MAY 2006
WEEK
ENDING MAY 6
PRODUCT
a) Baxter I-Pump Pain
Management System infusion pump, product codes 2L3107,
2L3107K and 2L3107R,
b) Baxter AP II Pain Management System infusion pump,
product codes 2L3105,
2L3105K, 2L3105R, 2L3105T and 2L3105W,
CODE
All serial numbers
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp, Round
Lake, IL
Manufacturer: Baxter
Healthcare Corp, Singapore, Singapore, .
REASON When infusing at flow rates below 0.5
mL/hr, the
upstream occlusion alarm of the pumps may not detect the occlusion.
VOLUME
OF PRODUCT IN COMMERCE 42,686 pumps
DISTRIBUTION Nationwide,
PR, Canada, Chile and China
PRODUCT
a) Baxter I-Pump Pain
Management System infusion pump, product codes 2L3107,
2L3107K and 2L3107R
b) Baxter AP II Pain Management System infusion pump,
product codes 2L3105,
2L3105K, 2L3105R, 2L3105T and 2L3105W
c) Baxter OCA II Syringe Infusion Pump, product codes 2L3104 and
2L3104R
CODE All serial numbers
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp, Round
Lake, IL
Manufacturer: Baxter
Healthcare Corp, Singapore, Singapore,
REASON Delivery of unrequested PCA doses of medication due
to damaged PCA cords, partial sticking of PCA button, and fluid ingress into the
pump or PCA button.
VOLUME OF PRODUCT IN COMMERCE 61,407
pumps
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Liko
Universal Slingbar 450 aluminum, used with the Viking M Patient Lift,
b) Liko Universal Slingbar 450 aluminum, used with the Viking L
Patient Lift,
CODE
a) Serial Numbers:
7100102 - 7100104; 7100109 7100147 - 7100159 7100179 --
7100182 7100257 -
7100261;
b) Serial Numbers: 7200202 - 7200216; 7200244 - 7200245; 7200250 -
7200257;
7200260 - 7200262
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Liko, Inc, Franklin, MA,
Manufacturer: Liko AB,
Lulea, Sweden,
REASON The swivel adapter which is
mounted directly above the slingbar's split center bolt could be removed and
allow the slingbar to be improperly mounted directly into the aluminum link arm.
This could cause an unsafe transfer. Patient may fall.
VOLUME OF PRODUCT
IN COMMERCE 54 lifts
DISTRIBUTION IL, MA, MO, PA and TN
PRODUCT Synthes Resorbable
Fixation Systems Resorbable Taps and Screws. Intended for use in fracture repair
and reconstructive procedures of the craniofacial skeleton,
CODE
Product, Catalog #, Lot #, Expiration Date 1.5MM
resorbable cortex screw 3MM-sterile, 800.603.10S, 1373642, 07/2009; 1.5MM
resorbable cortex screw 3MM-sterile, 800.603.20S, 1372400, 07/2009; 1.5MM
resorbable cortex screw 4MM-sterile, 800.604.02S, 1384887, 08/2009; 1.5MM
resorbable cortex screw 4MM-sterile, 800.604.02S, 1393224, 09/2009; 1.5MM
resorbable cortex screw 4MM-sterile, 800.604.04S, 2162367, 10/2009; 1.5MM
resorbable cortex screw 4MM-sterile, 800.604.04S, 2175547, 01/2010; 1.5MM
resorbable cortex screw 4MM-sterile, 800.604.04S, 2183488, 02/2010; 1.5MM
resorbable cortex screw 4MM-sterile, 800.604.10S, 1371226, 07/2009; 1.5MM
resorbable cortex screw 4MM-sterile, 800.604.20S, 1371227, 07/2009; 1.5MM
resorbable cortex screw 5MM-sterile, 800.605.10S, 1372687, 07/2009; 1.5MM
resorbable cortex screw 6MM-sterile, 800.606.10S, 1373640, 07/2009; 1.5MM
resorbable tack 4MM-sterile, 800.614.04S, 1384577, 08/2009; 1.5MM resorbable
tack 4MM-sterile, 800.614.04S, 1387942, 09/2009; 1.5MM resorbable tack
4MM-sterile, 800.614.10S, 1373751, 07/2009; 2.0MM resorbable cortex screw
4MM-sterile, 801.004.10S, 1374122, 07/2009; 2.0MM resorbable cortex screw
6MM-sterile, 801.006.04S, 2162368, 10/2009; 2.0MM resorbable cortex screw
6MM-sterile, 801.006.04S, 2184323, 02/2010; 2.0MM resorbable cortex screw
6MM-sterile, 801.006.10S, 1374135, 07/2009; 2.5MM resorbable emergency screw
8MM-sterile, 801.048.02S, 1384578, 8/2009; 1.5MM rapid resorbable cortex screw
3MM-sterile, 805.603.04S, 1384602, 08/2009; 1.5MM rapid resorbable cortex screw
3MM-sterile, 805.603.04S, 1393219, 09/2009; 1.5MM rapid resorbable cortex screw
3MM-sterile, 805.603.10S, 1372401, 07/2009; 1.5MM rapid resorbable cortex screw
3MM-sterile, 805.603.10S, 1376216, 08/2009; 1.5MM rapid resorbable cortex screw
3MM-sterile, 805.603.10S, 1377498, 08/2009; 1.5MM rapid resorbable cortex screw
3MM-sterile, 805.603.20S, 1372402, 07/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.02S, 2169297, 12/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.02S, 2180984, 02/2010; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.04S, 1384597, 08/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.04S, 1384598, 08/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.04S, 1384599, 08/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.04S, 1392087, 09/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.04S, 1392088, 09/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.04S, 1393230, 09/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.04S, 2162401, 10/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.04S, 2163458, 10/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.04S, 2163459, 10/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.04S, 2164282, 10/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.04S, 2167890, 10/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.04S, 2169299, 12/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.04S, 2175554, 01/2010; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.04S, 2175801, 01/2010; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.10S, 1370038, 07/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.10S, 1370040, 07/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.10S, 1370041, 07/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.10S, 1375932, 07/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.10S, 1375933, 07/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.10S, 1376307, 07/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.10S, 1377501, 07/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.10S, 1377502, 08/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.10S, 1380682, 08/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.10S, 1385761, 08/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.10S, 1385763, 08/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.10S, 1385764, 08/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.10S, 1385780, 08/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.10S, 1388207, 09/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.10S, 1390841, 09/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.10S, 1392090, 09/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.10S, 1393233, 09/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.10S, 1393234, 09/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.20S, 1370039, 07/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.20S, 1376219, 08/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.20S, 1377503, 08/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.20S, 1378428, 08/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.20S, 1383881, 08/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.20S, 1390843, 09/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.20S, 1392089, 09/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.20S, 2167288, 11/2009; 1.5MM rapid resorbable cortex screw
4MM-sterile, 805.604.20S, 2181842, 02/2010; 1.5MM rapid resorbable cortex screw
5MM-sterile, 805.605.04S, 1384604, 08/2009; 1.5MM rapid resorbable cortex screw
5MM-sterile, 805.605.04S, 1392091, 09/2009; 1.5MM rapid resorbable cortex screw
5MM-sterile, 805.605.04S, 2167289, 11/2009; 1.5MM rapid resorbable cortex screw
5MM-sterile, 805.605.10S, 1374134, 07/2009; 1.5MM rapid resorbable cortex screw
5MM-sterile, 805.605.10S, 2175551, 01/2010; 1.5MM rapid resorbable cortex screw
6MM-sterile, 805.606.02S, 1393239, 09/2009; 1.5MM rapid resorbable cortex screw
6MM-sterile, 805.606.02S, 2181849, 02/2010; 1.5MM rapid resorbable cortex screw
6MM-sterile, 805.606.04S, 2164288, 10/2010; 1.5MM rapid resorbable cortex screw
6MM-sterile, 805.606.10S, 1373641, 07/2009; 1.5MM rapid resorbable cortex screw
6MM-sterile, 805.606.10S, 2167291, 11/2009; 1.5MM rapid resorbable cortex screw
8MM-sterile, 805.608.02S, 2171103, 12/2009; 1.5MM rapid resorbable cortex screw
8MM-sterile, 805.608.04S, 2175552, 01/2010; 1.5MM rapid resorbable tack
4MM-sterile, 805.614.04S, 1387950, 09/2009; 1.5MM rapid resorbable tack
4MM-sterile, 805.614.10S, 2165696, 11/2009; 2.0MM rapid resorbable cortex screw
4MM-sterile, 806.004.04S, 2160255, 09/2009; 2.0MM rapid resorbable cortex screw
4MM-sterile, 806.004.04S, 2160256, 09/2009; 2.0MM rapid resorbable cortex screw
4MM-sterile, 806.004.10S, 1374125, 07/2009; 2.0MM rapid resorbable cortex screw
4MM-sterile, 806.004.10S, 1377504, 08/2009; 2.0MM rapid resorbable cortex screw
6MM-sterile, 806.006.02S, 2167290, 11/2009; 2.0MM rapid resorbable cortex screw
6MM-sterile, 806.006.04S, 1384596, 08/2009; 2.0MM rapid resorbable cortex screw
6MM-sterile, 806.006.04S, 1388815, 09/2009; 2.0MM rapid resorbable cortex screw
6MM-sterile, 806.006.04S, 1385773, 08/2009; 2.0MM rapid resorbable cortex screw
6MM-sterile, 806.006.04S, 1388795, 09/2009; 2.0MM rapid resorbable cortex screw
6MM-sterile, 806.006.10S, 1374136, 07/2009; 2.5MM rapid resorbable emergency
screw 4MM-sterile, 806.044.02S, 1392093, 09/2009; 2.5MM rapid resorbable
emergency screw 6MM-sterile, 806.046.02S, 2163371, 10/2009
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Synthes USA, West Chester, PA
Manufacturer:
Synthes GmbH, Switzerland,
REASON Integrity of outer mylar pouch could be
compromised, possibly rendering the exterior of the inner foil pouch unsterile.
