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
03/08/1995
Recalls and Field Corrections: Foods -- Class I -- 03/08/1995
March 8, 1995 95-10
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Unlabeled twelve piece box of variety candies, in 4.5 ounce
boxes. Recall #F-482-5.
CODE None
MANUFACTURER Harry and David Corporation, Medford, Oregon.
RECALLED BY Manufacturer, by sending mailgram December 28, 1994,
followed by letter dated January 31, 1995 to non-
respondents. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 22,318 boxes were distributed.
REASON Product contains hazelnut paste which is not declared on the
label.
_______________
PRODUCT Petit Fours, Doboshettes, Brownies and any gift pack
containing any of these products packaged and distributed by
Figi's, Inc.: (a) Gift #382 The Grandstand; (b) Gift #443
Classic Petit Fours. Recall #F-483/484-5.
CODE 4258 to 4297 on the gift packs, distributed prior to
10/25/94.
MANUFACTURER The Swiss Colony, Monroe, Wisconsin.
RECALLED BY Figi's, Inc., Marshfield, Wisconsin, by telephone October
21, 1994, followed by letters sent October 24 & 25, 1994.
Firm-initiated recall complete.
DISTRIBUTION Nationwide, Japan, Ireland.
QUANTITY 113 gift packs were distributed.
REASON The petit fours, doboshettes, and brownies, which are in the
various gift packs, are or may be contaminated with Listeria
monocytogenes.
_______________
PRODUCT Frozen Crabmeat in 1 pound plastic containers.
Recall #F-485-5.
CODE Packer number C-73.
MANUFACTURER William & Laurice Hardie, Stonington, Maine.
RECALLED BY Maine Shellfish Company, Ellsworth, Maine, by letter January
9, 1995. Firm-initiated recall complete.
DISTRIBUTION Massachusetts, Maine, New Hampshire.
QUANTITY Approximately 600 pounds were produced.
REASON Product is contaminated with Listeria monocytogenes.
_______________
PRODUCT Various Saranac brand potato salads in 10 pound plastic
tubs:
(a) Potato Salad; (b) Potato Salad with Mustard;
(c) German Potato Salad. Recall #F-486/488-5.
CODE All potato salad manufactured prior to 11/22/94 with a Best
If Used By date of 12/20/94 or earlier.
MANUFACTURER Saranac Brand Foods, Inc., Saranac, Michigan.
RECALLED BY Manufacturer, by hand delivered letters December 13, 1994.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY (a) 735 tubs; (b) 84 tubs; (c) 8 tubs were distributed.
REASON Products contain undeclared sulfites.
_______________
PRODUCT Various bran breads: (a) Oat 'n Bran Bread, 1 pound 8
ounces; (b) Country Oven Oat & Bran Bread, 1 pound 8 ounces;
(c) Honey & Oat Bran Bread, 1 pound 8 ounces.
Recall #F-492/494-5.
CODE All production codes prior to 017.
MANUFACTURER Continental Baking Company, Anchorage, Alaska.
RECALLED BY Continental Baking Company, St. Louis, Missouri, by
telephone January 17, 1995. Firm-initiated recall complete.
DISTRIBUTION Alaska.
QUANTITY Approximately 800 loaves were distributed; firm estimates
that less than 400 loaves remained on market at time of
recall initiation.
REASON Products contain undeclared walnuts.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Fresh Carrots with tops packaged 2 dozen bunches per carton,
under the following labels: Andy Boy, Angle Food, Big Jim,
Cream of the Crop, Morgreen, River Ranch, Topless, Western
Express. Recall #F-475-5.
-2- CODE All carrots from grower's field.
MANUFACTURER Cream of the Crop, Salinas, California.
RECALLED BY Manufacturer, by telephone January 26 and 27, 1995. Firm-
initiated recall complete.
DISTRIBUTION Arizona, California, Massachusetts, New York, Canada.
QUANTITY 4,225 cartons were distributed.
REASON Product exceeds tolerance for Endosulfan in carrots.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Mountain Dew in 12 fluid ounce cans. Recall #F-477-5.
CODE Lot #E114H 23:25.
MANUFACTURER Pepsi Cola General Bottlers, Inc., Fort Wayne, Indiana.
RECALLED BY Manufacturer, by telephone on or about May 19, 1994. Firm-
initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 194 cases (24 cans per case) were distributed; firm
estimates none remains on the market.
