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.
May 13, 1998 98-19
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Manhattan Frozen Pineapple Fruit Bars, 2.5 fluid
ounces. Recall #F-478-8.
CODE All lots.
MANUFACTURER Manhattan Frozen Products, Inc., San Antonio,
Texas.
RECALLED BY Manufacturer, by letter March 31, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Louisiana, Oklahoma, Texas.
QUANTITY 33 cases (1,584 bars) were distributed.
REASON Product contains undeclared FD&C Yellow No. 5.
_______________
PRODUCT Ready-to-eat and microwaveable sandwiches:
a) Tuna Salad Sandwich
b) Chicken Salad Sandwich
c) Egg Salad Sandwich
d) Real Cuban Sandwich
e) Junior Real Cuban Sandwich
f) Submarine Sandwich
h) Cheeseburger Deluxe (microwaveable)
I) Super Deluxe Cheeseburger (microwaveable)
Recall #F-480/487-8.
CODE All sell by dates prior, but not including, 4/16.
MANUFACTURER A to Z Sandwich Company, Jacksonville, Florida.
RECALLED BY Manufacturer, by telephone on April 1, 1998.
Firm-initiated recall complete.
DISTRIBUTION Georgia, Florida.
QUANTITY Approximately 2,000-5,000 sandwiches remained on
market at time of recall initiation.
REASON Products contained undeclared FD&C Yellow
No. 5.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
============
_______________
PRODUCT Kendall Healthcare Products brand Modudose, 0.9%
Sodium Chloride (saline Solution), single use vial
for respiratory therapy, in 1.5, 3, and 5 mL
vials. Reorder 5251 - NDC 50738-010-18; Reorder
5257 - NDC 50738-010-19; Reorder PR5251 - NDC
50738-010-18.
Recall #D-120-8.
CODE All lot numbers.
MANUFACTURER Kendall Healthcare Products Company, Ocala,
Florida.
RECALLED BY Kendall Healthcare Products, Mansfield,
Massachusetts, by press release on April 9, 1998,
followed by letter April 10-13, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Product code numbers #5251 and #5257 - 41,946
cases and 6,851 cases respectively (1000 vials per
case); Product code #PR5251 - 216 cases; Product
code #0454 - 200 cases distributed.
REASON Microbial contamination-Ralstonia Pickettii
(formerly Bulkholderia Pickettii formerly
Pseudomonas Pickettii).
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Various OTC products, distributed under generic
and various brand names including Health Care,
Pharmacy Classics, Personal Care, and Equality
Health Care:
a) Liquid Antacid (Magnesium Hydroxide 200
mg/Aluminum Hydroxide 200 mg) in 12 fluid ounce
bottles
b) Liquid Antacid with Simethicone (Magnesium
Hydroxide 200 mg/Aluminum Hydroxide 200
mg/Simethicone 20 mg), in 12 fluid ounce bottles
c) Children's Acetaminophen Elixir (Acetaminophen
160 mg) cherry flavored in 4 fluid ounce bottles
d) Sore Throat Spray (Phenol 1.4%) alcohol/sugar
free, in 6 fluid ounce bottles
e) Children's Night Time (Dextromethorphan
Hydrobromide 15 mg/Chlorpheniramine Maleate 2
mg/Pseudoephedrine Hydrochloride 30 mg), in 6
fluid ounce bottles
f) Nightime(Nite Time) for Adults (Acetaminophen
1000 mg/Dextromethorphan Hydrobromide 30
mg/Doxylamine Succinate;
g) Pink Bismuth (Bismuth subsalicylate 262
mg/tablespoon) in 6 fluid ounce bottles
h) Pediatric Tussin (Dextromethorphan Hydrobromide
7.5 mg) in 4 fluid ounce bottles
I) Tussin Syrup/Tussin DM (Guaifenesin USP 100
mg/Dextromethorphan Hydrobromide USP 10 mg) in 4
fluid ounce bottles
j) Milk of Magnesia (Magnesium Hydroxide 400 mg)
in 12 fluid ounce bottles.
Recall #D-121/130-8.