VOLUME OF PRODUCT IN COMMERCE
3,511
systems
DISTRIBUTION Nationwide and Canada
PRODUCT
a) Somatom CT System
Emotion 16, model number 7734713. Computed tomography x-ray system,
b) Somatom CT System Emotion 16, model number 7393114. Computed
tomography x-ray system,
c) Somatom CT System
Sensation 40, model number 8874427 and Sensation 64, model number 8377520.
Computed tomography x-ray system,
d) Somatom CT
System Sensation Open, model number 8872017. Computed tomography x-ray system,
CODE
a) Serial numbers: 39049, 39050,
39012, 39015 and 39077;
b) Serial numbers: 50693, 51600, 51570, 50882 and
51573;
c) Serial numbers 57021, 57028, 57015, 57037, 57001, 57038, 57019 and
Serial numbers 54219, 54508, 54060, 54436, 54482, 54437, 54188, 54407, 54154, 54051, 54422, 54530, 54528, 54056, 54445, 54480, 54489, 54556,
54560, 54418, 54463, 54016, 54534, 54404, 54064, 54488, 54269, 54416, 54529, 54305 and 54210;
d) Serial numbers: 49208, 49311, 49207,49307 and
49330
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens
Medical Solutions USA, Inc, Malvern, PA
Manufacturer: Seimens Medical Solutions,
Forchheim, Germany
REASON When using the LungCare
feature in the SOMATOM CT Systems some marks made on CT images may not be
saved.
VOLUME OF PRODUCT IN COMMERCE 53
units
DISTRIBUTION Nationwide
PRODUCT Somatom Sensation CT
Systems, Sensation 10, model number 7543015,
Sensation 16, model number
7393114, Sensation 64, model number 8377520, and
Sensation Open model number
8872017
CODE Software versions CT2006A and
CT2006G
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens
Medical Solutions USA, Inc, Malvern, PA,
Manufacturer: Siemens
Medical Solutions, Forchheim, Germany,
REASON Firm became aware of a potential problem that could
affect scan results and require patient exam to be repeated when using the
customized ECG-gated scan protocols in the CT2006A and CT2006G software of their
SOMAtOM Sensation CT Systems.
VOLUME OF PRODUCT IN COMMERCE 86
units
DISTRIBUTION Nationwide
PRODUCT FAST-FIX AB Curved Needle
Delivery System, Used for meniscal repair. Product Number: 7209399
CODE
Lot numbers: 50141993, 50145519, 50146091, 50146096,
50146362, 50148283, 50146365, 50153066, and 50150381
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Andover, MA,
Manufacturer: Smith & Nephew, Inc,
Endoscopy Division, Mansfield, MA,
REASON The implant consists of a T1 and T2 anchor which
are joined together by a suture. The T2 portion of the implant may not advance
into the deployment position preventing deployment of the T2
anchor.
VOLUME OF PRODUCT IN COMMERCE 1,800
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) Locator-Wand Cover
that is sold in a shelf carton (unit packaging) separate to the sterile tray
containing and identified as PORT-A-CATH II Fluoro-Free, Venous Access
System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4653-24.
Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow Polyurethane
Catheter with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer
Cap, 20G PORT-A-CATH needle, 18G Blunt Needle,
20G GRIPPER PLUS Non-Coring
Safety needle, 18G Extra Thin Wall Introducer Needle, 6 Fr Introducer, 2
''J'' Guidewires, Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3
Point-Lok Sharps Safety Devices, Product Information.
EtO Sterilized. Single Use, Re-order number 21-4653-24,
b) Locator-Wand Cover that is sold in a shelf carton (unit
packaging) separate to the sterile tray containing and identified as PORT-A-CATH II
Fluoro-Free, Venous Access System, PolyFlow Polyurethane
Catheter, 2.6mm O.D. tray. REF 21-4655-24. Contents: Portal with ULTRA-LOCK
Connector, Radiopaque PolyFlow Polyurethane Catheter with CATH-FINDER Sensor
Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 16G
Blunt Needle,
20G GRIPPER PLUS Non-Coring Safety needle, 18G Extra Thin Wall
Introducer Needle, 8.5 Fr Introducer, ''J'' Guidewire, Syringes, Vein Pick,
Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-Lok Sharps Safety
Devices, Product Information. EtO Sterilized. Single Use. Re-order Number
21-4655-24,
c) Locator-Wand Cover that is sold in a
shelf carton (unit packaging) separate to the sterile tray containing and
identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access System,
PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4672-24. Contents:
Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow Polyurethane Catheter
5.8Fr withCATH-FINDER Sensor Wire, Locator-Wand cover, Luer Cap, 20G PORT-A-CATH needle, 18G Blunt Needle, Vein Pick,
Point-Lok Sharps Safety
Device, Product Information. EtO Sterilized. Single Use. Re-order Number
21-4672-24,
d) Locator-Wand Cover that is sold in a
shelf carton (unit packaging) separate to the sterile tray containing and
identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access System,
PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4673-24. Contents:
Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow Polyurethane Catheter
with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer Cap, 20G
PORT-A-CATH
needle, 18G Blunt Needle, 20G GRIPPER PLUS Non-Coring Safety
needle, 18G Extra Thin Wall Introducer Needle, 6 Fr Introducer, 2 ''J''
Guidewires, 2 Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH
needle, 3 Point-Lok Sharps Safety Devices, Product Information. EtO
Sterilized. Single Use. Re-order number 21-4673-24,
e) Locator-Wand Cover that is sold in a shelf carton (unit
packaging) separate to the sterile tray containing and identified as PORT-A-CATH II
Fluoro-Free, Low Profile Venous Access System, PolyFlow
Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4683-24. Contents: Portal
with ULTRA-LOCK Connector, Radiopaque PolyFlow Polyurethane Catheter with CATH-FINDER Sensor
Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle,
18G Blunt Needle, 20G GRIPPER PLUS Non-Coring Safety
needle, 18G Extra Thin Wall Introducer Needle, 6 Fr Introducer, 2 ''J''
Guidewires, Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH
needle, 3 Point-Lok Sharps Safety Devices, Product Information. EtO
Sterilized. Single Use. Re-order number 21-4683-24,
f) Locator-Wand Cover that is sold in a shelf carton (unit packaging)
separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free,
Low Profile Venous Access System, PolyFlow Polyurethane
Catheter, 2.6mm O.D. tray. REF 21-4685-24. Contents: Portal with ULTRA-LOCK
Connector, Radiopaque PolyFlow Polyurethane Catheter with CATH-FINDER Sensor
Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle,
16G Blunt Needle, 20G GRIPPER PLUS Non-Coring Safety needle, 18G Extra Thin Wall Introducer Needle, 8.5 Fr Introducer, 2 ''J''
Guidewires,
Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-Lok
Sharps Safety Devices, Product Information. EtO Sterilized. Single
Use. Re-order number 21-4685-24,
g) Locator-Wand Cover
that is sold in a shelf carton (unit packaging) separate to the sterile tray
containing and identified as PORT-A-CATH P.A.S. PORT Elite Fluoro-Free,
Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF
21-4690-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow
Polyurethane Catheter 5.8Fr with CATH-FINDER Sensor Wire, Locator-Wand
cover, Luer Cap, 20G PORT-A-CATH needle, 18G Blunt Needle, Vein Pick, Point-Lok Sharps Safety Device, Product Information. EtO
Sterilized. Single
Use. Re-order number 21-4690-24,
h) Locator-Wand Cover
that is sold in a shelf carton (unit packaging) separate to the sterile tray
containing and identified as PORT-A-CATH II Dual-lumen Fluoro-Free Venous
Access System, Dual Lumen Silicone Catheter, 3.4mm O.D. tray. REF
21-8652-24. Contents: Dual-lumen Portal with WING-LOCK Connector, Radiopaque
Dual-lumen PolyFlow Polyurethane Catheter, 10.2 Fr
with CATH-FINDER Sensor
Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 18G
Blunt Needle, Vein Pick, 2 GRIPPER PLUS Non-Coring Safety needles 20G, 20G
90-degree PORT-A-CATH needle, 18G Extra Thin Wall Introducer Needle, 11 Fr
Introducer, ''J'' Guidewire, Syringes, Tunneling Tool, 3 Point-Lok Sharps
Safety Devices, Product Information. EtO Sterilized. Single Use. Re-order
number 21-8652-24,
CODE
a) Lot numbers: M42229,
M42693, M42899, M43378;
b) Lot numbers M42087, M43079;
c) Lot numbers:
M41277, M42230,
d) Lot number: M41249;
e) Lot numbers: M41020, M41851,
M42231, M42434, M42880, M43365;
f) Lot number M42679;
g) Lot number
M41399;
h) Lot number M40376
RECALLING FIRM/MANUFACTURER Smiths
Medical MD, Inc, Saint Paul, MN,
REASON One lot of Locator-Wand Cover sterile
pouches may have an insufficient seal and product sterility could be
compromised. The Locator-Wand Cover is supplied with the PORT-A-CATH II AND
P.A.S. PORT systems. The packaged Wand-Cover is placed on the outside of the
PORT-A-CATH II AND P.A.S. PORT tray.