REASON Product is contained in cans with defective lining.
_______________
PRODUCT Maple Walnut Ice Cream, packaged in 3 gallon cardboard bulk
containers. Recall #F-478-5.
CODE All bulk product manufactured in 1994 and in 1995 until
January 27, 1995.
MANUFACTURER Hagan Ice Cream Company, Uniontown, Pennsylvania.
RECALLED BY Manufacturer, by delivering a "Products Information Notice"
on February 1, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, Maryland, West Virginia, Ohio, Kentucky,
Virginia.
QUANTITY Undetermined.
REASON Product contains undeclared walnuts.
_______________
PRODUCT Butter Almond and Toasted Almond Fudge Ice Cream packaged in
3 gallon cardboard bulk containers. Recall #F-479/480-5.
CODE All bulk product manufactured in 1994 and in 1995 until
January 27, 1995.
MANUFACTURER Hagen Ice Cream Company, Uniontown, Pennsylvania.
RECALLED BY Manufacturer, by delivering a "Products Information Notice"
on February 1, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, Maryland, West Virginia, Ohio, Kentucky,
Virginia.
QUANTITY Undetermined.
REASON Products contain undeclared almonds.
_______________
PRODUCT Aqua Penn Spring Water, in 1 gallon PVC containers.
Recall #F-481-5.
CODE PRD 111594____(the last 4 digits would be a numeric code for
the time of manufacture).
MANUFACTURER Aqua Penn Spring Water Company, State College, Pennsylvania.
-3- RECALLED BY Manufacturer, by telephone, followed by letter.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 42,000 gallons were distributed; firm estimates that very
little product may remain on market.
REASON Product is contaminated with mold.
HUMAN TISSUE MANDATORY RECALLS:
===========================================
_______________
PRODUCT Human Banked Tissue, Skin From Cadaveric Donors.
Recall #B-193-5.
CODE All lots (donor numbers).
SUPPLIER Southern California Tissue Bank, Inc., Torrance, California.
RECALLED BY Supplier, by letter September 13, 1994. FDA ordered recall
complete.
DISTRIBUTION California.
QUANTITY 10 packages.
REASON Human skin tissue was distributed which lacked adequate
documentation of the donors' relevant medical history
related to risk factors for or clinical evidence of
hepatitis B, hepatitis C, or HIV infection.
_______________
PRODUCT Allograft Human Banked Tissue, Dehydrated and Frozen Human
Bone. Recall #B-194-5.
CODE Lot numbers: C-10, C-11, C-20, C-21, C-28, C-29, C-35,
C-36, C-38, C-40, C-44, C-46, C-49, C-50, C-51, C-53, C-61,
C-64, C-66, C-68, C-72, C-76, C-82, M-28.
SUPPLIER Flark Medical, Inc., Miami Beach, Florida.
RECALLED BY Allograft Technologies, Inc., doing business as San Diego
Regional Tissue Bank, San Diego, California, by letter
September 1, 1994. FDA ordered recall ongoing.
DISTRIBUTION Alabama, California, Colorado, Florida, Iowa, Maryland,
Minnesota, Nebraska, Nevada, New York, Ohio, Oregon,
Pennsylvania, South Dakota, Texas, Virginia, Washington
State, Puerto Rico.
QUANTITY Approximately 834 pieces were distributed.
REASON Human bone tissue was distributed which: 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; and lacked the required documentation of
the donors' medical histories in English as the original
record, or as a verified translation into English,
accompanied by the original record.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Red Blood Cells, Deglycerolized. Recall #B-176-5.
CODE Unit #1700075, 2127787, 2128060, 2128382, 7246281, 7246892,
8134610, 9111483, 9617809, 9617810.
-4- MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by letter November 2, 1993, by telephone
September 1994, followed by letters of October 28, 1994, and
November 8, 1994. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 10 units.
REASON Frozen Red Blood Cells which were deglycerolized using
outdated 12% sodium chloride, were distributed for
transfusion.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-177/178-5.
CODE Unit #13Y55354.
MANUFACTURER The American National Red Cross, Detroit, Michigan.
RECALLED BY Manufacturer, by letter August 5, 1993. Firm-initiated
recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit of each component.
REASON Blood products, collected from an ineligible donor due to a
reported history of cancer, were distributed for
transfusion.
