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 27, 1998 98-21
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II =========
_______________
PRODUCT Post Type Cylinder Valves, for medical gas
cylinders. Recall #D-134-8.
CODE All lot codes.
MANUFACTURER Ceodeux, Inc., Ultrapure Equipment Technology
S.A., Lintgen/Luxembourg.
RECALLED BY Rotarex, Inc., North America, Mt. Pleasant,
Pennsylvania, by letter dated March 25, 1998.
Firm-initiated field correction ongoing.
DISTRIBUTION Massachusetts, Georgia, California,
Pennsylvania, Maryland, North Carolina,
Kansas, Canada.
QUANTITY Approximately 125,000 units were manufactured
and of that approximately 43,750 remained on
market at time of recall initiation.
REASON High velocity valve stem ejection.
_______________
PRODUCT Sterile Vancomycin Hydrochloride, USP,
lyophilized, 10g/100mL vial, pharmacy bulk
package, not for direct infusion, Rx,
lyophilized powder for preparing intravenous
infusions for the treatment of serious or
severe infections caused by susceptible
strains of methicillin-resistant
staphylococci. NDC #0469-3140-61.
Recall #D-144-8.
CODE Lot numbers 170438 and 170449.
MANUFACTURER Fujisawa USA, Inc., Melrose Park, Illinois.
RECALLED BY Fujisawa USA, Inc., Deerfield, Illinois, by
letter dated April 30, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,455 vials were distributed; firm estimated
that 25 percent remained on market at time of
recall initiation.
REASON Incorrect volumes - Vials are labeled with
graduation marks that do not indicate an
accurate volume.
_______________
PRODUCT Propanolol HCL Capsules, Extended Release,
80 mg, in units of 30, indicated in the
management of hypertension.
NDC #54569-3097-0. Recall #D-146-8.
CODE 7140089, 7164046, 7176062, 7293083, 7311102.
MANUFACTURER Inwood Laboratories, Inc., Inwood, New York
(responsible firm).
RECALLED BY Allscripts, Inc., Libertyville, Illinois
(repackager), by letter dated April 6, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION New Hampshire, Iowa, Florida, New Mexico,
Illinois.
QUANTITY 103 bottles were distributed; firm estimated
that little, if any, product remained on
market at time of recall initiation.
REASON Dissolution failure.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Ranitidine Tablets, USP (Ranitidine
Hydrochloride), 150 mg, in 500 tablet bottles,
Rx for the short-term treatment of active
duodenal ulcer. NDC #55953-544-70.
Recall #D-145-8.
CODE Lot #108969C.
MANUFACTURER Novopharm, Ltd, Scarborough, Ontario, Canada.
RECALLED BY Novopharm USA, Inc., Schaumburg, Illinois, by
telephone on May 5, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION Maine, Florida, Louisiana, Pennsylvania,
Wisconsin, Missouri, Alabama, South Dakota,
Georgia, Ohio, Tennessee, Connecticut,
Minnesota.
QUANTITY 1,638 bottles were distributed; firm estimated
that 80 percent of the product remained on
market at time of recall initiation.
REASON Incorrect bottle desiccant.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Red Blood Cells. Recall #B-549-8.
CODE Unit #24196-6241.
MANUFACTURER Blood Systems, Inc., Rapid City, South Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on July 31, 1997, and by letter
dated August 27, 1997. Firm-initiated recall
complete.
DISTRIBUTION Illinois.
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 a) Red Blood Cells; b) Platelets; c) Recovered
Plasma, Frozen. Recall #B-795/797-8.
CODE Unit #28GK19453.
MANUFACTURER American Red Cross Blood Services, Savannah,
Georgia.
RECALLED BY Manufacturer, by letters dated October 10 and
29, 1997, and November 11, 1997. Firm-initiated
recall complete.
DISTRIBUTION Illinois, South Carolina, California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with a history of cancer.
_______________
PRODUCT Source Plasma. Recall #B-846-8.
CODE Unit #3448W.
