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The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
March 26, 2008
08-13
___________________________________
PRODUCT
Oriental Mascot Brand, Sweetened Sliced Coconut; Product of China Nt. Wt. 4 oz., Recall # F-246-8
CODE
No codes on product
RECALLING FIRM/MANUFACTURER
Recalling Firm: Summit Import Corp., Jersey City, NJ, by press release on February 1, 2008.
Manufacturer: Guangzhou Luoxi Marine Products. Firm initiated recall is ongoing.
REASON
New York State Department of Agriculture and Markets randomly sampled the product and found it to contain 70 mg (2459 ppm) of sulfites per serving.
VOLUME OF PRODUCT IN COMMERCE
14 cartons - 40 4 oz. containers per carton
DISTRIBUTION
NY, NJ and PA
___________________________________
PRODUCT
CIBO NATURALS classic basil pesto in 6 oz. plastic container labeled KEEP REFRIGERATED NET WT 6 OZ, Recall # F-247-8
CODE
Lot numbers include 34007344, 34007345, and 34007346. Lot numbers are ink stamped on bottom of container with black ink.
RECALLING FIRM/MANUFACTURER
CIBO Naturals, LLC., Seattle, WA, by press release and e-mail on February 1, 2008. Firm initiated recall is complete.
REASON
Product contains undeclared pine nuts.
VOLUME OF PRODUCT IN COMMERCE
20,704 /6 oz containers
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Queso Cincho Guerrero Cincho Cheese; a hard dry Mexican style cheese with dry chili peppers rubbed on the outside of the wheel of cheese; the 35 - 45 lb. wheels are wrapped in plastic wrap and placed in cardboard shipping cartons (the wheel label states "Net Weight 22 Lbs when Packed"); Keep refrigerated, Product of Mexico, UPC 6 56583 90001 7, Recall # F-248-8
CODE
All wheels distributed between April 16 and July 26, 2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mexican Cheese Producers, Inc., Monroe, WI, by press release on September 18, 2007.
Manufacturer: Quesos Sabrosos Mexicanos s.a. de c.v., Villahermosa.
Mexico, FDA initiated recall is complete.
REASON
The cheese is contaminated with Salmonella and Staphylococcus aureus bacteria.
VOLUME OF PRODUCT IN COMMERCE
2870 wheels of cheese
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Be Powered Protein Bar all natural chocolate raspberry, 4 bars Net WT 2.0 oz (57 g) / total net wt 8.0 oz (227g); Be Powered Protein Bar all natural chocolate raspberry, Net WT 2.0 oz (57 g), Recall # F-245-8
CODE
1-85337-0002-5 (single bars) 1-85337-00094-4 (4 bars per pack)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Be unlimited, ltd., Milwaukee, WI, by telephone on January 4, 2008.
Manufacturer: Colorado Baking Company, Colorado Springs, CO. Firm initiated recall is ongoing.
REASON
Manufacturing issue has been identified that results in the potential for these products to develop mold prior to their expiration date.
VOLUME OF PRODUCT IN COMMERCE
49,000 bars
DISTRIBUTION
MN
___________________________________
PRODUCT
Wellbutrin XL® (bupropion hydrochloride extended release tablets) 300 mg, 30 tablet bottles, Rx only, NDC 0173-0731-01, Recall # D-178-2008
CODE
Lot number P08A011, Expiration May 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: GlaxoSmithKline Inc., Zebulon, NC, by letters on March 7, 2008.
Manufacturer: Biovail Corporation, Steinbach Manitoba, Canada. Firm initiated recall is ongoing.
REASON
Presence of foreign material was found embedded within the tablets
VOLUME OF PRODUCT IN COMMERCE
24561 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Sore Relief First Aid Antiseptic (Benzethonium Chloride 0.2%) and Topical Analgesic (Lidocaine 2.0%),
Net Wt. 20g each, For Professional Use Only,
NDC 65123-749-01, Recall # D-179-2008;
b) Durable Closure First Aid Antiseptic (Benzethonium Chloride 0.2%); Net Wt 20g
each, For Professional Use Only, NDC 65123-747-01, Recall # D-180-2008
CODE
a) Lot #: 749.013, Exp. 03/08 and 749.015, Exp. 04/09;
b) Lot #: 749.011, Exp. 01/09
RECALLING FIRM/MANUFACTURER
Activ Group, Southlake, TX, by letter on January 21, 2008. Firm initiated recall is ongoing.
REASON
Misbranded; active ingredients in the formulation of this OTC drug are labeled as inactive on the package labeling and drug is promoted for uses not described on package label.
VOLUME OF PRODUCT IN COMMERCE
1,427/20g jars
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Medtronic - SynchroMed EL Implantable Infusion Pump, Model Number: 8626-10.
The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL
pump with reservoir valve. The implantable Medtronic SynchroMed EL
Programmable Pump is part of the SynchroMed EL Infusion System designed to
contain and administer parenteral drugs to a specific site. The implantable components
of the SynchroMed EL Infusion System include the pump with or without a side
catheter access port, catheters, and catheter accessories, Recall # Z-1142-2008;
b) Medtronic SynchroMed EL Implantable Infusion Pump, model 8626-18. The
contents of the inner package have been sterilized by ethylene oxide gas. 18 mL
pump with reservoir valve. The implantable Medtronic SynchroMed EL
Programmable Pump is part of the SynchroMed EL Infusion System designed to
contain and administer parenteral drugs to a specific site. The implantable
components of the SynchroMed EL Infusion System include the pump with or
without a side catheter access port, catheters, and catheter accessories.
