FDA Enforcement Report FOR 12/31/97

[FDA]

_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._
_________________________________________________________________

December 31, 1997 97-53

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
===========
_______________
PRODUCT Coumadin Tablets (Warfarin Sodium), 3 mg, in
hospital unit dose cards packed 10 tablets per card,
10 cards per box, an Rx anticoagulant, labeled for
hospital use only.
NDC #0056-0188-75. Recall D-033-8.
CODE Lot #LH354A.
MANUFACTURER Dupont Merck Pharma, Manati, Puerto Rico.
RECALLED BY DuPont Merck Pharmaceutical Company, Garden City,
New York, by letter faxed on October 15., 1997 and
mailed on October 16, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,476 units were distributed; firm estimated that less
than 1,238 units remained on market at time of recall
initiation.
REASON Labeling -- Incorrectly declared strength-some 3
mg units labeled as containing 8 mg or 9 mg
tablets.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III===========
_______________
PRODUCT Coumadin Tablets (Warfarin Sodium, USP), 5 mg,
in hospital unit dose cards, packed 10 tablets
per card, 10 cards per box, Rx anticoagulant.
NDC #0056-0172-75. Recall #D-056-8.
CODE Lot numbers: Lots: LF269A (exp. date 6/2000);
LE199B (exp.date 05/2000); LF340A (exp. date 6/2000).
MANUFACTURER DuPont Merck Pharmaceutical Company,
Garden City, New York.
RECALLED BY Manufacturer, by letter on November 5, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Venezuela, Barbados, Colombia.
QUANTITY 21,630 units of lot LF269A; 17,029 units of lot
LE199B; and 2,476 units of lot LF340A were
distributed.
REASON Mislabeling - Incorrectly declared strength-
Some 5 mg units labeled as containing 6 mg
tablets.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT a) Red Blood Cells; b) Red Blood Cells-Leukocytes
Removed; c) Fresh Frozen Plasma.
Recall #B-254/256-8.
CODE Unit numbers: a) 10489-4475; b) 10505-8490
c) 10489-4475.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated May 31, 1996. Firm-initiated recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from donors which
tested negative for the antibody to the human
T-lymphotropic virus type I (anti-HTLV-I), but
were collected from donors who previously tested
repeatedly reactive for anti-HTLV-I, on two
occasions.

_______________
PRODUCT Platelets, pheresis. Recall #B-335-8.
CODE Unit #4172041.
MANUFACTURER Central Texas Regional Blood & Tissue Center,
Austin, Texas.
RECALLED BY Manufacturer, by letter dated November 11, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product had a platelet yield above the
acceptable limit.

_______________
PRODUCT Red Blood Cells. Recall #B-337-8.
CODE Unit #03FQ07362.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by letter dated April 16, 1997.
Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to an area considered endemic for
malaria.

_______________
PRODUCT Red Blood Cells. Recall #B-366-8.
CODE Unit numbers: 009Q27140, 009Q27289, 009K86446, 009GN30451.
MANUFACTURER American Red Cross Blood Services, Omaha,
Nebraska.
RECALLED BY Manufacturer, by telephone on April 28, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nebraska.
QUANTITY 4 units were distributed.
REASON Blood products, which were exposed to unacceptable
storage temperatures.

_______________
PRODUCT a) Red Blood Cells; b) Platelets;
c) Recovered Plasma. Recall #B-381/383-8.
CODE Unit #03GM26760.
MANUFACTURER American Red Cross Blood Services,
Atlanta, Georgia.
RECALLED BY Manufacturer, by letter dated September 5, 1997,
and by telephone on September 2, 1997. Firm-initiated
recall complete.
DISTRIBUTION Georgia and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor whose
spouse has a history of hepatitis C.

_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-384/385-8.
CODE Unit #03FX06294.
MANUFACTURER American Red Cross Blood Services,
Atlanta, Georgia.
RECALLED BY Manufacturer, by telephone on April 8, 1997.
Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood products, corresponding to a unit of
Fresh Frozen Plasma which was positive for
coagulase negative Staphylococcus.

_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-386/387-8.
CODE Unit #H11737.
MANUFACTURER Northern Illinois Blood Bank,
Rockford, Illinois.
RECALLED BY Manufacturer, by telephone on October 16, 1997,
and by letter dated October 16, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
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 Platelets, Pheresis. Recall #B-388-8.
CODE Unit #40P55993.
MANUFACTURER American Red Cross, Peoria, Illinois.
RECALLED BY Manufacturer, by telephone on December 2, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for CMV, but was
collected from a donor who previously tested CMV
positive.

_______________
PRODUCT Red Blood Cells. Recall #B-389-8.
CODE Unit #09FH03275.
MANUFACTURER American Red Cross Blood Services, Omaha,
Nebraska.
RECALLED BY Manufacturer, by letter dated May 19, 1997.
Firm-initiated recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor
taking the drug Zovirax.

