FEBRUARY 2009

WEEK ENDING FEBRUARY 7

PRODUCT
a) Medtronic SynchroMed EL Programmable Pump, Model 8626-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids. 

b) Medtronic SynchroMed EL Programmable Pump, Model 8626L-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids. 

c) Medtronic SynchroMed EL Programmable Pump, Model 8626-18. 18 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids.

d) Medtronic SynchroMed EL Programmable Pump, Model 8626L-18. 18 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids. 

e) Medtronic SynchroMed EL Programmable Pump, Model 8627-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids.

f) Medtronic SynchroMed EL Programmable Pump, Model 8627L-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids. 

g) Medtronic SynchroMed EL Programmable Pump, Model 8627-18. 18 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids. 

h)  Medtronic SynchroMed EL Programmable Pump, Model 8627L-18. 18 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids.

i) Medtronic SynchroMed II Programmable Pump, Model 8637-20. 20 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed II programmable Pump is part of the SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories. The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the follosing drugs or fluids: -chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of preservative-free morphine sulfate sterile solution. - chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of serve chronic pain. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of preservative-free ziconotide sterile solution after the initial fill of the pump with this drug. -chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) in the management of severe spasticity. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of Lioresal Intrathecal (baclofen Injection). -Chronic intravascular infusion of floxuridine, (FUDR) or methotrexate for the treatment of primary or metastatic cancer. Bacteriostatic water or preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of chemotherapy drugs or to flush the pump reservoir. Saline or heparinized saline (unless contraindicated) may be used during an interruption in chemotherapy to maintain pump and catheter patency. 

j) Medtronic SynchroMed II Programmable Pump, Model 8637-40. 40 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed II programmable Pump is part of the SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories. The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the follosing drugs or fluids: -chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of preservative-free morphine sulfate sterile solution. - Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of serve chronic pain. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of preservative-free ziconotide sterile solution after the initial fill of the pump with this drug. – Chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) in the management of severe spasticity. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of Lioresal Intrathecal (baclofen Injection). - Chronic intravascular infusion of floxuridine, (FUDR) or methotrexate for the treatment of primary or metastatic cancer. Bacteriostatic water or preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of chemotherapy drugs or to flush the pump reservoir. Saline or heparinized saline (unless contraindicated) may be used during an interruption in chemotherapy to maintain pump and catheter patency. 
CODE All SynchroMed EL and SynchroMed II pumps
RECALLING FIRM/MANUFACTURER Medtronic Neuromodulation, Minneapolis, MN, 
REASON Medtronic issued a letter to healthcare professionals providing important safety information regarding MRI (magnetic resonance imaging) effects on SynchroMed EL and SynchroMed II implantable infusion pumps. As stated in product labeling, the magnetic field of an MRI will temporarily stop the rotor of the pump motor and suspend drug infusion for the duration of MRI exposure for all SynchroMed pumps. The pump should resume normal operation when removed from the MRI magnetic field, however new information has been identified related to the following MRI effects: 1) There is the potential for a delay in the return of proper drug infusion after an MRI (this affects all SynchroMed pumps) and 2) There is the potential for a delay in the logging of motor stall events after an MRI (this only affects SynchroMed II pumps).
VOLUME OF PRODUCT IN COMMERCE Approx 76,253
DISTRIBUTION Nationwide and countries of Algeria, Aruba, Austria, Belarus, Belgium, Croatia, Cyprus Czech Republic, Denmark, Egypt, Finland, France, French Polynesia, Germany, Greece, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy , Jordan Kuwait, Lebanon, Luxembourg, Malta, Netherlands, Netherlands Antilles, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia and Montenegro, Slovakia, Slovenia, Sough Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City State, New Caledonia, Brazil, Dominican Republic, Mexico, Hong Kong, Singapore, Canada, Australia and Japan

PRODUCT Liko AB Uno Lifts, Powered (non-AC) Patient Lift: a) Uno 100 EM/EE; b) Uno 101. Uno 100 and 102 are battery powered mobile lifts, designed to be used in most of the common lifting situations, for example transfers between bed and wheelchair, to and from the toilet and bathtub or for lifting to and from the floor.
CODE
a) Serial numbers: 7090001 through 7096200;
b) Serial numbers: 10001 through 1000. Production Dates: Manufactured prior to June 26, 2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Liko North America Inc., Franklin, MA,
Manufacturer: Liko AB, Lulea, Sweden. 
REASON Actuator of the lift has potential to separate when the upper arm is fully extended.
VOLUME OF PRODUCT IN COMMERCE 24,070 units
DISTRIBUTION Nationwide and Canada

PRODUCT DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is intended for draining the pericardial sac or the cardiac chambers. 
CODE Lot number: 2006100305
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Cardiovascular Revascularization & Surgical Therap,
Brooklyn Park, MN, 
Manufacturer: Atek Medical Manufacturing, Grand Rapids, MI. 
REASON Separates: Six complaints were received from two locations. In all cases the sump tip assembly separated from the tubing during device removal and had to be retrieved from the patient. There were no adverse events affecting these patients.
VOLUME OF PRODUCT IN COMMERCE 560 units
DISTRIBUTION NC, PA, IA, WI, IN, VA, IL, KY, and TX, and countries of Australia, France, Hong Kong, Netherlands, and Poland.

PRODUCT
a) CAD SCIENCES LLC 3 TP TheraMapTM Software, for oncology treatment planning, assessment and monitoring of the patient response. 

b) CAD SCIENCES LLC 3 TP PrecisionPointTM Software, for biopsy guidance.
CODE All software versions
RECALLING FIRM/MANUFACTURER  iCAD, Inc., Nashua, NH, 
REASON Software modules not approved for this indication.
VOLUME OF PRODUCT IN COMMERCE 35 units
DISTRIBUTION Nationwide

PRODUCT
a) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Hook Probe. Product Code EPS01.

b) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Spatula Probe. Product Code EPS02. 

c) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Right Angle Probe. Product Code EPS03. 

d) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Curved Dissector Probe. Product Code EPS04. 

e) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Hook Probe. Product Code EPS05. 

f) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Spatula Probe. Product Code EPS06. 

g) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Right Angle Probe. Product Code EPS07. 

h) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Curved Dissector Probe. Product Code EPS08.

i) Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 29 cm Needle Probe. Product Code EPS09. 
CODE
a) Lot # E4K594, Exp Date 2012-12; Lot # E4K67R, Exp Date 2012-12; Lot # E4K93J, Exp Date 2012-12; Lot # E4KC5J, Exp Date 2013-01; Lot # E4KF21, Exp Date 2013-01; Lot # E4KK1M, Exp Date 2013-02; Lot # E4KK7Z, Exp Date 2013-02; Lot # E4KL9T, Exp Date 2013-02; Lot # E4KM4A, Exp Date 2013-02; Lot # E4KP38, Exp Date 2013-02; Lot # E4KT81, Exp Date 2013-03; Lot # E4KU2X, Exp Date 2013-03; Lot # E4KX2D, Exp Date 2013-03; Lot # E4L01C, Exp Date 2013-04; Lot # E4L02M, Exp Date 2013-04; Lot # E4L21T, Exp Date 2013-04; Lot # E4L66N, Exp Date 2013-04; Lot # E4L738, Exp Date 2013-05; Lot # E4L82C, Exp Date 2013-05; Lot # E4LA6P, Exp Date 2013-05; Lot # E4LC88, Exp Date 2013-05; Lot # E4LE62, Exp Date 2013-05; Lot # E4LG4C, Exp Date 2013-06; Lot # E4LJ8W, Exp Date 2013-06; Lot # E4LK99, Exp Date 2013-06; Lot # E4LM57, Exp Date 2013-06; Lot # E4LP5G, Exp Date 2013-07; Lot # E4LU30, Exp Date 2013-07; Lot # E4LV48, Exp Date 2013-07; Lot # E4LX91, Exp Date 2013-07; Lot # E4M068, Exp Date 2013-08; Lot # E4M12K, Exp Date 2013-08; Lot # E4M23T, Exp Date 2013-08; Lot # E4M33W, Exp Date 2013-08; Lot # E4M387, Exp Date 2013-08; Lot # E4M43R, Exp Date 2013-08; Lot # E4M54H, Exp Date 2013-08; Lot # E4M75K, Exp Date 2013-09; Lot # E4M973, Exp Date 2013-09; and Lot # E4MA8R, Exp Date 2013-09;

b) Lot # E4K181, Exp. Date 2012-12; Lot # E4K58C, Exp. Date 2012-12; Lot # E4KC5X, Exp. Date 2013-01; Lot # E4KD1P, Exp. Date 2013-01; Lot # E4KF2N, Exp. Date 2013-01; Lot # E4KG70, Exp. Date 2013-01; Lot # E4KK22, Exp. Date 2013-02; Lot # E4KP2F, Exp. Date 2013-02; Lot # E4KV17, Exp. Date 2013-03; Lot # E4KY1A, Exp. Date 2013-03; Lot # E4KY70, Exp. Date 2013-03; Lot # E4L03H, Exp. Date 2013-04; Lot # E4L519, Exp. Date 2013-04; Lot # E4L73Z, Exp. Date 2013-05; Lot # E4L916, Exp. Date 2013-05; Lot # E4LC3K, Exp. Date 2013-05; Lot # E4LD8L, Exp. Date 2013-05; Lot # E4LF60, Exp. Date 2013-05; Lot # E4LG4D, Exp. Date 2013-06; Lot # E4LL7P, Exp. Date 2013-06; Lot # E4LT6E, Exp. Date 2013-07; Lot # E4LX4H, Exp. Date 2013-07; Lot # E4M045, Exp. Date 2013-08; Lot # E4M12L, Exp. Date 2013-08; Lot # E4M27N, Exp. Date 2013-08; Lot # E4M466, Exp. Date 2013-08; Lot # E4M535, Exp. Date 2013-08; Lot # E4M54F, Exp. Date 2013-08; Lot # E4M69H, Exp. Date 2013-09; Lot # E4M838, Exp. Date 2013-09; Lot # E4MA4M, Exp. Date 2013-09; and Lot # E4MC3A, Exp. Date 2013-09;