_______________
PRODUCT Source Plasma. Recall #B-181-5.
CODE PH07943, PH08443, PH08791, PH08864, PH09068, PH09132,
PH09384, PH09534, PH11351, PH11662, PH11899, PH12010,
PH12225, PH12335, PH12525, PH12786, PH13135, PH13325,
PH13467, PH13717, PH14154, PH14286, PH14531, PH14612,
PH14877, XH03700.
MANUFACTURER American Plasma Corporation, Atlanta, Georgia.
RECALLED BY Community Bio-Resources, Inc., Columbus, Georgia, by letter
July 22, 1994. Firm-initiated recall complete.
DISTRIBUTION Michigan, Austria.
QUANTITY 26 units.
REASON Blood products, which tested negative for the hepatitis B
surface antigen (HBsAg), but were collected from a donor who
previously tested repeatedly reactive for HBsAg, were
distributed.
_______________
PRODUCT Source Plasma. Recall #B-182-5.
CODE XH04602, XH04689, XH04799, XH04895, XH05039, XH05106,
XH05182, XH05241, XH05537, XH05667, XH09058, XH09281,
XH09332, XH09397, XH09437, XH09513, XH09894, XH10051,
XH10088, XH10586, XH10636, XH10735, XH10838.
MANUFACTURER American Plasma, Corporation, Atlanta, Georgia.
RECALLED BY Community Bio-Resources, Inc., Columbus, Georgia, by letter
May 27, 1994. Firm-initiated recall complete.
DISTRIBUTION Michigan, Austria.
QUANTITY 23 units.
-5- REASON Blood products, which tested negative for the hepatitis B
surface antigen (HBsAg), but were collected from a donor who
previously tested repeatedly reactive for HBsAg, were
distributed.
_______________
PRODUCT (a) Platelets; (b) Platelets Pheresis. Recall #B-183/184-5.
CODE Unit numbers: (a) E09143; (b) P20669.
MANUFACTURER Central California Blood Bank, Fresno, California.
RECALLED BY Manufacturer, by telephone on or about December 31, 1994.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit of each component.
REASON Blood products, which were labeled with incorrect expiration
dates were distributed for transfusion.
_______________
PRODUCT (a) Red Blood Cells; (b) Cryoprecipitated AHF.
Recall #B-187/188-5.
CODE Unit #6507011.
MANUFACTURER Community Blood Centers, Lauderhill, Florida.
RECALLED BY Manufacturer, by letter June 22, 1994. Firm-initiated
recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit of each component.
REASON Blood products, which tested negative for syphilis, but were
collected from a donor who had previously tested positive
for syphilis, were distributed.
_______________
PRODUCT Platelets. Recall #B-189-5.
CODE Unit #1897827.
MANUFACTURER Palm Beach Blood Bank, Inc., West Palm Beach, Florida.
RECALLED BY Manufacturer, by fax July 26, 1994. Firm-initiated recall
complete.
DISTRIBUTION New York.
QUANTITY 1 unit.
REASON Blood product, which tested initially reactive for the
antibody to the hepatitis C virus encoded antigen(anti-HCV),
were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-174/175-5.
CODE Unit #G10495.
MANUFACTURER Central California Blood Bank, Fresno, California.
RECALLED BY Manufacturer, by letter December 1, 1993. Firm-initiated
recall complete.
DISTRIBUTION California.
-6- QUANTITY 1 unit of each component.
REASON Blood products, untested for syphilis were distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-179-5.
CODE Unit #13Y55354.
MANUFACTURER The American National Red Cross, Detroit, Michigan.
RECALLED BY Manufacturer, by letter August 5, 1993. Firm-initiated
recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit.
REASON Blood product, collected from an ineligible donor due to a
reported history of cancer was distributed for further
manufacture into injectable products.
_______________
PRODUCT Recovered Plasma. Recall #B-180-5.
CODE Unit numbers: C12160, C12384, C12428, C12481, C12745.
MANUFACTURER Sewickley Valley Hospital, Sewickley, Pennsylvania.
RECALLED BY Manufacturer, by fax October 6, 1994, followed by letter.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 5 units.
REASON Blood products, collected from autologous donors who did not
meet all the donor suitability requirements for allogeneic
use, were distributed.
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells. Recall #B-185/186-5.
