OCTOBER 2005
WEEK ENDING OCTOBER 8
PRODUCT Hemashield Vantage
Vascular Graft. Vascular graft prosthesis.
CODE Catalog Number, Product Description, Lot Number:
M002023750060, HVVG 6mm x 100cm, 5649003; M002023750060, HVVG 6mm x 100cm,
5948031; M002023750060, HVVG 6mm x 100cm, 6639821; M002023750060, HVVG 6mm x
100cm, 6647296; M002023750060, HVVG 6mm x 100cm, 7030066; M002023750070, HVVG
7mm x 100cm, 5669601; M002023750070, HVVG 7mm x 100cm, 5728283; M002023750070,
HVVG 7mm x 100cm, 5821740; M002023750070, HVVG 7mm x 100cm, 6032950;
M002023750070, HVVG 7mm x 100cm, 6962284; M002023750080, HVVG 8mm x 100cm,
6007978; M002023750080, HVVG 8mm x 100cm, 6279546; M002023750080, HVVG 8mm x
100cm,6722180; M002023750080, HVVG 8mm x 100cm, 6919131; M002023750080, HVVG 8mm
x 100cm, 7161034; M002023750080, HVVG 8mm x 100cm, 7249926; M002023750080, HVVG
8mm x 100cm, 7402224; M002023750100, HVVG 10mm x 100cm, 6876321; M002023750100,
HVVG 10mm x 100cm, 6962286; M002023754060, HVVG 6mm x 40cm, 5721446;
M002023754060, HVVG 6mm x 40cm, 5728284; M002023754060, HVVG 6mm x 40cm,
5780318; M002023754060, HVVG 6mm x 40cm, 5860237; M002023754060, HVVG 6mm x
40cm, 5899944; M002023754060, HVVG 6mm x 40cm, 6011811; M002023754060, HVVG 6mm
x 40cm, 6239445; M002023754060, HVVG 6mm x 40cm, 6268215; M002023754060, HVVG
6mm x 40cm, 6304504; M002023754060, HVVG 6mm x 40cm, 6320785; M002023754060,
HVVG 6mm x 40cm, 6364795; M002023754060, HVVG 6mm x 40cm, 6440114;
M002023754060, HVVG 6mm x 40cm, 6615660; M002023754060, HVVG 6mm x 40cm,
6628696; M002023754060, HVVG 6mm x 40cm, 6647104; M002023754060, HVVG 6mm x
40cm, 6696492; M002023754060, HVVG 6mm x 40cm, 6807737; M002023754060, HVVG 6mm
x 40cm, 6917823; M002023754060, HVVG 6mm x 40cm, 6979854; M002023754060, HVVG
6mm x 40cm, 7000352; M002023754060, HVVG 6mm x 40cm, 7071546; M002023754060,
HVVG 6mm x 40cm, 7200982; M002023754070, HVVG 7mm x 40cm, 5691792;
M002023754070, HVVG 7mm x 40cm, 5726049; M002023754070, HVVG 7mm x 40cm,
5779847; M002023754070, HVVG 7mm x 40cm, 5797094; M002023754070, HVVG 7mm x
40cm, 5955887; M002023754070, HVVG 7mm x 40cm, 6011812; M002023754070, HVVG 7mm
x 40cm, 6037086; M002023754070, HVVG 7mm x 40cm, 6136721; M002023754070, HVVG
7mm x 40cm, 6611338; M002023754070, HVVG 7mm x 40cm, 6657664; M002023754070,
HVVG 7mm x 40cm, 6691603; M002023754070, HVVG 7mm x 40cm, 6851214;
M002023754070, HVVG 7mm x 40cm, 7161578; M002023754070, HVVG 7mm x 40cm,
7175592; M002023754070, HVVG 7mm x 40cm, 7249015; M002023754070, HVVG 7mm x
40cm, 7402368; M002023754070, HVVG 7mm x 40cm, 7403197; M002023754070, HVVG 7mm
x 40cm, 7535410; M002023754070, HVVG 7mm x 40cm, 7565108; M002023754070, HVVG
7mm x 40cm, 7631134; M002023754080, HVVG 8mm x 40cm, 5669605; M002023754080,
HVVG 8mm x 40cm, 5728288; M002023754080, HVVG 8mm x 40cm, 5783271;
M002023754080, HVVG 8mm x 40cm, 5797165; M002023754080, HVVG 8mm x 40cm,
5841181; M002023754080, HVVG 8mm x 40cm, 5912738; M002023754080, HVVG 8mm x
40cm, 5976346; M002023754080, HVVG 8mm x 40cm, 6008050; M002023754080, HVVG 8mm
x 40cm, 6107641; M002023754080, HVVG 8mm x 40cm, 6138907; M002023754080, HVVG
8mm x 40cm, 6238549; M002023754080, HVVG 8mm x 40cm, 6320790; M002023754080,
HVVG 8mm x 40cm, 6361655; M002023754080, HVVG 8mm x 40cm, 6427209;
M002023754080, HVVG 8mm x 40cm, 6598660; M002023754080, HVVG 8mm x 40cm,
6617325; M002023754080, HVVG 8mm x 40cm, 6646329; M002023754080, HVVG 8mm x
40cm, 6647152; M002023754080, HVVG 8mm x 40cm, 6691608; M002023754080, HVVG 8mm
x 40cm, 6876382; M002023754080, HVVG 8mm x 40cm, 7114368; M002023754080, HVVG
8mm x 40cm, 7138064; M002023754080, HVVG 8mm x 40cm, 7161580; M002023754080,
HVVG 8mm x 40cm, 7175587; M002023754080, HVVG 8mm x 40cm, 7276583;
M002023754080, HVVG 8mm x 40cm, 7402360; M002023754080, HVVG 8mm x 40cm,
7535409; M002023754100, HVVG 10mm x 40cm, 5691791; M002023754100, HVVG 10mm x
40cm, 5731519; M002023754100, HVVG 10mm x 40cm, 5891897; M002023754100, HVVG
10mm x 40cm, 6052007; M002023754100, HVVG 10mm x 40cm, 6418381; M002023754100,
HVVG 10mm x 40cm, 6926326; M002023754100, HVVG 10mm x 40cm, 7000766;
M002023754100, HVVG 10mm x 40cm, 7504489; M002023756060, HVVG 6mm x 60cm,
5707200; M002023756060, HVVG 6mm x 60cm, 5724793; M002023756060, HVVG 6mm x
60cm, 5745982; M002023756060, HVVG 6mm x 60cm, 5767491; M002023756060, HVVG 6mm
x 60cm, 5767495; M002023756060, HVVG 6mm x 60cm, 5852837; M002023756060, HVVG
6mm x 60cm, 5853224; M002023756060, HVVG 6mm x 60cm, 5891798; M002023756060,
HVVG 6mm x 60cm, 5947960; M002023756060, HVVG 6mm x 60cm, 5968420;
M002023756060, HVVG 6mm x 60cm, 5988577; M002023756060, HVVG 6mm x 60cm,
6050593; M002023756060, HVVG 6mm x 60cm, 6096033; M002023756060, HVVG 6mm x
60cm, 6268220; M002023756060, HVVG 6mm x 60cm, 6347541; M002023756060, HVVG 6mm
x 60cm, 6388858; M002023756060, HVVG 6mm x 60cm, 6418565; M002023756060, HVVG
6mm x 60cm, 6611350; M002023756060, HVVG 6mm x 60cm, 6628703; M002023756060,
HVVG 6mm x 60cm, 6654862; M002023756060, HVVG 6mm x 60cm, 6655453;
M002023756060, HVVG 6mm x 60cm, 6770384; M002023756060, HVVG 6mm x 60cm,
6807126; M002023756060, HVVG 6mm x 60cm, 6850094; M002023756060, HVVG 6mm x
60cm, 6919450; M002023756060, HVVG 6mm x 60cm, 7010071; M002023756060, HVVG 6mm
x 60cm, 7057154; M002023756060, HVVG 6mm x 60cm, 7075488; M002023756060, HVVG
6mm x 60cm, 7161035; M002023756060, HVVG 6mm x 60cm, 7173034; M002023756060,
HVVG 6mm x 60cm, 7230491; M002023756060, HVVG 6mm x 60cm, 7259726;
M002023756060, HVVG 6mm x 60cm, 7528090; M002023756070, HVVG 7mm x 60cm,
5633991; M002023756070, HVVG 7mm x 60cm, 5691790; M002023756070, HVVG 7mm x
60cm, 5745981; M002023756070, HVVG 7mm x 60cm, 5773786; M002023756070, HVVG 7mm
x 60cm, 5793283; M002023756070, HVVG 7mm x 60cm, 5853511; M002023756070, HVVG
7mm x 60cm, 5903684; M002023756070, HVVG 7mm x 60cm, 5988575; M002023756070,
HVVG 7mm x 60cm, 6011813; M002023756070, HVVG 7mm x 60cm, 6037090;
M002023756070, HVVG 7mm x 60cm, 6109301; M002023756070, HVVG 7mm x 60cm,
6282450; M002023756070, HVVG 7mm x 60cm, 6383841; M002023756070, HVVG 7mm x
60cm, 6440361; M002023756070, HVVG 7mm x 60cm, 6611337; M002023756070, HVVG 7mm
x 60cm, 6667242; M002023756070, HVVG 7mm x 60cm, 6754019; M002023756070, HVVG
7mm x 60cm, 6930145; M002023756070, HVVG 7mm x 60cm, 7137399; M002023756070,
HVVG 7mm x 60cm, 7276579; M002023756070, HVVG 7mm x 60cm, 7403200;
M002023756070, HVVG 7mm x 60cm, 7545048; M002023756070, HVVG 7mm x 60cm,
7545052; M002023756070, HVVG 7mm x 60cm, 7579389; M002023756080, HVVG 8mm x
60cm, 5633990; M002023756080, HVVG 8mm x 60cm, 5726141; M002023756080, HVVG 8mm
x 60cm, 5856535; M002023756080, HVVG 8mm x 60cm, 5891889; M002023756080, HVVG
8mm x 60cm, 5948034; M002023756080, HVVG 8mm x 60cm, 6073565; M002023756080,
HVVG 8mm x 60cm, 6185146; M002023756080, HVVG 8mm x 60cm, 6339117;
M002023756080, HVVG 8mm x 60cm, 6388288; M002023756080, HVVG 8mm x 60cm,
6415673; M002023756080, HVVG 8mm x 60cm, 6598671; M002023756080, HVVG 8mm x
60cm, 6610550; M002023756080, HVVG 8mm x 60cm, 6628701; M002023756080, HVVG 8mm