CODE All lots on the market within expiration date.
MANUFACTURER South Atlantic Industries, Inc., Greenville, South
Carolina.
RECALLED BY Manufacturer, by letter on or about April 1, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Michigan, Mississippi, North Carolina, Georgia,
California, Ohio, Illinois, New York.
QUANTITY Undetermined.
REASON Lack of good manufacturing practice controls.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Hemocare Blood Bank Data Management System
Computer Software, Revision 5.1 & Version 3.1.
Recall #B-556-8.
CODE Revision 5.1 and Version 3.1.
MANUFACTURER Mediware Information Systems, Inc. (MISI),
Melville, New York.
RECALLED BY Manufacturer, by letter on September 30, 1997, and
by newsletter on December 15, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Singapore.
QUANTITY Out of 226 sites, 225 have 5.1 version released
May 1995 and 1 have 3.1 version released July
1992.
REASON Computer software that: 1) Was not functioning as
intended in that discrepant displays of ABO test
results could be accepted after a system warning
and supervisory override, which could potentially
result in the release of mistyped or mislabeled
blood products; and 2) Possesses limitations for
use that are not adequately described in labeling.
_______________
PRODUCT Platelets, Pheresis. Recall #B-732-8.
CODE Unit numbers: 12GW11973A, 12GW11973B.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by telephone and letter on January
22, 1998. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 2 units were distributed.
REASON Blood products had high platelet counts.
_______________
PRODUCT Red Blood Cells. Recall #B-825-8.
CODE Unit #40FK34209.
MANUFACTURER American Red Cross, Heart of America Region,
Peoria, Illinois.
RECALLED BY Manufacturer, by letter dated February 24, 1998.
Firm-initiated recall complete.
DISTRIBUTION Missouri and Maryland.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to a malarial endemic area.
_______________
PRODUCT Red Blood Cells. Recall #B-835-8.
CODE Unit #49J74052.
MANUFACTURER American Red Cross Blood Services, Norman,
Oklahoma.
RECALLED BY American Red Cross Blood Services, Tulsa,
Oklahoma, by letter dated March 9, 1998.
Firm-initiated recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
reported travel to an area designated as endemic
for malaria.
_______________
PRODUCT Red Blood Cells; b) Platelets.
Recall #B-838/839-8.
CODE Unit #42FG48476.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letter dated June 23, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
reported travel to an area designated as endemic
for malaria.
_______________
PRODUCT Red Blood Cells. Recall #B-840-8.
CODE Unit #42T53275.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by telephone on March 6, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with an
unacceptable hemoglobin.
_______________
PRODUCT Baxter Fenwal Blood-Pack Container Systems.
Recall #B-917-8.
CODE Lot # M97J****, M97K****, M97L****
Where "****" are variety of numerals.
MANUFACTURER Baxter Healthcare Corporation, Fenwal Division,
Deerfield, Illinois.
RECALLED BY Manufacturer, by letter dated February 17, 1998.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY Approximately 3,000,000 units were distributed.
REASON Leaking cannulas in Baxter's blood pack Containers
may cause the volume of anticoagulant to be
reduced due to the flow from the original blood
container to the attached tubing and empty
satellite packs.
_______________
PRODUCT a) Red Blood Cells; b) Platelets
c) Cryoprecipitated AHF
d) Fresh Frozen Plasma
e) Recovered Plasma. Recall #B-965/969-8.
CODE Contact FDA, Center for Biologics Evaluation and
Research, Office of Compliance (301) 827-6220 for
individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letters dated September 1, 1997,
October 1 and 24, 1997, or February 26, 1998.
Firm-initiated recall complete.
DISTRIBUTION Illinois, Iowa, North Carolina, South Carolina,
Idaho, Mississippi.
QUANTITY a) 32 units; b) 2 units; c) 1 unit; d) 11 units;
e) 14 units were distributed.
REASON Blood products tested negative for the 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.