CODE Unit numbers: (a) G11088; (b) E04128 (Irradiated), G11222,
H13493.
MANUFACTURER Central California Blood Bank, Fresno, California.
RECALLED BY Manufacturer, by telephone on or about December 31, 1994.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY (a) 1 unit; (b) 3 units.
REASON Blood products which were labeled with incorrect expiration
dates, were distributed for transfusion.
_______________
PRODUCT (a) Platelets; (b) Source Leukocytes. Recall #B-190/191-5.
CODE Unit #9427891.
MANUFACTURER Community Regional Blood Center, Inc., St. Petersburg,
Florida.
RECALLED BY Manufacturer, by letter August 4, 1994. Firm-initiated
recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a donor who had
received the Mumps, Measles, and Rubella (MMR) vaccine
within 4 weeks of the donation, were distributed.
-7- RECALLS AND FIELD CORRECTIONS -- DEVICES: CLASS II
=======================
_______________
PRODUCT Storz SuperSorb Micro Eye Sponge, Sterile/Single Patient
Use, Catalog #E0976, microsurgical sponge with handle for
ophthalmic surgery and other surgery where a small absorbent
sponge is needed. Recall #Z-283-5.
CODE Lot Nos. 30690, 13491, 24091, 7092, 2693, 14193, 33693,
2191, 16491, 24291, 22592, 2793,14693, 20893, 1994, 6491,
19691, 24791, 23192, 2993, 15393, 29293, 6894, 11491, 20491,
29191, 27692, 8493, 15493, 30893, 8294, 11591, 23191, 4992,
28292, 9193, 15993, 32293, 12391, 23491, 5092, 32592, 9793,
20393, 32893, 12791, 23891, 6492, 33792, 14093, 22293,
33493.
MANUFACTURER MB Industries, Granite City, Illinois (contract packager and
responsible firm).
RECALLED BY Storz Instrument Company, St. Louis, Missouri, by letter
August 30, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 13,754 25 10-sponge envelope boxes were distributed.
REASON Packaging defects were found affecting the seals of some of
the plastic pouches (envelopes) containing the sponges,
thereby compromising the sterility.
_______________
PRODUCT Adult CAPNO-FLO Manual Resuscitator with Carbon Dioxide
Level Monitors, swivel elbow with port, small adult mask,
Model K-4032. Recall #Z-404-5.
CODE Lot #64035.
MANUFACTURER Kirk Specialty Systems, (KSS) Carrollton, Texas.
RECALLED BY Manufacturer, by letter October 17, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide
QUANTITY (See Update for Kirk Specialty Systems below).
REASON The plugs may fracture if resuscitators are exposed to
temperatures greater than 140 degrees F. Inserts that
accompany the resuscitators contain a warning not to store
the resuscitators in direct sunlight or expose to excessive
heat; however, the insert does not specify what temperature
is excessive.
_______________
PRODUCT Free-LockTM Femoral Fixation System Depth Gauge, used to
measure the depth of holes drilled into bones for insertion
of bone pins in fracture fixation procedures.
Recall #Z-429-5.
CODE Product #1180-40. Lot numbers: 47669200 and 50012400.
MANUFACTURER Zimmer, Inc., Warsaw, Indiana.
RECALLED BY Manufacturer, by letter December 15, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 62 pieces subject to recall.
-8- REASON The number at the 30 mm mark on the measurement scale is 35
instead of 30.
_______________
PRODUCT Manuals for Medisafe Sonic Irrigator, utilizes water,
detergent and ultra sonic pressure waves to clean and remove
debris from instruments used in procedures that are hollow
and therefore susceptible to blood and tissue invasion of
the internal and working parts. Recall #Z-430-5.
CODE All codes.
MANUFACTURER Sharn, Inc., Tampa, Florida.
RECALLED BY Manufacturer, by letter May 4, 1994. Firm-initiated field
correction (relabeling) ongoing.
DISTRIBUTION Pennsylvania, Nebraska, California, Colorado, Ohio, Kansas,
Iowa, Indiana, Washington State, Kentucky, Texas, Montana,
New Jersey, North Carolina, New Mexico, Massachusetts,
Vermont.
QUANTITY 29 units.
REASON The devices were being marketed for the intended use without
510k) clearance.