x 60cm, 6722144; M002023756080, HVVG 8mm x 60cm, 6754031; M002023756080, HVVG
8mm x 60cm, 6820115; M002023756080, HVVG 8mm x 60cm, 6861408; M002023756080,
HVVG 8mm x 60cm, 6926327; M002023756080, HVVG 8mm x 60cm, 6948142;
M002023756080, HVVG 8mm x 60cm, 7008949; M002023756080, HVVG 8mm x 60cm,
7071547; M002023756080, HVVG 8mm x 60cm, 7115438; M002023756080, HVVG 8mm x
60cm, 7528226; M002023756100, HVVG 10mm x 60cm, 5856641; M002023756100, HVVG
10mm x 60cm, 6051871; M002023756100, HVVG 10mm x 60cm, 6193600; M002023756100,
HVVG 10mm x 60cm, 6524295; M002023756100, HVVG 10mm x 60cm, 6620113;
M002023756100, HVVG 10mm x 60cm, 6691596; M002023756100, HVVG 10mm x 60cm,
6960306; M002023756100, HVVG 10mm x 60cm, 6961911; M002023758060, HVVG 6mm x
80cm, 5669380; M002023758060, HVVG 6mm x 80cm, 5779844; M002023758060, HVVG 6mm
x 80cm, 5922480; M002023758060, HVVG 6mm x 80cm, 5964495; M002023758060, HVVG
6mm x 80cm, 6032948; M002023758060, HVVG 6mm x 80cm, 6216685; M002023758060,
HVVG 6mm x 80cm, 6304505; M002023758060, HVVG 6mm x 80cm, 6347707;
M002023758060, HVVG 6mm x 80cm, 6364796; M002023758060, HVVG 6mm x 80cm,
6388362; M002023758060, HVVG 6mm x 80cm, 6416301; M002023758060, HVVG 6mm x
80cm, 6615663; M002023758060, HVVG 6mm x 80cm, 6628554; M002023758060, HVVG 6mm
x 80cm, 6646521; M002023758060, HVVG 6mm x 80cm, 6654376; M002023758060, HVVG
6mm x 80cm, 6696487; M002023758060, HVVG 6mm x 80cm, 6722189; M002023758060,
HVVG 6mm x 80cm, 6774183; M002023758060, HVVG 6mm x 80cm, 6816154;
M002023758060, HVVG 6mm x 80cm, 6930142; M002023758060, HVVG 6mm x 80cm,
7000351; M002023758060, HVVG 6mm x 80cm, 7010061; M002023758060, HVVG 6mm x
80cm, 7161036; M002023758060, HVVG 6mm x 80cm, 7230490; M002023758060, HVVG 6mm
x 80cm, 7630848; M002023758070, HVVG 7mm x 80cm, 5724827; M002023758070, HVVG
7mm x 80cm, 5728287; M002023758070, HVVG 7mm x 80cm, 5955888; M002023758070,
HVVG 7mm x 80cm, 6050597; M002023758070, HVVG 7mm x 80cm, 6230257;
M002023758070, HVVG 7mm x 80cm, 6288273; M002023758070, HVVG 7mm x 80cm,
6440359; M002023758070, HVVG 7mm x 80cm, 6691602; M002023758070, HVVG 7mm x
80cm, 6770192; M002023758070, HVVG 7mm x 80cm, 6851207; M002023758070, HVVG 7mm
x 80cm, 7161577; M002023758070, HVVG 7mm x 80cm, 7175590; M002023758070, HVVG
7mm x 80cm, 7248691; M002023758070, HVVG 7mm x 80cm, 7402229; M002023758070,
HVVG 7mm x 80cm, 7402371; M002023758070, HVVG 7mm x 80cm, 7631133;
M002023758080, HVVG 8mm x 80cm, 5700634; M002023758080, HVVG 8mm x 80cm,
5765239; M002023758080, HVVG 8mm x 80cm, 5815016; M002023758080, HVVG 8mm x
80cm, 5911567; M002023758080, HVVG 8mm x 80cm, 5972377; M002023758080, HVVG 8mm
x 80cm, 6068815; M002023758080, HVVG 8mm x 80cm, 6238548; M002023758080, HVVG
8mm x 80cm, 6256385; M002023758080, HVVG 8mm x 80cm, 6320652; M002023758080,
HVVG 8mm x 80cm, 6347706; M002023758080, HVVG 8mm x 80cm, 6416627;
M002023758080, HVVG 8mm x 80cm, 6598409; M002023758080, HVVG 8mm x 80cm,
6617271; M002023758080, HVVG 8mm x 80cm, 6647222; M002023758080, HVVG 8mm x
80cm, 6691605; M002023758080, HVVG 8mm x 80cm, 6876377; M002023758080, HVVG 8mm
x 80cm, 6962282; M002023758080, HVVG 8mm x 80cm, 7114366; M002023758080, HVVG
8mm x 80cm, 7138066; M002023758080, HVVG 8mm x 80cm, 7161579; M002023758080,
HVVG 8mm x 80cm, 7220186; M002023758080, HVVG 8mm x 80cm, 7276584;
M002023758080, HVVG 8mm x 80cm, 7317245; M002023758080, HVVG 8mm x 80cm,
7402219; M002023758100, HVVG 10mm x 80cm, 5783268; M002023758100, HVVG 10mm x
80cm, 5891786; M002023758100, HVVG 10mm x 80cm, 6165924; M002023758100, HVVG
10mm x 80cm, 6524301; M002023758100, HVVG 10mm x 80cm, 6598574; M002023758100,
HVVG 10mm x 80cm, 7031876; M002023758100, HVVG 10mm x 80cm, 7317854;
M002023758100, HVVG 10mm x 80cm, 7504480.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation,
Natick MA
Manufacturer: Boston
Scientific Corporation, Wayne, NJ.
REASON During surgery, several reports of the grafts
fraying and tearing upon suturing by the surgeon.
VOLUME OF PRODUCT IN
COMMERCE 3,487 devices
DISTRIBUTION Nationwide and
Internationally
PRODUCT LifeScan brand OneTouch
Ultra Meter – Owner's Booklet
CODE All System Kits shipped during June 2003 until
December 2003
RECALLING FIRM/MANUFACTURER Lifescan Inc., Milpitas, CA
REASON
LifeScan brand One Touch Ultra Meter – Owner's
Booklets are missing instructions on how to set the Units of Measurement
(UOM)—mg/dL versus mmol/L. This error has the postential to lead to acute
hyperglycemic complications if the user fails to realize that 18mg/dL of glucose
is equal to 1 (one) mmol/L.
VOLUME OF PRODUCT IN COMMERCE 572,000
units
DISTRIBUTION Nationwide
PRODUCT
a) Baxter Lock Box for
100 mL or 250 mL Bag Set, for use with 6060 Pump Family; Baxter product
code 2L9354 and previously marketed by Sabratek under product code 606194
b) Baxter Lock Box for 250 mL
Container, for use with 6060 Pump Family; Baxter product code 2L9363 and
previously marketed by Sabratek under product code 606160; Product code
2L9363 is sold separately and
as a component of the 6060 Pain kit, product code
2M9832P
CODE
a) All lot numbers/serial
numbers of product codes 2L9354 and 606194;
b) All lot numbers/serial
numbers of product codes 2L9363, 606160 and 2M9832P
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round
Lake, IL
Manufacturer: Baxter
Healthcare Corp., Andover, MA.
REASON The pump may free-flow if the door to the 6060 pump
is not closed prior to loading the pump in to the lock box. The pump will alarm
“Door Open", but if the pump is turned off to silence the alarm while remaining
in the lock box, the fluid will free-flow.
VOLUME OF PRODUCT IN
COMMERCE 1,486 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Bard® Luminexx®
Endoscopic Biliary Stent and Delivery System, 7.5 FR, 8 mm x 60 mm Catalog Number:
LXB08060
b) Bard® Luminexx®
Endoscopic Biliary Stent and Delivery System, 7.5 FR, 8 mm x 80 mm Catalog Number: LXB08080,
c) Bard® Luminexx®
Endoscopic Biliary Stent and Delivery System, 7.5 FR, 8 mm x 100 mm Catalog Number: LXB080100,
d) Bard® Luminexx®
Endoscopic Biliary Stent and Delivery System, 7.5 FR, 10 mm x 40 mm Catalog Number: LXB10040,
e) Bard® Luminexx®
Endoscopic Biliary Stent and Delivery System, 7.5 FR, 10 mm x 60 mm Catalog Number: LXB10060,
f) Bard® Luminexx®
Endoscopic Biliary Stent and Delivery System, 7.5 FR, 10 mm x 80 mm Catalog Number: LXB10080,
g) Bard® Luminexx®
Endoscopic Biliary Stent and Delivery System, 7.5 FR, 10 mm x 100 mm Catalog Number: LXB10100,
CODE
a) Lot
Number: 96CP1992;
b) Lot Number: 96CP1385;
c) Lot Number: 96CP2406;
d)
Lot Numbers: 96CP1388, 96CP1389, 96CP2244;
e) Lot Numbers: 96CP1390,
96CP1391, 96CP1392, 96CP1393, 96CP1988, 96CP2497, 96CP2498, 96CP1996;
f)
Lot Numbers: 96CP1394, 96CP1395, 96CP1396, 96CP1397, 96CP1995;
g) Lot
Number: 96CP2508
RECALLING FIRM/MANUFACTURER Angiomed Gmbh,
Karlsruhe, Germany, Federal Republic
REASON Biliary Stents may malfunction and cause failure to
expand, fracture, incomplete deployment, inaccurate positioning, migration, or
lumen perforation.