c) Lot # E4K182, Exp. Date 2012-12; Lot # E4K59R, Exp. Date 2012-12; Lot # E4K67T, Exp. Date 2012-12; Lot # E4K81D, Exp. Date 2012-12; Lot # E4K938, Exp. Date 2012-12; Lot # D4JL20, Exp. Date 2012-09; Lot # D4JL21, Exp. Date 2012-09; Lot # D4JL22, Exp. Date 2012-09; Lot # E4KC1M, Exp. Date 2013-01; Lot # E4KF20, Exp. Date 2013-01; Lot # E4KK23, Exp. Date 2013-02; Lot # E4KK6V, Exp. Date 2013-02; Lot # E4KL0N, Exp. Date 2013-02; Lot # E4KR6Y, Exp. Date 2013-03; Lot # E4KV1X, Exp. Date 2013-03; Lot # E4KX2Z, Exp. Date 2013-03; Lot # E4KY5H, Exp. Date 2013-03; Lot # E4L18A, Exp. Date 2013-04; Lot # E4L404, Exp. Date 2013-04; Lot # E4L66M, Exp. Date 2013-04; Lot # E4L69A, Exp. Date 2013-05; Lot # E4L871, Exp. Date 2013-05; Lot # E4LA7Z, Exp. Date 2013-05; Lot # E4LD0T, Exp. Date 2013-05; Lot # E4LF5F, Exp. Date 2013-05; Lot # E4LJ46, Exp. Date 2013-06; Lot # E4LJ4F, Exp. Date 2013-06; Lot # E4LK9C, Exp. Date 2013-06; Lot # E4LN16, Exp. Date 2013-06; Lot # E4LP57, Exp. Date 2013-07; Lot # E4LR66, Exp. Date 2013-07; Lot # E4LT3Y, Exp. Date 2013-07; Lot # E4LU2Z, Exp. Date 2013-07; Lot # E4LV56, Exp. Date 2013-07; Lot # E4M00W, Exp. Date 2013-08; Lot # E4M01X, Exp. Date 2013-08; Lot # E4M120, Exp. Date 2013-08; Lot # E4M20L, Exp. Date 2013-08; Lot # E4M23R, Exp. Date 2013-08; Lot # E4M31A, Exp. Date 2013-08; Lot # E4M376, Exp. Date 2013-08; Lot # E4M39C, Exp. Date 2013-08; Lot # E4M572, Exp. Date 2013-08; Lot # E4M57U, Exp. Date 2013-08; Lot # E4M62M, Exp. Date 2013-08; Lot # E4M914, Exp. Date 2013-09; Lot # E4MA2R, Exp. Date 2013-09; and Lot # E4MD45, Exp. Date 2013-09;

d) Lot # E4KC2J, Exp. Date 2013-01; Lot # E4KG8M, Exp. Date 2013-01; Lot # E4KP8H, Exp. Date 2013-02; Lot # E4KV0T, Exp. Date 2013-03; Lot # E4L030, Exp. Date 2013-04; Lot # E4L892, Exp. Date 2013-05; Lot # E4LD0R, Exp. Date 2013-05; Lot # E4LK7V, Exp. Date 2013-06; Lot # E4LX1D, Exp. Date 2013-07; Lot # E4M072, Exp. Date 2013-08; Lot # E4M28F, Exp. Date 2013-08; Lot # E4M91D, Exp. Date 2013-09; and Lot # E4MA2P, Exp. Date 2013-09;

e) Lot # E4K72Z, Exp. Date 2012-12; Lot # E4K92E, Exp. Date 2012-12; Lot # E4KE29, Exp. Date 2013-01; Lot # E4KH2L, Exp. Date 2013-01; Lot # E4KP2E, Exp. Date 2013-02; Lot # E4KU5K, Exp. Date 2013-03; Lot # E4KX1Y, Exp. Date 2013-03; Lot # E4L03G, Exp. Date 2013-04; Lot # E4L69Y, Exp. Date 2013-05; Lot # E4LA5X, Exp. Date 2013-05; Lot # E4LE64, Exp. Date 2013-05; Lot # E4LF6H, Exp. Date 2013-05; Lot # E4LN1K, Exp. Date 2013-06; Lot # E4LR3W, Exp. Date 2013-07; Lot # E4LU50, Exp. Date 2013-07; Lot # E4M00X, Exp. Date 2013-08; Lot # E4M24N, Exp. Date 2013-08; Lot # E4M506, Exp. Date 2013-08; Lot # E4M62L, Exp. Date 2013-08; Lot # E4M79W, Exp. Date 2013-09; and Lot # E4MA4P, Exp. Date 2013-09;

f) Lot # E4K730, Exp. Date 2012-12; Lot # E4K937, Exp. Date 2012-12; Lot # E4KE28, Exp. Date 2013-01; Lot # E4KF4E, Exp. Date 2013-01; Lot # E4KK3D, Exp. Date 2013-02; Lot # E4KK9Z, Exp. Date 2013-02; Lot # E4KT18, Exp. Date 2013-03; Lot # E4KU5A, Exp. Date 2013-03; Lot # E4KW7W, Exp. Date 2013-03; Lot # E4KY71, Exp. Date 2013-03; Lot # E4KZ5L, Exp. Date 2013-03; Lot # E4KZ9G, Exp. Date 2013-04; Lot # E4L189, Exp. Date 2013-04; Lot # E4L41U, Exp. Date 2013-04; Lot # E4L53G, Exp. Date 2013-04; Lot # E4L54M, Exp. Date 2013-04; Lot # E4L891, Exp. Date 2013-05; Lot # E4LA6F, Exp. Date 2013-05; Lot # E4LD1N, Exp. Date 2013-05; Lot # E4LF86, Exp. Date 2013-05; Lot # E4LJ4C, Exp. Date 2013-06; Lot # E4LN1J, Exp. Date 2013-06; Lot # E4LT6C, Exp. Date 2013-07; Lot # E4LU3P, Exp. Date 2013-07; Lot # E4M20H, Exp. Date 2013-08; Lot # E4M338, Exp. Date 2013-08; Lot # E4M457, Exp. Date 2013-08; Lot # E4M54G, Exp. Date 2013-08; Lot # E4M634, Exp. Date 2013-08; and Lot # E4MA4N, Exp. Date 2013-09;

g) Lot # E4KC1V, Exp Date 2013-01; Lot # E4KJ1J, Exp Date 2013-02; Lot # E4KM09, Exp Date 2013-02; Lot # E4KV1N, Exp Date 2013-03; Lot # E4KZ5M, Exp Date 2013-03; Lot # E4L464, Exp Date 2013-04; Lot # E4L664, Exp Date 2013-04; Lot # E4LA0W, Exp Date 2013-05; Lot # E4LC3M, Exp Date 2013-05; Lot # E4LE63, Exp Date 2013-05; Lot # E4LJ89, Exp Date 2013-06; Lot # E4LK9K, Exp Date 2013-06; Lot # E4LR3Y, Exp Date 2013-07; Lot # E4LX68, Exp Date 2013-07; Lot # E4LX88, Exp Date 2013-07; Lot # E4M071, Exp Date 2013-08; Lot # E4M43P, Exp Date 2013-08; Lot # E4M83K, Exp Date 2013-09; and Lot # E4M98Y, Exp Date 2013-09;

h) Lot # E4KF22, Exp. Date 2013-01; Lot # E4L088, Exp. Date 2013-04; Lot # E4LR3X, Exp. Date 2013-07; and Lot # E4MD46, Exp. Date 2013-09;

i) Lot # E4KC2H, Exp. Date 2013-01; Lot # E4KJ1H, Exp. Date 2013-02; Lot # E4KR73, Exp. Date 2013-03; Lot # E4KW8R, Exp. Date 2013-03; Lot # E4L465, Exp. Date 2013-04; Lot # E4LA5T, Exp. Date 2013-05; Lot # E4LD9H, Exp. Date 2013-05; Lot # E4LF6M, Exp. Date 2013-05; Lot # E4LK7U, Exp. Date 2013-06; Lot # E4LU3N, Exp. Date 2013-07; Lot # E4M33D, Exp. Date 2013-08; Lot # E4M69J, Exp. Date 2013-09; and Lot # E4M83N, Exp. Date 2013-09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon Endo-Surgery Inc., Cincinnati, OH, 
Manufacturer:  Ethicon Endo-Surgery, Inc. S.A. de C.V. Planta II, Ciudad Juarez, Chihuahua, Mexico. 
REASON Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy or sensitivity. Ethicon Endo-Surgery determined the presence of free nickel in the affected product could elicit a reaction in those patients with nickel sensitivity or could sensitize certain patients to nickel exposure in the future.
VOLUME OF PRODUCT IN COMMERCE 109,374 instruments
DISTRIBUTION Nationwide and countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Dominican Republic, Egypt, England, Equator, Germany, Greece, India, Indonesia, Israel, Italy, Japan, Korea, Malaysia, Mexico, Pakistan, Panama, Poland, Republic OF Yemen, Russia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad Turkey United Arab Emirates, Uruguay, and Venezuela

PRODUCT Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number: SC1439-1000. 
CODE Lot number: 17877-071707 exp. 7/2017
RECALLING FIRM/MANUFACTURER Stelkast Co., McMurray, PA, 
REASON Sterility may be compromised due to breach in packaging.
VOLUME OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION TX, WV

PRODUCT
a) Medtronic Maximo II DR D28DRG, for ventricular pacing and defibrillation. 

b) Medtronic Maximo II VR D284VRC, for ventricular pacing and defibrillation. 