VOLUME OF PRODUCT IN
COMMERCE 1,048 trays
DISTRIBUTION Nationwide and
International
PRODUCT AXIOM Artis X-ray systems
running software versions VB11K and VB22-G, AXIOM Artis FC model number 5904433,
AXIOM Artis BC model number 5904649, AXIOM Artis MP model number 5904466, AXIOM
Artis FA model number 5904441, AXIOM Artis BA model number 5904656, AXIOM Artis
TC model number 7728350, AXIOM Artis TA model number 7007755, AXIOM Artis dFC
model number 7412807, AXIOM Artis dFC-MN model number 7727717, AXIOM Artis dBC
model number 7728392, AXIOM Artis dTC model number 7413078, AXIOM Artis dFA
model number 7555373, AXIOM Artis dBA model number 7555357, AXIOM Artis dTA
model number 7008605, AXIOM Artis dMP model number 7555365.
CODE Software versions VB11K and VB22-G
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA,
Inc, Malvern, PA,
Manufacturer: Siemens
Medical Solutions, Forchheim, Germany
REASON The recalling firm became aware of a potential
problem when imaging patients on their stomach on the AXIOM Artis X-ray Systems
running software versions VB11K and VB22G. In some instances, the orientation
labels could be incorrect.
VOLUME OF PRODUCT IN COMMERCE 287
units
DISTRIBUTION Nationwide
PRODUCT Macan Model MC-4A Dental
Electrosurgical Unit,
CODE Serial numbers 7001
to 7456
RECALLING FIRM/MANUFACTURER Macan Engineering and
Manufacturing Co
REASON The product label
fails to warn users to use the device on patients with shielded pacemakers
only.
VOLUME OF PRODUCT IN COMMERCE 455
units
DISTRIBUTION Nationwide and Canada
PRODUCT MX6160R1, Custom CIPER
(Comprehensive Intracranial Presssure Evaluation and Relief) System. The product
is packaged in a tyvek pouch and is sold sterile. The product is labeled on the
tyvek pouch with a stick-on label that reads in part ,''medex Dublin, OH 43016
USA***STERILE**MX6160R1 ** Custom CIPER**Lot #:**Latex Free***SINGLE USE'', CODE
All Lot codes listed as follows are
affected: 30K200116, 31A160060, 31A250027, 31B280077, 31E160051,31H030002,
31I140023, 31J050052,31J250065, 32C070041, 32I050037, 32K250019, 33A300046,
33C170028, 33E290076, 33H220008, 3L170057, 34B16D038, 34B26D062, 34E05D055,
34F09D079, 34H05D023, 34H25D034, 34T17D091,34J14D021, 34L16D040
RECALLING
FIRM/MANUFACTURER Medex, Inc, Dublin, OH
REASON The product is
labeled as 'Latex Free'; however, one of the components of the finished product
may contain latex.
VOLUME OF PRODUCT IN COMMERCE 2,480
devices
DISTRIBUTION AL
PRODUCT MX441B, CVP Manometer.
The product is packaged in a cardboard box. The units are packed ten (10) per
case. The product is labeled on the outer case with a stick-on label that reads
in part, ''**STERILE***MX441B CVP Manometer**Lot#***Latex Free'',
CODE
All of the following lot codes are affected: Lot
Numbers: 30J030048, 30K150054, 31A030144, 31b120110, 31B355998, 31C190086,
31c260053, 31D300042, 31F80073, 31I240006, 31J220068, 32C250072, 32H050182,
32K050108, 33f030089, 33G210028, 33J270026, 34C01D100, 34G01D063, 35A04D101,
35A31D040, 35C29D125
RECALLING FIRM/MANUFACTURER Medex, Inc,
Dublin, OH
REASON The product is labeled as 'Latex Free' ,
however,one of the components of the finished product may contain
latex.
VOLUME OF PRODUCT IN COMMERCE 6,910
devices
DISTRIBUTION Nationwide and Canada
PRODUCT
a) TII0002 Implant Tube,
Implant Tube, Intralumenal(HDR), 10CM Drawdown
130CM Body, Sealed End, Cable
Insert & Gold Seed, Disposable,
b) VariSource AL
13199023 Implant Tube, Tongue/Soft Tissue, Puthawala/Syed:28cm Leader,
85cm
Body, 15cm Draw-Down, Cable Insert, & Nylon Retaining Buttons: 20/PKG,
c) TIT0001-003, Implant Tube, Tongue/Soft Tissue,
Puthawala/Syed:28cm Leader,
85cm Body, 15cm Draw-Down, Cable Insert, &
Nylon Retaining Buttons,
d) VariSource AL 13199024,
Implant Tube, Implant Tube, Intralumenal(HDR),
10CM Drawdown 130CM Body,
Sealed End, Cable Insert & Gold Seed, Disposable,
e) KCV0008-001, AOS Intralumenal Kit: Intralumenal Implant Tubes
(5EA),
f) VariSource AL 13197000, Tongue/Soft Tissue Kit
g) KTV0006-002, AOS Tongue And Soft Tissue Kit: AOS
Tngue And Soft Tissue
Inplant Tubes (20EA); 20CM S.S. Implant Needles, 14
Degrees (20EA),
h) VariSource AL13198000,
Intralumenal Kit,
CODE All lots
RECALLING
FIRM/MANUFACTURER Alpha Omega Services, Inc, Bellflower, CA
REASON
There is a possibility that the diameter of the
catheter does not meet specifications. As a result it may not be possible to
correctly connect the catheter to a VariSource Quick Connect. This would prevent
any treatment. Furthermore, since the problem would not be apparent until after
the catheter has been implanted an unnecessary surgical implantation procedure
would have taken place.
VOLUME OF PRODUCT IN COMMERCE 1,829
devices
DISTRIBUTION Nationwide and Internationally
PRODUCT CALM software. This
software is intended for use as a central monitoring system with signal analysis
and remote repeaters in the perinatal clinical environment. It interfaces with
standard fetal and maternal monitors and provides fetal surveillance, monitoring
of labor progress, charting, reporting and data analysis, display and archiving
functions,
CODE Software version
02.09.01
RECALLING FIRM/MANUFACTURER LMS Medical Systems Ltd,
Montreal, Canada
REASON A
deficiency in the software code can, in certain circumstances, cause data for
the wrong patient to be displayed in the Tracing Review screen when a user is
acknowledging an Alert.
VOLUME OF PRODUCT IN COMMERCE 8
units
DISTRIBUTION AL, IL, MD, NH, OH and Canada
PRODUCT
Keramos
Ceramic-on-Ceramic Acetabular System, Porous titanium flared rim acetabular
shell with three clustered holes in even sizes from 48 to 66mm, a hip prosthesis
component. The lot number on the product labeling is the unique identifier of
this component,
CODE Lot numbers: 276202 and
270512
RECALLING FIRM/MANUFACTURER Encore Medical, Lp, Austin, TX
REASON
Voids in the porous coating of a component used in
total hip replacement surgery.
VOLUME OF PRODUCT IN COMMERCE 30
units
DISTRIBUTION Nationwide
Respironics Issues Worldwide Recall of PLV® Continuum™ Ventilator
Respironics, Inc. announced that it has recalled 269 ventilators representing all models and serial numbers of the PLV® Continuum™ Ventilator. This recall is being conducted because the ventilator may suddenly stop providing mechanical ventilation. This could result in serious injury or death. The recalled ventilators should not be used until the problem is corrected. Customers have been directed to quarantine all PLV Continuum Ventilators and to use other ventilator models. If a customer does not have a suitable substitute ventilator, Respironics will loan them a comparable unit.