_______________
PRODUCT a) Red Blood Cells
b) Red Blood Cells, Leukocytes Removed
c) Platelets; d) Platelets, Pheresis
e) Fresh Frozen Plasma
f) Fresh Frozen Plasma, Pheresis
g) Source Leukocytes, for further manufacture
h) Recovered Plasma, Frozen
I) Recovered Plasma, Liquid
j) Platelets, for further mfg.
Recall #B-977/986-8.
CODE Contact FDA, Center for Biologics Evaluation and
Research, Office of Compliance (301) 827-6220 for
individual unit numbers recalled.
MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by telephone and by letters dated
June 30, 1997. Firm-initiated recall complete.
DISTRIBUTION Indiana, Massachusetts, Utah, New Jersey,
Switzerland.
QUANTITY a) 31 units; b) 1 unit; c) 9 units; d) 11 units;
e) 4 units; f) 1 unit; g) 3 unit; h) 19 units; I)
2 units; j) 5 units were distributed.
REASON Blood products tested negative for HBsAg, HIVAG,
HTLV, or HBc but collected from donors who
initially tested reactive for HBsAg, HIVAG, HTLV,
or HBc, with units not retested in duplicate, and
donors were incorrectly reentered.
_______________
PRODUCT Red Blood Cells. Recall #B-988-8.
CODE Unit #21GV00550.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by letter dated February 25, 1998.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with a
history of cancer.
_______________
PRODUCT Platelets, Pheresis. Recall #B-989-8.
CODE Unit #21P74690.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by letter dated February 11, 1998.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose
spouse tested positive for hepatitis C.
_______________
PRODUCT Red Blood Cells. Recall #B-990-8.
CODE Unit #11C93144.
MANUFACTURER American Red Cross Blood Services, St. Louis,
Missouri.
RECALLED BY Manufacturer, by telephone on December 31, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was not quarantined after the donor
requested that the unit be destroyed.
_______________
PRODUCT Red Blood Cells. Recall #B-1015-8.
CODE Unit #3881294.
MANUFACTURER Camp Memorial Blood Center, Fort Knox, Kentucky.
RECALLED BY Manufacturer, by fax dated September 25, 1997 and
November 14, 1997. Firm-initiated recall
complete.
DISTRIBUTION Virginia, District of Columbia, New Mexico,
California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose
suitability was not adequately determined.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall
#B-1019/1020-8.
CODE Unit numbers: 29GP42535, 29GP47484, 29GS02456.
MANUFACTURER The American Red Cross, Norfolk, Virginia.
RECALLED BY Manufacturer, by letter dated January 20, 1998.
Firm-initiated recall complete.
DISTRIBUTION California, North Carolina, Virginia, Switzerland.
QUANTITY 3 units of each component were distributed.
REASON Blood products were collected from a donor taking
Megestrol.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1025/1026-8.
CODE Unit #3877744.
MANUFACTURER Camp Memorial Blood Center, Fort Knox, Kentucky.
RECALLED BY Manufacturer, by fax dated either August 7 or 8,
1997. Firm-initiated recall complete.
DISTRIBUTION Kentucky, Missouri, Pennsylvania.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor whose
suitability was not adequately determined.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1035/1036-8.
CODE Unit #3876773.
MANUFACTURER Camp Memorial Blood Center, Fort Knox, Kentucky.
RECALLED BY Manufacturer, by dated August 7, 1997.
Firm-initiated recall complete.
DISTRIBUTION California, Pennsylvania, New Jersey.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who had
taken medication within four weeks of donation.
_______________
PRODUCT Recovered Plasma. Recall #B-1052-8.
CODE Unit #16LN10163.
MANUFACTURER American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY Manufacturer, by fax on November 24, 1997.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with a
history of Multiple Sclerosis.
_______________
PRODUCT Red Blood Cells. Recall #B-1053-8.
CODE Unit #3872547.
MANUFACTURER Camp Memorial Blood Center, Fort Knox, Kentucky.
RECALLED BY Manufacturer, by fax on September 12, 1997.
Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who may
have traveled to an area considered endemic for
malaria.
_______________
PRODUCT Platelets, Pheresis. Recall #B-1054-8.