VOLUME OF PRODUCT IN COMMERCE 204
units
DISTRIBUTION Nationwide
PRODUCT Cook brand Fascial
Dilator; 10FR/37cm, sterile, Rx only, Ref G14191; Catalog No. 0073710, CODE
Lots 15-U1320351 and 15-U1320349
RECALLING
FIRM/MANUFACTURER Cook Urological, Inc., Spencer, IN
REASON Mislabeled
as to size.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION CA and FL
PRODUCT Bard Luminexx 3 Biliary
Stent and Delivery System
CODE Catalog # Lot #
LUB06040 96DP1000; LUB06060 96CP1044 & 96DP2404; LUB14040 96CP2110; LUB14060
96CP0771, 96CP2307, & 96CP2771; LUB14080 96DP2900; LUC05060 96DP2937;
LUC06060 96CP2111 & 96DP2939; LUC08040 96CP2310 &
96DP2321
RECALLING FIRM/MANUFACTURER
Recalling Firm: Brad
Peripheral Vascular Inc., Tempe, AZ
Manufacturer: Angiomed Gmbh, Karlsruhe, Germany, Federal
Republic.
REASON Broken stent
struts of nitinol stents were noted in manufacturing.
VOLUME OF PRODUCT IN
COMMERCE 102 units
DISTRIBUTION Nationwide
PRODUCT Guidant OTW OMNILINK.018
& .035 Biliary Stent Systems
CODE Model
number of the device and manufacturing lots involved: OTW OmniLink 18 1007942-18
OTW OMNI 18 5.0MMX18MMX135CM 1007944-18 OTW OMNI 18 6.0MMX18MMX135CM 1007946-18
OTW OMNI 18 7.0MMX18MMX135CM 1007948-18 OTW OMNI 18 8.0MMX18MMX135CM 1007949-18
OTW OMNI 18 9.0MMX18MMX135CM 1007950-18 OTW OMNI 18 10.0MMX18MMX135CM 1007980-18
OTW OMNI 18 5.0MMX18MMX80CM 1007982-18 OTW OMNI 18 6.0MMX18MMX80CM 1007984-18
OTW OMNI 18 7.0MMX18MMX80CM 1007986-18 OTW OMNI 18 8.0MMX18MMX80CM 1007987-18
OTW OMNI 18 9.0MMX18MMX80CM 1007988-18 OTW OMNI 18 10.0MMX18MMX80CM 1007942-28
OTW OMNI 18 5.0MMX28MMX135CM 1007944-28 OTW OMNI 18 6.0MMX28MMX135CM 1007946-28
OTW OMNI 18 7.0MMX28MMX135CM 1007948-28 OTW OMNI 18 8.0MMX28MMX135CM 1007949-28
OTW OMNI 18 9.0MMX28MMX135CM 1007950-28 OTW OMNI 18 10.0MMX28MMX135CM 1007980-28
OTW OMNI 18 5.0MMX28MMX80CM 1007982-28 OTW OMNI 18 6.0MMX28MMX80CM 1007984-28
OTW OMNI 18 7.0MMX28MMX80CM 1007986-28 OTW OMNI 18 8.0MMX28MMX80CM 1007987-28
OTW OMNI 18 9.0MMX28MMX80CM 1007988-28 OTW OMNI 18 10.0MMX28MMX80CM 1007942-38
OTW OMNI 18 5.0MMX38MMX135CM 1007944-38 OTW OMNI 18 6.0MMX38MMX135CM 1007946-38
OTW OMNI 18 7.0MMX38MMX135CM 1007948-38 OTW OMNI 18 8.0MMX38MMX135CM 1007949-38
OTW OMNI 18 9.0MMX38MMX135CM 1007950-38 OTW OMNI 18 10.0MMX38MMX135CM 1007980-38
OTW OMNI 18 5.0MMX38MMX80CM 1007982-38 OTW OMNI 18 6.0MMX38MMX80CM 1007984-38
OTW OMNI 18 7.0MMX38MMX80CM 1007986-38 OTW OMNI 18 8.0MMX38MMX80CM 1007987-38
OTW OMNI 18 9.0MMX38MMX80CM 1007988-38 OTW OMNI 18 10.0MMX38MMX80CM 1007942-58
OTW OMNI 18 5.0MMX58MMX135CM 1007944-58 OTW OMNI 18 6.0MMX58MMX135CM 1007946-58
OTW OMNI 18 7.0MMX58MMX135CM 1007948-58 OTW OMNI 18 8.0MMX58MMX135CM 1007949-58
OTW OMNI 18 9.0MMX58MMX135CM 1007950-58 OTW OMNI 18 10.0MMX58MMX135CM 1007980-58
OTW OMNI 18 5.0MMX58MMX80CM 1007982-58 OTW OMNI 18 6.0MMX58MMX80CM 1007984-58
OTW OMNI 18 7.0MMX58MMX80CM 1007986-58 OTW OMNI 18 8.0MMX58MMX80CM 1007987-58
OTW OMNI 18 9.0MMX58MMX80CM 1007988-58 OTW OMNI 18 10.0MMX58MMX80CM 1007940-12
OTW OMNI 18 4.0MMX12MMX135CM 1007942-12 OTW OMNI 18 5.0MMX12MMX135CM 1007944-12
OTW OMNI 18 6.0MMX12MMX135CM 1007946-12 OTW OMNI 18 7.0MMX12MMX135CM 1007978-12
OTW OMNI 18 4.0MMX12MMX80CM 1007980-12 OTW OMNI 18 5.0MMX12MMX80CM 1007982-12
OTW OMNI 18 6.0MMX12MMX80CM 1007984-12 OTW OMNI 18 7.0MMX12MMX80CM 1007940-16
OTW OMNI 18 4.0MMX16MMX135CM 1007942-16 OTW OMNI 18 5.0MMX16MMX135CM 1007944-16
OTW OMNI 18 6.0MMX16MMX135CM 1007946-16 OTW OMNI 18 7.0MMX16MMX135CM 1007978-16
OTW OMNI 18 4.0MMX16MMX80CM 1007980-16 OTW OMNI 18 5.0MMX16MMX80CM 1007982-16
OTW OMNI 18 6.0MMX16MMX80CM 1007984-16 OTW OMNI 18 7.0MMX16MMX80CM 1007978-18
OTW OMNI 18 4.0MMX18MMX80CM 1007940-18 OTW OMNI 18 4.0MMX18MMX135CM US Part
Numbers Omnilink .035 1008159-18 OTW OMNI 35 4.0MMX18MMX135CM 1008161-18 OTW
OMNI 35 5.0MMX18MMX135CM 1008163-18 OTW OMNI 35 6.0MMX18MMX135CM 1008165-18 OTW
OMNI 35 7.0MMX18MMX135CM 1008167-18 OTW OMNI 35 8.0MMX18MMX135CM 1008168-18 OTW
OMNI 35 9.0MMX18MMX135CM 1008169-18 OTW OMNI 35 10.0MMX18MMX135CM 1008174-18 OTW
OMNI 35 4.0MMX18MMX80CM 1008176-18 OTW OMNI 35 5.0MMX18MMX80CM 1008178-18 OTW
OMNI 35 6.0MMX18MMX80CM 1008180-18 OTW OMNI 35 7.0MMX18MMX80CM 1008182-18 OTW
OMNI 35 8.0MMX18MMX80CM 1008183-18 OTW OMNI 35 9.0MMX18MMX80CM 1008184-18 OTW
OMNI 35 10.0MMX18MMX80CM 1008161-28 OTW OMNI 35 5.0MMX28MMX135CM 1008163-28 OTW
OMNI 35 6.0MMX28MMX135CM 1008165-28 OTW OMNI 35 7.0MMX28MMX135CM 1008167-28 OTW
OMNI 35 8.0MMX28MMX135CM 1008168-28 OTW OMNI 35 9.0MMX28MMX135CM 1008169-28 OTW
OMNI 35 10.0MMX28MMX135CM 1008176-28 OTW OMNI 35 5.0MMX28MMX80CM 1008178-28 OTW
OMNI 35 6.0MMX28MMX80CM 1008180-28 OTW OMNI 35 7.0MMX28MMX80CM 1008182-28 OTW
OMNI 35 8.0MMX28MMX80CM 1008183-28 OTW OMNI 35 9.0MMX28MMX80CM 1008184-28 OTW
OMNI 35 10.0MMX28MMX80CM 1008161-38 OTW OMNI 35 5.0MMX38MMX135CM 1008163-38 OTW
OMNI 35 6.0MMX38MMX135CM 1008165-38 OTW OMNI 35 7.0MMX38MMX135CM 1008167-38 OTW
OMNI 35 8.0MMX38MMX135CM 1008168-38 OTW OMNI 35 9.0MMX38MMX135CM 1008169-38 OTW
OMNI 35 10.0MMX38MMX135CM 1008176-38 OTW OMNI 35 5.0MMX38MMX80CM 1008178-38 OTW
OMNI 35 6.0MMX38MMX80CM 1008180-38 OTW OMNI 35 7.0MMX38MMX80CM 1008182-38 OTW
OMNI 35 8.0MMX38MMX80CM 1008183-38 OTW OMNI 35 9.0MMX38MMX80CM 1008184-38 OTW
OMNI 35 10.0MMX38MMX80CM 1008161-58 OTW OMNI 35 5.0MMX58MMX135CM 1008163-58 OTW
OMNI 35 6.0MMX58MMX135CM 1008165-58 OTW OMNI 35 7.0MMX58MMX135CM 1008167-58 OTW
OMNI 35 8.0MMX58MMX135CM 1008168-58 OTW OMNI 35 9.0MMX58MMX135CM 1008169-58 OTW
OMNI 35 10.0MMX58MMX135CM 1008176-58 OTW OMNI 35 5.0MMX58MMX80CM 1008178-58 OTW
OMNI 35 6.0MMX58MMX80CM 1008180-58 OTW OMNI 35 7.0MMX58MMX80CM 1008182-58 OTW
OMNI 35 8.0MMX58MMX80CM 1008183-58 OTW OMNI 35 9.0MMX58MMX80CM 1008184-58 OTW
OMNI 35 10.0MMX58MMX80CM 1008159-12 OTW OMNI 35 4.0MMX12MMX135CM 1008161-12 OTW
OMNI 35 5.0MMX12MMX135CM 1008163-12 OTW OMNI 35 6.0MMX12MMX135CM 1008165-12 OTW
OMNI 35 7.0MMX12MMX135CM 1008174-12 OTW OMNI 35 4.0MMX12MMX80CM 1008176-12 OTW
OMNI 35 5.0MMX12MMX80CM 1008178-12 OTW OMNI 35 6.0MMX12MMX80CM 1008180-12 OTW
OMNI 35 7.0MMX12MMX80CM 1008159-16 OTW OMNI 35 4.0MMX16MMX135CM 1008161-16 OTW
OMNI 35 5.0MMX16MMX135CM 1008163-16 OTW OMNI 35 6.0MMX16MMX135CM 1008165-16 OTW
OMNI 35 7.0MMX16MMX135CM 1008174-16 OTW OMNI 35 4.0MMX16MMX80CM 1008176-16 OTW
OMNI 35 5.0MMX16MMX80CM 1008178-16 OTW OMNI 35 6.0MMX16MMX80CM 1008180-16 OTW
OMNI 35 7.0MMX16MMX80CM
RECALLING FIRM/MANUFACTURER Guidant
Endovascular Solutions, Inc., Temecula, CA
REASON Stents may become loose or
dislodged from the delivery catheter.