c) Maximo II CRT D284TRK, for ventricular pacing and defibrillation. 
CODE
a) Lot Serial Number: PZM600131S PZM600054S PZM600616S PZM600617S PZM600620S PZM600615S PZM600523S PZM600111S PZM600213S PZM600502S PZM600595S PZM600600S PZM600277S PZM600078S PZM600581S PZM600582S PZM600597S PZM600602S PZM600530S PZM600108S PZM600495S PZM600497S PZM600498S PZM600500S PZM600501S PZM600151S PZM600152S PZM600153S PZM600446S PZM600447S PZM600448S PZM600264S PZM600278S PZM600469S PZM600094S PZM600401S PZM600052S PZM600053S PZM600517S PZM600621S PZM600622S PZM600233S PZM600539S PZM600129S PZM600130S PZM600132S PZM600160S PZM600162S PZM600207S PZM600208S PZM600138S PZM600140S PZM600145S PZM600146S PZM600148S PZM600156S PZM600198S PZM600056S PZM600092S PZM600104S PZM600105S PZM600147S PZM600168S PZM600252S PZM600051S PZM600199S PZM600057S PZM600273S PZM600075S PZM600232S PZM600472S PZM600049S PZM600203S PZM600276S PZM600071S PZM600143S PZM600098S PZM600110S PZM600167S PZM600101S PZM600109S PZM600126S PZM600150S PZM600491S PZM600492S PZM600080S PZM600081S PZM600281S PZM600282S PZM600283S PZM600284S PZM600285S PZM600286S PZM600287S PZM600288S PZM600289S PZM600290S PZM600184S PZM600192S PZM600245S PZM600180S PZM600262S PZM600526S PZM600643S PZM600473S PZM600186S PZM600189S PZM600243S PZM600266S PZM600247S PZM600254S PZM600556S PZM600557S PZM600558S PZM600559S PZM600560S PZM600561S PZM600562S PZM600563S PZM600584S PZM600586S PZM600112S PZM600544S PZM600599S PZM600486S PZM600405S PZM600406S PZM600407S PZM600408S PZM600409S PZM600410S PZM600411S PZM600412S PZM600413S PZM600414S PZM600415S PZM600416S PZM600417S PZM600418S PZM600419S PZM600420S PZM600421S PZM600422S PZM600423S PZM600424S PZM600425S PZM600426S PZM600427S PZM600428S PZM600429S PZM600430S PZM600431S PZM600432S PZM600433S PZM600434S PZM600435S PZM600436S PZM600437S PZM600438S PZM600439S PZM600440S PZM600441S PZM600442S PZM600443S PZM600444S PZM600445S PZM600059S PZM600060S PZM600061S PZM600062S PZM600063S PZM600064S PZM600065S PZM600066S PZM600135S PZM600136S PZM600137S PZM600116S PZM600117S PZM600118S PZM600119S PZM600120S PZM600121S PZM600122S PZM600123S PZM600124S PZM600125S PZM600079S PZM600206S PZM600578S PZM600215S PZM600216S PZM600217S PZM600218S PZM600219S PZM600220S PZM600221S PZM600222S PZM600223S PZM600224S PZM600265S PZM600083S PZM600470S PZM600528S PZM600533S PZM600640S PZM600577S PZM600076S PZM600594S PZM600241S PZM600242S PZM600272S PZM600274S PZM600573S PZM600574S PZM600576S PZM600161S PZM600163S PZM600234S PZM600133S PZM600134S PZM600193S PZM600194S PZM600090S PZM600509S PZM600072S PZM600142S PZM600173S PZM600623S PZM600624S PZM600482S PZM600196S PZM600197S PZM600535S PZM600536S PZM600067S PZM600068S PZM600077S PZM600490S PZM600190S PZM600611S PZM600612S PZM600084S PZM600087S PZM600088S PZM600089S PZM600231S PZM600201S PZM600202S PZM600141S PZM600471S PZM600546S PZM600235S PZM600236S PZM600048S PZM600128S PZM600550S PZM600551S PZM600073S PZM600085S PZM600055S PZM600158S PZM600251S PZM600165S PZM600280S PZM600070S PZM600170S PZM600204S PZM600097S PZM600545S PZM600058S PZM600166S PZM600587S PZM600512S PZM600513S PZM600291S PZM600292S PZM600293S PZM600107S PZM600510S PZM600050S PZM600149S PZM600102S PZM600238S PZM600240S PZM600598S PZM600601S PZM600086S PZM600091S PZM600596S PZM600099S PZM600100S PZM600093S PZM600155S PZM600157S PZM600159S PZM600253S PZM600171S PZM600590S PZM600493S PZM600074S PZM600209S PZM600580S PZM600494S PZM600069S PZM600200S PZM600144S PZM600154S PZM600047S PZM600095S PZM600275S PZM600547S PZM600225S PZM600113S PZM600613S PZM600614S PZM600542S PZM600237S PZM600402S PZM600403S PZM600404S PZM600514S PZM600515S PZM600258S PZM600259S PZM600487S PZM600248S PZM600279S PZM600508S PZM600256S PZM600257S PZM600608S PZM600609S PZM600488S PZM600489S PZM600261S PZM600263S PZM600641S PZM600642S PZM600270S PZM600516S PZM600589S PZM600592S PZM600255S PZM600249S PZM600169S PZM600172S PZM600174S PZM600175S PZM600176S PZM600177S PZM600178S PZM600179S PZM600181S PZM600182S PZM600183S PZM600187S PZM600191S PZM600246S PZM600474S PZM600644S PZM600507S PZM600543S PZM600250S PZM600244S PZM600534S PZM600548S PZM600549S PZM600537S PZM600538S PZM600552S PZM600553S PZM600185S PZM600188S PZM600521S PZM600522S PZM600271S PZM600527S PZM600607S PZM600627S PZM600555S PZM600646S PZM600294S PZM600295S PZM600511S PZM600713S PZM600714S PZM600260S PZM600524S PZM600525S PZM600554S PZM600268S PZM600269S PZM600475S PZM600476S PZM600477S PZM600214S PZM600541S PZM600210S PZM600212S PZM600520S PZM600540S PZM600114S PZM600115S PZM600226S PZM600229S PZM600230S PZM600483S PZM600484S PZM600485S PZM600529S PZM600205S PZM600572S PZM600575S PZM600267S PZM600106S PZM600164S PZM600103S and PZM600645S;

b) Lot Serial No PZN600430S PZN600431S PZN600436S PZN600428S PZN600422S PZN600385S PZN600317S PZN600383S PZN600308S PZN600418S PZN600388S PZN600409S PZN600410S PZN600250S PZN600391S PZN600392S PZN600374S PZN600375S PZN600116S PZN600333S PZN600334S PZN600335S PZN600336S PZN600337S PZN600145S PZN600146S PZN600147S PZN600148S PZN600348S PZN600349S PZN600057S PZN600058S PZN600351S PZN600352S PZN600247S PZN600248S PZN600328S PZN600462S PZN600419S PZN600199S PZN600200S PZN600129S PZN600130S PZN600131S PZN600132S PZN600134S PZN600151S PZN600152S PZN600153S PZN600154S PZN600167S PZN600181S PZN600182S PZN600201S PZN600208S PZN600209S PZN600210S PZN600211S PZN600212S PZN600213S PZN600214S PZN600249S PZN600325S PZN600326S PZN600327S PZN600329S PZN600330S PZN600362S PZN600381S PZN600463S PZN600464S PZN600082S PZN600083S PZN600084S PZN600085S PZN600086S PZN600071S PZN600088S PZN600149S PZN600138S PZN600079S PZN600429S PZN600442S PZN600101S PZN600135S PZN600140S PZN600183S PZN600111S PZN600067S PZN600361S PZN600074S PZN600055S PZN600107S PZN600143S PZN600170S PZN600171S PZN600266S PZN600169S PZN600341S PZN600254S PZN600255S PZN600256S PZN600257S PZN600258S PZN600259S PZN600260S PZN600261S PZN600262S PZN600263S PZN600197S PZN600237S PZN600239S PZN600219S PZN600246S PZN600236S PZN600203S PZN600227S PZN600252S PZN600164S PZN600202S PZN600396S PZN600397S PZN600398S PZN600399S PZN600400S PZN600401S PZN600402S PZN600403S PZN600404S PZN600405S PZN600425S PZN600426S PZN600427S PZN600196S PZN600318S PZN600195S PZN600354S PZN600316S PZN600127S PZN600123S PZN600313S PZN600312S PZN600268S PZN600269S PZN600270S PZN600271S PZN600272S PZN600273S PZN600274S PZN600275S PZN600276S PZN600277S PZN600278S PZN600060S PZN600061S PZN600062S PZN600063S PZN600064S PZN600574S PZN600136S PZN600137S PZN600359S PZN600547S PZN600251S PZN600370S PZN600372S PZN600114S PZN600117S PZN600184S PZN600185S PZN600186S PZN600187S PZN600188S PZN600189S PZN600190S PZN600191S PZN600307S PZN600103S PZN600379S PZN600380S PZN600087S PZN600407S PZN600408S PZN600180S PZN600363S PZN600364S PZN600365S PZN600366S PZN600414S PZN600415S PZN600465S PZN600466S PZN600467S PZN600133S PZN600166S PZN600100S PZN600075S PZN600340S PZN600115S PZN600434S PZN600435S PZN600320S PZN600168S PZN600068S PZN600069S PZN600324S PZN600078S PZN600423S PZN600094S PZN600420S PZN600097S PZN600098S PZN600099S PZN600122S PZN600090S PZN600091S PZN600175S PZN600176S PZN600141S PZN600303S PZN600304S PZN600389S PZN600206S PZN600207S PZN600049S PZN600050S PZN600053S PZN600054S PZN600128S PZN600424S PZN600073S PZN600095S PZN600076S PZN600077S PZN600059S PZN600080S PZN600139S PZN600155S PZN600302S PZN600350S PZN600105S PZN600106S PZN600215S PZN600216S PZN600546S PZN600144S PZN600118S PZN600119S PZN600120S PZN600052S PZN600437S PZN600438S PZN600439S PZN600112S PZN600113S PZN600440S PZN600441S PZN600096S PZN600241S PZN600109S PZN600110S PZN600102S PZN600065S PZN600072S PZN600331S PZN600066S PZN600081S PZN600413S PZN600421S PZN600332S PZN600070S PZN600172S PZN600173S PZN600142S PZN600433S PZN600048S PZN600108S PZN600104S PZN600056S PZN600125S PZN600386S PZN600051S PZN600265S PZN600217S PZN600267S PZN600345S PZN600346S PZN600231S PZN600232S PZN600321S PZN600223S PZN600339S PZN600229S PZN600230S PZN600305S PZN600306S PZN600322S PZN600323S PZN600235S PZN600369S PZN600245S PZN600347S PZN600406S PZN600228S PZN600432S PZN600156S PZN600157S PZN600158S PZN600159S PZN600161S PZN600163S PZN600165S PZN600218S PZN600220S PZN600221S PZN600222S PZN600198S PZN600360S PZN600238S PZN600338S PZN600240S PZN600224S PZN600226S PZN600367S PZN600390S PZN600377S PZN600378S PZN600393S PZN600394S PZN600160S PZN600162S PZN600355S PZN600356S PZN600357S PZN600358S PZN600204S PZN600205S PZN600371S PZN600395S PZN600469S PZN600387S PZN600264S PZN600342S PZN600628S PZN600629S PZN600233S PZN600368S PZN600243S PZN600244S PZN600353S PZN600382S PZN600314S PZN600315S PZN600319S PZN600384S PZN600416S PZN600192S PZN600193S PZN600311S PZN600417S PZN600443S PZN600194S PZN600309S PZN600310S PZN600124S PZN600126S PZN600289S PZN600344S PZN600343S PZN600373S PZN600178S PZN600179S PZN600242S PZN600376S PZN600089S and PZN600449S;