CODE Unit #P05801.
MANUFACTURER South Bend Medical Foundation, Inc., South Bend,
Indiana.
RECALLED BY Manufacturer, by telephone on March 6, 1998.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product was positive for anti-E antibodies
was labeled negative for unexpected antibodies.
_______________
PRODUCT a) Whole Blood; b) Red Blood Cells
c) Platelets; d) Platelets, Pheresis
e) Fresh Frozen Plasma; f) Plasma
g) Cryoprecipitated AHF
h) Recovered Plasma
I) Platelets, for further manufacture.
Recall #B-1055/1063-8.
CODE Contact FDA, Center for Biologics Evaluation and
Research, Office of Compliance (301) 827-6220 for
individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by telephone on September 27, 1996
and/or letters between October 3, 1996, and
September 23, 1997, and June 9, 1997 or October
10, 1997. Firm-initiated recall complete.
DISTRIBUTION Ohio, Wisconsin, Tennessee, California, New York,
Massachusetts, Florida, Switzerland.
QUANTITY a) 3 units; b) 76 units; c) 32 units; d) 49 units;
e) 2 units; f) 9 units; g) 3 units; h) 67 units;
I) 1 unit was distributed.
REASON Blood products tested negative for the antibody to
the human immunodeficiency virus type 1
(anti-HIV-1), but were collected from donors who
previously tested repeatedly reactive for
anti-HIV-1 and were incorrectly reentered.
_______________
UPDATE Red Blood Cells; Blood Cells, Leukocytes Removed;
Platelets, Fresh Frozen Plasma; Source Leukocytes;
Recovered Plasma, Recall #B-835/840-8, Central
Indiana Regional Blood Center, Inc., which
appeared in the April 22, 1998 Enforcement Report
has been recinded.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
______________
PRODUCT Red Blood Cells, Leukocytes Reduced.
Recall #B-836-8.
CODE Unit #11318-4356.
MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on March 5, 1998. Firm-initiated recall
complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was stored at an unacceptable
temperature.
_______________
PRODUCT Red Blood Cells. Recall #B-871-8.
CODE Unit numbers: GW25773 and GW26041.
MANUFACTURER Metropolitan Washington Blood Bank, Bethesda,
Maryland.
RECALLED BY Manufacturer, by telephone on or about January 22,
1997. Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 2 units were distributed.
REASON Blood products were labeled with an extended
expiration date.
_______________
PRODUCT Red Blood Cells. Recall #B-899-8.
CODE Unit #06GQ52620.
MANUFACTURER American Red Cross, Los Angeles, California.
RECALLED BY Manufacturer, by telephone on January 13, 1997.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was not quarantined after receiving
information concerning a post donation viral
infection.
_______________
PRODUCT Red Blood Cells. Recall #B-921-8.
CODE Unit numbers: 1412170 and 0261687.
MANUFACTURER Central Jersey Blood Center, Shrewsbury, New
Jersey.
RECALLED BY Manufacturer, by telephone on January 3, 1996.
Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 2 units were distributed.
REASON Blood products were labeled with an extended
expiration date.
_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-999/1000-8.
CODE Unit #11318-0525.
MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Blood Services, Inc., Scottsdale, Arizona, by
telephone on January 28, 1998. Firm-initiated
recall complete.
DISTRIBUTION Texas and New Mexico.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who's
suitability was not properly performed according
to the firm's procedures for medication deferral.
_______________
PRODUCT Red Blood Cells. Recall #B-1033-8.
CODE Unit #3881292.
MANUFACTURER Camp Memorial Blood Center, Fort Knox, Kentucky.
RECALLED BY Manufacturer, by fax dated September 25, 1997.
Firm-initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
reported having flu like symptoms.
_____________
PRODUCT Red Blood Cells. Recall #B-1034-8.
CODE Unit numbers: 13GQ06124, 13GZ27235, 13GZ27248.
MANUFACTURER American Red Cross Blood Services, Detroit,
Michigan.
RECALLED BY Manufacturer, by letter dated February 4, 1998.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 3 units were distributed.