The PLV Continuum Ventilator is used to provide mechanical ventilation for pediatric and adult patients who weigh at least 5 kg (11 lbs.). The device is intended for use at home, in an institution, or as a portable ventilator. These ventilators have been distributed in the United States, Australia, Argentina, Canada, Japan, Hong Kong, Netherlands, Saudi Arabia, and Taiwan. Respironics provided notification of the recall to distributors, sales personnel, and customers by letter on March 20, 2006. The firm is continuing to contact customers to arrange for the return of all the recalled ventilators.
Customers with questions may contact the Company at 877-544-9252.
WEEK ENDING MAY 13
PRODUCT Ventilator-PLV Continuum
(PLVC I), Model Number: P1000. The PLVC I is a microprocessor controlled,
compressor-based, mechanical ventilator. It is intended to control or assist
breathing by delivering room air to the patient. It utilizes an internal
compressor to generate compressed air for delivery to the patient. Breath
delivery is controlled by software algorithms. The PLVC I user interface has a
membrane keypad with indicator Light Emitting Diodes for the selection and
acceptance of patient settings and for the display of alarm conditions. PLVC I
provides the following types of ventilatory support: 1) Positive Pressure
Ventilation, delivered either invasively (via endotracheal or tracheostomy tube)
or non-invasively (via mask or mouthpiece ). 2) Assist/Control, Spontaneous
Intermittent Mandatory Ventilation (SIMV)or Continuous Positive Airway Pressure
(CPAP) modes of ventilation. 3) Volume-Controlled (VC). Available in AlC and
SIMV. 4) Pressure-Controlled (PC). Available in AlC and SIMV. 5) Pressure
Support (PS). Available in SIMV and SPONT,
CODE VS4702502, VS4700835, VS4700809, VS4700653,
VS4700833, VS4700819, VS4700580, VS4700776,VS4700554, VS4700754, VS4702535,
VS4702512, VS4702523, VS4702556, VS4702568, VS4700608, VS4700729, VS4700760,
VS4700620, VS4702586, VS4702677, VS4702750, VS4702784, VS4702848, VS4700773,
VS4700852, VS4700549, VS4700552, VS4700555, VS4700569, VS4700643, VS4700681,
VS4700718, VS4700823, VS4700836, VS4702776, VS4700802, VS4700588, VS4700789,
VS4700849, VS4700622, VS4700642, VS4702604, VS4700687, VS4700838, VS4702528,
VS4702545, VS4700663, VS4700694, VS4700725, VS4700822, VS4700853, VS4702572,
VS4700624, VS4700738, VS4702553, VS4702570, VS4700566, VS4700578, VS4702591,
VS4700558, VS4700615, VS4702800, VS4702505, VS4700783, VS4700791, VS4700821,
VS4702580, VS4700774, VS4702589, VS4700834, VS4700840, VS4700596, VS4700785,
VS4700846, VS4702501, VS4702519, VS4702548, VS4700786, VS4702650, VS4702590,
VS4700565, VS4702525, VS4702557, VS4702574, VS4700767, VS4700721, VS4702594,
VS4702709, VS4700724, VS4700814, VS4702573, VS4700824, VS4700536, VS4700574,
VS4700585, VS4700595, VS4700625, VS4700698, VS4700736, VS4700744, VS4700827,
VS4700855, VS4702555, VS4702575, VS4700842, VS4700790, VS4700544, VS4702552,
VS4702567, VS4702571, VS4700843, VS4702566, VS4700650, VS4700811, VS4700817,
VS4700850, VS4702857, VS4700635, VS4700796, VS4700816, VS4700649, VS4702689,
VS4702583, VS4702981, VS4702551, VS4702532, VS4702543, VS4702599, VS4700708,
VS4702600, VS4702811, VS4700770, VS4702623, VS4700673, VS4700617, VS4700539,
VS4700548, VS4700646, VS4700660, VS4700739, VS4700590, VS4700577, VS4702859,
VS4700782, VS4700780, VS4700614, VS4702647, VS4702805, VS4700813, VS4702688,
VS4700844, VS4700607, VS4700847, VS4700841, VS4702809. INTERNATIONAL
DISTRIBUTION: VS4700553, VS4700628, VS4700645, VS4700717, VS4702915,
VS4702962, VS4703006, VS4703023, VS4703041, VS4703056, VS4703064, VS4702500,
VS4702828, VS4702858, VS4700792, VS4702605, VS4702608, VS4702609, VS4702631,
VS4702632, VS4702634, VS4702642, VS4702643, VS4702659, VS4702719, VS4702754,
VS4702759, VS4702722, VS4700696, VS4700601, VS4700563, VS4700644, VS4700839,
VS4702645, VS4703027
RECALLING FIRM/MANUFACTURER Respironics
California Inc., Carlsbad, CA
REASON Flow valve failures- When failure occurs,
air flow from the ventilator ceases resulting in the PLVC I transitioning into a
'Vent Inop' mode whereby the safety valve is activated, opening the circuit to
ambient air. Ventilator dependent patients may not receive adequate ventilatory
support if this problem occurs.
VOLUME OF PRODUCT IN COMMERCE 191
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) Haemonetics Cell Saver
5 Autologous Blood Recovery System Model Numbr: LN02005-110-E.
b) Haemonetics Cell Saver 5+ Autologous Blood Recovery System
Model Number: LN02005-110EP,
CODE
a) Serial
Numbers: 94H180CD-1; 95A048CS; 95J177CS;
b) Serial Numbers: 05F022-1;
05F023-1; 05H103; 05C083-05C084;
05C087-05C089;05D006-05D011;05D037--05D040;
05D043-05D047;
05D060-05D068;05D080--05D081; 05D085-05D089;
05E026-05E035;05E054-1;
05E055-1; 05E056; 05E061-05E070; 05E091-05E095;
05F021; 05F066-05F072;
05F098-05F107; 05F142-05F144; 05F147; 05F149; 05F150;
05F157-05F159;
05G008-1; 05G009-05G012; 05G035-05G037; 05G038-1; 05G055-1;
05G057-
05G059; 05G080-05G084; 05H018; 05H022; 05H024- 05H027; 05H073-05H077;
05H100-05H101; 05H104; 05H163; 05J185-05J189; 05K011-05K013; 05K015-
05K017; 05K092-05K096; 05K168-05K173; 05K175; 05K201
RECALLING
FIRM/MANUFACTURER Haemonetics Corporation, Braintree, MA
REASON Device
emits radiofrequency which exceeds the IEC 60601-1-2 International
Standard
VOLUME OF PRODUCT IN COMMERCE 160
devices
DISTRIBUTION Nationwide
PRODUCT Hobbs Medical 3 Prong
Looped Retriever, a disposable device to be used by physician to remove foreign
object or cauterize polyp specimens from the GI tract. REF: 5030 and 5030S,
CODE
Lot Numbers: H11-05-040; H11-05-138;
H11-05-139; H11-05-140; H11-05-141; H11-05-205.
RECALLING
FIRM/MANUFACTURER Hobbs Medical, Inc., Stafford Springs, CT
REASON
Diameter
of device at the distal end would prevent it from passing through the
endoscope's working channel.
VOLUME OF PRODUCT IN COMMERCE 254
units
DISTRIBUTION AK, IA, KY, MI, NH, NC, UT, WI, Canada, and
UK
PRODUCT
a) Guidant CONTAK RENEWAL
3 (models H170, H175) CONTAK RENEWAL 3 HE
(models H177, H179) Cardiac
Resynchronization Therapy Defibrillator (CRT-D).
Sterile EO. Cardiac
resynchronization therapy defibrillators (CRT-D) provide
ventricular
tachyarrhythmia and cardiac resynchronization therapies. Ventricular
tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT)
and
ventricular fibrillation (VF), rhythms that are associated with sudden
cardiac death
(SCD). Cardiac resynchronization therapy is for the treatment
of heart failure (HF) and
uses biventricular electrical stimulation to
synchronize ventricular contractions.
Cardioversion/defibrillation therapies
include a range of low-and high-energy shocks
using either a biphasic or
monophasic waveform,
b) Guidant CONTAK RENEWAL 4 (models
H190, H195) CONTAK RENEWAL; 4 HE
(model H197). Cardiac Resynchronization
Therapy Defibrillator (CRT-D). Sterile EO.
Cardiac resynchronization therapy
defibrillators (CRT-D) provide ventricular
tachyarrhythmia and cardiac
resynchronization therapies. Ventricular tachyarrhythmia
therapy is for the
treatment of ventricular tachycardia (VT) and ventricular fibrillation
(VF),
rhythms that are associated with sudden cardiac death (SCD). Cardiac
resynchronization therapy is for the treatment of heart failure (HF) and
uses
biventricular electrical stimulation to synchronize ventricular
contractions.
