March 31, 2004
04-13
_______________________________
PRODUCT
Diltia XT Capsules (diltiazem HCI extended-release
capsules, USP) Once-A-Day Dosage, 240 mg, 100 count
bottles, Rx Only. Recall # D-124-4.
CODE
Lot Number/Expiration Date: 550C039 (11/04).
RECALLING FIRM/MANUFACTURER
Andrx Pharmaceuticals, Inc., Fort Lauderdale, FL, by letter on December 19,
2003. Firm initiated recall is ongoing.
REASON
Mislabeling: The recalled product lot was labeled with the incorrect expiration
date of November 2004 rather than actual expiration of November 2003.
VOLUME OF PRODUCT IN COMMERCE
6,552.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Morphine Sulfate in 5% Dextrose Injection, Each mL contains
morphine sulfate pentahydrate 1mg and dextrose hydrous
50mg, 1 mg/mL (250 ml total) Large Volume Glass Container,
Rx only. Recall # D-125-4.
CODE
Lot 04-736-DM.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, North Chicago, IL, by letters on March 2, 2004. Firm initiated
recall is ongoing.
REASON
Sub-potent; product labeled as containing 1mg/mL of Morphine Sulfate actually
contains 0.2mg/mL of Morphine Sulfate.
VOLUME OF PRODUCT IN COMMERCE
10,536 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Levothroid Tablets (levothyroxine sodium tablets, USP) 50 mcg., 100-ct. bottles,
Rx Only,. Recall # D-129-4.
CODE
Lot #30265, Exp. April 30, 2004.
RECALLING FIRM/MANUFACTURER
Forest Pharmaceuticals, Inc., Earth City, MO, by letter dated January 26,
2004. Firm initiated recall is ongoing.
REASON
Subpotent.
VOLUME OF PRODUCT IN COMMERCE
14,207/100-ct. bottles.
DISTRIBUTION
Nationwide.RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
_______________________________
PRODUCT
a) Bromhist-DM Drops, (Brompheniramine Maleate 1 mg,
Pseudoephedrine Hydrochloride 15 mg, and
Dextromethorphan Hydrobromide 4 mg), Rx Only.
Recall # D-126-4;
Bromhist Pediatric Drops, (Brompheniramine Maleate 1 mg,
Pseudoephedrine Hydrochloride 15 mg. Rx Only.
Recall # D-127-4.
CODE
a) and b) Lot number/Expiration date: P03106 (1/2006).
RECALLING FIRM/MANUFACTURER
Great Southern Laboratories, Houston, TX, by telephone and letter on March
4, 2004. Firm initiated recall is ongoing.
REASON
Mislabeling: Bromhist-DM drops packaged in Bromhist Pediatric Drops carton.
Carton is not labeled to contain Dextromethorphan Hydrobrimide 4mg/mL.
VOLUME OF PRODUCT IN COMMERCE
1,221 units.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
ORPHENGESIC FORTE TABLETS (Orphenadrine Citrate, Aspirin, and Caffeine Tablets)
50 mg/770 mg/60 mg, 100 and 500 tablet bottles, Rx only, NDC 49884-473-01 -
100 Tablets and NDC 49884-473-05 - 500 Tablets. Recall # D-128-4.
CODE
Lots 037407 and 037408, Expiration Date 3/2005.
RECALLING FIRM/MANUFACTURER
Par Pharmaceutical, Inc., Spring Valley, NY, by letters on March 3, 2004. Firm
initiated recall is ongoing.
REASON
Subpotent; caffeine (9-month stabilty test).
VOLUME OF PRODUCT IN COMMERCE
7,648 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
PREMARIN (conjugated estrogens tablets, USP), 0.625 mg, 1000 count bottles,
Rx only. Recall # D-130-4.
CODE
Lot Number/Expiration Date: A57921 (October 2005).
RECALLING FIRM/MANUFACTURER
Richmond Division of Wyeth, Richmond, VA, by letter dated on 3/10/2004. Firm
initiated recall is ongoing.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
48 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0827-4.