_______________
PRODUCT Biological Indicators for both steam and ethylene oxide
sterilizers:
(a) Proof Plus Self-Contained Biological Indicator;
(b) Proof Dual-Pack Biological Challenge Test;
(c) Proof Plus, packaged 10 vials per case;
(d) Proof Plus Sampler, packaged 3 vials per case;
(e) Proof Dual-Pack Sampler;
(f) Healthcare Kit, a sampler of AMSCO products for
healthcare use, kit includes one Proof Dual-Pack Sampler;
(g) Scientific Kit, a sample of AMSCO products for
scientific use, kit includes one Proof Plus Ampler.
Recall #Z-431/437-5.
CODE All lots within expiration.
MANUFACTURER AMSCO International, Inc., Apex, North Carolina.
RECALLED BY AMSCO International, Pittsburgh, Pennsylvania, by letter
December 19 and 20, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 51,037 cases were subject to recall.
REASON The firm was not able to validate the 24-hour reduced
incubation claim for steam processing; data indicated longer
grow-out times were needed to get an accurate read of the
results.
_______________
PRODUCT Zinetics 24 Single and Dual Channel Internal Reference
Catheters: (a) Part #15-245; (b) Part #15-247-05.
Recall #Z-440/441-5.
CODE Lot numbers: (a) Z926, Z961; (b) Z914, Z928, Z959.
MANUFACTURER Zinetics Medical, Inc., Salt Lake City, Utah.
-9- RECALLED BY Manufacturer, by letter on or about March 1, 1995. Firm-
initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 420 units were distributed; firm estimated that 268 units
remained on market at time of recall initiation.
REASON The telephone plugs fail to mate properly with the
receptacle of the recording instrument during use.
_______________
PRODUCT IV Administration Sets: (a) AVI Model 8C1230 Burette IV
Administration Set; (b) AVI Model 1610 Burette Neonatal-
Pediatric IV Administration Set; (c) AVI Model 8C2650
Filter/Burette IV Administration Set; (d) Model 8C1295 IV
Administration Set. Recall #Z-447/450-5.
CODE Lot numbers: (a) APR94K03; (b) MAR94K06; (c) FEB94K04,
SEP93K08; (d) AUG94K07.
MANUFACTURER Korea Green Cross Corporation, Seoul, South Korea.
RECALLED BY 3M Infusion Therapy, Arden Hills, Minnesota, by sending
"Urgent: Customer Notices", dated December 13, 1994,
followed by telephone. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Denmark, Argentina.
QUANTITY 797 boxes (30 sets per box) were distributed; firm estimated
that 100 boxes remained on market at time of recall
initiation.
REASON The sets would leak at connections of the lower piece of
tubing to the y-site and to the luer lock.
_______________
PRODUCT Datascope Passport Monitor with EL Panel Display, a portable
bedside patient monitoring device which can also be used in
transport mode. Recall #Z-456-5.
CODE All serial numbers below 15,000 having al EL decal on the
lower right section of the panel display. Model numbers
0998-00-0095-21 to 22, 24, 41 to 56, 61 to 64, 66, 68, 70 to
76, N41 to N44, H41 to H44, B41 to B44, H49 to H52, N61 to
N64, H61 to H64, B61 to B64, and H70 to H72.
MANUFACTURER Datascope Corporation, Paramus, New Jersey, by letter
November 3, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 8,689 units were distributed.
REASON The resistor can become hot when certain other components
fail, which in turn can cause the front panel of the device
to become too hot to touch.
_______________
PRODUCT Hewlett Packard Anesthetic Gas Analyzer, Model M1025B.
Recall #Z-457-5.
CODE Serial numbers shipped between 11/93 and 8/94: 3244D00399
and serial numbers between 3244D0096 and 3244D01255,
excluding 3244D00997, 3244D01000, 3244D01156, 3244D0152,
3244D00998, 3244D01137, 3244D01169, 3244D00999, 3244D01151,
3244D01237.
-10- MANUFACTURER Hewlett Packard GmbH, Medical Products Group - Europe,
Boebilingen, Germany; Hewlett Packard Company, Andover,
Massachusetts (U.S. importer).
RECALLED BY Manufacturer, by letter September 7, 1994. Firm-initiated
field correction ongoing.
DISTRIBUTION Alabama, Arkansas, Arizona, California, Florida, Georgia,
Illinois, Indiana, Louisiana, Maryland, New York, North
Carolina, Oregon, Pennsylvania, Texas, Vermont.