Cardioversion/defibrillation therapies include a range of
low-and high-energy shocks
using either a biphasic or monophasic waveform,
c) Guidant CONTAK RENEWAL 4 AVT (model M170). Cardiac
Resynchronization
Therapy Defibrillator (CRT-D). Sterile EO. Cardiac
resynchronization therapy
defibrillators (CRT-D) provide both atrial and
ventricular tachyarrhythmia and cardiac
resynchronization therapies.
Ventricular tachyarrhythmia therapy is for the treatment
of ventricular
tachycardia (VT) and ventricular fibrillation (VF), rhythms that are
associated with sudden cardiac death (SCD). Atrial tachyarrhythmia therapy
is for the
treatment of supraventricular tachycardia (SVT) and atrial
fibrillation (AF). Cardiac
resynchronization therapy is for the treatment of
heart failure (HF) and uses
biventricular electrical stimulation to
synchronize ventricular contractions. This device
also uses
accelerometer-based adaptive-rate bradycardia therapy.
Cardioversion/defibrillation therapies include a range of low-and
high-energy shocks
using either a biphasic or monophasic waveform,
d) Guidant VITALITY HE Implantable Cardioverter Defibrillator
(model T180). Sterile
EO. This ICD is designed to detect and terminate
ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide
bradycardia therapy (atrial and ventricular pacing). Therapies include both low-
and high-energy shocks using either a biphasic or monophasic waveform.
Bradycardia pacing, including adaptive-rate features, is available to detect and
treat bradyarrhythmias and to support the cardiac rhythm after defibrillation
therapy. The device offers dual-chamber bradycardia features (atrial and/or
ventricular pacing and sensing),
CODE
a) Model
H170, serial numbers: 364406, 364446, 364542, 364576, 364582, 364586, 364587,
364590, 364591, 364593, 364595, 364596, 364597, 364599, 364600, 364601,
364602, 364604, 364605, 364606, 364607, 364608, 364609, 364611, 364613,
364615, 364623, 364625, 364632, 364633, 364634, 364636, 364643, 364680,
364732, 364735, 364752.
Model H175, serial numbers: 315437, 315438, 315452,
315454, 315455, 315456, 315461, 315462, 315464, 315470, 315473, 315480,
315482, 315489, 315496, 315497, 315500, 315580, 315588, 315605. Model
H177, serial number: 285055, Model H179 serial numbers: 114267, 114268,
114269, 114270, 114271, 114280, 114470;
b) Model H190, serial numbers:
311739, 311740, 311742, 311743, 311744, 311745,
311747, 311748, 311751,
311769, 311811, 311834, 311850, 311852, 311853, 311884, 311895, 311900, Model H195 serial number: 353166.
Model H197, serial number:
310331;
c) Serial numbers: 200099, 200103, 200104;
d) Serial numbers:
204707, 204711, 204751, 204754, 204908
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Guidant Corporation, Saint Paul,
MN
Manufacturer:
Guidant-Ireland, Clomel, Ireland.
REASON 77 distributed devices may have a cracked layer of
insulation in a flexible hybrid circuit, leading to internal shorting during
charging such as during routine capacitor formation or for defibrillation. This
would likely render the device non-functional, resulting in no output and/or
telemetry communications.
VOLUME OF PRODUCT IN COMMERCE 77
devices
DISTRIBUTION Nationwide and Internationally
PRODUCT Medtronic Zinetics 24ME
Multi-Use External Reference pH Catheter. For Gastroesophageal pH Measurements.
Catalog number 9012P2121,
CODE Lot
0001491
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic
Gastroenterology/Urology, Shoreview, MN,
Manufacturer: Catheter & Disposal Technology, Plymouth, MN,
REASON
Lot 0001491 has a manufacturing
defect in the sensor spacing. Sensors have been placed 5 cm apart instead of 15
cm apart. Medtronic has determined that patient safety is not compromised.
Clinicians however should review and reassess the results of any patient studies
for which catheters from lot 0001491 were used.
VOLUME OF PRODUCT IN
COMMERCE 25 individual catheters
DISTRIBUTION MI, PA, and
TX
PRODUCT
a) RenalSoft
Observational Study v.2.0 - HD Module, PD Module and Medical
Record Module;
clinical data management software,
b) RenalSoft v.1.1 -
PD Module; clinical data management software,
c)
Renal Software Suite v.3.1 - HD Module; clinical data management software,
CODE
a) Version 2.0 - HD Modules, PD Modules
and Medical Record Modules only;
b) Version 1.1 - PD Module only;
c)
Version 3.1 - HD Module only
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Baxter Healthcare Renal Div., Mc Gaw Park, IL
Manufacturer: Baxter Healthcare Corporation, Largo, FL,
REASON
There are software anomalies present that
may increase the possibility of a medication error if the dialysis clinic
software is used to track, record, or coordinate the administration of
medications.
VOLUME OF PRODUCT IN COMMERCE 25 -- U.S., 157 -
International
DISTRIBUTION Nationwide and Internationally
PRODUCT Newton IQ 4 Lead Cycler
Set with stay-safe patient connectors, used for acute and chronic peritoneal
dialysis. Catalog Number: 050-87028
CODE Lot
Numbers: 5SR119; 52R124; 5SR125; 5SR149; 5SR150; 5SR173; 6AR014; 6AR015; 6AR032;
6AR044; 6AR045; 6AR055; 6AR069; 6AR085; 06AR086; 6AR267; 6AR280;6AR298;
6BR013;6BR031; 6BR040; 6BR043; 6BR064; 6BR075; 6BR091; 6BR092; 6BR110; 6BR127;
6BR141; 6BR281
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Fresenius Medical Care North America, Lexington, MA
Manufacturer: Erika De Reynosa S. A. de
C. V., Reynosa, Tamps, Mexico.
REASON Stay safe trigger body may not connect to the
extension set and result in associated peritonitis
VOLUME OF PRODUCT IN
COMMERCE 106,770 units
DISTRIBUTION Nationwide and
Canada
PRODUCT
a) 18F Tri-Funnel
Replacement Gastrostomy Tube, Product Code 000718,
b)
20F Tri-Funnel Replacement Gastrostomy Tube, Product Code 000720,
c) 22F Tri-Funnel Replacement Gastrostomy Tube, Product Code
000722,
d) 24F Tri-Funnel Replacement Gastrostomy
Tube, Product Code 000724
CODE
a) Lot
numbers: NGPL1892, NGPL2765;
b) Lot number: NGPL2270;
c) Lot number:
NGPL1161;
d) Lot numbers: NGPL2272, NGPL2556
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Bard Access Systems, Inc., Salt Lake
City, UT,
Manufacturer: Bard Medical, Nogales,
Sonora, Mexico.
REASON Packaging
for some gastrostomy tubes was labeled with incorrect balloon inflation data. An
underinflated balloon may cause misplacement, slippage or premature removal of
the tube. If an underinflated balloon allows the tube to be placed, or slip
into, the stomal tract and not the stomach, there is a risk of infusion of
fluids into the peritoneum. This carries the risk of infection.
VOLUME OF
PRODUCT IN COMMERCE 514 units
DISTRIBUTION Nationwide,
Canada, and Australia
PRODUCT Elasto-Gel Wound
Dressings, 3 product codes: Elasto-Gel Plus, Product DR8050, Elasto-Gel, DR
8000, and Elasto-Gel, DR 8000LV (for foreign distribution only), 4'' x 4'',
Sterile, each package contains 1 wound dressing, 5 packages per intermediate
box, 20 intermediate boxes (100 pkgs) per case,
CODE Lot 111004A, Lot 110904A., Lot
102504A
RECALLING FIRM/MANUFACTURER Southwest Technologies, Inc.,
N. Kansas City, MO, REASON The product is labeled as sterile and one of the
lots failed sterility during the quarterly radiation dose audit.
VOLUME OF
PRODUCT IN COMMERCE 174 cases
DISTRIBUTION Nationwide and
Belgium
PRODUCT Candela Laser VBeam
Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology,
Podiatry. Model Number: 9914-00-0300,
CODE Serial Number: SN 9998; 9914-0300-0001 through
9914-0300-0058
RECALLING FIRM/MANUFACTURER Candela Laser
Corporation, Wayland, MA
REASON Handle fires even when the finger is off the
switch.
VOLUME OF PRODUCT IN COMMERCE 59
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
IntraStent DoubleStrut LD
- Balloon Expandable Biliary Stent, Sterilized EO, ev3 4600 Nathan Lane North,
Plymouth, MN 55442-2920 USA. The IntraStent DoubleStrut LD Biliary Stent is a
balloon expandable stent. It is intended as a permanently implanted device. The
stent is made from a 316L stainless steel tube cut into an open lattice design.
It is designed to be crimped onto a non-compliant PTA balloon catheter that is
indicated for biliary stent expansion. After mounting onto a balloon catheter,
it is deployed and expanded by inflating the balloon. Model S15-36,
CODE
Lot number: 494438
RECALLING
FIRM/MANUFACTURER Ev3, Inc, Plymouth, MN
REASON IntraStent product S15-36 (P/N 90-1341-02) lot
494428 was labeled as IntraStent product S15-26 (P/N 90-1341-001). The stent is
10 mm longer than labeled.