VOLUME OF PRODUCT IN
COMMERCE 69,700 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) CryoValve, Pulmonary
Valve & Conduit, Model # PV00
b) CryoValve,
Aortic Valve & Conduit SG, Model # SGAV00
c)
CryoValve, Pulmonary Valve & Conduit SG, Model # SGPPV00
CODE
a) Donor #58842, Serial #7426089;
b) Donor
#65389, Serial #7943760;
c) Donor #62963, Serial #7819366
RECALLING
FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA
REASON Tissues
associated with complaints of alleged recipient infection.
VOLUME OF
PRODUCT IN COMMERCE 1 tissue
DISTRIBUTION MO, TX and
Australia
PRODUCT CryoValve, Pulmonary
Valve & Conduit, Donor #68538, Model # PV00
CODE Serial #8045214
RECALLING
FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA
REASON Mislabeling; An
allograft labeled as an aortic valve & conduit, actually contained a
pulmonary valve and conduit.
VOLUME OF PRODUCT IN COMMERCE 1
tissue
DISTRIBUTION CA
PRODUCT Elx800 microtiter plate
reader software program written for use with ORTHO HCV Version 3.0 ELISA Test
System.
CODE Version 12 and older
software
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Diasorin Inc., Stillwater, MN
Manufacturer: Ortho Clinical Diagnostics, Inc., Raritan, NJ.
REASON
An error in the acceptance
specification for the substrate blank optical density was discovered in the
Bio-Tek Elx800 programming specifications for the ORTHO HCV Version 3.0 ELISA
Test System Assay.
VOLUME OF PRODUCT IN
COMMERCE 128
DISTRIBUTION Nationwide
WEEK ENDING OCTOBER 15
PRODUCT
Prisma continuous renal
replacement system. Model/Catalog Numbers: 018080100, 018080101, 018080001D
CODE
All serial numbers
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Gambro Renal Products, Lakewood,
CO
Manufacturer: Gambro Dasco S.p.A. Monitor Division, Medolla, Italy.
REASON
Critically ill patients undergoing continuous renal
replacement therapy may suffer excessive fluid loss. Failure of the operator to
adequately address the cause for an ‘Incorrect Weight Change Detected” alarm and
choose to continue the procedure could resulting excessive ultrafiltration.
VOLUME OF PRODUCT IN COMMERCE
1,964
units
DISTRIBUTION Nationwide
PRODUCT FreeStyle CoPilot Web
Based Data Management System, and FreeStyle CoPilot Health Management System,
Versions 1 and 2. Web Based Data Management System, no packaging.
CODE
Versions 1 and 2. Built 1041 and 1048. Product is
a downloadable software package
RECALLING FIRM/MANUFACTURER Abbott
Laboratories Medisense Products, Alameda, CA
REASON Downloadable software obtained from the firm’s
website displays user data (including but not limited to insulin levels and pump
statistics data) in a matter that may be misinterpreted and result in
mistreatment of therapy.
VOLUME OF PRODUCT IN COMMERCE N/A. Product
is a downloadable software package.
DISTRIBUTION Nationwide
PRODUCT OASIS Medical Vidaurri
LASIK Flap Irrigator, Product Specification 4036V. The Vidaurri LASIK Flap
Irrigator is a 16g x 1/2" stainless steel cannula with two 25g x 9/16" tip
extensions. There are eight .25mm ports (four per tip).
CODE A. Product Specification 4036V Lot D1201AD Lot
D0702A Y Lot D0802J Lot D09028 Lot D0103V Lot D0303S Lot D1203AH Lot D0104AC Lot
D0304AQ Lot D0504AG Lot D0105AV Lot D0205J Lot D0305AH Lot D03058D Lot D0605AE
Lot D0705Y Lot D0805A8 B. Product Specification 8065403604 Lot D0304S Lot D0405A
Y Lot D05058H C. Product Specification MK-036V Lot D0305Y D. Product
Specification 8-4036V-NS Lot D060488 Lot D0804T Lot D0904A Lot D1004AV Lot
D12048X
RECALLING FIRM/MANUFACTURER Oasis Medical, Inc., Glendora, CA
REASON
Foreign deposit present on the surface of the
Vidaurri Lasik Flap Irrigators.
VOLUME OF PRODUCT IN COMMERCE 9,859
cannulas
DISTRIBUTION Nationwide and Internationally
WEEK ENDING OCTOBER 22
PRODUCT
a) Stackhouse FreedomAire
Lens/Hood; a sterile disposable protective head garment for use with the
FreedomAire Surgical Helmet System, providing a clear plastic bubble lens and protective head hood to connect to the
surgical helmet; individually
packaged hoods, 12 per case. Part #10450, Catalog # SA-500/US,
b) Stackhouse Lens/Hood, Mark III Universal; a
sterile
disposable protective head garment for use with the Steakhouse Mark III
Helmet, providing a clear plastic bubble lens and protective head hood to
connect to the
surgical helmet; individually packaged hoods, 12 per
case. Part #10567, Catalog # SA-300/US,
CODE
a) Lot number: 16963;
b) Lot number:
19253
RECALLING FIRM/MANUFACTURER
Recalling Firm: VIASYS Med
Systems, Wheeling, IL
Manufacturer: Servicios De Ensamble Internationales
S.A. de
C.V., Juarez, Mexico.
REASON The
packaging may be compromised such that sterility of the hoods cannot be
guaranteed.
VOLUME OF PRODUCT IN COMMERCE 606
cases
DISTRIBUTION Nationwide, Japan, Chile and Switzerland
PRODUCT D-Start Dry Hemostatic
Bandage. The product is an adhesive bandage.
CODE Lot numbers: 301323A and 301393
RECALLING
FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical, Inc,
Allentown, PA
Manufacturer:
Vascular Solutions, Minneapolis, MN.
REASON Package sealing defect -- product may not be
sterile.
VOLUME OF PRODUCT IN COMMERCE 60
units
DISTRIBUTION Nationwide
PRODUCT
a) Hard shell carry case
for the Lifepak 500 AED. Catalog number 3005384-000 through 002,
b) Hard shell carry case for the Lifepak CR Plus.
Catalog
number 3201582-000 through --002,
CODE Cases
do not contain serial numbers or lot numbers.
RECALLING
FIRM/MANUFACTURER Medtronic Emergency Response Systems, Inc., Redmond,WA
REASON
Some hard shell carry case for Lifepak 500 and
Lifepak CR Plus automated external defibrillators may have blocked pressure vent
which may make it difficult to open the case after a sudden decrease in altitude
(such as in aircraft landing or mountain descent).
VOLUME OF PRODUCT IN
COMMERCE
a) 4,608 cases;
b) 133
cases
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) Nichols Advantage
Invasive Trophoblast Antigen (ITA) Assay Cartridges. Catalog #62-7052
b) Hyperglycosylated Human Chorionic Gonadotropin
(H-hCG) Assay Cartridges. Catalog # 62-7039,
CODE
a) Lot # 62-500261;
b) Lot # 62-500262
RECALLING
FIRM/MANUFACTURER Nichols Institute Diagnostics, San Clemente, CA
REASON
Cartridge does not maintain its stability over the
12 month expiration dating of the product, and that stability is assured only
through 6 months.