Recall Z-1143-2008;
c) Medtronic SynchroMed EL Implantable Infusion Pump, model 8626L-10. The
contents of the inner package have been sterilized by ethylene oxide gas. 10 mL
pump with reservoir valve and suture loops. The implantable Medtronic SynchroMed
EL Programmable Pump is part of the SynchroMed EL Infusion System designed to
contain and administer parenteral drugs to a specific site. The implantable components
of the SynchroMed EL Infusion System include the pump with or without a side
catheter access port, catheters, and catheter accessories. Recall Z-1144-2008;
d) Medtronic SynchroMed EL Implantable Infusion Pump, model 8626L-18. The
contents of the inner package have been sterilized by ethylene oxide gas. 18 mL
pump with reservoir valve and suture loops. The implantable Medtronic SynchroMed
EL Programmable Pump is part of the SynchroMed EL Infusion System designed to
contain and administer parenteral drugs to a specific site. The implantable components
of the SynchroMed EL Infusion System include the pump with or without a side
catheter access port, catheters, and catheter accessories, Recall Z-1145-2008;
e) Medtronic SynchroMed EL Implantable Infusion Pump, model 8627-10. The contents
of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with
reservoir valve and screened side catheter access port. The implantable Medtronic
SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System
designed to contain and administer parenteral drugs to a specific site. The implantable
components of the SynchroMed EL Infusion System include the pump with or without
a side catheter access port, catheters, and catheter accessories, Recall Z-1146-2008;
f) Medtronic SynchroMed EL Implantable Infusion Pump, model 8627-18. The contents
of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with
reservoir valve and screened side catheter access port. The implantable Medtronic
SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System
designed to contain and administer parenteral drugs to a specific site. The implantable
components of the SynchroMed EL Infusion System include the pump with or without
a side catheter access port, catheters, and catheter accessories, Recall Z-1147-2008;
g) Medtronic SynchroMed EL Implantable Infusion Pump, model 8627L-10. The
contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump
with reservoir valve, screened side catheter access port and suture loops. The
implantable Medtronic SynchroMed EL Programmable Pump is part of the
SynchroMed EL Infusion System designed to contain and administer parenteral drugs
to a specific site. The implantable components of the SynchroMed EL Infusion
System include the pump with or without a side catheter access port, catheters, and
catheter accessories, Recall Z-1148-2008;
h) Medtronic SynchroMed EL Implantable Infusion Pump, model 8627L-18. The
contents of the inner package have been sterilized by ethylene oxide gas. 18 mL pump
with reservoir valve, screened side catheter access port and suture loops. The
implantable Medtronic SynchroMed EL Programmable Pump is part of the
SynchroMed EL Infusion System designed to contain and administer parenteral drugs
to a specific site. The implantable components of the SynchroMed EL Infusion
System include the pump with or without a side catheter access port, catheters, and
catheter accessories, Recall Z-1149-2008;
i) Medtronic SynchroMed II Programmable Pump, model 8637-20. The contents of the
inner package have been sterilized by ethylene oxide gas. 20 mL reservoir. The
implantable Medtronic SynchroMed II Programmable Pump is part of the SynchroMed
II Infusion System designed to contain and administer prescribed drugs to a specific
site. The implantable components of the SynchroMed II Infusion System include the
pump, catheter, and catheter accessories, Recall Z-1150-2008;
j) Medtronic SynchroMed II Programmable Pump, model 8637-40. The contents of the
inner package have been sterilized by ethylene oxide gas. 40 mL reservoir. The
implantable Medtronic SynchroMed II Programmable Pump is part of the SynchroMed
II Infusion System designed to contain and administer prescribed drugs to a specific
site. The implantable components of the SynchroMed II Infusion System include the
pump, catheter, and catheter accessories, Recall Z-1151-2008;
k) Medtronic IsoMed Implantable Constant-Flow Infusion Pump, model 8472-20. The
contents of the inner package have been sterilized by ethylene oxide gas. Reservoir
size: 20 mL. The implantable Medtronic IsoMed Constant-Flow Infusion Pump is
part of the IsoMed Constant-Flow Infusion System designed to contain and administer
parenteral drugs to a specific site. The components of the IsoMed Constant-Flow
Infusion System include the pump, Medtronic catheter, catheter accessories,
Medtronic Refill kit, and Medtronic catheter access port kit. IsoMed pumps are
implantable devices that store and dispense drugs according to a constant flow rate
set during the manufacturing process, Recall Z-1152-2008;
l) Medtronic IsoMed Implantable Constant-Flow Infusion Pump, model 8472-35. The
contents of the inner package have been sterilized by ethylene oxide gas. Reservoir
size: 35 mL. The implantable Medtronic IsoMed Constant-Flow Infusion Pump is
part of the IsoMed Constant-Flow Infusion System designed to contain and administer
parenteral drugs to a specific site. The components of the IsoMed Constant-Flow
Infusion System include the pump, Medtronic catheter, catheter accessories,
Medtronic Refill kit, and Medtronic catheter access port kit. IsoMed pumps are
implantable devices that store and dispense drugs according to a constant flow rate set
during the manufacturing process, Recall Z-1153-2008;
m) Medtronic IsoMed Implantable Constant-Flow Infusion Pump, model 8472-60. The
contents of the inner package have been sterilized by ethylene oxide gas. Reservoir
size: 60 mL. The implantable Medtronic IsoMed Constant-Flow Infusion Pump is
part of the IsoMed Constant-Flow Infusion System designed to contain and administer
parenteral drugs to a specific site. The components of the IsoMed Constant-Flow
Infusion System include the pump, Medtronic catheter, catheter accessories,
Medtronic Refill kit, and Medtronic catheter access port kit. IsoMed pumps are
implantable devices that store and dispense drugs according to a constant flow rate
set during the manufacturing process, Recall Z-1154-2008
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Medtronic Neuromodulation, Minneapolis, MN, by letter in January 2008. Firm initiated recall is ongoing.