_______________
PRODUCT Platelets, Pheresis. Recall #B-390-8.
CODE Unit numbers: 09P54256, 09P54935, 09P55309.
MANUFACTURER American Red Cross Blood Services, Omaha,
Nebraska.
RECALLED BY Manufacturer, by telephone on November 15 and 18,
1996, and by letter dated November 19, 1996.
Firm-initiated recall complete.
DISTRIBUTION Utah and Nebraska.
QUANTITY 3 units were 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-391-8.
CODE Unit #1382514.
MANUFACTURER Central Kentucky Blood Center (CKBC), Lexington,
Kentucky.
RECALLED BY Manufacturer, by letter on November 11, 1997.
Firm-initiated recall complete.
DISTRIBUTION Kentucky.
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 Recovered Plasma. Recall #B-394-8.
CODE Unit #1384156.
MANUFACTURER Central Texas Regional Blood & Tissue Center,
Austin, Texas.
RECALLED BY Manufacturer, by telephone on July 24, 1997, and
by letter dated August 21, 1997. Firm-initiated
recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was untested for Hepatitis B surface
antigen (HBsAg), and the antibodies to the human
immunodeficiency virus type 1/2 (anti-HIV-1/2),
Hepatitis C virus encoded antigen (anti-HCV),
Hepatitis B core antigen (anti-HBc), and syphilis.

_______________
PRODUCT a) Red Blood Cells; b) Platelets;
c) Fresh Frozen Plasma.
Recall #B-397/399-8.
CODE Unit #42G04937.
MANUFACTURER American Red Cross Blood Services, Cleveland Ohio.
RECALLED BY Manufacturer, by letter dated November 5, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
taking the drug Methotrexate.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Recovered Plasma. Recall #B-257-8.
CODE Unit #10505-8490.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated May 31, 1996. Firm-initiated
recall complete.
DISTRIBUTION Switzerland.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from donors which
tested negative for the antibody to the human
T-lymphotropic virus type I (anti-HTLV-I), but
were collected from donors who previously tested
repeatedly reactive for anti-HTLV-I, on two
occasions.

_______________
PRODUCT Red Blood Cells. Recall #B-336-8.
CODE Unit numbers: 11006187, 12003294, 12003296, 13000891,
31009637, 31009654, 31009672, 32005805.
MANUFACTURER W.E. & Lela I. Stewart Blood Center, Inc., Tyler,
Texas.
RECALLED BY Manufacturer, by telephone on July 23, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 8 units were distributed.
REASON Blood product were irradiated and labeled with
an extended expiration date.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS
II =========
_______________
PRODUCT Supreme II Blood glucose Meter, Part #S2005,
intended for the in-vitro measuring of the
glucose level in whole blood.
Recall #Z-203-8.
CODE All serial numbers less than 2100035601.
MANUFACTURER Applied Sciences Corporation, Hsinchu City,
Taiwan R.O.C.
RECALLED BY Chronimed, Inc., Minnetonka, Minnesota, by letter
on November 24, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 20,146 units were distributed.
REASON If this device is in the "plasma" mode and the
actual blood glucose level is 575 mg/dL or higher,
the device will display abnormally low glucose
readings.