VOLUME OF PRODUCT IN COMMERCE 196
units
DISTRIBUTION Nationwide, China, Germany and Australia
PRODUCT Architect c800 for
Conventional Units and SI Units, Version 5.00,
CODE
List number 08G98-07 for Conventional Units;
List
number 04J62-07 for SI Units
RECALLING FIRM/MANUFACTURER Abbott
laboratories, Inc., Irving, TX,
REASON Device has incorrect notation associated
with therapeutic drug monitoring assays. These assays have an "IUO" notation
after the results on the printed reports indicating that the results are for
"Investigational Use Only". For both Conventional Units and SI Units, the
ARCHITECT c8000 Assay Disk, Version 5.00 has the reagent name for Phenobarbital
identified incorrectly as PHEN0 with a zero (()) instead of with the letter "O".
This causes an error code to be generated during installation.
VOLUME OF
PRODUCT IN COMMERCE 310 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Synchron LX Systems
Version 4.5 Operating Software
CODE Synchron LX
20 and PRO Version 4.5 Operating Software Part Number A21127 (Upgrade Kit)
Software Versions V4.5N4.6 CDB (Chemistry Database). Synchron LXi Version 4.5
Operating Software A21128 (Upgrade Kit) Software Versions V4.5N4.6 CDB(Chemistry
Database)
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA
REASON
Synchron LX Systems Operating Software Version
4.5/v4.6 CBD (Chemistry Database) introduced an adjustment to the urine Uric
Acid database calculation scheme which for some patients, depending on the
volume of 24 hour urine sample, results may be reduced from above the upper
limit of the laboratory's reference interval to below the limit.
VOLUME
OF PRODUCT IN COMMERCE 868 units
DISTRIBUTION Nationwide and
Canada
PRODUCT Architect c8000 Analyzer
System Processing Module, a fully automated, random access, clinical chemistry
analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes
of measurement) for photometric based determinations. List number 1G06-01
CODE
All serial numbers
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Inc.,
Irving, TX
Manufacturer: Toshiba
Medical Systems Company, Tochigi-Ken, Japan.
REASON Software deficiency causing potential shift in
absorbance readings for test results.
VOLUME OF PRODUCT IN
COMMERCE 1,107 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Allocraft TLIF Bone
Inserter. Catalog No. 483600100
CODE Lot Code:
04C570
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker
Howmedica Osteonics Corp., Mahwah, NJ
Manufacturer: Stryke, Cestas, France.
REASON
The short arm of the bone inserter may fracture
during use and potentially result in an adverse health consequence.
VOLUME
OF PRODUCT IN COMMERCE 9 units
DISTRIBUTION Nationwide
PRODUCT EBI Trochanteric 11mm
Long Nail
CODE Catalog No./Lot Nos:
28226/164522; 28228/164523; 28230/175576; 28234/175583; 28238/175589;
28248/164527; 28324/164529; 28326/164531; 28328/164532; 28330/175614;
28332/170182; 28334/175621; 28338/175630; 28342/166415; 28344/164540;
28348/164545
RECALLING FIRM/MANUFACTURER EBI, L.P., Parsippany, NJ
REASON
Upon evaluation, the firm found that the fatigue
strength of the nails was below the required value as specified in the design
specification.
VOLUME OF PRODUCT IN COMMERCE 102
nails
DISTRIBUTION Nationwide
PRODUCT
a) TC-PLUS Tibial Insert
Ultra-Congruent Size 10; 9 mm, Model 25456
b) TC-PLUS Tibial Insert 2; 15 mm, Model 25309,
c)
TC-PLUS Tibial Insert UC 4; 11 mm, Model 25427,
d) TC-PLUS Tibial Insert UC 4; 13 mm, Model 25428,
e)
TC-PLUS Tibial Insert UC 6; 9 mm, Model 25436,
f) TC-PLUS Tibial Insert UC 6; 13 mm, Model 25438,
g)
TC-PLUS Tibial Insert UC 10; 11 mm, Model 25457,
CODE
a) Lot code: 0204.13.2355;
b) Lot code:
0303.13.1623;
c) Lot code: 0501.13.0198;
d) Lot code: 0501.13.0263;
e)
Lot code: 0501.13.0264;
f) Lot code: 0501.13.0199, 0303.13.1616;
g) Lot
code: 0501.13.0200
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Plus Orthopedics USA, San Diego, CA
Manufacturer: Plus Endoprothetik AG, Rotkreuz, Switzerland.
REASON
Products did not meet
specifications. The insert was produced with a smaller length dimension,
resulting in micromotion experienced in preoperative assembly of a tibial insert
and tibial baseplate.
VOLUME OF PRODUCT IN COMMERCE 108
units
DISTRIBUTION AZ, CA, ID, NY, TX, and VA
PRODUCT
a) Pioneer Surgical
brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog
number
10-575-PA-45.
b) Pioneer Surgical brand
Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number
10-575-PA-40
CODE
a) Lot code:
306507;
b) Lot code: 308623
RECALLING FIRM/MANUFACTURER Pioneer
Surgical Technology, Marquette, MI
REASON Screw may be incorrectly
etched as to length. Screw that is etched "45mm" may be 40mm rather than 45mm.
Manufacturer is recalling both lots because of a "potential of lot
contamination".
VOLUME OF PRODUCT IN COMMERCE 234
screws
DISTRIBUTION Nationwide
PRODUCT
Interis Allura BiPlane
X-Ray System
CODE The firm utilizes site
numbers: 520582, 531926, 535761, 535775, 520949, 530660, 530654, 522136, 521325,
532241, 531939, 520721, 104949, 530396, 532152, 530653, 532383, 531649, 534756,
533290, 521525, 533397, 534786, 520688, 522456, 520964, 532218, 521149, 520275,
532240, 531758, 520666, 519196, 531799, 519981, 520756, 76992,
534131
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips
Medical Systems North America Co. Phillips, Bothell, WA
Manufacturer: Philips Medical Systems, Netherlands.
REASON
1) During positioning of the
Lateral Stand the rotation and/or skew movement may travel unexpectedly in
opposite direction;
2) movement may be faster than normal speed; 3) the stand
may not stop immediately upon release of the joystick.
VOLUME OF PRODUCT
IN COMMERCE 38 units
DISTRIBUTION Nationwide
PRODUCT
a) Zimmer brand
Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented
use only in the
USA, Cat. no. 00430604000.
b) Zimmer brand Bigliani/Flatow Total Shoulder trabecular
metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA,
Cat. no. 00430604046
c) Zimmer brand Bigliani/Flatow
Total Shoulder trabecular metal glenoid component, 40 mm dia. articular
surface,med, sterile, for cemented use only in the USA, Cat. no.00430604640
d) Zimmer brand
Bigliani/Flatow Total
Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no.
00430604600
e) Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm
dia. articular surface, med, sterile, for
cemented use only in the USA, Cat. no. 00430604652,
f)
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid
component, 46 mm dia. articular surface, large, sterile, for cemented use
only in the USA, Cat. no. 00430605246
g) Zimmer
brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52
mm dia. articular surface, large, sterile, for cemented use only in the USA,
Cat. no. 00430605200
h) Zimmer brand Bigliani/Flatow
Total Shoulder trabecular metal glenoid component, 56 mm dia. articular
surface, small, sterile, for cemented use only in the USA, Cat. no. 00430605256
CODE
All lots
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc., Warsaw, IN
Manufacturer: Zimmer
Trabecular, Allendale, NJ.
REASON The implant may fracture at the junction of the base and
the trabecular metal keel if adequate support for the base has not been achieved
by the host bone and/or bone cement.
VOLUME OF PRODUCT IN
COMMERCE 723 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Rita Brand Habib 4X
Electrosurgical Coagulator, Catalog Number: 4401 US
CODE Lot number: 0011
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Rita Medical Systems, Fremont,
CA
Manufacturer: Rita Medical
Systems, Manchester, GA.
REASON Devices' sterility may be compromised as evidenced
by a loss of package integrity.
VOLUME OF PRODUCT IN COMMERCE 262
units
DISTRIBUTION Nationwide
PRODUCT Baxter's Patient Care
System (BPCS) software, composed of Pharmacy Management - Inpatient - product
code 2M5013, Point of Care - product code 2M5014 and Management Reports -
product code 2M5015,
CODE Software version
4.1-77, 4.0-66 and 3.4-18.24
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare, Corp., Round
Lake, IL5.
Manufacturer: Baxter
Healthcare Corp./Patient Care System, Toronto, Canada.
REASON If a
pharmacy end user alters the Administration Unit of Measure (AUOM) of an ordered
drug, the AUOM will display incorrectly on the Medication Administration Record
for the patient, possibly leading to medication errors.
VOLUME OF PRODUCT
IN COMMERCE 5 units
DISTRIBUTION MO, MA, VT, CA and
Canada
PRODUCT Stryker brand
Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000
CODE Serial numbers: 0428702183 through
0518008193
RECALLING FIRM/MANUFACTURER Stryker Instruments,
Division of Stryker Corporation, Kalamazoo, MI
REASON The pressure indicated may
be inaccurate, and this inaccuracy may be not detectable by the
user.