c) Lot Serial No PZP600096S PZP600610S PZP600608S PZP600546S PZP600149S PZP600569S PZP600587S PZP600589S PZP600612S PZP600450S PZP600557S PZP600193S PZP600558S PZP600559S PZP600531S PZP600533S PZP600534S PZP600535S PZP600536S PZP600199S PZP600215S PZP600473S PZP600474S PZP600475S PZP600476S PZP600477S PZP600478S PZP600479S PZP600480S PZP600607S PZP600513S PZP600514S PZP600515S PZP600516S PZP600530S PZP600092S PZP600093S PZP600562S PZP600571S PZP600609S PZP600596S PZP600166S PZP600467S PZP600529S PZP600638S PZP600134S PZP600135S PZP600172S PZP600133S PZP600509S PZP600128S PZP600196S PZP600103S PZP600111S PZP600140S PZP600142S PZP600169S PZP600527S PZP600611S PZP600636S PZP600656S PZP600614S PZP600090S PZP600141S PZP600195S PZP600137S PZP600089S PZP600112S PZP600178S PZP600127S PZP600173S PZP600211S PZP600213S PZP600511S PZP600524S PZP600577S PZP600542S PZP600091S PZP600154S PZP600174S PZP600466S PZP600177S PZP600454S PZP600455S PZP600456S PZP600457S PZP600458S PZP600459S PZP600462S PZP600463S PZP600464S PZP600465S PZP600543S PZP600552S PZP600434S PZP600510S PZP600438S PZP600439S PZP600584S PZP600221S PZP600521S PZP600180S PZP600544S PZP600604S PZP600605S PZP600606S PZP600436S PZP600517S PZP600588S PZP600113S PZP600114S PZP600115S PZP600116S PZP600117S PZP600118S PZP600119S PZP600120S PZP600121S PZP600122S PZP600097S PZP600098S PZP600099S PZP600100S PZP600101S PZP600163S PZP600164S PZP600165S PZP600448S PZP600197S PZP600200S PZP600202S PZP600203S PZP600204S PZP600205S PZP600206S PZP600207S PZP600208S PZP600209S PZP600210S PZP600136S PZP600550S PZP600637S PZP600568S PZP600109S PZP600586S PZP600159S PZP600198S PZP600160S PZP600176S PZP600161S PZP600581S PZP600582S PZP600132S PZP600108S PZP600168S PZP600170S PZP600214S PZP600512S PZP600526S PZP600545S PZP600191S PZP600192S PZP600566S PZP600567S PZP600110S PZP600528S PZP600634S PZP600155S PZP600126S PZP600129S PZP600130S PZP600131S PZP600148S PZP600123S PZP600124S PZP600171S PZP600508S PZP600158S PZP600105S PZP600153S PZP600095S PZP600094S PZP600167S PZP600212S PZP600547S PZP600538S PZP600216S PZP600217S PZP600435S PZP600162S PZP600641S PZP600146S PZP600532S PZP600592S PZP600593S PZP600594S PZP600595S PZP600143S PZP600144S PZP600555S PZP600556S PZP600618S PZP600620S PZP600506S PZP600507S PZP600657S PZP600560S PZP600561S PZP600646S PZP600649S PZP600654S PZP600107S PZP600104S PZP600147S PZP600615S PZP600617S PZP600537S PZP600598S PZP600102S PZP600194S PZP600583S PZP600157S PZP600175S PZP600087S PZP600088S PZP600444S PZP600575S PZP600576S PZP600151S PZP600106S PZP600525S PZP600471S PZP600472S PZP600599S PZP600231S PZP600232S PZP600520S PZP600226S PZP600453S PZP600541S PZP600229S PZP600230S PZP600522S PZP600523S PZP600432S PZP600433S PZP600623S PZP600624S PZP600223S PZP600585S PZP600228S PZP600653S PZP600225S PZP600179S PZP600182S PZP600183S PZP600184S PZP600185S PZP600186S PZP600188S PZP600190S PZP600218S PZP600219S PZP600222S PZP600452S PZP600629S PZP600632S PZP600437S PZP600539S PZP600224S PZP600573S PZP600574S PZP600564S PZP600565S PZP600578S PZP600579S PZP600481S PZP600482S PZP600483S PZP600484S PZP600442S PZP600621S PZP600622S PZP600580S PZP600551S PZP600644S PZP600645S PZP600468S PZP600469S PZP600470S PZP600540S PZP600655S PZP600572S PZP600625S PZP600553S PZP600554S PZP600440S PZP600626S PZP600628S PZP600630S PZP600631S PZP600150S PZP600152S PZP600548S PZP600549S PZP600570S PZP600633S PZP600518S PZP600597S PZP600145S PZP600563S PZP600139S and PZP600643S
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc. Cardiac Rhythm Management, Mounds View, MN, 
Manufacturer: Medtronic Puerto Rico Operations Company, Juncos, PR. 
REASON Maximo II VR ICD, DR ICD and CRT-D inadvertently include the Capture Management algorithm (Atrial/Right Ventricular/Left Ventricular Capture management). The Capture management algorithm monitors daily pacing thresholds and may increase or decrease pacing amplitudes in response to patients' needs. Although the algorithm is operating correctly, it is not accessible to the clinician for reprogramming.
VOLUME OF PRODUCT IN COMMERCE 1,108 units
DISTRIBUTION Nationwide and countries of Austria, Denmark, Finland, Germany, Italy, Spain, Sweden, UK, Greece, Hong Kong, India, Jordan and Saudi Arabia

PRODUCT Stratus CS Acute Care Troponin I TestPak, Catalog number: CCTNI, in vitro diagnostic, 
CODE Lot numbers: 238070002 exp 2008-09-06, 238077002 exp 2008-09-13, 238084002 exp 2008-09-20, 238091002 exp 2008-09-27, 238105002 exp 2008-10-11, 238112002 exp 2008-10-18, 238119002 exp 2008-10-25, 238126002 exp 2008-11-01, 238133002 exp 2008-11-08, and 238140002 exp 2008-11-15
RECALLING FIRM/MANUFACTURER Dade Behring, Inc., Newark, DE, 
REASON Incorrect result: Potential for false elevation of CTnl results.
VOLUME OF PRODUCT IN COMMERCE 5,868 cartons
DISTRIBUTION Nationwide and countries of Singapore, Saudi Arabia, Japan, Germany, Canada, Bahrain, Australia, Korea, and India

PRODUCT Hardy Diagnostic McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per box. Model number: Hardy = MS05. 
CODE Lot number: 08182; Expiration date: 10/28/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Trek Diagnostic Systems, Cleveland, OH, 
Manufacturer: Hardy Diagnostics, Santa Maria, CA. 
REASON Incorrect result: The absorbance has changed as the standards have aged; the standards’ turbidity has become denser. The recalled lot is now reading 0.15 ABS @ 625 nm. TREK’S internal specification and the manufacturer’s (Hardy Diagnostics) specification is 0.08 – 0.10 ABS @ 625 nm. CLSI specifies 0.08 – 0.13 ABS @ 625 nm.
VOLUME OF PRODUCT IN COMMERCE 4 vials
DISTRIBUTION OH, IL

PRODUCT GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.

CODE Software versions PACS 1.0CSR5/2.0CSR1 and all service packs
RECALLING FIRM/MANUFACTURER GE Healthcare Integrated IT Solutions, Barrington, IL, 
REASON There is a potential patient safety issue involving the use of the F12 keyboard Approve & Complete function. The issue may cause erroneous information to be added to a report when trying to approve and complete it.
VOLUME OF PRODUCT IN COMMERCE 138 units
DISTRIBUTION Nationwide and countries of Canada, China, Denmark, Germany, Hong Kong, India, Ireland, Italy, Japan, Korea, Lebanon, Mexico, Netherlands, Saudi Arabia, Spain, Taiwan and United Kingdom

PRODUCT
a) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/18 cm, sterile; Ref EUSCFS-060018-10-13; GPN REF G18116. Ureteral stent. 

b) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/20 cm, sterile; Ref EUSCFS-060020-10-13; GPN REF G18117. Ureteral stent. 

c) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/22 cm, sterile; Ref EUSCFS-060022-10-13; GPN REF G18118. Ureteral stent. 

d) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/24 cm, sterile; Ref EUSCFS-060024-10-13; GPN REF G18132. Ureteral stent. ;

e) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/26 cm, sterile; Ref EUSCFS-060026-10-13; GPN REF G18119. Ureteral stent. 

f) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/28 cm, sterile; Ref EUSCFS-060028-10-13; GPN REF G18120. Ureteral stent. 

g) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/30 cm, sterile; Ref EUSCFS-060030-10-13; GPN REF G18121. Ureteral stent. 

h) Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/18 cm, sterile; Ref EUSCFS-070018-14-13; GPN REF G18641. Ureteral stent. 

i) Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/20 cm, sterile; Ref EUSCFS-070020-14-13; GPN REF G18123. Ureteral stent. 

j) Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/22 cm, sterile; Ref EUSCFS-070022-14-13; GPN REF G18133. Ureteral stent.  
k) Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/24 cm, sterile; Ref EUSCFS-070024-14-13; GPN REF G18125. Ureteral stent.

l) Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/26 cm, sterile; Ref EUSCFS-070026-14-13; GPN REF G18127. Ureteral stent. 

m) Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/28 cm, sterile; Ref EUSCFS-070028-14-13; GPN REF G18134. Ureteral stent. 

n) Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/30 cm, sterile; Ref EUSCFS-070030-14-13; GPN REF G18130. Ureteral stent. 

o) Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/26 cm, sterile; Ref EUSCFS-060026-10-13; GPN REF G18131. Ureteral stent
CODE
a) Lot number: UF1560100;

b) Lot numbers: UF1565087, UF1401313, and UF1418996;

c) Lot numbers: UF1422329, UF1418997, UF1577105, UF1588937, UF1569283, UF1548852, UF1526279, UF1395329, UF1406376, UF1410869, UF1413150 and UF1385573;

d) Lot numbers: U1528861, U1542982, U1402436, U1361233, U1551529, U1391927, U1364946, U1347423, U1328716, U1416939, U1356437, U1525569, U1391927, U1328716, U1377093 and U1532644;

e) Lot numbers: U1368875, U1532226, U1541632, U1402438, U1356439, U1380409, U1418931, U1538110, U1362570, U1408480, U1411865, U1426173, U1527133, U1357612, U1416045, U1421059, UF1383702, UF1391074, U1426173 and U1525571;

f) Lot numbers: U1358169, U1346509, U1423782, U1342391, U1530194, U1532646, U1354142, U1412596, U1535132 and U1401255;

g) Lot number: UF1424956;

h) Lot number: UF1578018;

i) Lot number: UF1418998;
 
j) Lot numbers: UF1591697, UF1537682, UF1562307, UF1420730, UF1404622, UF1402891, UF1531085, UF1526725, UF1396538, UF1406357, UF1533678, UF1542186, UF1570187, UF1575838, UF1586147, UF1581083, UF1555888 and UF1389149;

k) Lot numbers: U1396476, U1352478, U1584786, U1342393, U1537634, U1530196, U1347425, U1398599, U1425757, U1391929, U1404166, U1360397, U1584786, U1412598, U1363042, U1391929, U1347425, UF1386555 and UF1387624;

l) Lot numbers: U1415656, U1392361, U1343299, U1416941, U1371126, U1363042, U1409768, U1405040, U1546157, U1414495, U1347427, U1551531, U1571113, U1533048, U1525573, U1535611 and U1409768S;

m) Lot numbers: UF1394511, UF1546568, UF1548011, UF1550302, UF1558381, UF1562308, UF1560070, UF1531086, UF1409854, UF1390546, UF1412673, UF1388726, UF1545756, UF1549848, UF1580601, UF1588492, UF1537146, UF1564616, UF1581084, UF1389605, UF1402894 and UF1404646;

n) Lot number: UF1406358;

o) Lot numbers: UF1537358 and UF1362608
RECALLING FIRM/MANUFACTURER Vance Products, Inc., Spencer, IN, by letter dated July 31, 2008. 
REASON The bond may break where the two materials meet, resulting in separation of the stent.
VOLUME OF PRODUCT IN COMMERCE 1,739 sets
DISTRIBUTION Nationwide, Australia, Canada, Colombia, Hong Kong, India, Ireland, Israel, Japan, Malaysia, Mexico, South Korea, Taiwan, Venezuela and Viet Nam

PRODUCT Integra Ruggles Surgical Instrument ACF Distraction Screws Sterile, Rx only; Catalog number: R6357A (12 mm), Catalog number: R6397A (16 mm). 
CODE Lot number: 326081; and Lot number: 327081
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, 
Manufacturer: Instrumed International, Inc., Schaumburg, IL. 
REASON A packaging error had occurred where 16 mm screws were packaged and labeled as 12 mm screws and vice versa.
VOLUME OF PRODUCT IN COMMERCE 351  - 12 mm screws
DISTRIBUTION Nationwide