_______________
PRODUCT Carlens (Y) Adapter Component to Tube Kits and
Connector pack:
a) U.S. Cat. No. 9589X and Intl Cat. No. 125-XX
Left Hand Broncho-Cath Tube;
b) U.S. Cat. No. 8588X and Intl Cat. No. 126-XX
Right Hand Broncho-Cath Tube;
c) U.S. Cat. No. 9587X and Intl Cat. No. 125-XX
-1 Left Hand Broncho Cath Tube with Cardinal Hook;
d) Intl. Cat. No. 125-10 Broncho-Cath Connector
Pack. Recall #Z-223/226-8.
CODE a) Broncho-Cath Endobronchial Tube, Left
U.S. Cat. No. Lot No.
95890 1997-02 5084
95890 1997-04 5617
95891 1997-04 5578
95892 1997-03 5256
95892 1997-03 5581
95892 1997-04 5662
95893 1997-03 5235
95893 1997-03 5244
95893 1997-03 5254
95893 1997-03 5265
95893 1997-03 5590
95893 1997-04 5266
95893 1997-04 5603
95893 1997-04 5610
95893 1997-04 5619
95893 1997-04 5633
95894 1997-02 5234
95894 1997-03 5257
95894 1997-03 5583
95894 1997-03 5584
95894 1997-04 5612
95894 1997-04 5627
95894 1997-04 5657
95895 1997-02 5081
95895 1997-03 5263
95895 1997-04 5598
International
Cat. No. Lot No.
125-28 1997-02 5233
125-28 1997-04 5577
125-28 1997-04 5616
125-32 1997-03 5248
125-32 1997-04 5579
125-35 1997-02 5069
125-35 1997-02 5228
125-35 1997-03 5249
125-35 1997-03 5255
125-35 1997-03 5580
125-35 1997-04 5634
125-37 1997-03 5227
125-37 1997-03 5229
125-37 1997-03 5230
125-37 1997-03 5250
125-37 1997-04 5251
125-37 1997-04 5613
125-37 1997-04 5652
125-39 1997-02 5232
125-39 1997-03 5226
125-39 1997-03 5258
125-39 1997-03 5259
125-39 1997-04 5628
125-41 1997-03 5238
125-41 1997-04 5654
b) Broncho-Cath Endobronchial Tube, Right
U.S. Cat. No. Lot No.
85885 1997-03 4169
85887 1997-02 4757
85887 1997-04 5601
85888 1997-03 4723
85888 1997-04 5243
International
Cat. No. Lot No.
126-35 1997-03 4725
126-35 1997-03 5240
126-35 1997-04 4711
126-37 1997-03 5241
126-37 1997-03 5267
126-39 1997-03 5242
126-39 1997-04 5268
126-41 1997-03 4729
126-41 1997-03 5587
c) Broncho-Cath Endobronchial Tube, Left with
Carinal Hook
U.S. Cat. No. Lot No.
95872 1997-04 5608
95873 1997-03 5245
95873 1997-04 5609
95874 1997-04 5246
95874 1997-04 5626
95875 1997-04 5236
International
Lot No. Lot No.
125-37-1 1997-03 4108
125-37-1 1997-04 5252
125-39-1 1997-03 4720
125-39-1 1997-03 4754
125-41-1 1997-04 4185
d) Broncho-Cath Connector pack assembly (not
distributed in the U.S)
International
Lot No. Lot No.
125-10 1997-04 5478.
MANUFACTURER Mallinckrodt medical, Athlone, Ireland.
RECALLED BY Mallinckrodt, Inc., Chesterfield, Missouri, by
letters issued on October 17 and 23, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY Approximately 56,550 adapters were distributed.
REASON The Carlens (Y) Adapter component may have a
small flap (flash) of excess plastic in one of
the ports where the smaller diameter tube joins
the connector, which can partially occlude the
inner diameter, causing some blockage of medical
gas to occur.

_______________
PRODUCT VENTAK R AV AICD Automatic Implantable
Cardioverter Defibrillator, Models 1810 & 1815.
Recall #Z-242/243-8.
CODE All serial numbers.
MANUFACTURER Guidant Corporation, Cardiac Pacemakers, Inc.
(CPI), Minneapolis, Minnesota.
RECALLED BY Manufacturer, by letter dated December 8, 1997.
Firm-initiated recall ongoing. Firms Action is
a field correction durning which the
defibrillators are being reprogramed. None of
the defibrillators are being returned or
explanted.
DISTRIBUTION Nationwide and international.
QUANTITY 3,770 units were distributed.
REASON A rare combination of device programming settings
and clinical patient circumstances create the
potential for the device to inappropriately
deliver brief periods of pacing at 190 beats per
minute.

_______________
PRODUCT Ausonics OPUS 2 Realtime Ultrasound System, a
ultrasound Scanner:
a) Model: COMPACT, product part number 040-170
b) Model: COMPACT, product part number 040-020.
Recall #Z-244/245-8.
CODE The affected serial numbers are:
A261412, A261712, A261812, A262012,
262112, A262412, A262712, A263012,
A263112, A263212 A263312, A263412,
A263512, A270101, A270201, A270401,
A571501, A571701, A571801, A572001,
A572201, A572401, A572501, A572601,
A572701, A572801, A572605, A572901,
A573203, A573303, A573603, A573803
D570105, D570106, D570110, D570205,
D570206, D570209, D570210, D570305,
D570309, D570310, D570405, D570406,
D570409, D570506, D570510, D570605,
D570606, D570705, D570706, D570708,
D570710, D570805, D570806, D570808,
D570809, D570906, D570908, D570909,
D571005, D571006, D571009, D571109,
D571209, D571210, D571308, D571405,
D571408, D571508, D571509, D571605,
D571608, D571609, D571709, D571710,
D571805, D571905, D571908, D571910,
D572105, D572110, D572205, D572208,
D572305, D572306, D572405, D572408,
D572409, D572505, D572508, D572509,
D572510, D572609, D572709, D573001,
D671005.
MANUFACTURER Diasonics Ultrasound, Inc., Santa Clara,
California.
RECALLED BY Manufacturer, by letter faxed beginning on
November 7, 1997, and by mail on November 26,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Florida, Indiana, Iowa, Louisiana, Maryland, New
Mexico, New York, Texas, international.
QUANTITY 91 units were distributed.
REASON During VCR playback, the probe membrane surface
temperature has the potential to exceed the
published FDA temperature limit of 41C.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT INNOFLUOR Digitoxin Calibrator Set, Catalog No.
41051, intended for monitoring digitoxin levels
in patients. Recall #Z-248-8.
CODE Lot No. 26216.
MANUFACTURER Oxis International, Inc., Portland, Oregon.
RECALLED BY Manufacturer, by fax on November 14, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION France, Belgium, Austria.
QUANTITY 10 sets were distributed.
REASON The device may not perform according to
specifications during the labeled shelf life.