VOLUME OF PRODUCT IN COMMERCE 473
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) Fetalgard Lite Fetal
Monitors, Model APIS (Single Fetus Monitoring)
b)
Fetalgard Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)
CODE
a) System Serial Numbers:
FA002021 FA002022 FA002025 FA002027 FA002033 FA002020 FA002029 FA002005
FA002041 FA002044 FA002046 FA002112 FA002097 FA002117 FA002028 FA002047
FA002048 FA002118 FA002034 FA002093 FA002095 FA002116 FA002008 FA002023
FA002030 FA002031 FA002009 FA002098 FA002040 FA002092 FA002024 FA002114
FA002113 FA002115 FA002026 FA002032 FA001328;
b) Serial Numbers: FA002010
FA002051 FA002054 FA002059 FA002061 FA002062 FA002064 FA002011 FA002013
FA002014 FA002056 FA002065 FA002058
RECALLING
FIRM/MANUFACTURER Analogic Corporation, Peabody, MA
REASON Unit
may not power up due to faulty circuit board.
VOLUME OF PRODUCT IN
COMMERCE 50 units
DISTRIBUTION CT, PR, and
Internationally
PRODUCT
a) Datex-Ohmeda S/5
Aespire Anesthesia System 7100,
b) Datex-Ohmeda S/5
Aespire Anesthesia System 7900,
c) Datex-Ohmeda
Aespire Carestation. This device is not marketed in the US
CODE
AMXJ00203, AMXJ00204, AMXJ00248 thru AMXJ00257,
AMXJ00259, AMXJ00260, AMXJ00262 thru AMXJ00305, AMXJ00308 thru
AMXJ00312, AMXJ00317, AMXJ00318, AMXJ00333 thru AMXJ00335, AMXJ00338 thru
AMXJ00342, AMXJ00350 thru AMXJ00354, AMXJ00380 thru AMXJ00411, AMXJ00416, AMXJ00419 thru AMXJ00425, AMXJ00429 thru
AMXJ00442, AMXJ00451
thru AMXJ00473, AMXJ00485 thru AMXJ00576, ZMXJ00581 thru AMXJ00629,
AMXJ00631 thru AMXJ00639, AMXJ00641 thru AMXJ00699;
b) ANCJ00100 thru
ANCJ00113, ANCJ00116, ANCJ00118;
c) AMZJ00111 thru AMZJ00146
RECALLING
FIRM/MANUFACTURER Datex-Ohmeda, Inc., Madison, WI
REASON Two
conditions may occur with the S/5 Aespire Anesthesia System. The internal
auxiliary flowmeter tubing may become disconnected if the auxiliary oxygen
supply tubing is occluded and the patient may not receive desired supplemental
oxygen which could lead to serious injury if undetected. Also the O2 switch may
leak or fail.
VOLUME OF PRODUCT IN COMMERCE 419
units
DISTRIBUTION Nationwide and Internationally
WEEK ENDING OCTOBER 29
PRODUCT VeriCal
Calibrator Set,
CODE Lot numbers:
161813, 161907, 161908, and 161909
RECALLING
FIRM/MANUFACTURER Biomerieux, Inc., Durham, NC,
REASON
The product is being recalled due to mis-assignment of ISI values associated with VeriCal use. This could lead to
inaccurate patient INR results.
VOLUME OF PRODUCT IN
COMMERCE 2,334
kits
DISTRIBUTION Nationwide
PRODUCT
a)
FreeStyle FLASH Blood Glucose Monitoring System,
b)
Tracker Blood Glucose Monitoring System,
c) Xceed
Blood Glucose Monitoring System,
d) ReliOn Ultima
Glucose Monitoring System,
e) Kroger Glucose
Monitoring System
f) RiteAid Glucose Monitoring System
g) Liberty Glucose Monitoring
System
h) Boots Glucose Monitoring System
i)
Optium Glucose Monitoring System
j) Xtra Classic Glucose
Monitoring System,
k) Easy Glucose Monitoring System
l) SofTrac Glucose Monitoring
System
m) FreeStyle Glucose Monitoring System
CODE
a) All lot numbers beginning with R and
all lot numbers T-G158-62981 and below are included.
b) All lot numbers
beginning with E are included in the recall;
c) All lot numbers beginning
with XC0999 and below are included in this recall;
d), e), f), g), h), i), j), k), and l) All lot numbers
are included in this recall;
m) For
lot numbers beginning with A, B, C, D, G, H, K, and M, all lot numbers are
included. All lot numbers
from V-G157-31584 and below are included, and also
all lot numbers Y-G018-32983 and below are included in the
recall.
RECALLING FIRM/MANUFACTURER Abbott Diabetes Care,
Inc., Alameda, CA
REASON User may inadvertently change the Units
of Measure from mg/dL to mmol/L and the blood glucose results could be
misinterpreted. This may lead to under treatment and potential for
hyperglycemia.
VOLUME OF PRODUCT IN
COMMERCE Approximately 10,005,206
meters
DISTRIBUTION Nationwide and
Internationally
PRODUCT Nichols
Advantage QuiCk-Intraoperative Bio-Intact PTH Assay, Catalog No. 62-7045
CODE
Lot 62-402651
RECALLING
FIRM/MANUFACTURER Nichols Institute Diagnostics, San Clemente, CA,
REASON
Controls were out of specification
range.
VOLUME OF PRODUCT IN COMMERCE 323
units
DISTRIBUTION Nationwide, Japan, Spain, Germany, and
Sweden
PRODUCT Thermocool
Irrigated Catheters Celsius LABEL US Part Number# EU CATALOG # L-1189-01-S
D17TCBLRT 35Q-13R PMA; L-1189-02-S D17TCDLRT 35Q-33R PMA; L-1189-03-S D17TCFLRT
35Q-53R PMA; L-1189-04-S D17TCJLRT 35Q-73R PMA; L-1189-15-S D71TCB5L252RT
35Q-17Q EXPORT; L-1189-16-S D71TCD5L252RT 35Q-37Q EXPORT; L-1189-17-S
D71TCF5L252FT 35Q-57Q EXPORT; L-1189-03-S D71TFL252RT 35R-53R EXPORT;
L-1192-03-S D71TFL252RT 35R-53R EXPORT; L-1192-15-S D71TB5L252RT 35R-17R EXPORT;
L-1192-16-S D7ITD5L252RT 35R-37R EXPORT; L-1189-02-SI D17TCDLRTI N/A IDE;
L-1189-15-SI D71TCB5L252RTI N/A IDE; L-1189-16-SI D71TCD5L252RTI N/A IDE;
L-1189-17-SI D71CF5L252RTI N/A IDE Navistar LABEL US Part Number# EU CATALOG #
L-1192-17-S D71TF5L252RT 35R-57R EXPORT; L-1197-14-S NI75TCBH 34H-17M PMA;
L-1197-15-S NI75TCCH 34H-27M PMA; L-1197-16-S NI75TCDH 34H-37M PMA; L-1197-17-S
NI75TCFH 34H-57M PMA; L-1197-18-S NI75TCJH 34H-J7M PMA; L-1208-05-S
NS75TBCT252HS 34G-17M PMA; L-1208-06-S NS75TCCT252HS 34G-27M PMA; L-1208-07-S
NS75TDCT252HS 34G-37M PMA; L-1208-08-S NS75TFCT252HS 34G-57M PMA; L-1197-14-SI
NI75TCBHI N/A IDE; L-1197-15-SI NI75TCCHI N/A IDE; L-1197-16-SI NI75TCDHI N/A
IDE; L-1197-17-SI NI75TCFHI N/A IDE; L-1197-18-SI NI75TCJHI N/A IDE;
L-1208-05-SI NS75TBCT252HSI N/A IDE; L-1208-06-SI NS75TCCT252HSI N/A IDE;
L-1208-07-SI NS75TDCT252HSI N/A IDE; L-1208-08-SI NS75TFCT252HSI N/A IDE
CODE
Lot numbers: 13027030 to
13044734
RECALLING FIRM/MANUFACTURER Biosense Webster,
Inc., Irwindale, CA
REASON Increased complaints regarding catheters
with leaks and flow obstruction.
VOLUME OF PRODUCT IN
COMMERCE 9,679 units
DISTRIBUTION FL, IL, MA,
MI, OH, OK and Internationally
PRODUCT
a) Scorpio
Total Knee Cruciate Retaining Femoral Component, #7, left, Catalog No.
70-4107L. 1 each to a package
b) Scorpio Total Knee
Cruciate Retaining Femoral Component, #7, right, Catalog No. 70-4107R. 1
each to a package,
CODE
a) Lot
Code: K04W537;
b) Lot code: K04W896
RECALLING
FIRM/MANUFACTURER Stryker Howmedica Osteonics, Corp., Mahwah, NJ
REASON The Left Scorpio Total Knee Cruciate Retaining
Waffle Femoral Component #7 packaged and labeled as left may contain a Right and
vice versa.
VOLUME OF PRODUCT IN COMMERCE 15
units
DISTRIBUTION Nationwide and Internationally
PRODUCT T2 Recon Nail
System
CODE Catalog
No./Description/Lot Code: 18976065S-- T2 Recon Lag Screw 6.5x65MM--K454322; T2
Recon Lag Screw 6.5x65MM--K518614; T2 Recon Lag Screw 6.5x65MM--K518615; T2
Recon Lag Screw 6.5x65MM--K518616; T2 Recon Lag Screw 6.5x65MM--K518617; T2
Recon Lag Screw 6.5x65MM--K678251; T2 Recon Lag Screw 6.5x65MM--K678252.
