, 1994. Firm-initiated recall
complete.
DISTRIBUTION Florida.
QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a donor who had a
history of nose piercing within 12 months of donation, were
distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-201/202-5.
-8- CODE Unit #2130944.
MANUFACTURER Manatee Community Blood Center, Inc., Brandenton, Florida.
RECALLED BY Manufacturer, by letter dated November 29, 1994. Firm-
initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit of each component.
REASON Blood products, which tested initially reactive for the
hepatitis B surface antigen (HBsAg) followed by a single
repeat negative test for HBsAg, were distributed.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-203-5.
CODE Unit #L24042.
MANUFACTURER South Bend Medical Foundation, Inc., South Bend, Indiana.
RECALLED BY Manufacturer, by telephone August 4, 1992. Firm-initiated
recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit.
REASON Blood product, which tested repeatedly reactive for the
antibody to the human immunodeficiency virus type 1 and 2
(anti-HIV-1/2), was distributed.
_______________
PRODUCT Whole Blood CPDA-1. Recall #B-204-5.
CODE Unit 5012683.
MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City,
Missouri.
RECALLED BY Manufacturer, by letter dated May 25, 1994. Firm-initiated
recall complete.
DISTRIBUTION Missouri.
QUANTITY 1 unit.
REASON Blood product, which tested negative for the antibody to the
human immunodeficiency virus type 1(anti-HIV-1) but was
collected from a donor who previously tested repeatedly
reactive to anti-HIV-1, was distributed.
_______________
PRODUCT Platelets, Pheresis. Recall #B-206-5.
CODE Unit #P01327.
MANUFACTURER South Bend Medical Foundation, Inc., South Bend, Indiana.
RECALLED BY Manufacturer, by telephone June 29, 1992. Firm-initiated
recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit.
REASON Blood product, which tested negative for the antibody to the
human immunodeficiency virus type 1 and 2 (anti-HIV-1/2) but
was collected from a donor who previously tested repeatedly
reactive for anti-HIV-1/2, was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-207-5.
CODE Unit #R20646.
-9- MANUFACTURER Walter L. Shepeard Community Blood Center, Augusta, Georgia.
RECALLED BY Manufacturer, by letter November 7, 1994. Firm-initiated
recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit.
REASON Blood product, which tested negative for the antibody to the
hepatitis B core antigen (anti-HBc) but was collected from a
donor who previously tested repeatedly reactive for anti-
HBc, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-208/209-5.
CODE Unit #E06025.
MANUFACTURER Walter L. Shepeard Community Blood Center, Augusta, Georgia.
RECALLED BY Manufacturer, by letter February 10, 1994. Firm-initiated
recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit of each component.
REASON Blood products, which tested initially reactive for the
antibody to the hepatitis B core antigen (anti-HBc), were
distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-218-5.
CODE Unit #R96189.
MANUFACTURER Mississippi Valley Regional Blood Center, Davenport, Iowa.
RECALLED BY Manufacturer, by telephone August 25, followed by letter
November 23, 1994. Firm-initiated recall complete
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product, which was improperly tested for the antibody
to the human immunodeficiency virus type 1 (anti-HIV-1), was
distributed.
RECALLS AND FIELD CORRECTIONS -- BIOLOGICS -- CLASS III
===================
_______________
PRODUCT Source Plasma. Recall #B-205-5.
CODE Unit NRD529.
MANUFACTURER Sera-Tec Biologicals, Inc., Fort Wayne, Indiana.
RECALLED BY Manufacturer, by telephone March 31, 1994. Firm-initiated
recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit.
REASON Source Plasma, which was collected from a donor who
previously tested positive for syphilis, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-210/211-5.
CODE Unit #1141915.
MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City,
Missouri.
-10- RECALLED BY Manufacturer, by letter May 25, 1994. Firm-initiated recall
complete.
DISTRIBUTION Missouri, Kansas.
QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a donor who tested
initially negative for the antibody to the hepatitis B core
antigen (anti-HBc) but on a subsequent donation tested
repeatedly reactive for anti-HBc, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Red Blood Cells - Leukocytes
Removed; (c) Platelets; (d) Fresh Frozen Plasma; (e)
Recovered Plasma. Recall #B-212/216-5.
CODE Unit numbers: (a) 4449525, 4449527, 2259316, 4143774,
4143785, 4450305, 4450369, 4450457; (b) 1903110, 4450307;
(c) 4449525, 4449527, 1903110, 4143774, 4450303, 4450306,
4450310, 4450363, 4450364, 4450369, 4450403, 4450412; (d)
1903110; (e) 4449525, 4449527, 4143785, 4143774.
MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, Florida.
RECALLED BY Manufacturer, by telephone, followed by letter dated
December 12, 1994. Firm-initiated recall complete.
DISTRIBUTION Ohio, Florida, Massachusetts, California, Tennessee.
QUANTITY (a) 8 units; (b) 2 units; (c) 12 units; (d) 1 unit; (e) 4
units.
REASON Blood products, which were collected from donors whose
health history screening were inadequately performed, were
distributed.
_______________
PRODUCT Platelets. Recall #B-217-5.
CODE Unit #1186273.
MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City,
Missouri.
RECALLED BY Manufacturer, by telephone August 21, 1994. Firm-initiated
recall complete.
DISTRIBUTION Missouri.
QUANTITY 1 unit.
REASON Platelets which were not stored under continuous agitation
were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Siemens MEVASIM Radiation Therapy Simulator Systems with
plastic rotatable cassette holders, teletherapy planning
systems for the treatment of cancer:
(a) MEVASIM Radiation Therapy Simulator System;
(b) MEVASIM 2 Radiation Therapy Simulator System;
(c) MEVASIM S Radiation Therapy Simulator System;
(d) MEVASIM S/27 Radiation Therapy Simulator System.
Recall #Z-335/338-5.
CODE All serial numbers.
-11- MANUFACTURER Mecaserto, St. Thibault-des-Vigenes, France.
RECALLED BY Siemens Medical Systems, Inc., Concord, California, by
letters mailed week of May 23, 1994. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 259 units are subject to field correction.
REASON Assemblies used to attach the rotatable cassette holder to a
MEVASIM system may fail causing the cassette holder assembly
to fall.
_______________
PRODUCT 5 in 1 Sterile Plastic Tubing Connectors, single use.
Recall #Z-601-5.
CODE Lot numbers: 9776, 9777, 9778, 9779 representing all lots.
MANUFACTURER MCP Industries, Inc., Decatur, Alabama.
RECALLED BY Sterile Design, Division of Maxxim Medical, Clearwater,
Florida, by letter February 14, 1995. Firm-initiated recall
complete.
DISTRIBUTION Alabama, Arkansas, California, Florida, Georgia,
Massachusetts, Mississippi, Missouri, New Jersey, North
Carolina, Pennsylvania, South Carolina, Tennessee, Texas,
West Virginia.
QUANTITY Approximately 216,000 devices were manufactured and are
subject to recall.
REASON The sterility of the connectors has been compromised due to
inadequate documentation to assure adequate sterilization.
_______________
PRODUCT MP Video, Medicam 900 Insufflator Sterile Disposable Filter
and Tubing Set. Recall #Z-602-5.
CODE Product #01-5212, Lot #AF4L0002.
MANUFACTURER Cybermedic, Boulder, Colorado.
RECALLED BY MP Video, Medway, Massachusetts, by telephone or by fax
January 26, 1995, followed by letter January 27, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Connecticut, Florida, Illinois, Massachusetts, Maine, North
Carolina, New Hampshire, New York, Texas, Utah, Wisconsin,
Chile, Spain, Colombia, Belgium.
QUANTITY 63 cases (10 bags per case) were distributed.
REASON The sterility of the device has been compromised as
evidenced by loss of package integrity.
_______________
PRODUCT Sterile Design Custom Surgical Procedure Trays containing
Coated VICRYL Sutures (NOTE: Only the referenced sutures
made by Ethicon are under recall NOT the entire surgical
tray). Recall #Z-603/635-5.