REASON
(UPDATED 03/27/08) Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. On January 16, 2008, Medtronic sent a letter to doctors who implant these devices and/or provide care to patients with the implanted device, describing the problem, patient risks, patient management, recommendations and next steps.
VOLUME OF PRODUCT IN COMMERCE
102,792 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
GreenLight HPS System, Surgical Laser System and Accessories. Part Numbers 0010-0070 and 0010-0075 (international units), Recall #Z-0130-2008
CODE
Serial Numbers (All starting with HPS2): 125, 167, 057, 067, 072, 106, 114, 120, 149, 193, 186, 161, 037, 039, 040, 044, 050, 088, 185, 190, 197, 035, 160, 208, 046, 076, 102, 074, 108, 121, 141, 173, 178, 089, 069, 030, 155, 172, 174, 148, 042, 164, 098, 175, 100, 169, 196, 056, 071, 132, 165, 036, 201, 033, 123, 065, 206, 170, 179, 095, 177, 073, 194, 086, 064, 122, 133, 049, 060, 078, 112, 150, 163, 130, 059, 101, 113, 135, 146, 137, 189, 195, 063, 157, 181, 166, 052, 043, 061, 092, 124, 029, 096, 093, 094, 138, 202, 211, 129, 144, 058, 162, 168, 045, 085, 066, 082, 053, 140, 158, 159, 090, 182, 183, 051, 087, 104, 116, 117, 205, 034, 203, 222, 223, 226, 229, 207, 214, 220, 230, 070, 103, 215, 110, 068, 077, 079, 128, 153, 075, 080, 083, 084, 097, 176, 105, 134, 136, 143, 147, 111, 171, 131, 151, 156, 109, 180, 145, 062, 118, 126, 127, 152, 139, 142, 209, 081, 099, 119
RECALLING FIRM/MANUFACTURER
Recalling Firm: AMS Innovative Center - San Jose, CA, by letters, dated April 17, 2007.
Manufacturer: American Medical Systems, Minnetonka, MN. Firm initiated recall is ongoing.
REASON
Component missing: Some products were issued without thermal protection switches.
VOLUME OF PRODUCT IN COMMERCE
169 systems
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Ventana Image Analysis System (VIAS) - PATHWAY anti-HER-2/neu (4B5) primary antibody with software version 2.3.0.2, Model Number: VIAS-799-10000-00, Pathology Image Analysis System, Recall # Z-0571-2008
CODE
Serial Numbers: HIS06086 HIS05042 HIS06047 HIS05018 HIS05022 HIS06046 HIS06092 HIS06059 HIS06053 HIS05053 HIS06035 HIS06038 HIS05026 HIS06100 HIS06021 HIS06074 HIS05041 HIS05017 HIS06031 HIS05051 HIS06061 HIS06028 HIS05011 HIS06083 HIS06064 HIS06057 HIS06055 HIS05047 HIS05012 HIS06054 HIS06073 HIS06088 HIS06076 HIS06002 HIS06001 HIS06004 HIS06034 HIS06015 HIS06098 HIS06069 HIS05044 HIS06033 HIS06050 HIS05046 HIS06030 HIS06095 HIS06067 HIS05028 HIS06027 HIS06056 HIS05033 HIS06049 HIS06026 HIS06008 HIS05049 HIS05013 HIS06079 HIS06072 HIS06089 HIS06084 HIS06044 HIS06007 HIS05027 HIS06051 HIS06052 HIS05025 HIS06096 HIS06066 HIS06039 HIS06065 HIS06019 HIS05052 HIS06029 HIS06022 HIS06068 HIS05048, and HIS05058
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ventana Medical Systems Inc., Tucson, AZ, by telephone beginning in June 20007 and by letter dated August 17, 2007.
Manufacturer: Bd Diagnostic Systems Tripath, Durham, NC. Firm initiated recall is complete.
REASON
Incomplete upgrade: The software upgrade from February 1, 2007 may not have been completed. This software upgrade adds the algorithm (Slidetype) for the PATHWAY anti-HER-2/neu (4B5) antibody to the VIAS system.
VOLUME OF PRODUCT IN COMMERCE
77 devices
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6 mm x 20 mm, P/N
7211109, Ligament Screw, Recall # Z-0593-2008
b) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6 mm x 25 mm, P/N
7211110, Ligament Screw, Recall # Z-0594-2008;
c) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 6
mm x 25 mm, P/N 7211111, Ligament Screw, Recall # Z-0595-2008;
d) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 20 mm, P/N
7211112, Ligament Screw, Recall # Z-0596-2008
e) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 25 mm, P/N
7211113, Ligament Screw, Recall # Z-0597-2008;
f) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, Reverse Thread,
7 mm x 25 mm, P/N 7211114, Ligament Screw, Recall # Z-0598-2008
g) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 30 mm,
P/N 7211115, Ligament Screw, Recall # Z-0599-2008;
h) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 25 mm,
P/N 7211116, Ligament Screw, Recall # Z-0600-2008;
i) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 30 mm,
P/N 7211117, Ligament Screw, Recall # Z-0601-2008;
j) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 35 mm,
P/N 7211118, Ligament Screw, Recall # Z-0602-2008;
k) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 25 mm,
P/N 7211119, Ligament Screw, Recall # Z-0603-2008;
l) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 30 mm,
P/N 7211120, Ligament Screw, Recall # Z-0604-2008;
m) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 35 mm,
P/N 7211121, Ligament Screw, Recall # Z-0605-2008;
n) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 25 mm,
P/N 7211122, Ligament Screw, Recall # Z-0606-2008;
o) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 30 mm,
P/N 7211123, Ligament Screw, Recall # Z-0607-2008;
p) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 35 mm,
P/N 7211124, Ligament Screw, Recall # Z-0608-2008;
q) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 30 mm,
P/N 7211125, Ligament Screw, Recall # Z-0609-2008;
r) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 35 mm,
P/N 7211126, Ligament Screw, Recall # Z-0610-2008;
s) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 12 mm x 35 mm,
P/N 7211127, Ligament Screw, Recall # Z-0611-2008;
t) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 20 mm,
P/N 72201069, Ligament Screw, Recall # Z-0612-2008;
u) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 20 mm,
P/N 72201070, Ligament Screw, Recall # Z-0613-2008;
v) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 20 mm,
P/N 72201071, Ligament Screw, Recall # Z-0614-2008;
w) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 25 mm,
P/N 72201072, Ligament Screw, Recall # Z-0615-2008;
x) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, Reverse Thread,
8 mm x 25 mm, P/N 72201073, Ligament Screw, Recall # Z-0616-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc., Endoscopy Division, Andover, MA, by letter on August 21 and August 23, 2007.