18976070S-- T2 Recon Lag Screw 6.5x70MM--K412886; T2 Recon Lag Screw
6.5x70MM--K412887; T2 Recon Lag Screw 6.5x70MM--K454324; T2 Recon Lag Screw
6.5x70MM--K497821; T2 Recon Lag Screw 6.5x70MM--K518728; T2 Recon Lag Screw
6.5x70MM--K678253; T2 Recon Lag Screw 6.5x70MM--K678254. 18976075S-- T2 Recon
Lag Screw 6.5x75MM--K400117; T2 Recon Lag Screw 6.5x75MM--K454326; T2 Recon Lag
Screw 6.5x75MM--K518854; T2 Recon Lag Screw 6.5x75MM--K518855; T2 Recon Lag
Screw 6.5x75MM--K518857; T2 Recon Lag Screw 6.5x75MM--K518858; T2 Recon Lag
Screw 6.5x75MM--K678255; T2 Recon Lag Screw 6.5x75MM--K678256. 18976080S-- T2
Recon Lag Screw 6.5x80MM--K400118; T2 Recon Lag Screw 6.5x80MM--K454327; T2
Recon Lag Screw 6.5x80MM--K519005; T2 Recon Lag Screw 6.5x80MM--K519008; T2
Recon Lag Screw 6.5x80MM--K519009; T2 Recon Lag Screw 6.5x80MM--K678257; T2
Recon Lag Screw 6.5x80MM--K678258. 18976085S-- T2 Recon Lag Screw
6.5x85MM--K400119; T2 Recon Lag Screw 6.5x85MM--K412895; T2 Recon Lag Screw
6.5x85MM--K454328; T2 Recon Lag Screw 6.5x85MM--K488715; T2 Recon Lag Screw
6.5x85MM--K519003; T2 Recon Lag Screw 6.5x85MM--K519176; T2 Recon Lag Screw
6.5x85MM--K519177; T2 Recon Lag Screw 6.5x85MM--K519178; T2 Recon Lag Screw
6.5x85MM--K519182; T2 Recon Lag Screw 6.5x85MM--K519183; T2 Recon Lag Screw
6.5x85MM--K519184; T2 Recon Lag Screw 6.5x85MM--K519185; T2 Recon Lag Screw
6.5x85MM--K519186; T2 Recon Lag Screw 6.5x85MM--K678259; T2 Recon Lag Screw
6.5x85MM--K678260; T2 Recon Lag Screw 6.5x85MM--K757952. 18976090S-- T2 Recon
Lag Screw 6.5x90MM--K400120; T2 Recon Lag Screw 6.5x90MM--K454329; T2 Recon Lag
Screw 6.5x90MM--K488717; T2 Recon Lag Screw 6.5x90MM--K519286; T2 Recon Lag
Screw 6.5x90MM--K519288; T2 Recon Lag Screw 6.5x90MM--K519289; T2 Recon Lag
Screw 6.5x90MM--K519290; T2 Recon Lag Screw 6.5x90MM--K519291; T2 Recon Lag
Screw 6.5x90MM--K519292; T2 Recon Lag Screw 6.5x90MM--K519293; T2 Recon Lag
Screw 6.5x90MM--K678262; T2 Recon Lag Screw 6.5x90MM--K757953. 18976095S-- T2
Recon Lag Screw 6.5x95MM--K400121; T2 Recon Lag Screw 6.5x95MM--K412911; T2
Recon Lag Screw 6.5x95MM--K412914; T2 Recon Lag Screw 6.5x95MM--K412920; T2
Recon Lag Screw 6.5x95MM--K454330; T2 Recon Lag Screw 6.5x95MM--K488720; T2
Recon Lag Screw 6.5x95MM--K519401; T2 Recon Lag Screw 6.5x95MM--K519402; T2
Recon Lag Screw 6.5x95MM--K519405; T2 Recon Lag Screw 6.5x95MM--K519406; T2
Recon Lag Screw 6.5x95MM--K519407; T2 Recon Lag Screw 6.5x95MM--K519408; T2
Recon Lag Screw 6.5x95MM--K669388; T2 Recon Lag Screw 6.5x95MM--K678264; T2
Recon Lag Screw 6.5x95MM--K757954. 18976100S-- T2 Recon Lag Screw
6.5x100MM--K400122; T2 Recon Lag Screw 6.5x100MM--K454331; T2 Recon Lag Screw
6.5x100MM--K488721; T2 Recon Lag Screw 6.5x100MM--K519501; T2 Recon Lag Screw
6.5x100MM--K519502; T2 Recon Lag Screw 6.5x100MM--K519503; T2 Recon Lag Screw
6.5x100MM--K519504; T2 Recon Lag Screw 6.5x100MM--K519505; T2 Recon Lag Screw
6.5x100MM--K519508; T2 Recon Lag Screw 6.5x100MM--K519509; T2 Recon Lag Screw
6.5x100MM--K678265; T2 Recon Lag Screw 6.5x100MM--K678266; T2 Recon Lag Screw
6.5x100MM--K757955. 18976105S-- T2 Recon Lag Screw 6.5x105MM--K400123; T2 Recon
Lag Screw 6.5x105MM--K454332; T2 Recon Lag Screw 6.5x105MM--K488751; T2 Recon
Lag Screw 6.5x105MM--K519604; T2 Recon Lag Screw 6.5x105MM--K519605; T2 Recon
Lag Screw 6.5x105MM--K519606; T2 Recon Lag Screw 6.5x105MM--K519607; T2 Recon
Lag Screw 6.5x105MM--K519608; T2 Recon Lag Screw 6.5x105MM--K519609; T2 Recon
Lag Screw 6.5x105MM--K519611; T2 Recon Lag Screw 6.5x105MM--K678267; T2 Recon
Lag Screw 6.5x105MM--K678268; T2 Recon Lag Screw 6.5x105MM--K757974. 18976110S--
T2 Recon Lag Screw 6.5x110MM--K400124; T2 Recon Lag Screw 6.5x110MM--K454333; T2
Recon Lag Screw 6.5x110MM--K488758; T2 Recon Lag Screw 6.5x110MM--K519730; T2
Recon Lag Screw 6.5x110MM--K519731; T2 Recon Lag Screw 6.5x110MM--K519736; T2
Recon Lag Screw 6.5x110MM--K678269; T2 Recon Lag Screw 6.5x110MM--K757979.
18976115S-- T2 Recon Lag Screw 6.5x115MM--K400125; T2 Recon Lag Screw
6.5x115MM--K454334; T2 Recon Lag Screw 6.5x115MM--K488759; T2 Recon Lag Screw
6.5x115MM--K497822; T2 Recon Lag Screw 6.5x115MM--K519899; T2 Recon Lag Screw
6.5x115MM--K519900; T2 Recon Lag Screw 6.5x115MM--K519901; T2 Recon Lag Screw
6.5x115MM--K678271; T2 Recon Lag Screw 6.5x115MM--K678293. 18976120S-- T2 Recon
Lag Screw 6.5x120MM--K400126; T2 Recon Lag Screw 6.5x120MM--K454335; T2 Recon
Lag Screw 6.5x120MM--K520037; T2 Recon Lag Screw 6.5x120MM--K520038; T2 Recon
Lag Screw 6.5x120MM--K520039; T2 Recon Lag Screw 6.5x120MM--K678294; T2 Recon
Lag Screw 6.5x120MM--K678295; T2 Recon Lag Screw 6.5x120MM--K757980. 18976125S--
T2 Recon Lag Screw 6.5x125MM--K454336; T2 Recon Lag Screw 6.5x125MM--K488786; T2
Recon Lag Screw 6.5x125MM--K520139; T2 Recon Lag Screw 6.5x125MM--K520140; T2
Recon Lag Screw 6.5x125MM--K678296; T2 Recon Lag Screw 6.5x125MM--K678297; T2
Recon Lag Screw 6.5x125MM--K808190. 18976130S-- T2 Recon Lag Screw
6.5x130MM--K454337; T2 Recon Lag Screw 6.5x130MM--K520156; T2 Recon Lag Screw
6.5x130MM--K520157; T2 Recon Lag Screw 6.5x130MM--K520158; T2 Recon Lag Screw
6.5x130MM--K520159; T2 Recon Lag Screw 6.5x130MM--K520160; T2 Recon Lag Screw
6.5x130MM--K678298; T2 Recon Lag Screw 6.5x130MM--K678299; T2 Recon Lag Screw
6.5x130MM--K757982
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Stryker Howmedica Osteonics, Corp., Mahwah, NJ
Manufacturer: Stryker Trauma, Kiel, Germany.
REASON
The blister pack containing the Recon 6.5
Lag Screws may become damage during shipment resulting in loss of
sterility.
VOLUME OF PRODUCT IN COMMERCE 4,698
units
DISTRIBUTION Nationwide
PRODUCT Baxter's
Patient Care System (BPCS) software, Pharmacy Management - Inpatient - product
code 2M5013 and Point of Care - product code 2M5014; made in Canada
CODE
All units of software versions 4.0 (66)
and 4.1 (77)
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Baxter Healthcare Corp., Round Lake, IL
Manufacturer: Baxter Healthcare Corp/Patient Care System, Toronto,
Canada.
REASON If an
administrative user modifies any of the seven pre-defined Monitoring Parameters
when they are attached to a medication in the drug file, a Point of Care end
user will be unable to enter monitoring parameter results on the
handheld.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION MO, MA, VT, CA and Canada
PRODUCT Boston
Scientific brand Position Acquisition Module (PAM), a component of Realtime
Position Management (RPM) System, Catalog/Model Numbers: 8200010, 8200TWA0
CODE
All lots
RECALLING
FIRM/MANUFACTURER Boston Scientific, San Jose, CA
REASON
The device has the potential for
overheating its transformer and has the potential for fire
hazard.
VOLUME OF PRODUCT IN COMMERCE 94
units
DISTRIBUTION Nationwide, EU and Canada
PRODUCT
a) Remington
Medical Ten Disposable Tear-Away Introducer Sets Size 7 French, Sterile:
Single Use/Disposable Radiopaque Contents Ethylene Oxide
Sterilized,
b) Remington Medical, Ten Disposable
Tear-Away Introducer Sets, Size 8 French, Sterile: Single
Use/Disposable Radiopague Contents Ethylene Oxide Sterilized,
c) Remington Medical, 8 French-Sheath Only, Size 8
French,
Single Use. Ethylene Oxide sterilized;
CODE
a) Lot No. 040508, 041111, 042116, 042367,
043146, 050077, 041464;
b) Lot No. 043003, 042674, 042313;
c) Lot No.