VOLUME OF PRODUCT IN COMMERCE 6
devices
DISTRIBUTION AR, GA, IN, MA, TN, and UT
PRODUCT EL-aCL Anti-Cardiolipin
ELISA Kit; an in-vitro diagnostic anticardiolipin immunological test system; 192
tests per kit, Catalog #201-204,
CODE catalog
#201-204: kit lot 09055514, exp. 14-JUL-2006, serum diluent lot 09055546, exp
04-OCT-2006; and kit lot 12055603, exp. 09-NOV-2006, serum diluent lot 11055595,
exp. 18-NOV-2007
RECALLING FIRM/MANUFACTURER Thera Test
Laboratories, Inc., Lombard, IL,
REASON The specimen diluent contained in the kits was
contaminated with a fungal growth. Also, a portion of kit lot 09055514 was
shipped without the Data Sheet, part #201-204.
VOLUME OF PRODUCT IN
COMMERCE 53 kits
DISTRIBUTION CA, CT, MD, PA, OH, NJ and
FL
PRODUCT Straumann Narrow Neck (NN) Healing Cap with integral occlusal screw Height: 3.4mm Ref: 048.043,
CODE
Lot number: A3667
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Straumann Manufacturing, Inc, Andover, MA,
Manufacturer:
Straumann Ag Inst, Basel, Switzerland.
REASON The occlusal screw is inserted in the
bottom of the healing cap body rather than correctly through the
top.
VOLUME OF PRODUCT IN COMMERCE 103
units
DISTRIBUTION Nationwide
WEEK ENDING MAY 20
PRODUCT
a) Krupin Eye Valve, P/N
6003,
b) Glaucoma Aqueous Shunt, 209 mm, valved, P/N
EG209V,
c) Glaucoma Aqueous Shunt, 365 mm, valved, P/N
EG365V,
d) Valve-EV Glaucoma Ultra-Smooth, P/N 6006,
CODE
a) Serial numbers: 10671A through 10714A;
10807A through 10813A;
108866A through 10905A;
b) Serial numbers: 10727A,
10733A, 10734A, 10735A, 10736A, 10737A, 10744A,
10745A, 10746A, 10747A,
10748A, 10749A, 10750A, 10751A, 10794A, 107795A,
10796A, 10797A, 10798A,
10799A, 10806A, 11056A through 11101A, and 11443A
through 11456A;
c)
Serial numbers: 10744A through 10751A, 11042A through 11047A, 11511A, 11512A,
11518A, 11550A, 11551A, 11554A, 11556A, and 11559A;
d) Serial numbers:
11102A through 11107A
RECALLING FIRM/MANUFACTURER Eagle Vision,
Inc., Memphis, TN
REASON Products may have deformed valves which would cause
the valve not to close within the specified pressure tolerances.
VOLUME OF
PRODUCT IN COMMERCE 192 units
DISTRIBUTION Nationwide,
Canada, Columbia, Turkey, and The Netherlands
PRODUCT Medtronic (TiMesh),
Screwdriver, 1.5mm, Cruciate, Self Tapping Shaft, Catalog Number 8001215, The
8001215 Screwdriver is a stainless steel part designed for use with cruciate-style screws in the firm's TiMesh System. The product is sold in
non-sterile, single unit packages. They are re-usable, and autoclavable.
CODE
TV 59965, TV 59967
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Medtronic Neurosurgery, Goleta,
CA,
Manufacturer: Antrin
Enterprises, Inc, Ojai, CA.
REASON Medtronic Neurosurgery has initiated this action
because it was determined that two lots of the Modular Screwdriver Blade
components may exhibit burrs along the tips of the Screwdriver, which may
prevent adequate engagement with the associated screws.
VOLUME OF PRODUCT
IN COMMERCE 60 units
DISTRIBUTION FL, IL, NY, PA, and TN
PRODUCT
a) MD3 X-ray system,
b) MD4 X-ray system,
CODE
a) Site numbers 59515, 62374, 13546, 47128, 76329,
83654, 82673, 35471, 59524,
37977, 74051, 6648, X0344, 38442, 41032, 74007,
46926, 86146, 25949, 26086,
47033, 38922, 62458, 76085, 38714, 38716, X0972,
44865, 67609, 6847, 44814,
86568, 35445, 62392, 73923, 26071, 74032, 40941,
83047, 74026, 62444, 38422,
25923, 25945, X1198, 6546, 50317, 38289, 17669,
6536, 6931, X0917, 35403,
X0345, 38409, 6498, X0663, X1677, 44772, 49593,
73976, 46637, X0911, 26019,
26020, 26021, 13661, 38418, 6937, 74015, X0470,
50026, 37932, 37878, 73860,
X0791, 59571, 44760, 41462, 82721, 17467, 37907,
47045, X0660, 38266, X0855,
76213, 101151, 62502, 76388, 37935, X0056,
X0346;
b) Site numbers 52459, 38929, 41378, 20279385, 38783, 20279430, 83957,
82628,
83038, 13721, 85034, 80306, 38993, 84930, X1321, X1077, 44812,
100014, 50328,
17656, 83367, 38586, 76834, 87176, 41426, 82800, 10388,
41111, 17622, 13918,
84854, 102034, 38202, 52471, 76804, 50251, 44898,
13258, 86545, 38587,
20283876, 82688, 38635, 47160, 45042, 38917, 20278521,
86328, 13879, 41069,
76975, X1277, X1078, 76951, 84463, 76877, 13172, 38944,
41143, 85694, 87140,
59546, 13704, 45039, 20280426, 76869, 52455, 84892,
41271, 87302, 6842, 41031,
6825, X0662, 87030, 76808, 6838, 86218, 85491,
50340, 82687, 38912, 41287,
41000, 100700, 41439, 41156, 10458, 35484,
103056, X0934, 38501, 14099, 62938
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North
America Co. Phillips, Bothell, WA
Manufacturer: Philips Medical Systems, Best, Netherlands.
REASON
Potential for unexpected table
movement
VOLUME OF PRODUCT IN COMMERCE MD3- 93 units; MD4 -- 94
units
DISTRIBUTION Nationwide
PRODUCT Advantage CT/PET Fusion
for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2
software (Version 4.0, 4.1, or 4.2),
CODE 100943VP0, 67392II1, 36521VE3, 70827VE1,
419453BU6436332BU1, 70800VE8, 44586VE6, 341GE8, 97197VP8, 99813VP8, 97983VP1,
70820VE6, 58626VE3, 70795VE0, FRB3510J25, 58630VE5, 58624VE8, 58589VE3, 7823VE0,
44579VE1, 44597VE3, 44585VE8, 25125VE6, 425022BU1, 70796VE8, 93086VE7, 37621BU4,
76906VE7, 76899VE4, 70798VE4, 65504VE3, 65603VE3, 36543VE7, 58628VE9, 70811VE5,
44584VE1, 44581VE7, FRB3430VBM, 44589VE0, 44598VE1, 44582VE5, 44594VE0,
72740VE4, 1189GE0, 2030GE5, 2085GE0, 2025GE5, 72477II3, 72480II7, 343GE4,
97203VP4, 98272VP8, 423277BU3, 349GE1, 425018BU9, FRB3300M6G, 99699VP1,
98371VP8, 101216VP0, 425015BU5, 237GE8, 364GE0, 339GE2, 101196VP4, 419382BU7,
419383BU5, 366GE5, 367GE3, 357GE4, 2085GE9, 419457BU7, 25128VE0, 98436VP9,
99981VP3, 36513VE0, 98623UP2, 101000VP8, 2028GE9, 2799GE5, 1089GE2, 419450BU2,
101280VP6, 67269VE1, 100855VP6, 66250II2, 346GE7, 363GE2, 345GE9, 1073VP5,
101170VP9, 98516VP8, 2802GE7, 419356BU1, 66244II5, 1487GE8, 67389II7, 365GE7,
425021BU3, 383GE0, 25132VE2, 101334VP1, 95972VP6, 419449BU4, 2031GE3, 2800GE1,
36517VE1, FRB33605L9, 1024GE9, 95307VP5, 102235VP9, 102232VP6, 425204BU5,
1124GE7, 1122GE1, 419455BU1, 419456BU9, 102220VP1, 102555VP0, 97622VP5,
72249II6, 67210VE5, FRB33605KX, 419257BU1, 95268VP9, 338GE4, 101404VP2, 2090GE9,
2087GE5, 101308VP5, 101251VP7, 421989BU5, 342GE6, 99627VP2, 97933VP6, 98653VP9,
66249II4, 72479II9, 25126VE4, 356GE6, 25130VE6, 65450VE9, DE31500056, 347GE5,
421367BU4, 100912VP5, 25123VE1, 25124VE9, 99867VP4, DE24600031, 99910VP2,
101246VP7, 419357BU9, 101171VP7, 102825VP7, 100664VP2, 102856VP2, 424101BU4,
425020BU5, 354GE1, 36518VE9, 100885VP3, 2801GE9, USV41104ST, 2091GE7,
USV41103MJ, 99994VP6, 102133VP6, 419549BU1, 25137VE1, 102078VP3, 425351BU4,
1066GE0, 98816VP2, 97591VP2, 99631VP4, 423318BU5, 2086GE7, 97905VP4, 100690VP7,
350GE9, 25139VE7, 1120GE5, 100001VP7, 2084GE2, 391228BU4, 101190VP7, 99909VP4,
1123GE9, 2803GE5, 98474VP0, 25127VE2, 67384II8, 98815VP4, 101288VP9, 101287VP1,
66241II1, 25134VE8
RECALLING FIRM/MANUFACTURER
Recalling
Firm: General Electric Medical Systems LLC, Waukesha, WI
Manufacturer: General Electric Medical Systems,
SCS,
Bue Cedex, France.
