December 24, 2003
03-52
_______________________________
PRODUCT
a) Fernando's Bakery, Gourmet Lemon Iced Pound Cake.
Net Wt. 5 oz. Private labels include Allison's Fine
Baked Goods and King Richard. Recall # F-039-4;
b) Fernando's Bakery, Pineapple Pound Cake. Net Wt. 3.5 oz.
Private labels include Allison's Fine Baked Goods
and King Richard. Recall # F-040-4.
CODE
a) and b) All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Fernando's Bakery, Inc., Perth Amboy, NJ, by letter dated February 17, 2003. New York State initiated recall is complete.
REASON
The products contain undeclared color, FD&C Yellow #5.
VOLUME OF PRODUCT IN COMMERCE
2,900 pieces.
DISTRIBUTION
NY.
_______________________________
PRODUCT
Firm Tofu. Product packaged in a styrofoam tray, wrapped in plastic. Recall
# F-043-4.
CODE
10.15.03 and 10.17.03.
RECALLING FIRM/MANUFACTURER
Northwest Tofu, Inc., Seattle, WA, by on site visit on October 8, 2003. Firm
initiated recall is complete.
REASON
The product contains undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
72 packages.
DISTRIBUTION
WA.
_______________________________
PRODUCT
Imperial brand Custard Cream Filling Cake (Sponge Cake with Custard Cream Filling),
individual package net wt. 20 g. Recall # F-056-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Vinh Sanh Trading Corp., Los Angeles, CA, by telephone on November 5, 2003.
FDA initiated recall is ongoing.
REASON
The product contains undeclared color tartrazine (certifiable as FD&C Yellow
no 5).
VOLUME OF PRODUCT IN COMMERCE
2,808 units.
DISTRIBUTION
CA, VA, GA, TX, AZ, WA, MN, and IA.
_______________________________
PRODUCT
Platelets. Recall # B-0383-4.
CODE
Unit number: 24218-1900.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AR, by telephone on December
13, 2002, and by letter, dated January 28, 2003.
Manufacturing Firm: Blood Systems, Inc., Rapid City, SD. Firm initiated recall
is complete.
REASON
Blood products, manufactured after clots were detected during the leukocyte
reduction process, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
SD.
_______________________________
PRODUCT
Source Plasma. Recall # B-0385-4.
CODE
Unit numbers G-16712-070, G-16867-070, G-17438-070, G-18025-070, G-18253-070,
G-18650-070, G-19063-070, G-19261-070, G-19594-070, G-19778-070, G-20444-070,
G-20640-070, F-00005-070, F-00213-070, F-01357-070, F-01783-070, F-02339-070,
F-02494-070, F-02883-070, and F-06054-070.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA, by facsimile
on December 2, 2002.
Manufacturer: Alpha Therapeutic Corporation, Vancouver, WA. 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
20 units.
DISTRIBUTION
North Carolina and Spain.
_______________________________
PRODUCT
Source Plasma. Recall # B-0386-4.
CODE
Unit numbers 02FINA1588, 02FINA1829, 02FINA2253, 02FINA2456, 02FINA2815, 02FINA3118,
02FINA3322, 02FINA3588, and 02FINA3915.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Fort Wayne, IN, by facsimile on August 12, 2002.
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
9 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-0387-4.
CODE
Unit numbers 0820847510, 0820846613, and 0820846283.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Detroit, MI, by facsimile on February 25, 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
3 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # 0391-4.
CODE
Unit numbers: F-26184-014, F-25754-014, F-25389-014,
F-24914-014, F-24575-014, F-23943-014, F-23748-014,
F-22938-014, F-22712-014, F-22138-014, and F-20707-014.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic, National City, CA, by letter, dated September 22, 2003. Firm
initiated recall is complete.
REASON
Blood products, collected from a donor who was not deferred upon the discovery
of a new tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units.
DISTRIBUTION
Sweden.
_______________________________
PRODUCT
Source Plasma. Recall # B-0392-4.
CODE
Unit numbers: G-78414-070, G-78705-070, G-79119-070, G-79333-070, G-80262-070,
G-83907-070, G-84061-070, and G-84497-070.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA, by facsimile,
dated July 12, 2002.
Manufacturing Firm: Alpha Therapeutic Corporation, Vancouver, WA. Firm initiated
recall is complete.
REASON
Blood products, collected from a donor who had a tattoo applied within twelve
months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
Spain and Switzerland.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0394-4;
b) Platelets. Recall # B-0395-4;
c) Fresh Frozen Plasma. Recall # B-0396-4;
d) Recovered Plasma. Recall # B-0397-4.