MANUFACTURER Concho Biologics, Inc., San Angelo, Texas.
RECALLED BY Manufacturer, by telephone and fax on August
25, 1997. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
previously tested reactive for syphilis within
one year of donation.
_______________
PRODUCT Red Blood Cells. Recall #B-991-8
CODE Unit GW29790
MANUFACTURER Metropolitan Washington Blood Banks, Bethesda,
Maryland.
RECALLED BY Manufacturer, by letter dated May 9, 1997.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product tested repeatedly reactive for
the antibody to the Hepatitis B core antigen
(anti-HBc).
_______________
PRODUCT Red Blood Cells. Recall #B-992-8.
CODE Unit GW27208
MANUFACTURER Metropolitan Washington Blood Banks, Bethesda,
Maryland.
RECALLED BY Manufacturer, by telephone and letter on March
1, 1997. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product tested non-reactive for the
antibody to the Hepatitis B core antigen
(anti-HBc), but was collected from a donor
who
was previously repeatedly reactive for
anti-HBc on two separate donations.
_______________
PRODUCT Red Blood Cells. Recall #B-1009-8.
CODE Unit #3878789.
MANUFACTURER Camp Memorial Blood Center, Fort Knox,
Kentucky.
RECALLED BY Manufacturer, by fax dated August 7 or 8,
1997. Firm-initiated recall complete.
DISTRIBUTION Georgia and Missouri.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
received either a tattoo, body piercing,
acupuncture, or accidental needle stick,
within twelve months of donation.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma. Recall #B-1078/1080-9.
CODE Unit numbers: a) 18Y86733 and 18W87490
b) 18Y86733; c) 18Y86733 and 18W87490.
MANUFACTURER American Red Cross Great Lakes Region,
Lansing, Michigan.
RECALLED BY Manufacturer, by letter either on February 24
or 27, 1998, by telephone on February 27,
1998, and by second letter on March 10 or 19,
1998. Firm-initiated recall complete.
DISTRIBUTION Michigan and California.
QUANTITY a) 2 units; b) 1 unit; c) 2 units were
distributed.
REASON Blood products were collected from a donor
whose spouse had active hepatitis C.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma, frozen. Recall #B-1081/1083-8.
CODE Unit #1017534.
MANUFACTURER Community Blood Center, Dayton, Ohio.
RECALLED BY Manufacturer, by letter dated August 29, 1997,
or September 9, 1997. Firm-initiated recall
complete.
DISTRIBUTION Indiana, Ohio, California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with a history of jaundice.
_______________
PRODUCT Red Blood Cells. Recall #B-1085-8.
CODE Unit #GW32455.
MANUFACTURER Metropolitan Washington Blood Banks, Inc.,
Bethesda, Maryland.
RECALLED BY Manufacturer, by telephone on August 12, 1997.
Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit was distributed.
REASON Blood product tested positive for syphilis.
_______________
PRODUCT Platelets, Pheresis. Recall #B-1086-8.
CODE Unit #KZ24929.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Metropolitan Washington Blood Banks, Inc.,
Bethesda, Maryland, by telephone and fax on
December 8, 1995. Firm-initiated recall
complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.
_______________
PRODUCT a) Platelets, Pooled; b) Fresh Frozen Plasma.
Recall #B-1095/1096-8.
CODE Unit numbers: a) P62602; b) 9137888.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by telephone on March 12, 1998,
and by letter dated March 13, 1998.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit of each component was distributed.
REASON Blood products corresponded to a unit of
clotted red blood cells.
_______________
PRODUCT a) Platelets; b) Fresh Frozen Plasma.
Recall #B-1097/1098-8.
CODE Unit #9138815.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by telephone on March 14, 1998,
and by letter dated April 16, 1998.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit of each component was distributed.
REASON Blood products corresponded to a unit of
clotted red blood cells.
_______________
PRODUCT a) Platelets, Pooled; b) Fresh Frozen Plasma.
Recall #B-1099/1100-8.