REASON Blood products were leukoreduced greater than
seven days after collection.
_______________
PRODUCT Reduced Volume Platelets. Recall #B-1037-8.
CODE Unit #12R75503.
MANUFACTURER American Red Cross, Appalachian Regional Blood
Services, Roanoke, Virginia.
RECALLED BY Manufacturer, by telephone on February 27, 1998,
and by letter dated March 9, 1998. Firm-initiated
recall complete.
DISTRIBUTION West Virginia.
QUANTITY 1 unit was distributed.
REASON Unlicensed blood product was distributed in
interstate commerce.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1038/1039-8.
CODE Unit #2259840.
MANUFACTURER Camp Memorial Blood Center, Fort Knox, Kentucky.
RECALLED BY Manufacturer, by fax dated September 12, 1997, or
November 10, 1997. Firm-initiated recall
complete.
DISTRIBUTION Virginia, Georgia, District of Columbia.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
exceeded the donation acceptance criteria for body
temperature.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1050/1051-8.
CODE Unit #36245-2887.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated October 6, 1997. Firm-initiated
recall complete.
DISTRIBUTION California and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a
history of ulcerative colitis.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
==========
_______________
PRODUCT Tesio Extender Adaptor used with the Tesio
Catheter. The catheter extender is connected
after the catheter is inserted to allow for easier
access during dialysis treatments, and is part of
a hemodialysis access kit:
a) Part #MBR-6 Trays; b) Part #MBL-6 Trays.
Recall #Z-544/545-8.
CODE MBL-6'S EXP MBR-6'S EXP
M726310 11/02 M722710 09/02
M726320 11/02 M723740 10/02
M726920 11/02 M724260 10/02
M726930 11/02 M724350 10/02
M727450 11/02 M724640 10/02
M729700 12/02 M724680 10/02
M800910 01/03 M724960 10/02
M801550 01/03 M724980 10/02
M801850 2003/01 M725160 10/02
M801940 2003/01 M725170 10/02
M726330 11/02
M726340 12/02
M726350 12/02
M727900 11/02
M727980 12/02
M729000 12/02
M729430 12/02
M729540 12/02
M729710 12/02
M729720 12/02
M730050 01/03
M730730 01/03
M800180 01/03
M800190 01/03
M800900 01/03
M801870 2003/01.
MANUFACTURER Martech Medical Products, Inc., Harleysville,
Pennsylvania (component).
RECALLED BY Medical Components, Inc. (MEDCOMP), Harleysville,
Pennsylvania, by fax letter on March 24, 1998.
Firm-initiated recall ongoing. See also FDA press
release 98-11, dated March 27, 1998.
DISTRIBUTION California, Florida, Michigan, Minnesota,
Missouri, New Jersey, Tennessee, Texas, Utah,
Virginia, Washington, and international.
QUANTITY Approximately 7,000 kits were distributed.
REASON The extender may separate from the adaptor.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT 20" Color Display, Part #960-208-010 used in
Horizon 9000WS Cath Lab:
a) Model No. GDM-20E01T
b) Model No. GDM-20SE10;
c) Model No. GDM-2039. Recall #Z-550/552-8.
CODE None.
MANUFACTURER Mennen Medical Corporation, Clarence, New York,
RECALLED BY Manufacturer, by voice mail followed by memorandum
dated May 24, 1995. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 82 units were distributed.
REASON The base of display cracked and fell from its
mount.
_______________
PRODUCT Mitsubishi Product No. EXL-150 OP Linear
Accelerator Patient Couch, uses electronically
produced radiation to treat various types of
cancers. Recall #Z-557-8.
CODE Serial #4511.
MANUFACTURER Mitsubishi Electric Corporation, Amagaski City,
Hyogo, Japan.
RECALLED BY Mitsubishi Electronics America, Somerset, New
Jersey, by telephone on October 23, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 1 unit was distributed.
REASON The motor stop functions cannot be controlled via
the couch button release, and the "stop" circuit
is disabled when the drive unit cover microswitch
is actuated, possibly causing patient injury.
