December 3, 2003
03-49
_______________________________
PRODUCT
Source Plasma. Recall # B-0289-4.
CODE
Units 0820847522, 0820846792, and 0820846441.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Detroit, MI, by facsimile on February 12, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which the questions regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0322-4.
CODE
Unit numbers 0820847552, 0820847180, 0820846460, and 0820846208.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Detroit, MI, by facsimile on February 12, 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
4 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0323-4.
CODE
Unit numbers 0820847539, 0820846868, and 0820846419.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Detroit, MI, by facsimile on February 12 and 27, 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 # B-0328-4.
CODE
Units 0410922872, 0410922682, and 0410922144.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Oak Park, MI, by facsimile on February 21, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which the questions regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0329-4.
CODE
Units 0410923479, and 0410922710.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Oak Park, MI, by facsimile on February 21, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which the questions regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0330-4.
CODE
Units 0820847456, 0820846543 and 0820846066.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Detroit, MI, by facsimile on February 12, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which the questions regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0331-4.
CODE
Units 0820847685 and 0820846107.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Detroit, MI, by facsimile on February 13, and February 25, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which the questions regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0332-4.
CODE
Units 69239311, 69235467, 69225451, 69204623, 69198069, 69193477, and 69185649..
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Evansville, IN, by facsimile on August 8, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which the questions regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Source Plasma. Recall # B-0333-4.
CODE
Units 0820847492, 0820846844 and 0820846429.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Detroit, MI, by facsimile on February 12 and February 25, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which the questions regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0334-4.
CODE
Units 0820847398, 0820846635 and 0820845994.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Detroit, MI, by facsimile on February 18, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which the questions regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0335-4.
CODE
Units 0820846185 and 0820946623.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Detroit, MI, by facsimile on February 18, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which the questions regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0336-4.
CODE
Units 0820847690, 0820847353, 0820846586, and 0820846296.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Detroit, MI, by facsimile on February 14, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which the questions regarding Creutzfeldt-Jakob disease (CJD) were incomplete on the donation record, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-0337-4.
CODE
Unit number: 02GMIE7353.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Walker, MI, by facsimile dated November 6, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening did not include questions regarding risk factors for Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-0339-4.
CODE
Unit number: FM72430.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by letter dated July 25, 2003. 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
RI.
_______________________________
PRODUCT
Source Plasma. Recall # B-0342-4.
CODE
Unit numbers 0410909205, 0410908973, 0410905035, and 0410903438.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Oak Park, MI, by facsimile on December 2, 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
4 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0321-4.
CODE
Unit numbers 13GL14700 and 13FV19628.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on July 18, 2003, and letter on August 12, 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
2 units.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Source Plasma. Recall # B-0327-4.
CODE
Unit: 02RMIB0423.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Grand Rapids, MI, by facsimile on December 10, 2002. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from a donor whose medical history was not determined at the time of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Coulter DNA Prep Reagents Kit Part 6607055. Recall # Z-0136-04.
CODE
Lot # 760203k-760208k, 760213k, 760218k.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter on October
10, 2003. Firm initiated recall is ongoing.
REASON
Labeling Error-Omission of "Research Use Only".
VOLUME OF PRODUCT IN COMMERCE
284.
DISTRIBUTION
Nationwide and Canada.
_______________________________
PRODUCT
a) Monarch Inflation Device and Fluid Dispensing Syringe -
Latex Free MERIT MEDICAL. Sterile if package is unopened
or undamaged. Part # IN2125/B. Recall # Z-0137-04;
b) IntelliSystem25 Inflation Device and Fluid Dispensing
Syringe - Label on package reads in part: "NTELLISYSTEM
25 WITH MAP152 MAP152 CONTAINS: MERIT ACCESS PLUS LARGE
BORE HEMOSTASIS VALVE, TORGUE DEVICE AND METAL GUIDE
WIRE INSERTION TOOL...MERIT MEDICAL" Latex free. Sterile
if package is unopened or undamaged. Part # 1525/B.
Recall # Z-0138-04;
c) VacLok Syringe. Label reads in part: ''VACLOC SYRINGE 60
ml VACLOF SYRINGE-FIXED MALE LUER ... MERIT MEDICAL''.