REASON Display in fused mode- viewer allows 2 studies (
PET/CT) registered in the same spatial domain to be viewed simultaneously. These
2 images should be visually aligned to a precision of less than 1/2 PET Voxel. A
problem associated with this version of software may introduce a shift of up to
1.5 PET Voxels, which can be as much as 8 mm with certain zoom
factors.
VOLUME OF PRODUCT IN COMMERCE 199
units
DISTRIBUTION Nationwide and Internationally
PRODUCT CR DX-S, DX-S, Computed
radiography system (Digitizer), Software versions: STR1102B and below,
CODE
Serial numbers: SN10001-SN1079
RECALLING
FIRM/MANUFACTURER
Recalling Firm: AGFA Corporation, Greenville,
SC,
Manufacturer: AGFA, Mortsel, Belgium.
REASON Corrupted image after system
start; Corrupted image after workflow interruption; An erasure unit problem can
cause system to stop.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION DC, MS, OR
PRODUCT Convex Array Transducer
used with B-K Ultrasound Scanners, Model number: 8667,
CODE Serial Numbers: 1855380, 1855547, 1855548, 1856835,
1856837, 1857171, 1857173, 1857180, 1857427, 1857435, 1857515, 1857748, 1858482,
1858841, 1859751, 1859902, 1860250, 1860262, 1860487, 1860661, 1860858, 1861488,
1861580, 1861581, 1861823, 1861849, 1863084, 1863082
RECALLING
FIRM/MANUFACTURER
Recalling Firm: B K Medical Systems, Inc,
Wilmington, MA,
Manufacturer: B-K Medical
A/S, Herlev, Denmark.
REASON Due
to a problem with calibration, the device can produce up to 50% elevated
acoustic output and up to 2 degrees higher surface temperature.
VOLUME OF
PRODUCT IN COMMERCE 28 units
DISTRIBUTION Nationwide
PRODUCT Datex-Ohmeda S/5
Anesthesia Delivery Unit (ADU),
CODE 6025108
thru 6025111, 6025114 thru 6025117, 6025119, 6025120, 6025122 thru 6025128,
6025130 thru 6025132, 6025134, 6025136, 6025137, 6035737, 6035738, 6035740 thru
6035745, 6035747, 6035751, 6035757, 6035758, 6035760, 6035762, 6035765, 6035772
thru 6035774, 6035784, 6048756 thru 6048761, 6048764, 6048847, 6048849, 6048853
thru 6048856 and 40300736
RECALLING FIRM/MANUFACTURER GE
Healthcare, Madison, WI
REASON Alarm sound-It is possible that the
audible alarms from the speaker from the Datex-Ohmeda S/5 Anesthesia Delivery
Unit (ADU) machine may dampen or disappear as a result of normal handling of the
anesthesia machine. Visual alarms on the ADU are unaffected by this condition.
The dampening or absence of audible alarms on the ADU may result in a delay in
treatment.
VOLUME OF PRODUCT IN COMMERCE 113
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
Prolieve™ Thermodilatation® Kit, consisting of a Prolieve Thermodilatation Catheter,
Prolieve Heat Exchanger cartridge and 500 ml bag of sterile water, Catalog #
880-8023, Material Number M0068808023,
CODE Lot
600783 Exp Feb-08 Lot 600815 Exp Jan-08 Lot 600874 Exp Feb-08 Lot 600875 Exp
Jan-08 Lot 600814 Exp Jan-08 Lot 600771 Exp Jan-08 Lot 600692 Exp Dec-07 Lot
600540 Exp Nov-07 Lot 600630 Exp Dec-07 Lot 600538 Exp Dec-07 Lot 600408 Exp
Dec-07 Lot 600145 Exp Sep-07 Lot 600146 Exp Sep-07 Lot 600147 Exp Sep-07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Celsion
Corporation, Inc, Columbia, MD
Manufacturer: Accellent Juarez, Inc, Juarez, Chihuahua, Mexico.
REASON
Surgical treatment kits
containing medical device components were mislabeled with extended expiration
dates.
VOLUME OF PRODUCT IN COMMERCE 1,515
kits
DISTRIBUTION MA, IL, NJ, FL, NY, CO, OH, and MI
PRODUCT Cook Esophageal Dilator
Set ------- Small label applied by OEM supplier: C CEDS 58 70 * Use By 2008/04 *
Lot No. F1734513 * Sterile * Rx only * Cook® *** Large product label applied at
Cook Endoscopy: Cook Esophageal Dilator Set * Catheter Diameter: 20 FR. Catheter
Length: 15cm. * Dilator Diameter: 58 FR. * Dilator Length: 70 CM. * Disposable
Single Use Only * Rx Only * 2008/05 * Cook® *
CODE Lot: W2110292, Correct expiration on Small OEM
Label: Mar-08, Expiration date on Large Label Apr-08; W2118663, Correct exp.:
Mar-08, Exp. On large label: Apr-08; W2126166, Correct exp.: Apr-08, Exp. On
large label: May-08; W2128638, Correct exp.: Apr-08, Exp. On large label:
May-08; W2128639, Correct exp.: Apr-08, Exp. On large label: May-08; W2138018,
Correct exp.: Apr-08, Exp. On large label: May-08; W2143643, Correct exp.:
Apr-08, Exp. On large label: May-08; W2150003, Correct exp.: Apr-08, Exp. On
large label: May-08; W2177983, Correct exp.: Apr-08, Exp. On large label:
May-08; W2190096, Correct exp.: Sep-08, Exp. On large label: Oct-08; W2194318,
Correct exp.: Sep-08, Exp. On large label: Oct-08
RECALLING
FIRM/MANUFACTURER Cook Endoscopy, Winston Salem, NC
REASON Large
product label contains an incorrect expiration date.
VOLUME OF PRODUCT IN
COMMERCE 43 units
DISTRIBUTION AL
PRODUCT K-ASSAY CRP (2) Reagent.
Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance ITA. Kit contains 2 vials.
One vial labeled K-ASSAY CRP (2) R-1 30 mL 170 mM Glycine Buffer, via has a
white cap. The other vial labeled K-ASSAY CRP (2) R-2 20 mL Latex Suspension
human CRP rabbit antibodies, vial has a red cap.
CODE Lot Number: 666011, Exp: 07/2007
RECALLING
FIRM/MANUFACTURER Kamiya Biomedical Company, Seattle, WA
REASON Kits may contain 2 vials of the same reagent
instead of 1 vial of buffer reagent and 1 vial of antibody reagent.
VOLUME
OF PRODUCT IN COMMERCE 185 kits
DISTRIBUTION Nationwide and
Singapore
PRODUCT Affymetrix GeneChip
Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with
autoloader, FS450Dx fluidics station and GCOSDX Software,
CODE Serial Numbers: 7SLJX61 - GX280 ; 3V35V61-GX280;
6SLJX61 - GX280; 7S35V61 - GX280; FT35V61 -GX280; GS35V61 - GX280; JT35V61
-GX280; 1V35V61 - GX280; 4V35V61 -GX280; 8V35V61 - GX280; DT35V61 - GX280;
BV35V61 -GX280; JV35V61 -GX280; GV35V61 - GX280; JS35V61 -GX280; BPB1761 - GX280
RECALLING FIRM/MANUFACTURER Affymetrix, Inc, Bedford, MA
REASON
Incorrect software version of instrument
controller is not compatible with new configuration. This incorrect
configuration may cause the instrument system to fail at start-up or during a
run.
VOLUME OF PRODUCT IN COMMERCE 13
units
DISTRIBUTION CA, IN, The Netherlands, and Switzerland
WEEK ENDING MAY 27
PRODUCT GE Signa Advantage
nuclear magnetic resonance imaging system,
CODE All GE Signa Advantage MRI magnets with the model
numbers 46-260805G1, 46-260805G2, 46-281380G1, 46-281380G2, 46-281380G3,
46-281380G4, 46-281380G5, 46-281380G6, 46-281380G7 and
46-281380G8
RECALLING FIRM/MANUFACTURER General Electric Med
Systems LLC, Waukesha, WI,
REASON During use of GE
Signa nuclear magnetic resonance imaging system, a flexible Teflon tube that was
part of the magnet vent system ruptured and allowed the magnet to vent into the
scan room. Because of helium pressure inside the room, the scan room door could
not be reopened after the patient was removed from the scan room.