CODE
Unit 33GV41007.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by telephone on November
19, 2003, and/or by letters dated November 25, 2003. Firm initiated recall
is complete.
REASON
Blood products, which were collected from a donor who was taking the medication
Avodart (dusteride), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA and CT.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Removed. Recall # B-0969-4;
b) Recovered Plasma. Recall # B-0970-4.
CODE
a) and b) Unit numbers: 53FL04501, 53FL12153, 53GM42009.
RECALLING FIRM/MANUFACTURER
American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD,
by letter, dated October 23, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from
an ineligible donor due to a subsequent disclosure of previous positive hepatitis
testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
MD, D.C., and CA.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0975-4;
b) Platelets. Recall # B-0976-4;
c) Plasma. Recall # B-0977-4;
d) Recovered Plasma. Recall # B-0978-4.
CODE
a) and b) Units 29KL05404, 29FN28677;
c) Unit 29FN28677;
d) Unit 29KL15404.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by facsimile
or letter dated July 22, 2002.
REASON
Blood products, collected from a donor who engaged in high risk behavior
associated with an increased risk of infection with the human immunodeficiency
virus (HIV) or the hepatitis B virus (HBV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
VA, NC, and CA.
_______________________________
PRODUCT
Plasma Frozen. Recall # B-0979-4.
CODE
Unit number: 53FN96605.
RECALLING FIRM/MANUFACTURER
American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD,
by telephone on October 20, 2003 and by letter, dated October 21, 2003. Firm
initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0980-4; b) Recovered Plasma.
Recall # B-0981-4.
444444CODE
a) and b) Unit 29GM92967.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by telephone
on March 1, 2002, by letter dated March 5, 2002, and by facsimile on March
6, 2002. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from
a donor who disclosed a previous positive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC and CA
_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0982-4.
CODE
Unit number: L92645.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by telephone on October 15, 2003,
and by letter, dated November 18, 2003. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-0994-4.
CODE
Unit number S39842.
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone on June 26, 2002 and by letter
on July 2, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-0995-4.
CODE
Unit numbers: G-25986-093, G-25232-093, G-25004-093,
N-19840-093, N-19796-093, G-96181-093, G-94488-093,
G-88286-093, G-82434-093, G-82125-093, G-07421-093,
G-63885-093, G-63553-093, G-62702-093, G-62418-093,
G-60913-093, G-59946-093, G-58898-093, G-57720-093,
G-57461-093, G-56052-093, G-55868-093, G-55124-093,
G-54764-093, and G-53928-093.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corp., Brownsville, TX, by facsimile on March 1 and 22,
2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had received tattoos within the
prior 12 months, were distributed.
VOLUME OF PRODUCT IN COMMERCE
25 units.
DISTRIBUTION
CA, NC, and Spain.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0996-4.
CODE
Units W045003042843, W045003042835, W045003042831, W045003042827, W045003042893,
W045003042929, W045003042920, W045003042913, W045003042907, W045003042933,
W045003042851, W045003042830, W045003042880, W045003042894, W045003042884,
W045003042900, W045003042978, W045003042957.
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO, by letters
dated November 17, 2003 and December 29, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from donors with inaccurate hemoglobin determinations,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
KS and MO.
_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-1000-4;
b) Fresh Frozen Plasma. Recall # B-1001-4.
CODE
a) and b) Unit 53J71056.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore,
MD, by letter dated October 23, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information
of testing positive for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD and D.C.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1002-4.
CODE
Unit number S39843.
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone on June 26, 2002, and by letter
on July 9, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-1003-4.
CODE
Unit number P04865.
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone and by letter on May 20, 2002.
Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-1004-4.
CODE
Unit number S35452.
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone and by letter on May 14, 2002.
Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1005-4.
CODE
Unit number 12801-5948.
RECALLING FIRM/MANUFACTURER
Recall Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on December
11, 2003.
Manufacturer: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall
is complete.
REASON
Blood product, collected using a phlebotomy method that may have compromised
the sterility of the products, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NM.
_______________________________
PRODUCT
Source Plasma. Recall # B-1006-4.
