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