CODE Unit numbers: a) P62626; b) 9232101.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by telephone on March 12, 1998,
and by letter dated March 13, 1998.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit of each component was distributed.
REASON Blood products corresponded to a unit of
clotted red blood cells.
_______________
PRODUCT Platelets, Pooled. Recall #B-1101-8.
CODE Unit #P62698.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by telephone on March 11, 1998,
and by letter dated March 16, 1998.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of
clotted red blood cells.
_______________
PRODUCT Platelet Pheresis. Recall #B-1103-8.
CODE Unit #21 P76619.
MANUFACTURER American Red Cross, Portland, Oregon.
RECALLED BY Manufacturer, by letter dated April 3, 1998.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
received a tattoo within 12 months of
donation.
_______________
PRODUCT Red Blood Cells. Recall #B-1105-8.
CODE Unit numbers: 21GC20021 and 21GL30711.
MANUFACTURER American Red Cross, Portland, Oregon.
RECALLED BY Manufacturer, by letter dated March 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION Oregon and California.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor
with a history of cancer.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1106/1107-8.
CODE Unit #21365-8659.
MANUFACTURER Blood Systems, Inc., United Blood Services,
Fargo, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letters dated October 6, 1997, and April 20,
1998. Firm-initiated recall complete.
DISTRIBUTION Illinois and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with a history of hepatitis.
_______________
PRODUCT Source Plasma. Recall #B-1108-8.
CODE Unit numbers: 33-ZBP950-0, 33-ZBQ284-0,
33-ZBQ417-0, 33ZBQ715-0.
MANUFACTURER Centeon Bio-Services, Inc., West Allis,
Wisconsin.
RECALLED BY Centeon Bio-Services, Inc., Knoxville,
Tennessee, by an electronic message dated
November 11, 1996. Firm-initiated recall
complete.
DISTRIBUTION Germany.
QUANTITY 4 units were distributed.
REASON Blood products were collected from an
unsuitable donor.
_______________
PRODUCT Source Plasma. Recall #B-1109-8.
CODE Unit numbers: 33-ZB7452-B, 33-ZB7515-B,
33-ZB7507-B, 33-ZB7563-B
MANUFACTURER Centeon Bio-Services, Inc., West Allis,
Wisconsin.
RECALLED BY Centeon Bio-Services, Inc., Knoxville,
Tennessee, by an electronic message dated
November 20, 1996. Firm-initiated recall
complete.
DISTRIBUTION Germany.
QUANTITY 4 units were distributed.
REASON Blood products were collected from unsuitable
donors.
_______________
PRODUCT Recovered Plasma. Recall #B-1111-8.
CODE Unit #GW06654.
MANUFACTURER Metropolitan Washington Blood Banks, Inc.,
Bethesda, Maryland.
RECALLED BY Manufacturer, by telephone on December 27,
1994. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product tested repeatedly reactive for
the antibody to the hepatitis C virus encoded
antigen (anti-HCV).
_______________
PRODUCT Source Plasma. Recall #B-1112-8.
CODE Unit #DR071359.
MANUFACTURER Sera-Tec Biologicals Limited Partnership, Del
Rio, Texas.
RECALLED BY Sera-Tec Biologicals Limited Partnership,
Harrisburg, Pennsylvania, by telefax on
December 3, 1997. Firm-initiated recall
complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product had an elevated ALT.
_______________
PRODUCT Platelets. Recall #B-1113-8.
CODE Unit #53GT06124.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated February 20,
1998. Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit was distributed.
REASON Blood product tested positive for anti-Rho(D)
antibodies.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-1114/1115-8.
CODE Unit numbers: a) KH67776, KH68200, KH69840,
KH68861, KH70977, KH71003, KH73915, KH75739
b) KH67776, KH69840, KH68861, KH70977,
KH71003, KH73915.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by letter dated April 10, 1998.
Firm-initiated recall complete.
DISTRIBUTION Maryland and Virginia.