PRODUCT
a) CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2994-6 24 sets / case CombiSet Bloodlines Including split-septum injection site, viral-retentive transducer protectors, & priming set & Twister device. 

b) CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister) Product Code: 03-2794-0 Bonded CombiSets - includes priming set w/ needleless access port & Y-injection site bonded to arterial line, viral-retentive transducers and Twister device, 
CODE
a) Lot number: 8LR902;
b) Lot numbers: 8ER273, 8HR038, 8JR021, 8KR013, 8LR013, 8ER283, 8HR066, 8JR075, 8KR032, 8LR020, 8HR114, 8JR136, 8KR060, 8LR048, 8HR125, 8JR142, 8KR113, 8LR074, 8HR189, 8JR167, 8KR131, 8LR123, 8HR207, 8JR193, 8KR159, 8LR209, 8HR225, 8JR209, 8KR170, 8LR909, 8HR241, 8JR222, 8KR200, 8HR266, 8JR266, 8KR210, 8HR285, 8KR228, 8KR250, and 8KR271
RECALLING FIRM/MANUFACTURER Fresenius Medical Care North America, Waltham, MA  
REASON Port may crack and separate resulting in potential blood exposure/blood loss for the patient.
VOLUME OF PRODUCT IN COMMERCE 351,800 units
DISTRIBUTION Nationwide and Canada

PRODUCT
a) Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional - Articular surface, Size Blue, 14 MM Height, nonsterile; REF 5971-50-14. Used during total knee arthroplasty surgery to determine the required thickness of the tibial bearing surface to be implanted. Reusable, non-implantable.

b) Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional - Articular surface, Size Blue, 12 MM Height, nonsterile; REF 5971-50-12. Used during total knee arthroplasty surgery to determine the required thickness of the tibial bearing surface to be implanted. Reusable, non-implantable. 
CODE
a) Lot numbers: 60969810 and 60969811;
b) Lot numbers: 61007188, 60987590, 60969807, 60976981 and 60976982
RECALLING FIRM/MANUFACTURER Zimmer Inc., Warsaw, IN, 
REASON Some 12 mm thick devices may have been etched and packaged as 14 mm thick, and vice versa.
VOLUME OF PRODUCT IN COMMERCE 131 devices
DISTRIBUTION Nationwide, Canada, Denmark, Finland, Germany, Poland, Spain, Sweden and United Kingdom

PRODUCT
a) Expressaire, Disposable Tourniquet Cuff 34", 1 line (18), sterile; Cuff type A70107010. Each cuff is marked ExpressAire by Sammons Preston and A70107010. The tourniquet cuff is placed on a patient's thigh during an operation procedure of the lower leg. The cuff is not operational until it is attached to an air pump supply that is owned by the care giving facility (hospital). 

b) Expressaire, Disposable Tourniquet Cuff 34", 2 line (18), sterile; Cuff type A70107011. Each cuff is marked ExpressAire by Sammons Preston and A70107011. The tourniquet cuff is placed on a patient's thigh during an operation procedure of the lower leg. The cuff is not operational until it is attached to an air pump supply that is owned by the care giving facility (hospital). 
CODE
a) Lot numbers: SO590, SO1205, and SO1300;
b) Lot numbers: SO1106, SO2202, SO2227, and SO2232
RECALLING FIRM/MANUFACTURER Virtus, Inc., Batesville, IN, 
REASON The inflation tube may come loose at the connection to the cuff during use.
VOLUME OF PRODUCT IN COMMERCE 5,958 units
DISTRIBUTION Nationwide

PRODUCT Somatom Definition AS, Model number: 8098027. Computed tomography x-ray system. 
CODE Serial numbers: 64064, 64065, 64067, 64068, 64071, 64074, 64077, 64078, 64081, 64085, 64087, 64091, 64097, 64103, 64104, 64105, 64111, 64112, 64113, 64114, 64115, 64117, 64118, 64122, 64123, 64138, 64140, 64142, 64145, 64154, 64164, 64166, 64168, 64169, 64170, 64171, 64172, 64177, 64179, 64180, and 64181
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, 
Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. 
REASON Possible improper installation of tilt transport lock/tilt limiter.
VOLUME OF PRODUCT IN COMMERCE 42 units
DISTRIBUTION Nationwide

PRODUCT Obwegeser Ramus Clamp w/ wide shield, 20 cm, 8", Right. ORAL-MAXILLO-CRANIO-FACIAL SURGERY, Original OBWEGESER Instruments. NOTE: None distributed domestically. Cranio-maxillofacial manual instrumentation to be used to aid in the treatment and care of patients, as determined appropriate, by a trained medical professional. The Obwegeser Ramus Clamps are self-retaining clamps, used on the ascending ramus of the mandible with an extension on one of the blades (shields) to aid in retracting the soft tissue of the cheek. 
CODE Lot Number: 050801
RECALLING FIRM/MANUFACTURER Biomet Microfixation, Inc., Jacksonville, FL, 
REASON The Biomet Microfixation Obwegeser Ramus Clamp, Wide Right 01-7996 were incorrectly etched as the left part number 01-7997.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION Ireland, Japan

PRODUCT AMS InteXen LP Collagen Dermal Matrix, REF 72404066. Product Size: 8 x 12 cm. AMS InteXen LP is a sterile non-perforated processed porcine collagen dermal matrix. Sterile EO. The AMS collagen dermal matric is intended for use in the treatment of hernias where connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, or gastroenterological anatomy. 
CODE Lot/serial numbers: 567398002, 567398003
RECALLING FIRM/MANUFACTURER American Medical Systems, Inc., Minnetonka, MN
REASON The product size shown on the carton labeling does not match the size on the product inside.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION Nationwide

PRODUCT Bard 3D Max Mesh, Left large , Sterile Pre-formed Knitted Polypropylene Product Code: 0151531. Bard 3D Max Mesh is an anatomically shaped pre-formed polypropylene mesh indicated for use in the repair of hernias and chest wall defects. It is designated in two orientations - "Right" and "Left" for use to the right or left side of the human body. There is a blue monofilament Medial marker "M" and a small arrow stitched into each orientation to designate the right or left medial edge of the product. 
CODE Lot number: 43JQD016
RECALLING FIRM/MANUFACTURER
Recalling Firm: Davol, Inc., Sub. C. R. Bard, Inc., Warwick, RI, 
Manufacturer: Bard Shannon Limited, Humacao, PR. 
 REASON Mislabeled; Product labeled as left large, may contain a Right Large.
VOLUME OF PRODUCT IN COMMERCE 232 units
DISTRIBUTION Nationwide

WEEK ENDING FEBRUARY 14

PRODUCT Medtronic O-Arm Intraoperative Imaging System, Catalog number: Bl-700-0027, CODE Software versions prior to version 3.0.2 S/N: 102-155
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Navigation, Inc., Louisville, CO, 
Manufacturer: Medtronic Navigation, Inc., Littleton, MA. 
REASON Navigation accuracy problem: Accuracy may fall outside of specification when used in combination with the Medtronic Synergy Experience StealthStation System Spine Software with the O-Arm Intraoperative Imaging System and tracker.
VOLUME OF PRODUCT IN COMMERCE
54 units
DISTRIBUTION Nationwide, Canada, Czech Republic, Denmark, Germany, Netherlands, South Korea, Poland, South Africa, and Singapore

PRODUCT Excelsior SL-10 Microcatheter, placed in sterile pouch. The ExcelsiorTM SL-10 Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature; a) Model Number M0031681890, Catalog Number 168189, b) Model Number, M0031681810, Catalog Number 168181. 
CODE