Manufacturer: Smith & Nephew, Inc., Endoscopy Division, Mansfield, MA. Firm initiated recall is ongoing.
REASON
Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
VOLUME OF PRODUCT IN COMMERCE
68,285 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous, 60mm O.D., Tivanium TI-6AL-4V Alloy, Hip Prosthesis Component, REF 6200-060-22, Catalog # 00-6200-060-22, Recall # Z-0620-2008
CODE
Lot Number: 26208600; exp. 2013-02
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc., Warsaw, IN, by letter dated October 19, 2007.
Manufacturer: Zimmer Manufacturing B.V., Mercedita, PR. Firm initiated recall is complete.
REASON
Parts missing and incomplete etch: The units may not contain the locking ring or the etched alignment marks on the rim.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Stryker Orthopaedics, UHR Universal Bipolar Component; 26 x 42 mm, Hip
Prosthesis Component, Recall # Z-0621-2008;
2) Stryker Orthopaedics UHR Universal Bipolar Component; 26 x 44 mm, Hip
Prosthesis Component, Recall # Z-0622-2008;
3) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 44 mm, Hip
Prosthesis Component, Recall # Z-0623-2008;
4) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 45 mm, Hip
Prosthesis Component, Recall # Z-0624-2008;
5) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 45 mm, Hip
Prosthesis Component, Recall # Z-0625-2008;
6) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 46 mm, Hip
Prosthesis Component, Recall # Z-0626-2008;
7) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 46 mm, Hip
Prosthesis Component, Recall # Z-0627-2008;
8) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 43 mm, Hip
Prosthesis Component, Recall # Z-0628-2008;
9) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 47 mm, Hip
Prosthesis Component, Recall # Z-0629-2008;
10) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 47 mm, Hip
Prosthesis Component, Recall # Z-0630-2008;
11) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 48 mm, Hip
Prosthesis Component, Recall # Z-0631-2008;
12) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 48 mm, Hip
Prosthesis Component, Recall # Z-0632-2008;
13) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 49 mm, Hip
Prosthesis Component, Recall # Z-0633-2008;
14) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 49 mm, Hip
Prosthesis Component, Recall # Z-0634-2008;
15) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 50 mm, Hip
Prosthesis Component, Recall # Z-0635-2008;
16) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 50 mm, Hip
Prosthesis Component, Recall # Z-0636-2008;
17) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 51 mm, Hip
Prosthesis Component, Recall # Z-0637-2008;
18) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 51 mm, Hip
Prosthesis Component, Recall # Z-0638-2008;
19) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 52 mm, Hip
Prosthesis Component, Recall # Z-0639-2008;
20) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 53 mm, Hip
Prosthesis Component, Recall # Z-0640-2008;
21) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 52 mm, Hip
Prosthesis Component, Recall # Z-0641-2008;
22) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 53 mm, Hip
Prosthesis Component, Recall # Z-0642-2008;
23) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 54 mm, Hip
Prosthesis Component, Recall # Z-0643-2008;
24) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 55 mm, Hip
Prosthesis Component, Recall # Z-0644-2008;
25) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 55 mm, Hip
Prosthesis Component, Recall # Z-0645-2008;
26) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 56 mm, Hip
Prosthesis Component, Recall # Z-0646-2008;
27) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 41 mm, Hip
Prosthesis Component, Recall # Z-0647-2008;
28) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 54 mm, Hip
Prosthesis Component, Recall # Z-0648-2008;
29) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 56 mm, Hip
Prosthesis Component, Recall # Z-0649-2008;
30) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 56 mm, Hip
Prosthesis Component, Recall # Z-0650-2008;
31) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 58 mm, Hip
Prosthesis Component, Recall # Z-0651-2008;
32) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 61 mm, Hip
Prosthesis Component, Recall # Z-0652-2008;
33) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 61 mm, Hip
Prosthesis Component, Recall # Z-0653-2008;
34) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 68 mm, Hip
Prosthesis Component, Recall # Z-0654-2008;
35) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 68 mm, Hip
Prosthesis Component, Recall # Z-0655-2008;
36) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 72 mm, Hip
Prosthesis Component, Recall # Z-0656-2008
CODE
1) Ref No: Description: Lot Code: UH1-42-26 UHR BIPOLAR 26X42mm HD8MJA
UH1-42-26 K53MND UH1-42-26 TK6MEA;
2) Ref No: Description: Lot Code: UH1-44-26 UHR BIPOLAR 26X44mm 5NDMLA
UH1-44-26 UHR BIPOLAR 26X44mm 5NEMLA UH1-44-26 UHR BIPOLAR
26X44mm 7PDMCA UH1-44-26 UHR BIPOLAR 26X44mm PEKMEA UH1-44-28
UHR BIPOLAR 26X44mm 2RKMED UH1-44-26 29AMPD UH1-44-26 4JDMPD
UH1-44-26 4JEMPD UH1-44-26 DT9MND UH1-44-26 M15MHD;
3) Ref No: Description: Lot Code: UH1-44-28 UHR BIPOLAR 28X44mm 3K4MMD
UH1-44-28 UHR BIPOLAR 28X44mm 5P0MLA UH1-44-28 UHR BIPOLAR
28X44mm JEMMNA UH1-44-28 04YMPD UH1-44-28 0YHMMD UH1-44-28
247MMD UH1-44-28 29EMPD UH1-44-28 2HYMRA UH1-44-28 66NMKD
UH1-44-28 6W5MPD UH1-44-28 6W6MPD UH1-44-28 8XEMPD UH1-44-28
8XKMPD UH1-44-28 9W0MJA UH1-44-28 D05MKD UH1-44-28 ED8MND
UH1-44-28 EP2MPA UH1-44-28 K57MND UH1-44-28 K6LMND UH1-44-28
LA6MPA UH1-44-28 V13MLD UH1-44-28 V17MLD;
4) Ref No: Description: Lot Code: UH1-45-26 UHR BIPOLAR 26X45mm 2RJMPA
UH1-45-26 UHR BIPOLAR 26X45mm 2RMMPA UH1-45-26 UHR BIPOLAR
26X45mm K15MPA UH1-45-26 3KDMMD UH1-45-26 3KLMPD UH1-45-26
4JHMPD UH1-45-26 637MKD UH1-45-26 75TMMD UH1-45-26 E94MPD
UH1-45-26 EDAMND UH1-45-26 EDDMND UH1-45-26 K4VMND;
5) Ref No: Description: Lot Code: UH1-45-28 UHR BIPOLAR 28X45mm 6AWMNA
UH1-45-28 UHR BIPOLAR 28X45mm 88LMNA UH1-45-28 UHR BIPOLAR
28X45mm V1RMLD UH1-45-28 0YMMMD UH1-45-28 3KKMMD UH1-45-28
4JJMPD UH1-45-28 6W7MPD UH1-45-28 8XLMPD UH1-45-28 DTEMND
UH1-45-28 EHRMKA UH1-45-28 L96MPA UH1-45-28 PM5MEA UH1-45-28
PM7MEA UH1-45-28 V1LMLD UH1-45-28 V1MMLD UH1-45-28 V1NMLD
UH1-45-28 V1TMLD;
6) Ref No: Description: Lot Code: UH1-46-26 UHR BIPOLAR 26X46mm 0A4MLA
UH1-46-26 UHR BIPOLAR 26X46mm 88WMNA UH1-46-26 UHR BIPOLAR
26X46mm D4KMDD UH1-46-26 UHR BIPOLAR 26X46mm D7YMKA
UH1-46-26 7YYMPD UH1-46-26 8P4MLD UH1-46-26 JD0MND;
7) Ref No: Description: Lot Code: UH1-46-28 UHR BIPOLAR 28X46mm 155MJA
UH1-46-28 UHR BIPOLAR 28X46mm 1V9MED UH1-46-28 UHR BIPOLAR
28X46mm 615MMD UH1-46-28 UHR BIPOLAR 28X46mm 9PMMMA
UH1-46-28 UHR BIPOLAR 28X46mm T55MEA UH1-46-28 0YJMMD
UH1-46-28 248MMD UH1-46-28 29JMPD UH1-46-28 3K2MMD
UH1-46-28 4DLMMD UH1-46-28 800MPD UH1-46-28 8XMMPD
UH1-46-28 E98MPD UH1-46-28 LAPMPA UH1-46-28 LARMPA
UH1-46-28 N8WMPA UH1-46-28 N93MPA UH1-46-28 N94MPA;
8) Ref No: Description: Lot Code: UH1-43-26 UHR BIPOLAR 26X43mm 341MCA
UH1-43-26 UHR BIPOLAR 26X43mm 4DEMMD UH1-43-26 UHR BIPOLAR
26X43mm J9YMAD UH1-43-26 UHR BIPOLAR 26X43mm KP6MJD
UH1-43-26 1DYMPD UH1-43-26 3KHMPD UH1-43-26 ED7MND;
9) Ref No: Description: Lot Code: UH1-47-26 UHR BIPOLAR 26X47mm 0A8MMA
UH1-47-26 UHR BIPOLAR 26X47mm K1AMHA UH1-47-26 801MPD
UH1-47-26 K1AMHA;
10) Ref No: Description: Lot Code: UH1-47-28 UHR BIPOLAR 28X47mm
87YMCA UH1-47-28 2J3MHA UH1-47-28 6W8MPD UH1-47-28 K5HMND
UH1-47-28 L94MPA UHI -47-28 057MPD;
11) Ref No: Description: Lot Code: UH1-48-26 UHR BIPOLAR 26X48mm ELYMLA