MOD/CAT#
CODE Akron City Hosp 87/ACH01AO, 88/ACH01AO,
89/ACH01AO
-12- Baptist Hospital Nashville 70/BH33NT, 68/BH33NT, 71/BH33NT
Baptist Med Ctr 48/BM04KCM, 46/BM04KCM
47/BM04KCM, 33/BMC12OCO
31/BMC12OCO, 32/BMC12OCO
35/BMC12OCO, 18/BMC23OCO
19/BMC23OCO, 34/BMC12OCO
Community Hosp 03/CH07MI, 03/CH09MI
03/CH08MI, 04/CH08MI
03/CH09MI, 04/CH07MI
04/CH09MI, 05/CH08MI
Cuyahoga Falls Hosp 03/CFGH17CFO, 04/CFGH17CFO
05/CFGH15CFO, 07/CFGH10CFO
08/CFGH10CFO, 03/CFGH18CFO
06/CFGH12CFO, 04/CFGH15CFO
02/CFGH18CFO
Cuyahoga Falls Hosp 04/CFGH18CFO, 01/CFGH19CFO
Dr. Michael Katz 17/MK01VF
Elyria Memorial 02/EMH03EC
Geisinger Med Ctr 30/GMC09DP, 57/GMC04DP
21/GMC10DP, 22/GMC10DP
40/GMC06DP
Gillette Childrens 18/GCH06SPM
Heb Harris Med 94/HEB01BT
Heb Harris Meth 19/HEB18BT, 20/HEB18BT
92/HEB01BT, 93/HEB01BT
Hillcrest Hospital 14/HH12MHO, 15/HH12MHO
Iowa Methodist 02/IMM02DI, 03/IMM02DI
Jennie Edmundson 26/JEH02CBI
Jewish Hospital 12/JH01LK, 13/JH01LK, 14/JH01LK
Lutheran General 01/LGH25PRI, 02/LGH25PRI
03/LGH25PRI
Mendocino Coast 32/MCH01FBC, 33/MCH01FBC
Menorah Medical Ctr 69/MMC10KCM, 50/MMC12KCM
51/MMC12KCM, 70/MMC10KCM
49/MMC12KCM, 68/MMC10KCM
Methodist Southlake 52/MH03MI, 53/MH03MI, 86/MH10MI
37/MH13MI
Mississippi Meth 25/MMRC05JM, 24/MMRC07JM
26/MMRC05JM
Missouri Baptist 94/MBHO4SLM, 95/MBH04SLM
96/MBH04SLM
N.C. Baptist Hosp 38/NCBH03WSNC, 86/NCBH01WSNC
87/NCBH01WSNC, 39/NCBH03WSNC
88/NCBH01WSNC, 40/NCBH01WSNC
90/NCBH01WSNC
Nix Med Ctr 14/NMC06SAT, 15/NMC06SAT
Sentara Leigh Hosp 71/LMH04NV
St. Anthony Med Ctr 49/SAMC11SLM
St. Catherine's Hosp 62/SCH13ECI
St. Clare Hosp 01/SCH09TW
St. Joseph Hosp MI 04/SJM04MI
St. Joseph Hosp 01/SJH11TF
-13- St. Mary Med Ctr 57/SMMC05HI, 58/SMMC05HI
11/SMMC06HI, 56/SMMC05HI
St. Marys Hosp 18/SMH20RV, 19/SMH20RV
22/SMH18RV, 20/SMH20RV
07/SMH19RV
Trinity Luth Hosp 78/TLH01KCM, 79/TLH01KCM
Williamsport Hosp 13/WHP03WP.
MANUFACTURER Sterile Design, Clearwater, Florida.
RECALLED BY Manufacturer, letters of September 16 and 19, 1994. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 1,873 trays were distributed.
REASON The sterility of the sutures contained in these devices
cannot be assured because of possible microorganism
contamination during aseptic processing, following
sterilization.
_______________
PRODUCT IV Extension Set with Add-on Filter, indicated for the IV
infusion of medical fluids. Recall #Z-636-5.