CODE
Unit numbers 6270293481, 6270292625, 6270292244, 6270290893, 6270290489,
and 6270289242.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., South Salt Lake City, UT, by facsimile on February 6,
2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did
not include questioning regarding risk factors for new variant Creutzfeldt-Jacob
disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-1008-4.
CODE
Unit numbers 6270256441, 6270256896, 6270261504, 6270262124, 6270272050,
6270272993, 6270274477, 6270275483, 6270276859, 6270286424, 6270288439, 6270288878,
6270290983, 6270292276, 6270293124, and 6270293873.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., South Salt Lake City, UT, by facsimile on January 31,
2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of residing
in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob
Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
a) Red Blood Cells for manufacture, non-injectables.
Recall # B-1009-4;
b) Recovered Plasma. Recall # B-1010-4.
CODE
a) and b) Unit number 53KW23236.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore,
MD, by letters dated June 6, 2003, and July 11, 2003, and by fax on June
12, 2003 and August 11, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information
of testing positive for hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL, CA, and DC.
_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-1013-4;
b) Platelets, Leukoreduced. Recall # B-1014-4;
c) Recovered Plasma. Recall # B-1015-4.
CODE
a), b), and c) Unit # 16GR04676.
RECALLING FIRM/MANUFACTURER
The American Red Cross, Central Ohio Region, Columbus, OH, by letter or email
dated January 5, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor at increased risk for new variant
Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OH and CA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1026-4.
CODE
Unit number 12KL55031.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte,
NC, by letter dated April 12, 2001. Manufacturer: The American National Red
Cross, Winston-Salem, NC. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on living in an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-1027-4.
CODE
Unit number 12GM62039.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte,
NC, by letter dated March 30, 2001. Manufacturer: The American National Red
Cross, Asheville, NC. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on living in an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1028-4;
b) Recovered Plasma. Recall # B-1029-4.
CODE
a) and b) Unit numbers 12GN523341 and 12LS48833.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte,
NC, by letter on October 26, 2000. Manufacturer: The American National Red
Cross, Asheville, NC. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus
(anti-HCV), but were collected from an ineligible donor based on the subsequent
disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NC and CA.
_______________________________
PRODUCT
Recovered Plasma. Recall # B-0828-4.
CODE
Unit 33GV41007.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by telephone on November
19, 2003, and/or by letters dated November 25, 2003. Firm initiated recall
is complete.
REASON
Blood products, which were collected from a donor who was taking the medication
Avodart (dusteride), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA and CT.
_______________________________
PRODUCT
Platelets Pheresis. Recall # B-0993-4.
CODE
Unit number E85041.
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by telephone on April 12, 2002, and by letter
on May14, 2002. Firm initiated recall is complete.
REASON
Blood product, collected in an expired collection bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
a) Red Blood Cells. Recall B-0997-4;
b) Red Blood Cells, Leukoreduced. Recall # B-0998-4;
c) Platelets. Recall # B-0999-4.
CODE
a) Unit 2058789;
b) Units 2058781, 2058793;
c) Unit 2058784.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by telephone on November
25, 2003. Firm initiated recall is complete.
REASON
Blood Products, with unacceptable test results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
KY.
_______________________________
PRODUCT
Source Plasma. Recall # B-1007-4.
CODE
Unit numbers G-25016-093, G-25327-093, G-25613-093, G-25930-093, G-26200-093,
G-26529-093, G-26793-093, G-27162-093, G-27401-093, G-27748-093, G-29089-093,
G-29261-093, G-29991-093, G-30357-093, G-30507-093, G-30862-093, G-31032-093,
G-32019-093, and G-32898-093.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Brownsville, TX, by facsimile on March 7,
2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected
from an unsuitable donor based on ear piercing within the previous twelve
months, were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units.
DISTRIBUTION
NC, Switzerland, and the United Kingdom.
_______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1019-4.
CODE
Units: 01LF14990, 01LF14991.
RECALLING FIRM/MANUFACTURER
The American Red Cross, New York-Penn Region, West Henrietta, NY, by telephone
on April 2, 2003. Firm initiated recall is complete.