QUANTITY a) 8 units; b) 6 units were distributed.
REASON Blood products, collected from donors who
traveled to areas considered endemic for
malaria.
_______________
PRODUCT Platelets, Pheresis. Recall #B-1116-8.
CODE Unit #0310189A.
MANUFACTURER Inland Northwest Blood Center, Spokane,
Washington.
RECALLED BY Manufacturer, by telephone on December 19,
1997. Firm-initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-1117/1118-8.
CODE Unit #GW39677.
MANUFACTURER Metropolitan Washington Blood Bank, Bethesda,
Maryland.
RECALLED BY Manufacturer, by letter dated April 27, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Virginia.
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-1119-8.
CODE Unit #21FM34832.
MANUFACTURER American Red Cross, Portland, Oregon.
RECALLED BY Manufacturer, by letter dated March 10, 1998.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor
taking the drug Proscar.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma. Recall #B-1120/1122-8.
CODE Unit #42S53953.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letters dated February 17 &
19, 1997. Firm-initiated recall complete.
DISTRIBUTION Ohio and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
taking the drug Lupron.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-1123-8.
CODE Unit #17KX25737.
MANUFACTURER American Red Cross Blood Services, St Paul,
Minnesota.
RECALLED BY Manufacturer, by telephone on September 30,
1997. Firm-initiated recall complete.
DISTRIBUTION Minnesota.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with
a history of cancer.
_______________
PRODUCT Recovered Plasma. Recall #B-1126-8.
CODE Unit #17FC88836.
MANUFACTURER American Red Cross Blood Services, St. Paul,
Minnesota.
RECALLED BY Manufacturer, by fax on November 6, 1997.
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 Recovered Plasma. Recall #B-1127-8.
CODE Unit numbers: 17KP40578 and 17GL50917
MANUFACTURER American Red Cross Blood Services, North
Central Blood Services, St. Paul,
Minnesota.
RECALLED BY Manufacturer, by fax on February 18, 1998.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor
with a history of cancer.
_______________
PRODUCT Red Blood Cells. Recall #B-1138-8.
CODE Unit #53KT47365.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by telephone on November 11,
1997. Firm-initiated recall complete.
DISTRIBUTION District of Columbia.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of plasma
that was hemolyzed.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1140/1141-8.
CODE Unit #24021-4622.
MANUFACTURER Blood Systems, Inc., United Blood Services,
Rapid City, South Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letters dated December 4, 1997, and April 20,
1998. Firm-initiated recall complete.
DISTRIBUTION Illinois and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
may have received an injection of Hepatitis B
Immune Globulin within 12 months of donation.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1142/1143-8.
CODE Unit numbers: 24GS12055, 24GS18888
MANUFACTURER American Red Cross Blood Services, Louisville,
Kentucky.
RECALLED BY Manufacturer, by letter dated March 18 or 19,
1998, and March 16, 1998. Firm-initiated
recall complete.
DISTRIBUTION Indiana, Ohio, California.
QUANTITY 2 units of each component were distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (HIV-1), but were collected from donors
who previously tested repeatedly reactive for
the antibody, and was subject to additional
testing.
_______________
PRODUCT Platelets. Recall #B-1144-8.
CODE Unit #36LC03141.
MANUFACTURER American Red Cross Blood Services, Columbia,
South Carolina.
RECALLED BY Manufacturer, by letter dated September 4,
1996. Firm-initiated recall complete.
DISTRIBUTION South Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
whole blood with an extended collection time.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1146/1147-8.
CODE Unit #42FH66597.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by telephone on September 23 and
24, 1997, and by letter on September 24, 1998.
Firm-initiated recall complete.
DISTRIBUTION Ohio and California.
QUANTITY 1 unit was distributed.
REASON Blood products were incorrectly tested for the
hepatitis B surface antigen (HbsAg).
_______________
PRODUCT Recovered Plasma. Recall #B-1148-8.
CODE Unit #GW43585.