CODE
a) Units F69455, E54651, C95140, Y80043, X87770;
b) Units F69455, E54651, X87770;
c) Units F69455, E54651, C95140;
d) Units Y80043, X87770.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by letter dated
September 3, 2003 and by fax on September 2, 2003. Firm initiated recall is
complete.
REASON
Blood products, collected from a donor whose sexual partner had resided in a
HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units.
DISTRIBUTION
IL, IN, and Switzerland.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0398;
b) Platelets. Recall # B-0399-4.
CODE
a) and b) Unit number 7868746.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on September 4, 2003. Firm initiated
recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0400-4;
b) Platelets. Recall # B-0401-4.
CODE
a) and b) Unit number 2728633.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on September 23, 2003. Firm initiated
recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Source Plasma. Recall # B-0402-4.
CODE
Unit numbers G-27471-009, G-27692-009, G-28182-009, and G-28442-009.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA, by facsimile
on December 19, 2002.
Manufacturer: Alpha Therapeutic Corporation, Tacoma, WA. 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
4 units.
DISTRIBUTION
Spain.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0403-4.
CODE
Unit number 2026044.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by facsimile on October
17, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to a medical diagnosis
of porphyria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Removed. Recall # B-0406-4;
b) Fresh Frozen Plasma. Recall # B-0407-4.
CODE
a) and b)Unit number 18N87593.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by facsimile or
telephone on September 25 and 26, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had not completed a CJD related question
regarding whether a bovine insulin injection had been received, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0408-4.
CODE
Unit numbers 18FY07334 and 18FR80204
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by telephone,
facsimile, or letter on October 8, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Source Plasma. Recall # B-0410-4.
CODE
Unit numbers 69391750 and 6140027883.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Evansville, IN, by facsimile on April 1, 2003, and November
11, 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
2 units.
DISTRIBUTION
NC, and CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-0411-4.
CODE
Unit numbers BMMTYF, BMMRHN, BMMQTP, BMMQPZ, BMMPZJ, BMMPFR, BMMPCV, BMLZCW,
BMLYZZ, and BMLYLD.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., West Lafayette, IN, by facsimile on October 14,
2002. 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
10 units.
DISTRIBUTION
IL.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0404-4;
b) Platelets Pheresis, Leukocytes Reduced. Recall # B-0405-4
CODE
a) unit numbers 55FR24713, 55FR24714, 55FR24715, 55FR24721,
55R41405, 55R41407, 55F89593, 55FG46281, 55FH52782,
55R41410, 55R41415, 55S21268, 55S21273, 55S21274,
55L39661, 49K60960, 49W37516, 55R41473, 18GS61832,
18GS61833, 18GS61834, 18GS61836, 18GS61838, 55FH53101,
55FR24672, 55FR24686, 55FR24708, 55S21236, 55S21240,
55W35111, 55W35117, 55FH52885, 55FR24775, 55FH52778,
55FR24720, 55S21269, 36GE24165, 36GK10227, 36GK10251,
36LE06952, 55FG46520, 55FH52981, 55FH53088, 55W35254,
55L39807, 55FH52878, 55FR24751, 55FL07629, 55L39811,
36Q72432, 36FY27918, 55FY06335, 49M40038, 49W38332,
55FG46545, 55FH53018, 55FR24765, 55S21374, 50LJ38581,
50LJ38729, 18GJ61823, 18GJ61839, 24KE41560, 24KM72925,
24KV11375, 24KY49484, 24KZ29484, 55W35067, 55W35215,
55FG46492, 55FY06347, 55S21377, 55S21407, 55W35112,
55W35121, 55FK22430, 55FH52779, 55FH52780, 55T13266,
55FK22553, 55FR24895, 55FR24924, 55S21409, 55FG46473,
55FG46479, 55FG46484, 55FH52990, 55FH53012, 55FH53017,
55FH53021, 55FH53032, 55FH53038, 55FH53040, 55L39871,
55Z51377, 55Z51391, 55FG46288, 55FG46300, 55FG46305,
55FG46314, 55FG46325, 55FG46327, 55FG46332, 55FG46333,
55FG46345, 55FH52929, 55FH52948, 55FN20370, 55T13264,
55V20881, 55J20890, 55H85913, 55FW01661, 55FW01662, and
55C60799;
b) unit numbers 55FP19047, 55FP19061, 55FP19065, 55FP19060,
55FP19064, 55FP19052, 55FP19055, and 55FP19053; and the
following units were distributed as two split products:
unit numbers 55FP19045 and 55FP19046
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Ozarks - Arkansas Region, Little Rock,
AR, by telephone and letter beginning December 20, 2001. Firm initiated recall
is complete.