REASON
Blood products, labeled with extended expiration dates, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NY.
______________________________
PRODUCT
Red Blood Cells. Recall # B-1030-4.
CODE
Unit number 71H82497-0.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Gainesville, FL, by facsimile
on July 28, 2003.
Responsible Firm: LifeSouth Community Blood Centers, Northeast Georgia Region,
Gainesville, GA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer one of the medical
history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
GA.
_______________________________
PRODUCT
Source Plasma. Recall # B-1031-4.
CODE
Unit number JG0046917.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on November 28, 2001. Firm initiated
recall is complete.
REASON
Blood product, collected from a donor that did not answer medical history
questions concerning behavior known to increase risk of infection with the
human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
_______________________________
PRODUCT
VITEK GPS-107Gram Positive Susceptibility Card,
Catalog # V4368, for in-vitro diagnostic use, 20
cards per package. Recall # Z-0721-04.
CODE
Lot #M83X, Exp. 4/15/05.
RECALLING FIRM/MANUFACTURER
BioMerieux, Inc., Hazelwood, MO, by letters dated January 28, 2004 and March
9, 2004. Firm initiated recall is ongoing.
REASON
Some of the cards were stamped with an incorrect card code causing the system
to read and report the cards incorrectly.
VOLUME OF PRODUCT IN COMMERCE
1,988/20-card boxes.
DISTRIBUTION
Nationwide, Colombia, Costa Rica, and China.
_______________________________
PRODUCT
VITEK GPS-106 Gram Positive Susceptibility Card,
Catalog #V4335, for in-vitro diagnostic use, 20 cards
per package. Recall # Z-0725-04.
CODE
Lot P61X, Exp. 5/12/05.
RECALLING FIRM/MANUFACTURER
BioMerieux, Inc, Hazelwood, MO, by letters dated January 15, 2004, and March
9, 2004. Firm initiated recall is ongoing.
REASON
The cards were stamped with an incorrect card code that causes the system to
read and analyze the cards incorrectly.
VOLUME OF PRODUCT IN COMMERCE
1,955/20-card boxes.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Hill Rom brand Advanta bed; model P1600. Recall # Z-0726-04.
CODE
All units distributed between January 1, 2004 and February ll, 2004.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letter dated March 8, 2004. Firm initiated
recall is ongoing.
REASON
A potential pinch/shear point exists between the restraint strap hook located
underneath the knee section and the foot rail mounting of the bed.
VOLUME OF PRODUCT IN COMMERCE
294 units.
DISTRIBUTION
Nationwide and Canada.
______________________________
PRODUCT
PatientNet Monitoring System - PatientNet Central Stations utilizing software
Versions 1.03.14, 1.04xx, 2.00xx. Recall # Z-0727-04.
CODE
All PatientNet Central Stations.
RECALLING FIRM/MANUFACTURER
General Electric Medical Systems Information Technology, Milwaukee, WI, by
letter on February 27, 2004. Firm initiated recall is ongoing.
REASON
Non-invasive blood pressure readings on central station may not match bedside
monitor due to software anomaly.
VOLUME OF PRODUCT IN COMMERCE
574 software units.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Impulse Single 5F 145 Multipack Catheters, Catalog Number H749163913011. Recall
# Z-0729-04.
CODE
Lot Number 400934.
RECALLING FIRM/MANUFACTURER
Boston Scientific Scimed, Maple Grove, MN, by letter dated February 13, 2004.
Firm initiated recall is ongoing.
REASON
Some of the catheters may have yellow foreign material in their pigtail tips.
The foreign material in the device could cause a stroke or significant damage
to organs other than the brain.
VOLUME OF PRODUCT IN COMMERCE
11 catheters.
DISTRIBUTION
FL.
______________________________
PRODUCT
Vision Hollow Fiber Oxygenator with GBS Coating. Recall # Z-0730-04.
CODE
Various codes. Lot numbers specified in each customer’s letter.