a) Domestic Lot/Batch Numbers: 9410580 11094006 9182538 9410580 9797825 11002715 11279121 9797825 11112088 9549061 9761925 9812892 11037582 11022392 11103887 11055248 9468202 11279121 9489075 9558487 11022392 11037582 9567011 9539686 11055248 11280366 9360513 11103722 11037582 11103887 9474771 9563837 9549061 9786599 8559155 9407572 9403111 9466592 9567133 9403111 9410580 9463008 9474934 9805069 9797825 9805069 11022392 11103722 11051431 11103889 11016347 11021069 8559155 9277244 9407574 9323623 9466592 9497150 9407574 9410580 9420194 9539686 9805069 9761923 9797825 11025202 11094006 11021070 9811899 11086559 11279696 11085511 11086559 9360513 11137647 11085284 9277244 9558487 11037582 9786599 9800091 11097465 9497151 9800091 11103886 11055248 9549849 9549062 9813014 9702841 9797824 9797726 11085282 11103886 11002715 11129185 11065054 11112088 9539686 9786599 11103887 11085282 11093861 9474771 9497151 9796878 11023381 11095396 11055248 9471043 11023381 9786599 11034065 11120294 9360513 9471043 9471044 9565700 9540909 9805069 9812499 11002716 9761925 11103722 11085282 11037582 9811899 11065054 11095396 11276374 11110298 11152045 11107242 9800091 9797825 11021072 9797825 11085284 11103886 11279696 11280366 11085511 9796878 9414130 9439020 9468202 9549062 11002715 11279696 9439020 9335697 8559155 9323623 9335694 9323623 9328893 9323623 9332195 9414130 9403111 9360513 9335694 9417932 9317444 9463008 9407572 9439020 9427379 9407574 9471043 9418154 9567011 9563838 9521760 11092289 11107242 9414130 9466590 9427378 9497151 11103722 11065056 11153871 9497151 11103889 8559155 9466592 9549060 11016347 8563856 9466592 9474771 9761925 9778433 9797824 11037582 11280366 11103889 9563837 9796878 11021069 11021072 11108176 11283875 11110298 11146441 9549062 9323623 9558487 9761925 11150467 11034065 9317444 9427379 9812497 9562124 9812497 11110298 9815767 8559155 9471044 9407574 11085511 9761923 11120293 9468202 11002715 11037582 9182538 9497151 9786599 11021070 11071036 11137647 11095396 11129185 11023381 11073526 11137647 11146238 11021069 9815767 9317444 9815768 11036567 8563856 9277244 9357310 9414130 9471044 9474934 9439931 9471044 9805069 9549061 9812497 9797824 11025202 11002430 11051431 11108176 9800091 11071037 9563838 11065054 9805069 9357310 9414130 9427379 9549060 9549061 11112088 9332195 9414130 9427379 9471043 9466591 9539686 9562126 9549849 9567133 9427379 9332195 11021072 11021069 11025202 11021069 11110298 11107242 9474934 11120294 9328893 9277244 9796878 9471043 9417932 9797825 9418154 9471047 9468202 9407574 9474771 9435037 9565700 9812497 9797824 9812891 9813014 11055248 9811899 11086780 11153871 9328893 9414130 11103722 9407572 9407574 9540909 9335697 9805069 11037582 11093861 11088219 11280366 9562124 11103889 11036567 11129185 11152045 11054197 11280366 9797824 11016347 11055248 9414130 9328893 9812361 9539334 9407572 9489075 9496078 9463008 9417932 9567133 9427379 9463008 9427379 9556944 9439020 9463008 9815767 9702841 9797824 11023381 9812891 9817640 11021072 11022392 11103886 11085284 11088219 11129185 11085511 11153871 11085284 9811899 11071037 11023381 11153871 11279121 11021072 9549849 9182538 9417932 9815768 9812891 9796878 9817640 11036567 9812499 11065054 11085511 11086780 9357310 9407574 9277244 9474935 9497150 9471044 11094006 11097465 11225675 8559155 9497151 11103722 9521763 9420194 9471043 9277244 9328893 9277244 9317444 9403111 9539686 11103889 9800091 11094006 11088219 9317444 9439020 9800091 11103886 11134246 11283875 9489075 9474935 9815768 9797824 9817640 11103887 11103722 11021070 11093860 9815767 9407574 11120293 9417931 9468202 9420194 9521763 9471044 9815767 9812891 11016346 11051431 9815768 9812361 9182538 9439020 9526083 9563837 11085282 9474771 9466591 9797824 9812892 9815768 11021069 11103887 9797825 11021069 11103722 9797824 11036567 11103886 11276374 11086559 11120293 9562126 9489075 9796877 9797824 11022392 11051431 11107242 9549062 9812497 11150468 11021072 11025202 11103722 11279121 9549062 11023381 11002430 9474771 9471043 9567133 9563837 9815767 9562124 9471043 11034065 11073526 9800091 11016346 9811899 9439020 9468202 9817640 11016346 11279121 11120293 9786599 11023381 11021072 11002430 9317444 9182538 9317444 9407572 9474771 9335697 9563837 9815767 11279121 11103887 9466592 9539334 11121598 9549062 9521763 9317444 9562124 9182538 9562126 9466592 11085284 9435037 9335697 8559155 9407574 9414130 9439020 9407572 9471043 9414130 9549060 9797825 11021069 11279121 11055248 11092289 11150468 9563837 9420194 9796878 11103887 9539686 9796878 9817388 9812891 11085284 11085282 11016347 11085511 9474934 9427379 11088219 9332195 9761923 9489075 9702841 9496078 11103722 11150468 9403111 9328893 9567011 9796878 9489075 11103886 9332195 9435037 9317444 9360513 9474771 9815768 8563856 9563838 9549062 11034065 11025202 11073526 9797824 11016347 11103887 11107242 9463008 9317444 9497151 9549061 9471044 9702841 11002715 11103886 11021069 11093861 11103886 8563856 9812497 9815767 11085282 11073526 9466590 9817640 11021069 9812361 11021070 8563856 9332195 9328893 9407574 9439020 9497150 9466591 9407574 9474771 9463008 9439929 9439020 9489075 9439929 9558487 9549061 9567133 9526083 9539688 9563837 9558486 9563837 9549060 9335697 9565700 11036567 9812891 9786599 9812891 11021069 11103889 11016346 11022392 9796878 11022392 11037582 11034065 11182789 11021069 11085282 11016346 11086559 11280366 11110298 11055248 11150468 11121598 11093860 11092289 11112088 11073526 11022392 9815768 11150467 9439020 9549061 9549062 9489075 9797824 11025202 11225675 9526083 9800091 9778171 11037582 9813014 11103722 9796878 11150468 11107242 9521760 9815767 11129185 11088219 9796878 9812497 9761925 11002430 8563856 9539334 9549062 9779107 11065056 11086559 9497150 9751645 9735635 9817640 11021070 11225676 9797825 11055248 9439020 9567133 9563837 9817640 11103887 11150468 11134246 9812361 11153871 11121598 9407572 9567133 9463008 9357310 9420194 9549062 9556943 9556944 9812891 11021069 11085511 11065054 11153871 11065054 11112088 9182538 9332195 9439020 9563837 9420194 9796878 9549060 9817640 9812891 11002430 9497152 11016346 9797824 11085511 11021069 11023381 8559155 9539686 9562126 9796877 9817640 11097465 11023381 9779107 11095396 11120293 11121598 11103887 9414130 11085284 11088219 9815767 9797726 11016346 8563856 9439020 9435037 9521763 9439020 9497150 9439020 9471043 9562126 9466590 9471044 9797824 9754894 9812892 9805069 11103889 9800091 11002716 11129938 9797825 9812497 11153871 11021072 11279696 9761923 11279121 9332195 9328893 9439932 9468202 9540909 9420194 9435037 9565700 9563837 9797726 11021069 11037582 11103722 11097465 9562126 9812892 11055248 11129185 11121598 9471043 9323623 9489075 9549062 9562126 9562124 11002716 11108176 11023381 11022392 8563856 8559155 9332195 9357310 9407574 9407572 9407574 9407572 9407574 9357310 9489075 9439020 9466592 9471044 9471043 9497150 9526083 9420194 9471044 9497151 9565700 9521760 9567133 9526083 9558487 9539686 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b) Lot/Batch Numbers: 9703869 9582725 11032901 9563839 9703869 11017848 11018893 9582725 11017847 11018893 11067023 11032901 9800280 9750583 9446914 9637671 11257964 9703869 11017847 9499078 9750583 11067023 9750583 9827896 9499078 11018895 11017848 9499078 11019057 9827896 9582725 11007160 9446914 9703869 9750582 9582725 11018893 9827896 9446914 11019057 9499078 11017847 9499078 9800280 9446914 9499078 9582725 9446914 9582725 9827896 11017848 9827896 11017847 9637671 11018895 9827896 11017847 9563839 11007160 9800280 9563839 11018893 11067023 11032901 11017847 11019057 11032901 9703869 9499078 9637671 9582725 9750583 9582725 9637671 9446914 11019057 9827896 9563839 11018893 11032901 9750582 9827896 9499078 11018893 9563839 11019057 11067023 9750583 9703869 11032902 9582725 9827896 11019057 11018895 9582725 9563839 9750583 9800280 11018893 11067023 11017848 11018893 9446914 9563839 9582725 11032902 11007160 11257964 11067023 11018893 9499078 9800280 9750582 9800280 9750582 11018895 11019057 9446914 9750582 9582725 11017847 9703869 9637671 11017848 11018893 11032901 9800280 9499078 9637671 11018895 11067023 11018893 11032902 11067023 9499078 11017848 11017847 11067023 11019057 9750582 9637671 9827896 11017847 9827896 9750582 11032902 11018895 11257964 9563839 11017847 11067023 9750582 11067023 9563839 11017848 11018893 9499078 11018894 9563839 9499078 9750583 9827896 11067023 9827896 9637671 9703869 9827896 9703869 11017848 9446914 11019057 9499078 9446914 9582725 11017848 11032902 9827896 9800280 11019057 9800280 9499078 9750582 9446914 11017847 11018893 11067023 9750582 9499078 11017847 9800280 11018893 9750582 9446914 11018895 9750582 11032901 11017847 9827896 9563839 11018893 9750582 11007160 9750583 9582725 9563839 9827896 11018893 11067023 9827896 11018895 11032901 11032902 11019057 9499078 9446914 9750583 9750582 9637671 9446914 9800280 9446914 11017848 11257964 9800280 9637671 9499078 9750582 9499078 9563839 11019057 9750582 9827896 9800280 9563839 11017848 11017847 9637671 9499078 9582725 9637671 9750583 9637671 9800280 9750582 9446914 9499078 9582725 11032901 9800280 11067023 11018893 11017847 11019057 9563839 11018894 9750582 9750583 9563839 9446914 9800280 11017848 9827896 11018893 9750582 9800280 9827896 11257964 9637671 9827896 11257964 11018895 11017847 11018893 9703869 11017848 11017847 11067023 9827896 11018895 9637671 9582725 0009213455 0009224253 0009224267 0009368091 0009368638 0009368640 0009446914 0009499078 0009563839 0009582725 0009613990 0009637671 0009645145 0009668007 0009678226 0009678228 0009703869 0009750582 0009750583 0009800280 0009827896 0011007160 0011007161 0011017847 0011017848 0011018893 0011018894 0011018895 0011019057 0011032901 0011032902 0011067023 0011257964 and 0011261956.
For International Lot Numbers, contact your Boston Scientific Corporation representative.
RECALLING FIRM/MANUFACTURER Boston Scientific Corporation, Fremont, CA, 
REASON Packaging issue may result in failure to maintain sterile barrier.
VOLUME OF PRODUCT IN COMMERCE
21,423 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Stryker Medical Stair-PRO Stair-Chair with wheels, patient transport device, Model 6251.

b) Stryker Medical Stair-PRO Stair-Chair with wheels and a track system, patient transport device, Model 6252. 

c) Stryker Medical Stair-PRO Evacuation Chair civilian use stair chair, patient transport device, Model 6253. 
CODE
a) Serial numbers: 080940844, 080940845, 080940858, 080940819, 080940820 and 080940640;

b) Serial numbers: 080940553, 080940768, 080940600, 080940601, 080940831, 080940592, 080940899, 080940821, 080940822, 080940766, 080940767, 080940597, 080940642, 080940643, 080940832, 080940833, 080940834, 080940835, 080940836, 080940580, 080940581, 080940825, 080940639, 080940595, 080940596, 080940589, 080940765, 080940838, 080940839, 080940840, 080940607, 080940608, 080940829, 080940594, 080940582, 080940583, 080940584, 080940611, 080940612, 080940613, 080940830, 080940763, 080940826, 080940827, 080940871, 080940644, 080940859, 080940860, 080940861, 080940862, 080940863, 080940864, 080940865, 080940866, 080940867, 080940868, 080940869, 080940828, 080940593, 080940760, 080940761, 080940898, 080940837, 080940551, 080940552, 080940752, 080940769, 080940873, 080940874, 080940875, 080940876, 080940877, 080940641, 080940770, 080940843, 080940247, 080940248, 080940762, 080940842, 080940753, 080940754, 080940755, 080940756, 080940757, 080940758, 080940759, 080940841, 080940587, 080940588, 080940585, 080940586, 080940771, 080940550, 080940645, 080940646, 080940647, 080940648, 080940649, 080940750, 080940751, 080940823, 080940824, 080940870, 080940764 and 080940872;

c) Serial numbers: 080940895, 080940896, 080940578, 080940614, 080940615, 080940616, 080940618, 080940619, 080940620, 080940621, 080940623, 080940624, 080940625, 080940626, 080940628, 080940880, 080940571, 080940572, 080940573, 080940574, 080940575, 080940576, 080940629, 080940630, 080940599, 080940554, 080940555, 080940887, 080940888, 080940889, 080940890, 080940891, 080940892, 080940893, 080940894, 800940881, 080940772, 080940773, 080940774, 080940564, 080940565, 080940566, 080940850, 080940856, 080940556, 800940557, 080940558, 080940559, 080940560, 080940561, 800940562, 080940563, 080940633, 080940634, 080940635, 080940636, 080940245, 080940246, 080940851, 080940852, 080940853, 080940854, 080940846, 080940847, 080940848, 080940849, 080940810, 080940811, 080940812, 080940813, 080940814, 080940815, 080940577, 080940631, 080940632, 080940617, 080940622, 080940627, 080940818, 080940857, 080940882, 080940897, 080940816, 080940817, 080940567, 080940568, 080940569, 080940570, 080940579, 080940800, 080940801, 080940802, 080940878, 080940879, 080940855, 080940883, 080940884, 080940885, 080940886, 080940637, 080940638 and 080940803
RECALLING FIRM/MANUFACTURER Stryker Medical Division of Stryker Corp., Portage, MI
REASON Handle could come off. The bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay in evacuation.
VOLUME OF PRODUCT IN COMMERCE
213 chairs
DISTRIBUTION Nationwide, India, Netherlands and United Kingdom