VOLUME
OF PRODUCT IN COMMERCE 644 devices
DISTRIBUTION Nationwide
and Internationally
PRODUCT Cool-tip RF Generator,
for use in percutaneous, laparoscopic, intraoperative coagulation and ablation
of tissue. Product Number: CTRF117 and CTRF220,
CODE Lot numbers: C4K101C thru C4K122C, C4K126C thru
C4K133C, C4L134C thru C4L147C, C5A148C thru C5A158C, C5B159C thru C5B174C,
C5C175C thru C5C191C, C5D192C thru C5D199C, C5E200C thru C5E213C, C5F214C thru
C5F231C, C5G232C thru C5G235C, C5H236C thru C5H241C, C5I242C thru C5I246C,
C5J247C thru C5J263C, C5K264C thru C5K272C, C5L273C thru C5L282C, C6A283C thru
C6A286C
RECALLING FIRM/MANUFACTURER Valleylab, Boulder, CO
REASON
Electrosurgical ablation device may experience loss
of power during use, when used with Cool-tip Switching controller in ablation
mode.
VOLUME OF PRODUCT IN COMMERCE 137
units
DISTRIBUTION Nationwide and Internationally
PRODUCT REGIUS Image Manager (AKA
REGIUS IM, RIM). Catalogue Number 5900554. The Konica REGIUS Image Manager
Software (RIM) is used to receive and manage computerized X-Ray image file
workflow,
CODE Units distributed between June
2003 and January 2006. Software version prior to January 31,
2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Konica
Minolta Medical Imaging USA, Inc., Wayne, NJ,
Manufacturer: Konica Minolta
Medical & Graphic, Inc., Tokyo, Japan,
REASON If the patient demographic data is entered into the
CS-1 manually, and the user fails to enter any data in one of the demographic
data fields labeled as Birthday, Sex, Name or Patient Comments, etc, the RIM
will populate the fields where no data has been entered with data from the
previous patient.
VOLUME OF PRODUCT IN COMMERCE 58
units
DISTRIBUTION Nationwide
PRODUCT
a) Kimberly Clark * 20'
Minibore Extension Line * Single Use * Sterile * Rx only *
This is a Pain
Management Product that is sold in a wide variety of kits including both
standard tray configurations and custom kits, Product Code: 18938,
b) Kimberly Clark * Facet Block Tray * Single Use *
Sterile * Rx only *,
Product Code: 18146,
c) Kimberly
Clark * Nerve Block Tray * Single Use * Sterile * Rx only * Product
Code:
18164, Product Code: 181027, Product Code: 181A040, Product Code:
181A108,
Product Code: 181A144, Product Code: 181A170,
d) Kimberly
Clark * Nerve Root Block Tray * Single Use * Sterile * Rx only *,
Product
Code: 181236,
e) Kimberly Clark * Selective Nerve Block
Tray * Single Use * Sterile * Rx only *,
Product Code: 181A236,
f) Kimberly Clark * Universal Block Tray * Single Use * Sterile *
Rx only *,
Product Code: 181000, Product Code: 181053, Product Code: 181066,
Product Code: 181069, Product Code: 181126, Product Code: 181128, Product
Code:
181167, Product Code: 181253, Product Code: 181255, Product Code:
181269,
Product Code: 181A055, Product Code: 181A088, and Product Code:
181A237,
CODE
a) Lot #321922;
b) Lot
#330104;
c) Lot #330105, Lot #327294, Lot #324535, Lot #326465, Lot #327309,
Lot #328365;
d) Lot #324523;
e) Lot #329218 and Lot #327315
f) Lot
#324507, Lot #325536, Lot #327295, Lot #326447 & Lot #330094, Product Code:
181126, Lot #327296, Product Code: 181128, Lot #324516, Product Code: 181167,
Lot #319874, Product Code: 181253, Lot #326455, Product Code: 181255, Lot
#330100, Product Code: 181269, Lot #326456, Product Code: 181A055, Lot #329119,
Product Code: 181A088, Lot #328354 and Product Code: 181A237, Lot #329220
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kimberly-Clark
Corporation, Roswell, GA,
Manufacturer: Ballard Medical Products, Draper, UT,
REASON
The Pain Management Procedural
Trays may contain extension sets that do not meet USP specification requirements
for non pyrogenicity (less than or equal to 2.25 EU/device (Endotoxin
Units/device).
VOLUME OF PRODUCT IN COMMERCE 4,385 units from 25
lots
DISTRIBUTION Nationwide
PRODUCT ESP 140 Syringe Pump.
Used for medication infusion. Model 140A and 140D,
CODE All Serial Numbers since 1996
RECALLING
FIRM/MANUFACTURER Excelsior Medical Corp, Neptune, NJ,
REASON
Potential for
alarm failure when the 140 pump completes infusion and/or the pump encounters a
mid-infusion occlusion, when used in the 140 mode with a 140cc syringe. The ESP
Pump works correctly when used in 60 mode with a 60cc syringe or
smaller.
VOLUME OF PRODUCT IN COMMERCE 3,695
units
DISTRIBUTION Nationwide and Canada
PRODUCT Sterile empty vials,
10mL/20mm closure sold 25/case. Labels on case states CAUTION: For
manufacturing, Processing or Repacking Rx only NON_RETURNABLE LOT, CODE Lot # 6743, Item #s 7515ZA, 7515ZC,
7515ZD
RECALLING FIRM/MANUFACTURER Hollister Stier Laboratories LLC, Spokane,
WA
REASON Potential for vials to be cracked at the vial
stopper interface. This could compromise the sterility of the products
compounded into the vials.
VOLUME OF PRODUCT IN COMMERCE 87,900
vials
DISTRIBUTION Nationwide
PRODUCT Zimmer Cannulated Screw
System Cannulated Driver, 5.0 mm Hex, REF 1147-49-50; Catalog # 00-1147-049-50,
CODE
Lot #'s 51198300, 51217200, 51234800,
51260000 and 51302600
RECALLING FIRM/MANUFACTURER Pioneer Surgical
Technology, Marquette, MI,
REASON There may be an
obstruction in the cannula that will prevent the guide wire from passing through
it. The obstruction in the cannula can force the guide wire to advance further
into the patient than intended.
VOLUME OF PRODUCT IN COMMERCE 74
units
DISTRIBUTION Nationwide
PRODUCT SYNCHRON Systems
Vancomycin Reagent, in vitro diagnostic. Part Number 474824,
CODE Lot #'s M507219 and M511327
RECALLING
FIRM/MANUFACTURER Beckman Coulter, Inc, Brea, CA
REASON Beckman Coulter has
received reports of patient samples and quality control recovery shifting low
when using Vancomycin reagent lots M507219 and M11327. Internal QC recovery was
as much as 15% lower than the assigned target value.
VOLUME OF PRODUCT IN
COMMERCE 3147 units
DISTRIBUTION Nationwide and
Canada
PRODUCT CONTAK RENEWAL 3 RF
(models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219), CONTAK RENEWAL
4 RF (models H230, H235) CONTAK RENEWAL 4 RF HE (model H239) cardiac
resynchronization therapy defibrillator (CRT-D), provide ventricular
tachyarrhythmia and cardiac resynchronization therapies. Ventricular
tachyarrhythmia therapy is for the treatment of ventricualar tachycardia (VT)
and ventricular fibrillation (VF), rhythms that are associated with suden
cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of
heart failure (HF) and uses biventricular electrical stimulation to synchronize
ventricular contractions. The device also uses accelerometer-based adaptive-rate
bradycardia therapy. These CONTAK RENEWAL RF devices feature enhanced telemetry
communication with wandless ZIP telemetry. Cardioversion/defibrillation
therapies include a range of low- and high-energy shocks using either a biphasic
or monophasic waveform,
CODE Issue affecting
devices is a pre-implant issue. Serial number ranges listed below may also
include devices not affected (i.e. implanted devices). Model H210 serial number
200031 thru 202462. Model H215 serial numbers 700016 thru 702646. Model H217
serial numbers 700006 thru 702543. Model H219 serial numbers 200021 thru 201747.
Model H230 serial numbers 100012 thru 200526. Model H235 serial numbers 100018
thru 650559. Model H239 serial numbers 100018 thru 650272
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Guidant Corporation, St. Paul,
MN,
Manufacturer: Guidant-Ireland, Clomel, Ireland,
REASON
Guidant received 39 reports of devices
that exhibited lower than expected battery voltage prior to implant; none of
these devices were implanted.
VOLUME OF PRODUCT IN
COMMERCE Approximately 5,500 devices
DISTRIBUTION Nationwide
and Internationally