MANUFACTURER Metropolitan Washington Blood Bank, Bethesda,
Maryland.
RECALLED BY Manufacturer, by fax on April 14, 1998,
followed by letter on April 27, 1998.
Firm-initiated recall complete.
DISTRIBUTION Switzerland.
QUANTITY 1 unit was distributed.
REASON Blood product tested repeatedly reactive for
the antibody to the human immunodeficiency
virus types 1 and 2 (anti-HIV-1/2).
_______________
PRODUCT Source Plasma. Recall #B-1150-8.
CODE Unit #XZ94131, XZ94132, XZ94381.
MANUFACTURER Community Bio-Resources, Inc., Eau Claire,
Wisconsin.
RECALLED BY Community Bio-Resources, Inc., Hoover,
Alabama, by letter dated September 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 3 units were distributed.
REASON Blood products, which were not tested for
syphilis.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Red Blood Cells. Recall #B-1023-8.
CODE Unit #3872515.
MANUFACTURER Camp Memorial Blood Center, Fort Knox,
Kentucky.
RECALLED BY Manufacturer, by fax dated September 12 or 16,
1997. Firm-initiated recall complete.
DISTRIBUTION Texas and California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
exceeded the donation acceptance criteria for
body temperature.
_______________
PRODUCT Autologous Red Blood Cells. Recall #B-1084-8.
CODE Unit #25-17833.
MANUFACTURER Michigan Community Blood Centers, Grand
Rapids, Michigan.
RECALLED BY Manufacturer, by telephone on August 12, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product tested positive for the antibody
to the hepatitis C virus encoded antigen
(anti-HCV), was distributed without a
biohazard label or physician approval.
_______________
PRODUCT a) Platelets; b) Platelets, Pheresis.
Recall #B-1087/1088-8.
CODE Unit numbers: a) 10530-9056, 10531-1112,
10530-9096, 10530-7173, 10531-0485,
10531-0483, 10531-0106, 10531-1102
b) 10530-0108, 10530-8638, 10530-0125,
10530-0128, 10530-6151, 10530-6157.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated July 24, 1997. Firm-initiated
recall complete.
DISTRIBUTION Arizona.
QUANTITY a) 8 units; b) 6 units were distributed.
REASON Blood products were stored at an unacceptable
temperature.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-1102-8.
CODE Unit #9138817.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by telephone on March 31, 1998,
and by letter dated April 2, 1998.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a unit of
whole blood with an extended collection time.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS
II =========
_______________
PRODUCT Isolette, Model C2HS (C2000), incubator used
for critically ill newborn premature babies.
Recall #Z-570-8.
CODE All product marketed since November 1996.
MANUFACTURER Hill-Rom Air-Shields, Hatboro, Pennsylvania.
RECALLED BY Manufacturer, by letter dated May 18, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 2000 units were distributed.
REASON The controller and humidity module are subject
to temperature fluctuations, humidity
departures from set points and air flow probe
failures.
_______________
PRODUCT CORFLO - CuBBy LPDG Low Profile Gastrostomy
Device; an Rx sterile single patient use
device consisting of an inner balloon that
rests against the patient's stomach wall and
an outer portion that rests on the patient's
skin, which provides access to the patient's
stomach for enteral feedings and medications:
a) Catalog No. 31-1820, 18FR, 2.0 cm length;
b) Catalog No. 31-2020, 20FR, 2.0 cm length.
Recall #Z-578/579-8.
CODE Lot numbers: a) A01LK and A01LK-1;
b) A01IB.
MANUFACTURER Manufacturing & Research, Inc. (MRI), Tucson,
Arizona.
RECALLED BY Corpak MedSystems, Wheeling, Illinois, by
letter dated May 1, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION Pennsylvania, Florida, California,
Connecticut, Missouri, Texas, Maryland, South
Carolina, New York, Oklahoma, Michigan,
District of Columbia, North Carolina,
Tennessee and Kentucky.