PRODUCT
a) Terumo Advanced Perfusion System 1 Air Bubble Detection Module; Catalog number 802110. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures. 

b) Terumo Advanced Perfusion System 1 Pressure Monitoring Unit; Catalog number 802112. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures. 

c) Terumo Advanced Perfusion System 1 Temperature Monitoring Systems; Catalog number 802114. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures. 

d) Terumo Advanced Perfusion System 1 Pressure Venous Occluder; Catalog number 803480. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures. 

e) Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures. 
CODE
a) Serial number: 0727;

b) Serial numbers: 00001 through 01246, 01257 through 01277, 01279 through 01286, 01288 through 01295. 01298 through 01308, 01310 through 01315 and 01319 through 01320;

c) Serial number: 0637;

d) Serial number: 0220;

e) Serial number: 0188 
RECALLING FIRM/MANUFACTURER Terumo Cardiovascular Systems Corp., Ann Arbor, MI, 
REASON The system may malfunction due to t-filter corrosion on an internal circuit board.
VOLUME OF PRODUCT IN COMMERCE
1,219 units
DISTRIBUTION Nationwide and countries of Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam

PRODUCT Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456. Medical device, intended for ultrasound examination of peripheral pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. 
CODE
Batch/Lot numbers: 11420600, 11420601, 11420602, 11611665, 11716746, 11720663, 11721240, 11722752, 11727107, 11727873, 11727874, 11728458, 11731354, 11732665, 11735762, 11736559, 11739563, 11742590, 11754455, 11758051, 11764281, 11777994, 11788045, 11790848, 11820112, 11897802, 11897904, and 11904295
RECALLING FIRM/MANUFACTURER Boston Scientific Corp., Fremont, CA,
REASON Product is mislabeled as having a shelf life of 3 years, where the actual shelf life is 1 year.
VOLUME OF PRODUCT IN COMMERCE
1,033 units
DISTRIBUTION Nationwide and Panama

PRODUCT
a) REF: 915-1006 Lactosorb System, Lacto Endobrow Lift Complete, 10X13CM. (3.75X5.25") (WXL), Polypropylene, Radel. Non Sterile Product. Aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. 

b) REF: 915-1000 Lactosorb, Office Fixation Kit, 1 Screwdriver, 1 Tap Handle, 1 Drill Bit, 1 Screw Extractor, 1 Self Drilling Tap, S/S. Aluminum , Teflon, Ra del. Non Sterile Product. Aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. 

c) REF: 01-6871 IMF Set 254 X 127 X34MM (10"X1"X1.2") Polypropylene, Radel, AL, SS, T.C. Non Sterile Product. Aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. 

d) REF 01-6851 Office System 1.5/IMF Small Office Set, 156MMX125MM, (6.4"X4.9") Polypropylene, Ultem, Radel, AL, SS. Non Sterile Product.  Aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. 
CODE
a) Lot numbers: 026660, 044820, 044830, 044900, 069630, 119940, 175710, 207320, 286830, 323270, 373220, 375190, 393190, 396390, 464030, 620270, and 718350;

b) Lot numbers: 056960, 060930, 071130, 085650, 155540, 181390, 2247100, 248520, 368120, 584110, 716090, 716100, 716110, 717510, 782200, 851620, 990550, and 999999;

c) Lot numbers: 907650, 252341, and 300870;

d) Lot numbers: 108450, and 103010
RECALLING FIRM/MANUFACTURER Biomet Microfixation, Inc., Jacksonville, FL, 
REASON The finished trays were packaged and shipped to facilities without the instructions for use and without the single use symbol on the packaged tray label.
VOLUME OF PRODUCT IN COMMERCE
420 units
DISTRIBUTION Nationwide and countries of Argentina, Australia, Canada, Columbia, Hong Kong, Japan, Mexico, New Zealand, Puerto Rico, Taiwan, Thailand, Denmark, France, Netherlands, Greece, Italy, Norway, Finland, Spain, Czech Republic, and Venezuela

PRODUCT Restoration Modular Conical Distal Stem; Sterile, Titanium Alloy. One unit per package. This system is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. Catalog No. 6276-7-017 (17mm), Catalog No. 6276-7-014, (14mm). 
CODE Lot Code CAXHA68D; Lot Code CAXHB18A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, 
Manufacturer: Stryker Ireland, Ltd., Orthopedics, Carrigtohill, County Cork, Ireland. 
REASON Stryker became aware of a lot for lot mix up.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION Nationwide

PRODUCT Regenesis Biomedical PROVANT Wound Therapy System, Model 4201 - The Provant Wound Therapy System is a solid-state, fixed-power output radio frequency generator and transmitter designed to operate at the FCC authorized medical device frequency of 27.12 MHz. Provant transmits a fixed dose of non-ionizing, non-thermal RF energy via an applicator pad that is placed adjacent to the patient's dressed wound. The Provant Wound Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. 
CODE Serial Numbers: 704, 920, 460, 709, 711, 714, and 727
RECALLING FIRM/MANUFACTURER
Regenesis Biomedical Inc., Scottsdale, AZ, 
REASON Under certain unusual clinical circumstance, the affected devices may be unable to generate a therapeutic dose of radio frequency energy. As such, for these few devices, the effectiveness of Provant therapy may be impaired.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION WV, VA and NC

PRODUCT
a)  Solar Shoulder Humeral Stem. These devices are modular components of a total shoulder system. These humeral stems are intended for use with humeral heads and glenoid components in primary or revision total shoulder arthroplasty. Catalog Numbers, Description 5351-4103 SHOULDER - HUMERAL STEM 7mm, 5351-4105 SHOULDER - HUMERAL STEM 9mm, 5351-4105 SHOULDER - HUMERAL STEM 9mm, 5351-4107 SHOULDER - HUMERAL STEM 11mm, 5351-4108 SHOULDER - HUMERAL STEM 12mm, 5351-4108 SHOULDER - HUMERAL STEM 12mm, 5351-4109 SHOULDER - HUMERAL STEM 13mm VWHMKE, 5351-4110 SHOULDER - HUMERAL STEM 14mm HTXMKE, 5351-4110 SHOULDER - HUMERAL STEM 14mm, 5351-4113 SHOULDER - HUMERAL STEM 17mm, and 5351-4205 SHOULDER - HUMERAL 200mmX9mm. 

b) Triathlon Cemented Stem - Knee These devices are modular components of a total knee system. These modular stems are intended for use with femoral and tibial components in primary or revision total knee arthroplasty. Item Number, Product Name: 5560-S-209 TRI CEMENTED STEM 9MMX100MM and 5560-S-209 TRI CEMENTED STEM 9MMX100MM.

c) Triathlon-Press-Fit Stem These devices are modular components of a total knee system. These modular stems are intended for use with femoral and tibial components in primary or revision total knee arthroplasty. Catalog numbers, Description: 5565-S-015 TRI PRESS-FIT STEM 15MM X 100MM, 5565-S-016 TRI PRESS-FIT STEM 16MM X 100MM, 5565-S-016 TRI PRESS-FIT STEM 16MM X 100MM, 5565-S-017 TRI PRESS-FIT STEM 17MM X 100MM, 5566-S-012 TRI PRESS-FIT STEM 12X150MM, 5566-S-013 TRI PRESS-FIT STEM 13X150MM, and 5566-S-018 TRI PRESS-FIT STEM 18X150MM. 

d) Omnifit HA Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog number, Description: 6017-0525A OMNIFIT HA HIP STEM #5 and 6017-1035A OMNIFIT HA HIP STEM #10.

e) Omnifit Normalized Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog number, Description: 6034-0730 OMNIFIT NORMALIZED HIP STEM. 

f) Secur-Fit Max Hip Stem. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog numbers, Description: 6051-0625S SECUR-FIT MAX 132 HIP STEM #6, 6051-0730S SECUR-FIT MAX 132 HIP STEM #7, 6051-0730S SECUR-FIT MAX 132 HIP STEM #7, 6051-0830S SECUR-FIT MAX 132 HIP STEM #8, 6051-0830S SECUR-FIT MAX 132 HIP STEM #8, 6051-0935S SECUR-FIT MAX 132 HIP STEM #9, 6051-1035S SECUR-FIT MAX 132 HIP STEM #10, 6051-1140S SECUR-FIT MAX 132 HIP STEM #11, 6051-1140S SECUR-FIT MAX 132 HIP STEM #11, 6052-0830S SECUR-FIT MAX 127 HIP STEM #8, 6052-0935S SECUR-FIT MAX 127 HIP STEM #9, 6052-1035S SECUR-FIT MAX 127 HIP STEM #10, 6052-1035S SECUR-FIT MAX 127 HIP STEM #10 and 6052-1240S SECUR-FIT MAX 127 HIP STEM #12. 

g) Primary Secur-fit Plus Max Hip Stem. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog numbers, Description: 6054-0812S PRIMARY SECUR-FIT PLUS MAX #8/12, 6054-0812S PRIMARY SECUR-FIT PLUS MAX #8/12, 6054-0915S PRIMARY SECUR-FIT PLUS MAX #9/15, 6054-1014S PRIMARY SECUR-FIT PLUS MAX #10/14, 6054-1014S PRIMARY SECUR-FIT PLUS MAX #10/14, 6054-1014S PRIMARY SECUR-FIT PLUS MAX #10/14 and 6054-1218S PRIMARY SECUR-FIT PLUS MAX #12/18. 

h) Accolade C CS. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog number, Description: 6057-0335D ACCOLADE C CS 127 NK, 6057-0537D ACCOLADE C CS 127 NK, 6057-0740D ACCOLADE C CS 127 NK and 6058-0335D ACCOLADE C CS 132 NK. 

i) Omnifit HFX Hip Stem. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog numbers, Description: 6070-0730A OMNIFIT HFX HIP STEM SIZE #07 132, 6070-0730A OMNIFIT HFX HIP STEM SIZE #07 132, 6070-0730A OMNIFIT HFX HIP STEM SIZE #07 132, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 and 6070-1140A OMNIFIT HFX HIP STEM SIZE #11 132. 

j) Accolade HFx. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty.  Catalog # Description: 6077-0230 Accolade HFx Size #2, 6077-0230 Accolade HFx Size #2, 6077-0335 Accolade HFx Size #3, 6077-0435 Accolade HFx Size #4, 6077-0435 Accolade HFx Size #4 and 6077-0435 Accolade HFx Size #4. 

k) Omnifit FC Cemented Stem. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog number, Description: 6093-1035 OMNIFIT-FC CEMENTED STEM and 6093-1035 ONMIFIT FC CEMENTED STEM. 

l) Omnifit Eon. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog number, Description: 6098-0630 OMNIFIT EON 132, 6098-0630 OMNIFIT EON 132, 6098-0735 OMNIFIT EON 132, 6098-0940 OMNIFIT EON 132 and 6098-1140 OMNIFIT EON 132. 