QUANTITY 98 units.
REASON A manufacturing process change may cause up to 50 percent
drift in the measured values of respired and anesthetic
gases (i.e. displayed values to be as little as half the
actual gas concentrations).
_______________
UPDATE Kirk Specialty Systems Pediatric, Infant and Adult CAPNO-FLO
Manual Resuscitators with Carbon Dioxide Level Monitors,
Recall Numbers Z-127/134-5; Z-136/140-5; Z-142-5 which
appeared in the January 4, 1995 Enforcement Report has been
extended to include additional lots:
Z-127-5 Model K-4130 Lots 84001, 84057;
Model K-4130EA Lots 54072, 64017,
74038, 84031;
Z-128-5 Model K-4133 Lots 54086, 64013,
64059, 84008, 84030,
Model K-4133EA Lots 54067, 54096,
64006, 64030, 74012,
84005, 84032;
Z-129-5 Model K-4143 Lots 64011, 74024;
Model K-4143EA Lot 64021;
Z-130-5 Model K-4230 Lots 64060 and 74024;
Model K-4230EA Lots 54071, 64018,
74039, 84034 and
84037;
Z-131-5 Model K-4235 Lots 54087, 64001,
64061, 74026, 74027,
84051;
Model K-4235EA Lots 54095, 64005,
64022, 74013, 74023,
74028, 74029, 84018,
84033, 84036;
Z-132-5 Model K-4245 Lot 84006;
Model K-4245EA Lots 84010, 84049
Z-133-5 Model K-4000 Lots 54085, 64023,
64041, 74018, 74040;
Model K-4000EA Lots 54066, 64012,
84019, 84029, 84055;
Z-134-5 Model K-4001 Lots 54084, 64002,
64024, 64056, 74021,
74041;
Model K-4001EA Lots 54063, 64057,
84020, 84053;
-11- Z-136-5 Model K-4020 Lots 54053, 64008,
64040, 74017, 84003,
84046;
Model K-4020EA Lots 54062, 64009,
64042, 74037, 84015,
84045, 84047;
Z-137-5 Model K-4021 Lots 54065, 64003,
64019, 64053, 74023,
74045, 84027, 84043;
Model K-4021EA Lots 64010, 64020,
64052, 74022, 74030,
74046, 84004, 84035,
84040;
Z-138-5 Model K-4022 Lots 54074, 84021;
Z-139-5 Model K-4027 Lot 84022;
Model K-4027EA Lots 84024, 84054;
Z-140-5 Model K-4031 Lots 54076, 74016,
84042;
Model K-4031EA Lot 64051
Z-142-5 Model K-4521 Lots 54073, 54090,
64025, 64062, 84017;
Model K-4521EA Lots 63034, 64034, and
84044.
MANUFACTURER Kirk Specialty Systems (KSS), Carrollton, Texas.
RECALLED BY Manufacturer, by letter October 17, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 6,094 units were distributed (includes quantity for Model K-
4032 listed above).
REASON The plugs may fracture if resuscitators are exposed to
temperatures greater than 140 degrees F. Inserts that
accompany the resuscitators contain a warning to store the
resuscitators in direct sunlight or expose to excessive
heat; however, the insert does not specify what temperature
is excessive.
_______________
UPDATE BLD Pulmanex Manual Resuscitators. Please disregard
previous recall numbers Z-397/402-5, which appeared in the
February 22, 1995 Enforcement Report. These numbers will be
reassigned. The following is the new and revised text for
that recall:
PRODUCT (a) Catalog No. 9150, Pediatric Pulmanex, 40" Hose
Reservoir, Swivel Elbow with no ports, Pediatric Mask -
Packed in clamshells, six per case;
(b) Catalog No. 9050-2, Adult Pulmanex, 40" Hose Reservoir,
Swivel Elbow, with no ports, Packed in folding cartons, 24
per case;
(c) Catalog No. 9050-471, Adult Pulmanex, 40" Hose
Reservoir, Swivel Elbow with no ports, Adult Mask - Packed
in folding cartons, 16 per case;
-12- (d) Catalog No. 9050-7, Adult Pulmanex, 40" Hose Reservoir,
Swivel Elbow with no ports, Adult Mask - Packed in polybags,
16 per case;
(e) Catalog No. 9050-877, Adult Pulmanex, 60" Hose
Reservoir, Standard Elbow Adult Mask - Packed in polybags,
six per case;
(f) Catalog No. 9070-2, Adult Pulmanex, 60" Hose Reservoir,
Bonded Swivel Elbow with no ports, Adult Mask - Packed in
folding cartons, 24 per case;
(g) Catalog No. 9070-7, Adult Pulmanex, 60" Hose Reservoir,
Bonded Swivel Elbow with no ports, Adult Mask - Packed in
polybags, six per case. Recall #Z-477/483-5.