UH1-48-26 UHR BIPOLAR 26X48mm LXWMHD UH1-48-26 802MPD
UH1-48-26 E99MPD UH1-48-26 RDRMEA UH1-48-26 RDVMEA;
12) Ref No: Description: Lot Code: UH1-48-28 UHR BIPOLAR 28X48mm 0YNMMD
UH1-48-28 UHR BIPOLAR 28X48mm 1A7MEA UH1-48-28 UHR BIPOLAR
28X48mm 611MMD UH1-48-28 UHR BIPOLAR 28X48mm EYRMLD
UH1-48-28 UHR BIPOLAR 28X48mm MALMDA UH1-48-28 1A7MEA
UH1-48-28 62JMKD UH1-48-28 803MPD UH1-48-28 A24MND;
13) Ref No: Description: Lot Code: UH1-49-26 UHR BIPOLAR 26X49mm 0N3MJD
UH1-49-26 UHR BIPOLAR 26X49mm K22MHA UH1-49-26 804MPD
UH1-49-26 D10MKD;
14) Ref No: Description: Lot Code: UH1-49-28 UHR BIPOLAR 28X49mm 63PMDD
UH1-49-28 4JNMPD UH1-49-28 D78MKA UH1-49-28 K51MND UH1-49-28
KHRMEA UH1-49-28 KHTMEA UH1-49-28 KHWMEA UH1-49-28 MHLMKD;
15) Ref No: Description: Lot Code: UH1-50-26 UHR BIPOLAR 26X50mm 6X5MAD
UH1-50-26 UHR BIPOLAR 26X50mm J3VMKA UH1-50-26 UHR BIPOLAR
26X50mm J84MDA UH1-50-26 KJ1MEA UH1-50-26 KJ4MEA UH1-50-26
KJ8MEA UH1-50-26 KJ9MEA UH1-50-26 KJAMEA;
16) Ref No: Description: Lot Code: UH1-50-28 UHR BIPOLAR 28X50mm 0L7MHD
UH1-50-28 UHR BIPOLAR 28X50mm 3JDMKA UH1-50-28 UHR BIPOLAR
28X50mm N4NMRA UH1-50-28 1E6MEA UH1-50-28 1EEMPD UH1-50-28
4E4MMD UH1-50-28 685MTA UH1-50-28 6W9MPD UH1-50-28 805MPD
UH1-50-28 8HMMJA UH1-50-28 8XNMPD UH1-50-28 E9EMPD UH1-50-28
EKPMEA UH1-50-28 HHYMDA UH1-50-28 HLEMEA UH1-50-28 K5AMND;
17) Ref No: Description: Lot Code: UH1-51-28 UHR BIPOLAR 28X51mm AD0MLA
UH1-51-28 UHR BIPOLAR 28X51mm D8XMLD UH1-51-28 0MNMJD
UH1-51-28 763MMD UH1-51-28 7DJMND;
18) Ref No: Description: Lot Code: UH1-51-26 UHR BIPOLAR 26X51mm 38RMNA
UH1-51-26 UHR BIPOLAR 26X51mm 8MXMDD UH1-51-26 D91MPD UH1-51-
26 K52MND;
19) Ref No: Description: Lot Code: UH1-52-26 UHR BIPOLAR 26X52mm 09NMKA
UH1-52-26 UHR BIPOLAR 26X52mm MVHMTA UH1-52-26 3KTMPD
UH1-52-26 8XPMPD UH1-52-26 D92MPD UH1-52-26 EDKMND
UH1-52-26 K6RMND;
20) Ref No: Description: Lot Code: UH1-53-26 UHR BIPOLAR 26X53mm 0N2MJD
UH1-53-26 UHR BIPOLAR 26X53mm N40MRA UH1-53-26 UHR BIPOLAR
26X53mm XLJMKD UH1-53-26 0N1MJD UH1-53-26 29NMPD UH1-53-26
806MPD;
21) Ref No: Description: Lot Code: UH1-52-28 UHR BIPOLAR 28X52mm 1VKMED
UH1-52-28 UHR BIPOLAR 28X52mm 53MMLD UH1-52-28 3KXMPD
UH1-52-28 3KYMPD UH1-52-28 4KPMCA UH1-52-28 5JMMPD
UH1-52-28 77MMLD UH1-52-28 8XRMPD UH1-52-28 D93MPD
UH1-52-28 E9HMPD UH1-52-28 EDLMND UH1-52-28 EDRMND;
22) Ref No: Description: Lot Code: UH1-53-28 UHR BIPOLAR 28X53mm 65KMDD
UH1-53-28 28601C UH1-53-28 29PMPD UH1-53-28 406MTA UH1-53-28
807MPD;
23) Ref No: Description: Lot Code: UH1-54-26 UHR BIPOLAR 26X54mm 8EYMCA
UH1-54-26 4JTMPD UH1-54-26 K6VMND;
24) Catalog number; description; lot code: UH1-55-26 UHR BIPOLAR 26X55mm
REYMKD UH1-55-26 UHR BIPOLAR 26X55mm XAHMAD UH1-55-26
8XWMPD UH1-55-26 W22MEA;
25) Catalog Number; description; lot code: UH1-55-28 UHR BIPOLAR 28X55mm
1EHMPD UH1-55-28 UHR BIPOLAR 28X55mm D31MLA;
26) Ref No: Description: Lot Code: UH1-56-28 UHR BIPOLAR 28X56mm 8Y1MED
UH1-56-28 4JWMPD UH1-56-28 8HRMCA UH1-56-28 8Y0MPD UH1-56-28
8Y1MED UH1-56-28 K5JMND;
27) Ref No: Lot Code: UH1-41-26 A7LMKD UH1-41-26 DT8MND;
28) Ref No: Lot Code: UH1-54-28 5JNMPD UH1-54-28 EDTMND UH1-54-28
HE2MND UH1-54-28 KX6MKD UH1-54-28 LPYMNA UH1-54-28 NARMKD;
29) Ref No: Lot Code: UH1-56-28 4JWMPD UH1-56-28 8HRMCA UH1-56-28
8Y0MPD UH1-56-28 8Y1MED UH1-56-28 K5JMND;
30) Ref No: Lot Code: UH1-56-26 4JVMPD UH1-56-26 8XXMPD UH1-56-26
DTPMND;
31) Ref No: Lot Code: UH1-58-28 3L0MPD UH1-58-28 3L1MPD
UH1-58-28 86TMND UH1-58-28 86VMND;
32) Ref No: Lot Code: UH1-61-26 EDWMND;
33) Ref No: Lot Number: UH1-61-28 7DVMND UH1-61-28 DTRMND;
34) Ref No: Lot Number: UH1-68-26 80AMPD UH1-68-26 A34MPD;
35) Ref No: Lot Number: UH1-68-28 MR0MMD;
36) Ref No: Lot Number: UH1-72-28 05AMPD;
RECALLING FIRM/MANUFACTURER
Styker Howmedica Osteonics Corp., Mahwah, NJ, by letters on October 26, 2007, November 2, 2007 and November 6, 2007. Firm initiated recall is ongoing.