041603, 041731, 050201, 050274
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Remington Medical Inc.,
Alpharetta, GA
Manufacturer: B. Braum Medical, Inc., Allentown, PA.
REASON
The Tear-Away introducer sheath
in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked
hubs/handles and or improper peeling of the sheath during use.
VOLUME
OF PRODUCT IN COMMERCE 4,800
units
DISTRIBUTION Nationwide
PRODUCT Gemini GXL
PET/CT Systems, 6, 10, 16 slice configurations. (Product Numbers/manufacturer
numbers: 16 slice: 4535 679 71891, 10 slice: 4535 679 75691, 6 slice: 4535 679
75691. Catalog numbers: 16 slice: 882410, 10 slice: 882400, 6 slice: 882390.)
CODE
Serial numbers:
4001-4019
RECALLING FIRM/MANUFACTURER Philips Medical
Systems (Cleveland), Inc., Cleveland, OH
REASON The image balance
center point correction algorithm used in CT image reconstruction may cause a
disappearance or alteration of small circular anatomical structures that are
both near the image center and perpendicular to the image plane. This artifact
may lead to the misinterpretation of anatomy at the center of the
image.
VOLUME OF PRODUCT IN COMMERCE 19
devices
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) DTX(tm)
Plus DT-DL60 Continuous flush catheter, Part Number 682028;
b) CRITIFLOW(tm) TA4004 continuous flush catheter,
Part Number 682060
c) TAKHPQ60R continuous flow catheter, Part
Number 682117.
d) CRITIFLO(tm) TAK0460 continuous
flow catheter, Part number 682118.
e) DT-DL60-1
W/Bifurcated, Part Number 682147,
f) CRITIFLO(tm)
flush kit. Part Number 687198,
g) CRITIFLO(tm) Flush
Kit. Part Number 687566,
CODE
a)
Lot numbers: 102034, 103270, 106049, 107034, 108073, 109040, 107034, 110023,
110037, 111023, 203021, 205038, 206055, 207079, 207525, 208110, 208476, 209101, 210095, 211082, 212097, 301139, 301666,
303123, 303616, 305027,
306242, 308059, 309106, 310143, 311160, 312121, 401036, 402022, 403063, 404043, 405079;
b) Lot numbers: 012485, 101226, 102036, 103011, 103370,
106015, 107041, 108033, 109060, 110004, 111037, 201056, 204002, 205041,
206026, 207062, 208073, 211376, 212407, 301104, 302256, 303085, 303246,
304562, 306211, 306443, 308071, 308169, 308518, 309086, 310124, 311143,
312418, 403315, 404050, 405097, 407055, 407468, 408018;
c) Lot numbers
107612, 109012, 110019, 112035, 210060, 212386, 301150;
d) Lot Numbers
402035, 409152;
e) Lot numbers 010019, 102055, 105054, 103029, 106054, 107040, 108079, 109045, 110042, 201072, 203025,
207529, 310143, 310147,
311166, 312127, 401042, 401589, 403069;
f) Lot Numbers 301850, 302267,
303012, 305055;
g) Lot Number 302520
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson Medical Systems,
Sandy, UT,
Manufacturer: Bd Critical Care
Systems P. L., Singapore.
REASON Device could permit an over-infusion of
IV solutions during pressure monitoring procedures.
VOLUME OF PRODUCT
IN COMMERCE 27,085
units
DISTRIBUTION Nationwide
PRODUCT J-VAC
Reservoir is a component of the J-VAC Closed Wound Drainage System. This system
is a sterile, portable system used for closed wound drainage. This system is
composed of two parts: the J-VAC Reservoir and Suction Drains
CODE
Product code 2179 Lot 520198, exp June
2010; Lot 520200, exp June 2010
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Ethicon, Inc., Somerville,
NJ
Manufacturer: Avil Medical
Products, Inc., San Diego, CA.
REASON Two lots of J-VAC Drain Reservors were shipped to
Japan prior to sterilization and were released.
VOLUME OF PRODUCT IN
COMMERCE 4,630 units
DISTRIBUTION Japan
PRODUCT
a) Merit
Custom Procedure Kit, Part number: K08-01894,
b) Merit
Custom Procedure Kit, Part number: K09-08347,
c) Merit
Custom Procedure Kit, Part number: K09-05248P,
d)
Merit Custom Procedure Kit, Part number: K09-05248AP,
e) Merit Custom Procedure Kit, Part number:
K09-06702,
CODE
a) Lot number: A306856;
b) Lot numbers:
A304591, A322679;
c) Lot numbers: A304826, A314447, A316544, A322290,
A325742, A336903, A345355;
d) Lot numbers: A348563, A360799, A365773, A370274, A372525, A377402, A382733, A388638,
F392744;
e) Lot number:
C229306
RECALLING FIRM/MANUFACTURER Merit Medical
Systems, Inc., South Jordan, UT
REASON Component of procedure kits
may allow higher than desired amount of IV solution to be infused in to patient
during pressure monitoring procedure.
VOLUME OF PRODUCT IN
COMMERCE 917 kits
DISTRIBUTION DC, MD, VA,
the Netherlands and Switzerland
PRODUCT
a) Medrad
Avanta Single Patient Disposable Sets. Catalog number AVA 500 SPAT,
b) Medrad Avanta Multi-patient Disposable Sets. Catalog number AVA 500 MPAT,
CODE
a) Lot number 50577, 50578, 51219, 51220,
51221, and 52208;
b) Lot numbers 50627, 50628, 51069, 51070, 51071,
and 51747
RECALLING FIRM/MANUFACTURER Medrad, Inc.,
Indianola, PA
REASON Stress crack on the
stopcock.
VOLUME OF PRODUCT IN COMMERCE 2,425
sets
DISTRIBUTION Nationwide, Netherlands, Denmark,
France, and Italy
PRODUCT Serum Blood
Collection Tubes
CODE Item #455071,
Lot #B040513 and Item #455092, Lot #B040503
RECALLING
FIRM/MANUFACTURER Greiner VACUETTE North America, Monroe, NC
REASON
Serum Blood Collection tubes found with
excess of Blood Clot Accelerator (BCA) solution.
VOLUME OF PRODUCT IN
COMMERCE 1,623 cases (1,947,600
pieces)
DISTRIBUTION Nationwide and Internationally
PRODUCT Y-valve,
catalog number 7427-01 and T-valve, catalog number 7990-01, PSD/4 with Valve and
Syringe Drive Module parts, catalog number 51863-01-IL
CODE For 7427-01 (Lot number, date of
manufacture): 277702, 4/29/2003; 282550A, 8/11/2003; 282550, 8/13/2003; 286630,
10/1/2003; 287449, 10/20/2003; 287137, 10/20/2003; 287949, 12/18/2003; 301809,
6/30/2004; 305599, 8/19/2005; 309328, 11/5/2004; 313276, 12/17/2004; 314662,
3/7/2005; 317940, 4/6/2005; 319506, 4/11/2005; 321121, 5/6/2005; 324204,
6/23/2005; 325483, 7/20/2005. For 7990-01: 277703, 4/30/2003; 283119, 9/30/2003
291279, 1/7/2004; 303942, 7/19/2004; 303687, 7/19/2004; 318833, 3/24/2005;
319684, 5/5/2005
RECALLING FIRM/MANUFACTURER Hamilton,
CO. Reno, NV
REASON The product valve has a high probability
of deforming and may result in leakage during use.
VOLUME OF PRODUCT
IN COMMERCE 171 Y valves and 30 Y valves were
distributed.
DISTRIBUTION CA. MA. MI, WI, Japan and
Switzerland
PRODUCT Misys
Laboratory version 6.1 - Microbiology Module,
CODE All serial numbers for these
models
RECALLING FIRM/MANUFACTURER Misys Healthcare
Systems, Tucson, AZ
REASON Software problem when the user has
indicated to enter a coded comment instead of using the defined keyboard, then
enters 100,000 the system will file the number 100 instead of number
100,000.
VOLUME OF PRODUCT IN COMMERCE 67
units
DISTRIBUTION Nationwide and Internationally
PRODUCT Dual Lumen
Cannula, 12Fr., sterile, disposable, Model V V 12F,
CODE Lot number: 36BC20121
RECALLING
FIRM/MANUFACTURER Origen Biomedical, Inc., Austin, TX
REASON
Leak between two lumens causes reduced
performance.
VOLUME OF PRODUCT IN COMMERCE 170
catheters
DISTRIBUTION Nationwide, United Kingdom,
Canada, and Germany
PRODUCT HoverMatt
Patient Transfer Solution/Air Transfer Mattress, Model numbers: HM28DC, HM34HS,
HM34DC, HM39HS, HM39DC
CODE ???
RECALLING
FIRM/MANUFACTURER D. T. Davis Enterprises, Ltd., Bethlehem, PA
REASON
Instructions for use are not adhering to
the product.
VOLUME OF PRODUCT IN COMMERCE 866
units
DISTRIBUTION Nationwide, United Kingdom, Canada,
and Australia
PRODUCT Look Brand
Black Monofilament Nylon Suture. 2xS Taper Straight 61 mm 2/0 Black Monofilament
Nylon 30”. Model number 933B. The product is shipped in boxes containing 12
units.
CODE Lot number:
M732780
RECALLING FIRM/MANUFACTURER Surgical Specialties
Corp, Reading, PA
REASON Mislabeled as double armed straight
needle.
VOLUME OF PRODUCT IN COMMERCE 27
boxes
DISTRIBUTION Nationwide