CODE Catalog #V5812, lot #F4K307.
MANUFACTURER McGaw, Inc., Sabana Grande, Puerto Rico.
RECALLED BY McGaw, Inc., Irvine, California, by letter December 22,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 643 cases were distributed.
REASON Due to an inadequate solvent bond, the product leaks between
the tubing and filter assembly, which could lead to under-
infusion and blood loss.
_______________
PRODUCT Groshong Catheter Trays: (a) 9.5 French Dual Lumen Groshong
Catheter Tray; (b) 7 French Single Lumen Groshong Catheter
Tray. Recall #Z-640/641-5.
CODE Product No. Lot No.
(a) 7726952 36IE1909
(b) 60366-4 36IE1909.
MANUFACTURER Bard Access Systems, Inc., Salt Lake City, Utah.
RECALLED BY Manufacturer, by telephone November 22, 1994, followed by
letter November 28, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Alabama, Arizona, California, Colorado, Florida, Illinois,
Michigan, New Hampshire, New Jersey, Oklahoma, Texas, West
Virginia.
QUANTITY 64 units were distributed.
REASON Mislabeling -- Single lumen catheters were inadvertently
mixed in with dual lumen catheters.
_______________
UPDATE Recall #Z-440/441-5, Zinetics 24 Single and Dual Channel
Internal Reference Catheters, manufactured by Zinetics
Medical, Inc., Salt Lake City, Utah, which appeared in the
March 8, 1995 Enforcement Report has been extended to
-14- include additional lot numbers:
Z-440-5 - Part #15-245, Lot #Z910;
Z-441-5 - Part #15-247-15, Lot numbers: Z917, Z963.
_______________
UPDATE Recall #Z-471-5, Pegasys 2.1 Software System, manufactured
by ADAC Laboratories, Milpitas, California, which appeared
in the March 15, 1995 Enforcement Report should read:
REASON: An error in the software could cause the upper
portion of the image to appear brighter than it should be.
The problem could lead to a misdiagnosis.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Rota-Stat, in-vitro diagnostic test kits, used to detect
rotavirus's. Recall #Z-638-5.
CODE Lot #12094.
MANUFACTURER Eldan Technologies Company, Ltd., Jerusalem, Israel.
RECALLED BY Isolab, Inc., Norton, Ohio, by letter February 1, 1995.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 41 kits were distributed.
REASON The control latex in this kit is clumping or agglutinating.
_______________
PRODUCT Sportrol Growth Promotion Test Suspension (Candida
albicans), used to test the growth properties of prepared
bacteriological media. Recall #Z-639-5.
CODE Lot #GCA009-08.
MANUFACTURER NAmSA, Northwood, Ohio.
RECALLED BY Manufacturer, by telephone, followed by letter dated January
30, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Japan.
QUANTITY 35 vials were distributed.
REASON The growth promotion test suspension is contaminated with
Bacillus species.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS I
============
_______________
PRODUCT Complete Feed, custom batch. Recall #V-025-5.
CODE Bulk custom mix.
MANUFACTURER Coldwater Grain Company, Coldwater, Ohio.
RECALLED BY Premiere Agri Technologies, Inc., doing business as Henwood
Feed Additives, Fort Wayne, Indiana, by telephone May 10,
1994. Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 3-ton batch was distributed. Product has been reworked
and relabeled.
REASON Superpotent for Arsanilic Acid.
-15- RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT Kent 18% Golden Nugget ASP 250 Medicated Type C Category II
pelleted feed, in 50-pound bags. Recall #V-027-5.
CODE Lot #R218A.
MANUFACTURER Kent Feeds, Inc., Rockford, Illinois.
RECALLED BY Manufacturer, by telephone February 10-13, 1995. Firm-
initiated recall complete.
DISTRIBUTION Illinois, Wisconsin.
QUANTITY 395 bags were distributed; firm estimates none remains on
the market.
REASON Feed was subpotent for penicillin.
-16-
END OF ENFORCEMENT REPORT FOR APRIL 12, 1995. BLANK PAGES MAY
FOLLOW.
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