Sterile if package is unopened or undamaged. Part
#VAC160. Recall # Z-0139-04;
d) Inflation Kit. Label reads in part: "CUSTOM KIT...MERIT
MEDICAL". Latex free, Sterile if package is unopened or
undamaged. Part Numbers: K05-00122H, K05-50031D,
K05-10570, K05-01536A, K05-01153C, K05-00276C,
K05-0019313, K05-00077F, K05-01296A, K05-00134D,
K05-01676, K05-01250, K05-00800, K05-01545, K05-00819,
K05-01069C, K05-00559F, K05-50078B, K05-00116C,
K05-00459C, K05-01290A,K05-01146, K05-50054D,
K05-00946B, K05-00203K, K05-00682B, K05-YSI008A,
K05-YPI011, K05-00746, K05-003139, K05-00751G,
K05-00180G, and K05-00553F. Recall # Z-0140-04;
e) Manifold Custom Kit. Label reads in part: "CUSTOM
KIT...MERIT MEDICAL". Latex free, Sterile if package is
unopened or undamaged. Part # K09-07862B, # K09-07873,
#K09-02498F, #K09-07828b, #K09-00970J, #K09-06383B,
#K09-07002A, #K09-04734D, #K09-00794K, and #K09-08037A.
Recall # Z- 0141-04;
f) Waste Collection Kit. Label reads in part: "CUSTOM
KIT...MERIT MEDICAL". Latex free, Sterile if package is
unopened or undamaged. Part # K10-01047. Recall # Z-
0142-04.
CODE
a) Lot # A284004 and Lot # A287115;
b) Lot # A285003;
c) Lot # A282003;
d) Lot # A286536 # A286573 #A284710, #A286572, #A284696,
#A286544, #A289876, #A286529, #A286569, #A286538,
#A290146, #A287547, #A284668, #A286552 #A284703,
#A287540, #A286565, #A284616 #A284618, #A286535,
#A286547, #A284998 #A284694, #A284617, #A286560,
#A286542 #A286550, #A287554, #A287553, #A279791,
#A290033, #A290053, #A286541, and #A283067;
e) Lot # A279212, #A28360, #A286211, #A282726 #A281641,
#A279931, #A282796, #A288051, #A285173, #A284256, and
#A290244;
f) Lot # A289183.
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT, by letter dated October 3, 2003. Firm initiated recall is ongoing.
REASON
There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.
VOLUME OF PRODUCT IN COMMERCE
11,022 units.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Hyfrecator 20)0 Electrosurgical Unit. Hyfrecator 2000, P/N 7-900-XXX (where XXX may equal -100, -115, -220 and -230). Recall # Z-0144-04.
CODE
Serial numbers: 01AGJ199, 01AGJ262, 01DGJ251, 01EGJ125, 01JGJ177, 01MGJ243, 02CGJ244, 02EGJ160, 02EGJ311 and 02LGJ211.
RECALLING FIRM/MANUFACTURER
ConMed Electrosurgery, Centennial, CO, by letter on September 15, 2003. Firm initiated recall is ongoing.
REASON
The Hyfrecator 2000 units were released without documented adherence to their voltage output specification.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
CA, CT, IL, ME, and the Phillipines.
_______________________________
PRODUCT
Portable Oxygen Analyzer. Recall # Z-0145-04.
CODE
Model # AX300, MX300.
RECALLING FIRM/MANUFACTURER
Teledyne Analytical Instruments, Rowland Heights, CA, by letter on October 27, 2003. Firm initiated recall is ongoing.
REASON
Potential failure to display the battery low light to the end-user.
VOLUME OF PRODUCT IN COMMERCE
170.
DISTRIBUTION
FL, CA, UT, AZ, MO, New Zeland, Australia, Canada and the United Kingdom.
_______________________________
PRODUCT
a) KyphX Xpander brand Inflation Syringe; Merit Medical
Part Number: K05-01290A. Kyphon Catalog Number: A08A.
The medical device is distributed by Kyphon under the
brand name KyphX Xpander Inflation Syringe. This medical
device is provided as an individual stand-alone package
(which also contains an accessory locking syringe
device) and as an individually packaged component of the
KyphoPak Tray. The Inflation Syringe packaging and
contents are identical whether provided as a stand-alone
package or as a component of the KyphoPak Tray.
Recall # Z-0146-04;
b) KyphXR brand KyphoPak Tray, a Introducer Tool kit for
Inflation Syringe Kyphon Catalog Number: KPT1001,
KPT1002, KPT1003, KPT1501, KPT1503, KPT2002, KPT2003
The medical device is distributed by Kyphon under the
brand name KyphX Xpander Inflation Syringe. This medical
device is provided as an individual stand-alone package
(which also contains an accessory locking syringe
device) and as an individually packaged component of the
KyphoPak Tray. The Inflation Syringe packaging and
contents are identical whether provided as a stand-alone
package or as a component of the KyphoPak Tray.
Recall # Z-0147-04.
CODE
a) Lot nos. A284998, A282736, A284998, A282736;
b) Lot No. 03090901, Lot No. 03090902, Lot No. 03090903,
Lot No. 03091704, Lot No. 03091705, Lot No. 03090807,
Lot No. 03090806.