QUANTITY 104 units of 31-1820 and 25 units of 31-2020
were distributed between November 1997 through
April 1998, firm estimated that 20% remained
on the market at time of recall initiation.
REASON There may be separation or partial separation
of the tube from the dome of the device.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Kendall Sher-I-Bronch Left-Sided Endobronchial
Tube a) Product Code: 5-16039 (39Fr); b) Product
Code: 5-16037 (37Fr) , indicated for
use in thoracic surgery, bronchospirometry,
for the administration of endobronchial
anesthesia and other uses commonly associated
with endobronchial tubes.
Recall #Z-573/574-8.
CODE Lot Numbers: a) 063534; b) 063532.
MANUFACTURER Kendall Sheridan, Argyle, New York.
RECALLED BY Kendall Healthcare Products Company,
Mansfield, Massachusetts, by letter between
March 23 and 25, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY a) 306 units; b) 312 units were distributed.
REASON Unit pouch is mislabeled with incorrect French
size.
_______________
PRODUCT Suture Retrievers: a) BTS Mini-Laparotomy MMK
Set, Model No. UM250 (Part No. 120089)
b) Laparotomy Bladder Neck Suspension Kit,
Model No. MW-100
c) BTS Urethropexy Suture Placement Set,
Model No. UM-300, (Part No. 120148).
Recall #Z-575/577-8.
CODE Lot numbers: a) 9ML80206-04;
b) 9ML7015-01, 9ML70814-01, 9ML71021-04,
9SL71023-7, 9ML71023-01;
c) 9ML80206-01, 9ML71201-03.
MANUFACTURER Louisville Laboratories, Inc., Louisville,
Kentucky.
RECALLED BY Medworks Corporation, Louisville, Kentucky, by
letter dated April 16, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION California, Colorado, Florida, Georgia,
Illinois, Kentucky, Massachusetts, Maryland,
Missouri, New Jersey, Nevada, New York
Oklahoma, Pennsylvania, Texas, Virginia,
Washington state.
QUANTITY a) 52 devices; b) 43 devices; c) 97 devices
were distributed.
REASON That the plastic handle of the suture
retriever may crack at the point where the
stainless steel needle attaches to the plastic
handle.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT Dexamethasone sodium phosphate injection - 4
mg/ml (used as an anti-inflammatory sterile
intravenous injection). Product is packaged
with two labels:
Steris Laboratories, Inc., Phoenix, Arizona-
Dexamethasone Sodium Phosphate Injection Vetus
Animal Health, Dexaject SP., distributed by
Burns Veterinary Supply and manufactured by
Steris Laboratories, Inc. Recall #V-022-8.
CODE Lot numbers: 96G832, 96K080, 96L460, 96L830,
97A340, 97B810, 97E460, 97H260, 97H570,
97H571, 97H700, 97H701, 97L230, 97L231.
MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona.
RECALLED BY Manufacturer, by letter dated April 22, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico (Steris label);
Texas (Vetus label).
QUANTITY QUANTITY DISTRIBUTED QUANTITY DISTRIBUTED
Lot # STERIS LABEL VETUS LABEL
96G832 12036 2996
96K080 17820 0
96L460 14870 3022
96L830 10895 3021
97A340 16279 3019
97B810 18324 0
97E460 18012 2952
97H260 17724 0
97H570 8820 0
97H571 1416 0
97H700 5328 3023
97H701 8880 0
97L230 3588 0
97L231 4734 0.
REASON Stability data does not support labeled
expiration dates.
MEDICAL DEVICE SAFETY ALERTS: ==============================
_______________
UPDATE Recall #Z-561-8, Adult BagEasy Disposable
Manual Resuscitators (All Types and Models),
Lot Nos. A960521 through A971201 and B960521
through B971201 (Respironics, Murrysville,
PA), which appeared in the May 13, 1998
Enforcement Report, has been reclassified as a
voluntary Safety Alert and assigned Safety
Alert #N-005-8.
END OF ENFORCEMENT REPORT FOR MAY 27, 1998.
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