______________
PRODUCT Child and Infant Bageasy Disposable Manual
Resuscitators:
a) Child Bageasy Manual Resuscitator
Part/Catalog Part Number Description
562042 Child BagEasy with Peep and
Mask, Sample (Single)
562043 Child BagEasy with Peep, Sample
(Single)
562044 Child BagEasy with Mask, Sample
(Single)
562045 Child BagEasy, Sample (Single)
562052 Large Child BagEasy w/Peep and
Mask Sample (Single)
562053 Large Child BagEasy with Peep,
Mask and 10 ft.
562068 Large Child BagEasy with Mask &
10 ft. Tubing, Box of 12
562069 Child BagEasy with Peep, Mask &
10 ft.Tubing, Box of 12
562070 Child BagEasy with Peep and 10
ft. Tubing, Box of 12
562071 Child BagEasy with Mask & 10 ft,
tubing, Box of 12
562072 Child BagEasy with 10 ft. Tubing,
Box of 12
562080 Child BagEasy with Peep & Mask,
Box of 12
562081 Child BagEasy with Peep without
Mask, Box of 12
562082 Child BagEasy without Peep with
Mask, Box of 12
562083 Child BagEasy without Peep
without Mask, Box of 12
562132 Child/Large Child BagEasy with
Mask, Box of 12
562133 Child/Large Child BagEasy with
Peep and Mask, Box of 12
b) Infant Bageasy Manual Resuscitators
Part/Catalog Part Number Description
562046 Infant BagEasy with Peep and
Mask, Sample (Single)
562047 Infant BagEasy with Peep, Sample
(Single)
562048 Infant BagEasy with Mask, Sample
(Single)
562049 Infant BagEasy Sample (Single)
562050 Neonatal/Infant BagEasy with Mask
Sample (Single)
562051 Neonatal/Infant BagEasy with Peep
& Mask Sample (Single)
562073 Infant BagEasy with Peep, Mask
and 10 ft. Tubing, Box of 12
562074 Infant BagEasy with Peep and 10
ft.Tubing, Box of 12
562075 Infant BagEasy with Mask and 10
ft. Tubing, Box of 12
562076 Infant BagEasy with 10 ft.
Tubing, Box of 12
562077 Neonatal/Infant BagEasy with Mask
and 10 ft.
562079 Neonatal/Infant BagEasy with
Peep, Mask and 10 ft
562084 Infant BagEasy with Peep and
Mask, Box of 12
562085 Infant BagEasy with Peep without
Mask, Box of 12
562086 Infant BagEasy without Peep with
Mask, Box of 12
562087 Infant BagEasy without Peep
without Mask, Box of 12
562110 Neonatal/Infant BagEasy with
Mask, Box of 12
562111 Neonatal/Infant BagEasy with Peep
and Mask, Box of 12.
Recall #Z-559/560-8.
CODE Lot Nos. A960521 through A971201.
MANUFACTURER Respironics, Murrysville, Pennsylvania.
RECALLED BY Manufacturer, by telephone on December 5, 1997,
followed by letter on December 8, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and United Arab Emirate.
QUANTITY 43,000 units were distributed.
REASON The duckbill valve sticks and will not allow the
caregiver to ventilate the patient.
_______________
PRODUCT Adult Bageasy Disposable Manual Resuscitators, all
types and models. Recall #Z-561-8
CODE A960521 through A971201 and B960521 through
B971201.
MANUFACTURER Respironics, Inc., Murrysville, Pennsylvania.
RECALLED BY Manufacturer, by letter on December 8, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 430,000 units were distributed.
REASON The duckbill valve sticks and will not allow the
caregiver to ventilate the patient.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Todd Hewitt with CNA (Lim Broth), recommended for
use in qualitative procedures to isolate group B
streptococci from clinical specimens containing
mixed bacterial flora:
a) Product #06-4810; b) Product #06-4812.
Recall #Z-489/490-8.
CODE Lot #5516 EXP 8/31/97.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone on October 21 and 22,
1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 9,240 plates were distributed.