REASON
Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
VOLUME OF PRODUCT IN COMMERCE
360 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Siemens Magnetom Harmony Mobile MRI System. Model Number: 4759309,
Recall # Z-1042-2008;
b) Siemens Magnetom Harmony syngo. Model Number: 7106714, Recall # Z-1043-2008;
c) Siemens Magnetom Harmony sygno. Model Number: 7104693, Recall # Z-1044-2008;
d) Siemens Magentom Symphony, Model Number: 4760265, Recall # Z-1045-2008;
e) Siemens Magnetom Sonata syngo, Model Number: 7106425, Recall # Z-1046-2008;
f) Siemens Magnetom Symphony syngo, Model Number: 7104594, Recall # Z-1047-
2008;
g) Siemens Magentom Symphony syngo Upgrade, Model Number: 7106557,
Recall # Z-1048-2008;
h) Siemens Magnetom Sonata syngo, Model Number: 7104719, Recall # Z-1049-2008
CODE
a) Serial Numbers: 10018, 10022, 10029, 10032 10036, 10160, 10167, 10255,
10289, 10316, 10386, and 10429;
b) Serial Numbers: 10510, 10555, 10565, 10620,10663, 10665, and 10669;
c) Serial Numbers: 11006, 11044, 11065, 11090, 11102, 11112, 11115, 11127, 11157,
and 11162;
d) Serial Numbers: 13309 and 13390;
e) Serial Number: 21936;
f) Serial Numbers: 22021, 22024, 22060, 22074, 22079, 22108, 22115, 22116, 22121,
22127, 22172, 22196, 22225, 22242, 22272, 22306, 22311, 22342, 22352, 22353,
22356, 22402, 22440, 22441, 22446, 22471, 22498, 22510, 22520, 22523, 22530,
22561, 22565, 22596, 22598, 22604, 22619, 22621 22622, 22636, 22674, 22690,
22698, 22711, 22801, 22810, 22825, 22835, 22836, 22865, 22881, 22885, 22907,
22911, 22914, 22916, 22944, 22967, 23001, 23057, 23059, 23085, 23099, 23104,
23132, 23136, 23156, 23176, 23199, 23218, 23247, 23252, 23255, 23284, 23315,
23323, 23357, 23381, 23491, 23497, 23507, 23538, 23552, 23574, 23578, 23579,
23580, 23585, 23590, 23594, 23596, 23602, 23604, 23605, 23610, 23613, 23628,
23641, 23642, 23672, 23682, 23687, 23691, 23698, 23731, 23760, 23762, 23764,
23782, 23783, 23788, 23796, 23804, 23823, 23834, 23839, 23883, 23885, 23902,
23904, 23913, 23919, 23932, 23943, 23950, 23956, 23984, 23986, 23987, 23994,
23997, 23999, 24017, 24019, 24022, 24030, 24043, 24071, 24099, 24104, and 24107;
g) Serial Numbers: 14001, 14087, 14101, 14182, 14184, 14186, 14206, 14220, 14235,
14236, 14238, 14247, 14252, 14264, 14272, 14276, 14278, 14312, 14334, 14344,
14357, 14359, 14360, 14362, 14268, 14427, 14424, 14427, 14430, 14431, 14434,
14436, 14438, 14443, and 14447;
h) Serial Numbers: 21238 and 21269
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by an Update Instruction package in December 2007.
Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.
REASON
Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.
VOLUME OF PRODUCT IN COMMERCE
156 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505,
Recall # Z-1051-2008;
b) Draeger GT500. Globe Trotter Transport System. Catalog Number: MU20508,
Recall # Z-1052-2008;
c) Draeger Globe Trotter IC, Catalog Number: MU20509, Recall # Z-1053-2008
CODE
a) Serial Numbers: PK05967, PK05990, PK05973, PK05986, PK05987, PK05988,
PK05962, PK05963, PK05964, PK05965, PK05989, PK05976, PK05972, LT05951,
PK05968, LT05952, PK05969, and PK05974;
b) Serial Numbers: PK00983 and PK00982;
c) Serial Numbers: QT05675, QT05676, ST05708, and ST05704
RECALLING FIRM/MANUFACTURER
Draeger Medical, Inc., Telford, PA, by letter on February 1, 2008. Firm initiated recall is ongoing.
REASON
Heating failure - The power board which controls the incubator heater may not regulate the temperature properly resulting in a high temperature alarm and a loss of temperature control within the patient compartment.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
UniCel Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access Immunoassay Systems, Part Number : 386167, Recall # Z-1108-2008
CODE
Lot Code: 1201291 & 1201431
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter on July 19, 2007.
Manufacturer: Nypro, Gurnee, IL. Firm initiated recall is complete.
REASON
Erroneous Results - UniCel Dxl Access Immunoassay Systems Reaction Vessels have been found to be defective and there is a potential for an increase in signal leading to an erroneous result.
VOLUME OF PRODUCT IN COMMERCE
264 units in US; 9 units in Canada
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Abbott Clinical Chemistry Creatine Kinase, Model LN 7D63-30, Expires October 19, 2007, RCR#2018433-10/25/07-006R, Recall # Z-1109-2008
CODE
Lot Number: 52044HW00
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., South Pasadena, CA, by letter on October 12, 2007. Firm initiated recall is ongoing.
REASON
Three potential issues with Creatine Kinase Lot Number: 52044HW00: (1) Decrease in quality control and/or patient results (2) An Increased imprecision, or (3) Error Code 1054 (Unable to calculate results, Reaction Failure) on Architect cSystems.