RECALLING FIRM/MANUFACTURER
Kyphon, Inc., Sunnyvale, CA, by letter and on-site visit on October 13, 2003. Firm initiated recall is ongoing.
REASON
Devices for which sterility may be compromised as evidenced by a loss of package integrity.
VOLUME OF PRODUCT IN COMMERCE
982 syringes.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set. Catalog/Model number CL-07011. Recall # Z-0088-04.
CODE
Lot number CF03075226.
RECALLING FIRM/MANUFACTURER
Arrow International, Inc., Reading, Pa, via telephone on October 22, 2003. Firm initiated recall is ongoing.
REASON
Package lid identifies the contents incorrectly.
VOLUME OF PRODUCT IN COMMERCE
80 kits.
DISTRIBUTION
AR, CA, NH, VA, VT and Srialanka.
_______________________________
PRODUCT
a) ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL.
Sterile. Rx. For intraocular use. Product Number: 1000. Recall # Z-0108-04;
b) Staarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe.
Sterile. Rx. For intraocular use. P/N490-001.
Recall # Z-0109-04.
c) Amvisc Sodium Hyaluronate 0.8 mL 12 mg/mL Syringe.
Sterile. RX. For intraocular use. Product Number: 780A.
Recall # Z-0110-04;
d) DomiVisc Sodium Hyaluronate 0.8 mL 12 mg.mL Syringe.
Sterile.RX. For intraocular use Product Numbner; P012-
180A. Recall # Z-0111-04;
e) Hialuronato Sodico Sodium Hyaluronate 12 mg/mL 1X0.8 mL
Sterile. RX. For Intraocular use. Product Number: 014-
180A. Recall # Z-0112-04;
f) Amvisc Intraocular Injection Sodium hyaluronate 12 mg/ml
For European Distribution. Recall # Z-0113-04.
CODE
a) Lot Number: B020122B;
b) Lot Number: B020122E;
c) Lot Numbers: B0201222, B020122D, B020122G;
d) Lot Numbers: B020122A, B020122J;
e) Lot Number: B020122H;
f) Lot Numbers: B020122C, B020122F.
RECALLING FIRM/MANUFACTURER
Anika Therapeutics, Woburn, MA, by letter on October 8, 2003. Firm initiated recall is ongoing.
REASON
Stability failure at the 20 month for viscosity specification.
VOLUME OF PRODUCT IN COMMERCE
40,698 units.
DISTRIBUTION
CA, MO, NC, and VA.
_______________________________
PRODUCT
CONFIRM c-KIT, Antibody (rabbit polyclonal), Catalog number 790-2939. Recall # Z-0115-04.
CODE
Lot Numbers: 23095A, 23340A, and 30116A.
RECALLING FIRM/MANUFACTURER
Ventana Medical Systems, Inc., Tucson, AZ, by letter on April 4, 2003. Firm initiated recall is ongoing.
REASON
Increased level of non-specific or background staining.
VOLUME OF PRODUCT IN COMMERCE
95.
DISTRIBUTION
Nationwide, Japan, France and Puerto Rico.
_______________________________
PRODUCT
Datex-Ohmeda Cardiocap/5 Patient Monitors. Recall # Z-0143-04.
CODE
The monitors in the serial number range FBWF00725 through FBWF03055 and FBWG00001 through FBWG02015 could be affected by the problem if they are mounted on the optional mounting stands for the product.
RECALLING FIRM/MANUFACTURER
Datex-Ohmeda, Inc., Madison, WI, by letters dated October 15, 2003. Firm initiated recall is ongoing.
REASON
Datex-Ohmeda Cardiocap/5 Patient Monitors have bracket pins which do not adequately secure them to their optional mounting stand so the monitors may fall.
VOLUME OF PRODUCT IN COMMERCE
875 units.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Accelerated Genetics Performance Plus 20-20 AM Calf Milk Replacer (A non-medicated calf milk replacer). Recall # V-004-4
CODE
06-9502-0152.
RECALLING FIRM/MANUFACTURER
Milk Products, Inc., Chilton, WI, by e-mail, telephone, and letter on December 6, 2002. Firm initiated recall is ongoing.
REASON
The product involved is non-medicated calf milk replacer. Carryover of Neomycin/Oxtetracycline was confirmed thru testing on 12/6/02.
VOLUME OF PRODUCT IN COMMERCE
292-50 pound bags.
DISTRIBUTION
Nationwide.
END OF ENFORCEMENT REPORT FOR DECEMBER 3, 2003
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Hypertext created by clb 2003-DEC-03.