REASON Some patient isolates were exhibiting variable
growth patterns of Group B Streptococcus in the
medium.
_______________
PRODUCT TAS Prothrombin (PT) Time Cards, intended for use
with the TAS Analyzer and TAS aPTT test card to
provide a quality control method for the system.
Recall #Z-553-8.
CODE Catalog No. 1001, Lot Nos. 93001701, 93001702,
93001703, 30201701, 30201702, 30201703, 302049702.
MANUFACTURER Cardiovascular Diagnostics, Inc., Raleigh, North
Carolina.
RECALLED BY Manufacturer, by letter on June 4, 1997.
Firm-initiated recall complete.
DISTRIBUTION Arizona, California, Iowa, Illinois, Louisiana,
Michigan, Minnesota, Pennsylvania, South Carolina,
Virginia.
QUANTITY 538 units were distributed.
REASON The prothrombin results were high on patients on
warfarin and the cards are subject to premature
stability degradation.
_______________
PRODUCT TAS APTT Abnormal Control Test Cards, used with
the TAS Analyzer and is intended for the
determination of the Prothrombin time of citrated
whole blood or plasma.
Recall #Z-554-8.
CODE Catalog #1024, Lot #137039701.
MANUFACTURER Cardiovascular Diagnostics, Inc., Raleigh, North
Carolina.
RECALLED BY Manufacturer, by letters on June 5 and 19, 1997.
Firm-initiated recall complete.
DISTRIBUTION Florida, Louisiana, Michigan.
QUANTITY 49 units were distributed.
REASON There was premature stability degradation.
_______________
PRODUCT QED Salvia Alcohol Tests, in-vitro diagnostic used
as a test to determine the alcohol content in a
person's salvia:
a) QED Saliva Alcohol Test A150;
b) QED Saliva Alcohol Test A350.
Recall #Z-555/556-8.
CODE All lot numbers with an expiration date of July
1998 and later.
MANUFACTURER STC Technologies, Inc., Bethlehem, Pennsylvania.
RECALLED BY Manufacturer, by telephone on February 3, 1998,
and by fax on February 16, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimated that less than 10 percent of
product remained on market at time of recall
initiation.
REASON The QA stop does not develop within 5 minutes
using negative samples, as specified in the
product labeling.
_______________
PRODUCT Triflex Sterile Latex Surgical Gloves.
Recall #Z-558-8.
CODE Catalog 2D7252, Lot PGJ7N009, size 6-1/2
MANUFACTURER Allegiance Healthcare Corporation, West Malaysia.
RECALLED BY Allegiance Healthcare Corporation, McGaw Park,
Illinois, by letter dated April 16, 1998.
Firm-initiated ongoing.
DISTRIBUTION Nationwide.
QUANTITY 262,800 pairs of gloves were distributed; firm
estimated that 33 percent of product remained on
market at time of recall initiation.
REASON Mislabeling - The sterile pouch, labeled as size
6-1/2 gloves, may actually contain size 7-1/2
gloves which are marked properly as size 7-1/2 on
the glove and inner wallet. The sterile pouches,
boxes and cases are all labeled as size 6-1/2.
_______________
PRODUCT Ventricular Catheter, Small, Barium Impregnated,
23 cm. Recall #Z-562-8.
CODE Catalog #41207, Lot #L0391 EXP 10/02.
MANUFACTURER Medtronics PS Medical, Goleta, California.
RECALLED BY Manufacturer, by telephone on March 13, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION California, Virginia, Texas, North Carolina,
Pennsylvania, Ohio, Wisconsin, Washington state,
Indiana, Louisiana, Connecticut, Austria, Belgium.
QUANTITY 100 units were distributed.
REASON The label on the outer carton may not be
consistent with the correct label on the inner
product package. The outer carton label may state
that the catalog number is 41101 and that its
catheter size is standard. However, the outer
carton should have been labeled with catalog
number 41207 and with a catheter size of small.
END OF ENFORCEMENT REPORT FOR MAY 13, 1998. BLANK PAGES MAY
FOLLOW.
End of Enforcement Report for
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