REASON
Blood products possibly exposed to unacceptable storage temperatures were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 115 units;
b) 12 units.
DISTRIBUTION
MO, and AK.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-0384-4.
CODE
Unit number: 24218-1890.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AR, by telephone on December
13, 2002, and by letter, dated January 28, 2003.
Manufacturing Firm: Blood Systems, Inc., Rapid City, SD. Firm initiated recall
is complete.
REASON
Blood products, manufactured after clots were detected during the leukocyte
reduction process, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
SD.
_______________________________
PRODUCT
Source Plasma. Recall # B-0390-4.
CODE
Unit number: 450719.
RECALLING FIRM/MANUFACTURER
Aventis Bio Services, Flint, MI, by facsimile, dated April 13, 2002.Firm initiated
recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately
performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0409-4.
CODE
Unit number 18GL33449.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by telephone
on July 8, 2003, and by letter on July 10, 2003. Firm initiated recall is complete.
REASON
Blood products, that were not leukoreduced within the appropriate time period
after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Source Plasma. Recall # B-0412-4.
CODE
Unit number 833037.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Flint, MI, by facsimile on August 23, 2002. Firm
initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0413-4.
CODE
Unit number 832513.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Flint, MI, by facsimile on September 9, 2002. Firm
initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0414-4.
CODE
Unit number 831342
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Flint, MI, by facsimile on August 6, 2002. Firm
initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0415-4.
CODE
Unit number 459237.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Flint, MI, by facsimile on July 11, 2002. Firm initiated
recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0416-4.
CODE
Unit numbers: 55FP21998, 55FP22000.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Greater Ozarks - Arkansas Region, Little
Rock, AR, by letters, dated June 23 and July 21, 2003. Firm initiated recall
is complete.
REASON
Blood products, labeled with the incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.
_______________________________
PRODUCT
ARCHITECT Processing Module. Recall # Z-0172-04.
CODE
All Serial numbers.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by technical service bulletins in February
2003. Firm initiated recall is complete.
REASON
If the interlock cable connected to the door lid sensor is disconnected or fails,
the lid is detected as closed even though it may be open.
VOLUME OF PRODUCT IN COMMERCE
1,167 units.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Hill-Rom brand Resident LT bed ambulatory assist bar accessory; accessory P865A.
Recall # Z-0206.4.
CODE
All units distributed between March 1997 and September 2003.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letter dated November 12, 2003. Firm initiated
recall is ongoing.
REASON
The ambulatory assist bar may not lock into position and may come out of place
due to incorrect assembly.
VOLUME OF PRODUCT IN COMMERCE
1,400.
DISTRIBUTION
Nationwide and Canada.
_______________________________
PRODUCT
Scopix( LR 5200P( Laser Imagers, Type 8394/600, Model number LR 5200P, Catalog
number EMQT S000. Recall # Z-0207-4.
CODE
Types: 8394/600, Serial numbers: 4000 through 5266.
RECALLING FIRM/MANUFACTURER
AGFA Corp., Greenville, SC, by letter on November 25, 2003. Firm initiated recall
is ongoing.
REASON
The GS1 circuit board may fail resulting in smoke or fire.
VOLUME OF PRODUCT IN COMMERCE
115 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Aeroset Phenobarbital, LN 1E08-01. Recall # Z-0208-04.
CODE
Lots: 01066HW00 expires 10/31/2003, 06030HW00 expires 4/30/2004, 08060HW00 expires
7/31/2004.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories Diagnostic Div., South Pasadena, CA, by telephone and letter
on November 3, 2003. Firm initiated recall is ongoing.
REASON
Assay is imprecise.
VOLUME OF PRODUCT IN COMMERCE
112.
DISTRIBUTION
Nationwide, Mexico, England and Canada.
_______________________________
PRODUCT
Exacta-Mix 2400 pharmacy compounding system. Recall # Z-0210-04.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Baxa Corp, Englewood, CO, by telephone and fax on November 7, 2003. Firm initiated
recall is ongoing.
REASON
If device stops due to an alarm or operator pause, inlet valves will remain
open, allowing some unwanted mixing of ingredients in the valve chamber
VOLUME OF PRODUCT IN COMMERCE
231 systems.
DISTRIBUTION
Nationwide, and UK.