RECALLING FIRM/MANUFACTURER
Gish Biomedical, Inc., Rancho Santa Margarita, CA, by letters on March 4, 2004.
Firm initiated recall is ongoing.
REASON
Customers reported leakage.
VOLUME OF PRODUCT IN COMMERCE
950.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
a) Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter,
Mini Titanium port, Implantable Port System, Model #
M001452150, Catalog #45-215. Recall # Z-0731-04;
b) Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter,
STD Titanium Port, Implantable Port System, Model #
M001453620, Catalog #45-362. Recall # Z-0732-04;
c) Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter,
Low Profile PS port, Implantable Port System, Model #
M001452380, Catalog #45-238. Recall # Z-0733-04;
d) Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter,
STD PS port, Implantable Port System, Model #
M001453660, Catalog #45-366. Recall # Z-0734-04.
CODE
a) 866561, 876068, 885270, 885444, 886041, 886398, 887738,
888993, 889702, 890163, 903721;
b) 866762, 885272, 887739, 889302, 889704, 892898, 896675,
903724, 904485.
c) 791484, 791485;
d) 866764, 879997, 885445, 886400, 887133, 888995, 903726.
RECALLING FIRM/MANUFACTURER
Boston Scientific Corporation, Natick, MA, by letters dated February 9, 2004.
Firm initiated recall is ongoing.
REASON
Reports of catheter separation/fracture after implantation resulting in distal
migration of the catheter.
VOLUME OF PRODUCT IN COMMERCE
1,656 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
NucliSensâ Easy Q Incubator, Product Number 285204 (this
number can be found at the back of the instrument. Recall
# Z-0735-04.
CODE
Serial Numbers: 36061, 36065 and 36068.
RECALLING FIRM/MANUFACTURER
Biomerieux, Inc, Durham, NC, by service representative beginning on February
26, 2004. Firm initiated recall is complete.
REASON
Instrument malfunction. Electrical short circuit may occur resulting in damage
or a fire hazard.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CT, MD, and MT.
_______________________________
PRODUCT
a) ACL Futura Instrument Analyzer. Recall # Z-0736-04;
b) ACL Advance Instrument Analyzer. Recall # Z-0737-04.
CODE
a) Software prior to Version V3-5;
b) Software version prior to V2-1.
RECALLING FIRM/MANUFACTURE
Instrumentation Laboratory Co, Lexington, MA, by letter on March 9, 2004. Firm
initiated recall is ongoing.
REASON
Software may cause instrument to omit step causing reagent carryover which
may effect patient test result.
VOLUME OF PRODUCT IN COMMERCE
462 units.
DISTRIBUTION
FL, and Canada.
_______________________________
PRODUCT
a) CryoValve, Aortic Valve and Conduit. Recall # Z-0746-04;
b) CryoValve, Pulmonary Valve and Conduit. Recall #
Z-0747-04.
CODE
a) Donor #68607, Serial #8044081, Model #AV00;
b) Donor #68607, Serial #8044091, Model #PV00.
RECALLING FIRM/MANUFACTURER
Cryolife Inc, Kennesaw, GA, by telephone on February 18, 2004. Firm initiated
recall is complete.
REASON
CryoLife received additional information after release of tissue indicating
the donor had repeatedly reactive test results for antibody to HCV (EIA) in
1995.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
DC, and TX.
_______________________________
PRODUCT
TDx/TDxFLx Cortisol Reagent Pack, list 9116-65.
Recall # Z-0723-04.
CODE
List 9116-65, Lots 04111M200, 10239M200, 10060M200, 10060M201.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter dated February
16, 2004. Firm initiated recall is ongoing.
REASON
The package inserts contain incorrect control values for the urinary free cortisol
extraction procedure.
VOLUME OF PRODUCT IN COMMERCE
1,487 kits.
DISTRIBUTION
Internationally.
_______________________________
PRODUCT
IMMULITE 2000 Intact PTH kit. Recall # Z-0724-04.
CODE
Kit lots L2KPP 117 (exp date Aug 31 2004) and 118 (exp date Oct 31 2004).