CODE Lot numbers: (a) 448082; (b) 448048; (c) 448054;
(d) 448081; (e) 448047; (f) 448112; (g) 448035.
MANUFACTURER Bird Life Design (BLD), Dallas, Texas.
RECALLED BY Manufacturer, by telephone December 9, 1994. Firm-initiated
recall complete.
DISTRIBUTION Alabama, Illinois, Kentucky, Louisiana, New York, Ohio,
Oklahoma, Texas.
QUANTITY Firm estimates none remains on the market.
REASON There was a potential for cracking at the attachment point
of the hose type oxygen reservoir to the bag, which results
in a weakening of the rear housing allowing the hose to be
broken off the resuscitator.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Software for Fonar Ultimate 3000 and Beta Models B-3000/B-
3000M MRI Scanners fixed and mobile sites, used in the
production of images of multiple planes in the head and the
body. Recall #Z-427/428-5.
CODE Software Versions: 2.2, 3.0, 1 (2/7/94), 1 (8/93);
Sites -- B-3000: 039, 047, 048, 050, 062;
Ultimate: 177, 187.
MANUFACTURER Fonar Corporation, Melville, New York.
RECALLED BY Manufacturer, by field update letters August 31, 1994.
Firm-initiated field correction ongoing.
DISTRIBUTION New York, Texas, California, Florida, and international.
QUANTITY Out of 103 active sites, 7 need to be brought up to the
latest software version.
REASON The software had several "bugs" which impeded proper
functioning.
_______________
PRODUCT Dade Fibrinogen Degradation (FDP) Detection Set which
determines the presence of FDP/fdp in serum or urine.
Recall #Z-475-5.
CODE Baxter Diagnostic of PR Inc., Aguada, Puerto Rico.
RECALLED BY Baxter Diagnostic, Inc., Miami, Florida, by letter dated
December 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
-13- QUANTITY 233 kits containing 2 vials each were distributed.
REASON During testing the Fibrinogen Control recovered a negative
reaction on the 1:5 dilution which should be a positive
reaction.
MEDICAL DEVICE SAFETY ALERTS:
============================================
_______________
PRODUCT Mar Cor Dialysis Water Systems. Safety Alert #N-005-5.
CODE All distributed systems intended for use in hemodialysis are
involved.
MANUFACTURER Mar Cor Services, Inc., Harleysville, Pennsylvania.
ALERTED BY Manufacturer, by letter February 14, 1995.
DISTRIBUTION Pennsylvania, New York, New Jersey, Delaware,Alabama,
Maryland, Virginia.
QUANTITY 74 units were distributed.
REASON To alert customers to test their treated water to determine
if it meets AAMI standards against microbiological
contamination.
SEIZURES:
=================================================================
_______________
PRODUCTS Dry Heat Sterilizers, Steam Sterilizer Autoclaves, and
components thereof (93-700-673/4).
CHARGE Adulterated - The articles are class III devices for which
there are no approved premarket approval applications in
effect, nor do the articles have investigational device
exemptions.
LOCATION D.A. Kadan Co., Inc., Pineville, North Carolina.
FILED January 9, 1995; U.S. District Court for the Western
District of North Carolina; Civ. # 3:95CV1-H; FDC #66911.
SEIZED January 11, 1995 - goods valued at approximately $45,000.
_______________
PRODUCT Canned Mushrooms (95-786-249).
CHARGE Misbranded - The article's labeling is false and misleading
because it represents and suggests that the article was
packed and grown in Taiwan, which is contrary to fact.
LOCATION Grimes Distribution Services, Jacksonville, Florida.
FILED February 3, 1995; U.S. District Court for the Middle
District of Florida; Civ. #95-106-CIV-J-20; FDC #67042.
SEIZED February 13, 1995 - goods valued at approximately $57,600.
-14-
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