______________________________
PRODUCT
C-Tek Anterior Cervical Plate System: 2.3mm/4.0mm Step Drill-14mm & 2.3mm/4.0mm
Step Drill-16mm. Catalog # 1100-9019 & # 1100-9020. Recall # Z-0211-04.
CODE
Lot #25947.
RECALLING FIRM/MANUFACTURER
Interpore Cross International, Inc., Irvine, CA, by letter on November 7, 2003.
Firm initiated recall is ongoing.
REASON
Step drills from Lot 25947
VOLUME OF PRODUCT IN COMMERCE
433.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Konica Minolta Duplicating Film Emulsions, Konica Medical Film. Film type SR-DUP
8x10, 10x12, 11x14, and 14x17. Film type PPD DUP 10x12 only. SR-DUP C 14x17.
Recall # Z-0150-04.
CODE
Emulsion numbers (X=any number): X742, X842, X152, and X023.
RECALLING FIRM/MANUFACTURER
Konica Medical Imaging, Inc., Wayne, NJ, by letter on October 9, 2003. Firm
initiated recall is ongoing.
REASON
Loss of detail at density of 1.00 to 2.00, on certain bony structures found
in original clinical films.
VOLUME OF PRODUCT IN COMMERCE
4,383.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Chocolate II Agar (GC II Agar with Hemoglobin and Iso Vitalex), microbiological
media plates, Catalog #221267, packaged in cardboard carton, 100 plates per
carton. Recall # Z-0164-04.
CODE
Lot/EXP 3197678/November 13, 2003;
3197693/November 14, 2003; 3198565/November 07, 2003;
3212853/November 25, 2003; 3212901/November 27, 2003;
3212919/November 28, 2003; 3212956/December 02, 2003;
3212972/December 03, 2003.
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Co., Sparks, MD, by fax and letter on October 10, 2003. Firm
initiated recall is ongoing.
REASON
Microbiological media may exhibit reduced colony size of bacteria, Haemophilus
species.
VOLUME OF PRODUCT IN COMMERCE
7,302 cartons.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Magnetic Resonance Imaging. Brand names: Concerto, Concerto Upgrade, Syngo Harmony,
Syngo Harmony 087S, Syngo Harmony Upgrade, Syngo Sonata, Syngo Sonata Upgrade,
Syngo Symphony, Syngo Symphony Q, and Syngo Symphony Upgrade. Model numbers
4772906, 7106995, 7104693, 5751438, 7106714, 7104719, 7106425, 7104594, 4772971,
and 7106557. Recall # Z-0175-03.
CODE
Software version VA21C.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by visit starting on October
16, 2003. Firm initiated recall is ongoing.
REASON
Equipment SAR monitor does not accept new patient data, incorrect RF levels
may be administered to the patient.
VOLUME OF PRODUCT IN COMMERCE
118 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Architect Anti-HBs Reagent Kit:
a) list 7C18-20, 4x100 tests;
b) list 7C18-25, 100 tests. Recall # Z-0209-04.
CODE
a) Lots 07779M300, exp 06/19/2004 and 95551M300,
exp 01/26/2004;
b) Lot 07779M301, exp 06/19/2004.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter on November 5,
2003. Firm initiated recall is ongoing.
REASON
Aspiration errors in the conjugate component due to microbial contamination
of the conjugate.
VOLUME OF PRODUCT IN COMMERCE
2,244 kits.
DISTRIBUTION
Canada, Japan, Australia, New Zealand, Germany and England.
_______________________________
PRODUCT
a) Mahurkar QPlus Dual Lumen Catheter Kit with Curved
Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis,
apheresis, and infusion. Reference: 8888-135192.
Recall # Z-0233-04;
b) Mahurkar QPlus Dual Lumen Catheter Insertion Tray with
Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis,
apheresis, and infusion Reference: 8888-135195.
Recall # Z-0234-04.
CODE
a) Lot Number: 140885;
b) Lot Number: 140774.
RECALLING FIRM/MANUFACTURER
Kendall Healthcare Products Co, Mansfield, MA, by letter on December 1, 2003.
Firm initiated recall is ongoing.
REASON
Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5
cm may contain a 13.5Fr x 16.0 cm.
VOLUME OF PRODUCT IN COMMERCE
55 catheters.
DISTRIBUTION
IL, MA, OH, TN, TX, VA.
END OF ENFORCEMENT REPORT FOR DECEMBER 24, 2003
###
Office of Public Affairs
Hypertext created by clb 2003-DEC-23.