RECALLING FIRM/MANUFACTURER
Diagnostic Products Corp, Los Angeles, CA, by letter on February 23, 2004.
Firm initiated recall is ongoing.
REASON
High bias noted in samples collected with EDTA. Indication is to not run samples
with EDTA.
VOLUME OF PRODUCT IN COMMERCE
2,416.
DISTRIBUTION
MO, CO, VA, CT, DC, and Internationally.
_______________________________
PRODUCT
a) FreshLook ColorBlends®, Daily wear soft (hydrophilic)
contact lens, BC: Median, DIA: 14.5, Rx Only, Sterile,
SPH -5.25, LOT ***, 2006-08. Product is packed in 6
packs. Recall # Z-0740-04;
b) FreshLook® Colors, Daily wear soft (hydrophilic) contact
lens, BC: Median, DIA: 14.5, Rx Only, Sterile, SPH ***,
LOT ***, 2006-11, 6-pack, 2 pack and single trial.
Product is packed in 6 packs, 2 packs and single trial
packs (Samples not for sale). Recall # Z-0741-04;
c) FreshLook® Enhancers, Daily wear soft (hydrophilic)
contact lens, BC: Median, DIA: 14.5, Sterile, SPH-0.75,
LOT ***, 2008-06, WJ®, Product is packed in 6 packs.
Recall # Z-0742-04.
d) FreshLook® Toric, Daily wear soft (hydrophilic) contact
lens, BC: Median, DIA: 14.5, Sterile, SPH -1.50, CYL -
0.75, AXIS 020, LOT ***, 2006-04, Product is packed in 6
packs. Recall # Z-0743-04.
CODE
a) Lot #063302, Exp. Date: 2006-08, Lot #088472, Exp. Date:
2008-07, Lot #073059, Exp. Date 2008-02, Lot #074338,
Exp. Date: 2008-02;
b) Lot #067121, Exp. Date 2006-11, Lot #065047, Exp. Date
2006-11, Lot #065530, Exp. Date 2006-11, Lot #079803,
Exp. Date 2003-08, Lot #065310, Exp. Date: 2006-11, Lot
#0-65427, Exp. Date: 2006-11;
c) Lot #085612, Exp. Date: 2008-06, Lot #095007, Exp. Date:
2008-06, Lot #098003, Exp. Date 2008-06;
d) Lot #072145, Exp. Date: 2006-04.
RECALLING FIRM/MANUFACTURER
Ciba Vision Corporation, Duluth, GA, by letter on March 11, 2004. Firm initiated
recall is ongoing.
REASON
The lens inside the package does not match the prescription information labeled
on the primary package.
VOLUME OF PRODUCT IN COMMERCE
7420 6pk, 1000 2pk, 1720 single blister.
DISTRIBUTION
Nationwide and Internationally.
______________________________
PRODUCT
Acuson Cypress Echocardiography System. Catalog number 8264604; Recall # Z-0744-04.
CODE
Serial numbers 73480 through 73535, 71165, 71561, 72532, 73125, and 73292.
RECALLING FIRM/MANUFACTURER
Siemans Medial Solutions USA, Inc, Plymouth Meeting, PA, by telephone from
February 22/16, 2004. Firm initiated recall in ongoing.
REASON
Software problem - mode does not appear on screen.
VOLUME OF PRODUCT IN COMMERCE
46 units.
DISTRIBUTION
Nationwide and Internationally.
______________________________
PRODUCT
RAD SOURCE RS 3000 Blood Irradiator Three Bag Option. Recall # Z-0745-04.
CODE
Serial numbers: 1002 through 1005, 1007 through 1009, 1011 through 1023.
RECALLING FIRM/MANUFACTURER
Rad-Source Technologies, Inc., Boca Raton, FL, by e-mail on May 9, 2002. Firm
initiated recall is complete.
REASON
The firm completed a cooling system retrofit to preclude overheating and failure.
VOLUME OF PRODUCT IN COMMERCE
20.
DISTRIBUTION
Nationwide.
END OF ENFORCEMENT REPORT FOR MARCH 31, 2004
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