VOLUME OF PRODUCT IN COMMERCE
714 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Stryker Orthopedics, Locking Screw, T7, Catalog Number: 40-27622, Size: 2.7X22MM, Non Sterile, Titanium Alloy, Recall # Z-1297-2008
CODE
Lot Numbers: H8W00F0B41; H9H00FB41, and H9R00F0B41
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on January 28, 2008.
Manufacturer: Stryker Leibinger Gmbh, Freiburg, Germany. Firm initiated recall is ongoing.
REASON
Screws do not have locking threads.
VOLUME OF PRODUCT IN COMMERCE
100 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Gambro cartridge blood set with Phoenix Hemodialysis System, Recall # Z-1367-2008
CODE
All catalog numbers involving the Gambro Cartridge Blood Sets: 6184071, 6186886, 6186886, 6187439, 6187660, 6187686, 617894, 6032536, 6188320, 6189153, 6189211, 6189450, 6280481, 6280598, 003409-400, 003409-410, 003410-500, 003410-510, 004310-710, 003411-500, 003412-500, 003414-500, 003414-510, 003415-510, 003422-500, 003422-515, 003422-520, 003429-500
RECALLING FIRM/MANUFACTURER
Gambro Dasco S.p.A. Monitor Division, Medolla, Italy, by letter on September 10, 2007. Firm initiated recall is ongoing.
REASON
Tube kinking - Improper tubing installation may result in serious injury or death.
VOLUME OF PRODUCT IN COMMERCE
66,438,390 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Parks Medical Ultrasonic Doppler Flow Detector, Model 811-B (finished assembly
without accompanying probes), Recall # Z-0670-2008;
b) Parks Medical Ultrasonic Doppler Flow Detector with Cautery Suppressor, Model
811-BL (finished assembly without accompanying probes), Recall # Z-0671-2008;
c) Parks Medical Ultrasonic Doppler Flow Detector, Model 811-BTS (finished
assembly without accompanying probes), Recall # Z-0672-2008;
d) Parks Medical Dual Frequency Doppler Vascular Flow Detector, Model 915-BL
(finished assembly without accompanying probes), Recall # Z-0673-2008
CODE
a) Serial Numbers: 811-B-600001762 thru 600001769 (to Australian consignee)
811-B-600001876 thru 600001880 and 600001882 thru 600001884 (to Brazilian
consignee) 811-B-600001896 thru 600001901 811-B-600001910 thru 600001912
811-B-600001926 811-B-600001955 and 1956 811-B-600001959 thru 1962
811-B-600001974 and 1975 811-B-600001998 811-B-600002005 thru 2007
811-B-600002010 thru 2019 811-B-600002022 thru 2027 811-B-600002029 thru
2031 811-B-600002036 thru 2039 811-B-600002050 thru 2055 811-B-600002057
thru 2059 Code Breakdown Example: 811B-600001896; 811B = the series; 6 = the
version; 00 = the revision; 001896 = the unique identifier number;
b) Serial Number: 811-B-400001438;
c) Serial numbers to be provided by firm;
d) Serial Numbers:: 915B-000001329 thru 1332 Code Breakdown Example:
915B-000001329; 915B = the final assembly of series 915-BL; 0 = the version;
00 = the revision; 001329 = the unique identifier number
RECALLING FIRM/MANUFACTURER
Parks Medical Electronics Inc., Aloha, OR, by email on September 28, 2007 and November 8, 2007, by telephone on October 1, 2007 and by letters on November 28, 2007. Firm initiated recall is ongoing.
REASON
Premature battery failure: Wrong acid flux used on circuit board which may lead to premature battery failure of ultrasonic non-directional doppler flowmeter.
VOLUME OF PRODUCT IN COMMERCE
164 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
CIVCO Latex-Free Needle Guide, Sterile transrectal needle guide for use with Shimadzu UB1OR-065U transducer, Part #677-057, packaged 1 needle guide per tyvek pouch, 20 pouches per box, Recall # Z-1054-2008
CODE
Lot Numbers: M102250 and M105440
RECALLING FIRM/MANUFACTURER
Civco Medical Instruments Inc., Kalona, IA, on January 16, 2008. Firm initiated recall is complete.
REASON
Incorrect Needle Guide- The individual pouches contained V53W Endocavity Needle guide (p/n/034-054) instead of the Shimadzu T/R Needle guide (p/n134-054).
VOLUME OF PRODUCT IN COMMERCE
7 boxes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005,
Recall # Z-1298-2008;
b) AlloCraft DBM with Syringe Assembly, 10 CC, Recall # Z-1299-2008
CODE
a) Lot Numbers: B07F25I; Exp 4/2009; B07F25J: Exp 4/2009; and B07425H;
Exp 3/2009.
b) Lot Numbers: B06E02E; Exp 3/2008; B06E02F, Exp. 3/2008;
B07C29B, Exp 2/2009; B07E14E, Exp 3/2009; B07G24B, Exp 5/2009;
B07G24C, Exp 5/2009; B07G24E, Exp 5/2009; and B07G24F, Exp 5/2009
RECALLING FIRM/MANUFACTURER
LifeCell Corporation, Somerville, NJ, by telephone, and letter on October 17, 2007. Firm initiated recall is ongoing.
REASON
Improper donor screening test; diagnostic test kits were used in lieu of a donor screening test kits for HBsAG and HBcAB (later re-testing with FDA-approved donor screening test found samples non-reactive for both Hepatitis B Surface Antigen and Hepatitis B Core IgM/IgG Antibody)
VOLUME OF PRODUCT IN COMMERCE
156 kits
DISTRIBUTION
NJ
END OF ENFORCEMENT REPORT FOR MARCH 26, 2008
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