m)  Japanese Omnifit Eon 127 NK. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Item number: J6097-0425, Item number J6097-05390. 

n) Reunion HA Fracture Stem. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog numbers, Description: R5351-4507 REUNION HA FRACTURE STEM 7MM, R5351-4508 ReUnion HA Fracture Stem 8MM, R5351-4508 ReUnion HA Fracture Stem 8MM and R5351-4509 REUNION HA FRACTURE STEM 9MM. 

o) Secur-Fit ARC/HA Collar Stem. These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty. Catalog number, Description: S-2337-HF09 SECUR-FIT ARC/HA COLLAR STEM #9, S-2337-HF09 SECUR-FIT ARC/HA COLLAR STEM#9 and S-2337-HF10 SECURFIT ARC/HA COLLAR STEM#10.  
CODE
a) Lot Numbers: XKRMHE, 8ETMJE, 8EYMJE, V45MKE, VV3MKE, VV4MKE, VWHMKE, HTKMKE, T7TMKE, KKHMKE and MT9MKE;

b) Lot numbers: N3N31K, N3N31W;

c) Lot numbers: M3M07B, M3M01B, M3M01E, M3M03A, M3L11F, M3L12B, M3L17D;

d) Lot numbers: 3PMMNE, NKAMME;

e) Lot number: PJ9MLE;

f) Lot numbers: HKNMME, K03MME, K08MME, E56MLE, J41MLE, EN1MME, 70PMME, 4PMMME, 901MME, V3PMLE, 5ERMME, 69WMME, AL8MME, EP4MME;

g) Lot numbers: 72MMME, WA5MLE, 11AMME, AKKMME, AKXMME, DHKMME, EP2MME;

h) Lot numbers: JYLMME, JYNMME, E5EMME, JYVMME;

i) Lot numbers: P7MMME, RHWMME, VJMMME, 0J0MNE, D9VMME, VK0MME, T9RMME, 0HDMNE, 0HEMNE, P7XMME, RE8MME, REDMME, VK2MME, VK3MME, 0HKMNE;

j) Lot numbers: 8XAMLE, 8XEMLE, 8PAMME, 8PEMME, PJLMLE, R27MLE;

k) Lot numbers: 28RMLE, 3DHME;

l) Lot numbers: 48HMME, TAMMME, 0W9MNE, TN3MLE, 2HNMME;

m) Lot number: TN7MLE and lot number: 41WMME;

n) Lot numbers: T2T72836-J, T2N71522-I, T2T72422-C, T2N71523-G;

o) Lot numbers: 8T3MME, 99EMME, 2H0MME
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, 
REASON Stryker Orthopedics became aware of a visual defect in certain blister packages of certain devices.
VOLUME OF PRODUCT IN COMMERCE
322 units
DISTRIBUTION Nationwide and countries of Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden

WEEK ENDING FEBRUARY 21

PRODUCT DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A portable, AC-powered or compressed air-powered suction pump. The device may include a microbial filter. 
CODE
Serial numbers: PRD000006, PRD000012, PRD000013, PRD000014, PRD000046, PRD000082, PRD000083, PRD000084, PRD000088, PRD000090, PRD000091, PRD000099, PRD000100, PRD000101, PRD000102, PRD000152, PRD000174, PRD000175, PRD000177, PRD000184, PRD000186, PRD000189, PRD000191, PRD000193, PRD000201, PRD000202, PRD000203, PRD000206, PRD000207, PRD000209, PRD000225, PRD000226, PRD000229, PRD000230, PRD000262, PRD000269, PRD000323, PRD000341, PRD000355, PRD000363, PRD000364, PRD000368, PRD000370, PRD000371, PRD000373, PRD000374, PRD000375, PRD000383, PRD000385, PRD000386, PRD000388, PRD000389, PRD000390, PRD000392, PRD000393, PRD000399, PRD000400, PRD000401, PRD000403, PRD000405, PRD000406, PRD000407, PRD000409, PRD000411, PRD000415, PRD000417, PRD000419, PRD000420, PRD000422, PRD000425, PRD000426, PRD000428, PRD000432, PRD000443, PRD000447, PRD000448, PRD000449, PRD000450, 0425198002000, and 04275195001000
RECALLING FIRM/MANUFACTURER Sunrise Medical, Somerset , PA
REASON Improper suction: Regulator knob does not turn properly which can affect the suction level.
VOLUME OF PRODUCT IN COMMERCE 78 units
DISTRIBUTION Nationwide and countries of Mexico , Guatemala , Columbia , and Costa Rica

PRODUCT SERVO Ventilator 300A (SV300A). The device is intended for general and critical ventilatory care of adult, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside and for intra-hospital transport. It is not intended for transport use in ambulances or in helicopters in the US market. 
CODE All units of SV300A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Maquet, Inc., Bridgewater , NJ , 
Manufacturer: Maquet Critical Care AB , Solna , Sweden . 
REASON SERVO Ventilator 300A could cause hyperventilation if the use of the PC or PRVC mode with the Automode function set to "On" in Neonatal and Pediatric patient ranges with small tidal volumes and short set inspiratory rise time.
VOLUME OF PRODUCT IN COMMERCE 3,688 units
DISTRIBUTION Nationwide

PRODUCT
a) Zimmer TIV Self Tap Screw, 40 mm. Item number: 48231904000. NOTE: This product is not sold in the United States . The device is used to attach healing plates to long bones for stabilization of fractures during the normal healing process. Devices are individually packaged and sold sterile. 

b) Zimmer TIV Self Tap Screw, 42 mm. Item number: 48231904200. NOTE: This product is not sold in the United States . The device is used to attach healing plates to long bones for stabilization of fractures during the normal healing process. Devices are individually packaged and sold sterile. CODE
a) Lot number: 60557215;
b) Lot numbers: 60548987, 60548986, 60548999, 60557220 and 60557219
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer, Inc., Warsaw , IN , 
Manufacturer: Zimmer Manufacturing B.V., Mercedita, PR. 
REASON The package may contain a 40 mm long screw instead of the labeled 42 mm long screw, or vice versa.
VOLUME OF PRODUCT IN COMMERCE 508 units
DISTRIBUTION Japan

PRODUCT
a) Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile; Cat. no./REF 6647, a) inner pouch UPN M00566470 and b) outer carton UPN M00566471. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means. 
 
b) Boston Scientific EndoVive 24F (8 mm) Safety PEG Kit, Push Method for use with sterile Xylocaine ampule, latex free, sterile; Cat. no./REF 6649, a) inner pouch UPN M00566490 and b) outer carton UPN M00566491. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means. 
 
c) Boston Scientific EndoVive 20Fr (6.7 mm) Safety PEG Kit, Push Method, latex free, sterile; Cat. no./REF 6653, a) inner pouch UPN M00566530 and b) outer carton UPN M00566531. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means. 
 
d) Boston Scientific EndoVive 20F (6.7 mm) Safety PEG Kit, Push Method for use with pre-filled lidocaine syringe, latex free, sterile; Cat. no./REF 6673, a) inner pouch UPN M00566730 and b) outer carton UPN M00566731. The devices are indicated for providing nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means. 
CODE
a) a) Lot numbers: 12004380, 12017735, 12039127, 12068485, 12074073, 1209443, 12115001, 12127100 and 12159831; b) lot numbers of 12069493, 12069494, 12112331, 12123598 and 12145424;
 
b) a) Lot numbers: 12007899 and b) lot numbers: 12065904 and 12148450;
 
c) Lot number: 12080466 on both pouches;
 
d) a) Lot numbers: 12015222, 12015223, 12017140, 12035930, 12037032, 12038621, 12056814, 12074992, 12096466, 12110667, 12111382, 12111566, 12112012, 12113348, 12129137, 12133028, 12133803 and 12133804; b) lot numbers: 12065719, 12065900, 12065903, 12088673, 12105251, 12115743, 12119946, 12145423 and 12148447
RECALLING FIRM/MANUFACTURER Boston Scientific, Corp., Spencer , IN 
REASON The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
VOLUME OF PRODUCT IN COMMERCE 2,460 units
DISTRIBUTION Nationwide

PRODUCT
a) Stryker PainPump, Two Site Infusion Kit with ExFen 2.5", 120 mL Infusion Kit, sterile, 5 per box. Product number: 0500-166-025, REF 500-166-25. A disposable syringe infuser which uses sustained vacuum pressure to deliver a continuous infusion of medications or fluids at a controlled rate. It delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. It is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous.
 
b) Stryker PainPump Two Site Infusion Kit with ExFen 5.0", 120 mL Infusion Kit, sterile, 5 per box. Product number: 0500-166-050, REF 500-166-50. A disposable syringe infuser which uses sustained vacuum pressure to deliver a continuous infusion of medications or fluids at a controlled rate. It delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. It is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous. ;
 
c) Stryker PainPump Two Site Infusion Set, sterile, 10 per box. Product number: 0500-200-000, REF 500-200. A disposable syringe infuser which uses sustained vacuum pressure to deliver a continuous infusion of medications or fluids at a controlled rate. It delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. It is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous. 
CODE
a) Lot number: 2008011403, 2008020502, 2008061701 and 2008072102;
b) Lot number: 2008011404 and 2008050201;
c) Lot number: 2008011601, 2008040204 and 2008061801;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Instruments Div. of Stryker Corp., Portage , MI , 
Manufacturer: Medisize Donegal Healthcare, Donegal , Ireland . 
REASON There is a potential for the pump to overinfuse.
VOLUME OF PRODUCT IN COMMERCE 118 boxes
DISTRIBUTION Nationwide

PRODUCT Stryker PainPump 2 Blockaid, 400 mL PainPump for Continuous Nerve Block, sterile, 5 per box. REF 575-100, Product Number 0575-100-000. The device is used to deliver controlled amounts of medication and narcotics directly to the intraoperative site for pain management; the pump infuses the medication at an hourly flow rate and provides the option for patient controlled bolus doses. Medications and narcotics are infused through intramuscular, subcutaneous and epidural routs. It is also intended for controlled delivery of local anesthetics and narcotics in close proximity to nerves for postoperative regional anesthesia and pain management, in which case routes of administration may be intraoperative, perineural or percutaneous.
CODE
Lot numbers: 08219012, 08220012, 08221012, 08222012, 08225012, 08226012, 08229012, 08231022, 08233012, 08234012, 08235012, 08238022, 08239012, 08241012, 08242012, 08243012, 08246022, 08247012, 08249032, 08250012, 08252022, 08252032, 08253012, 08254012, 08256032, 08256042, 08257012 and 08259022
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Instruments, Div. of Stryker Corp., Portage , MI , 
Manufacturer: Stryker Puerto Rico, Inc., Arroyo, PRng.
REASON The pump may display an E-4 error message, which causes the pump to stop dispensing the pain medication.
VOLUME OF PRODUCT IN COMMERCE 2,009 boxes
DISTRIBUTION Nationwide and Canada

PRODUCT Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build 122. Part Number 8139789. 
CODE
Serial numbers: 5190, 5350, 5355, 5364, 5367, 5374, 5377, 5398, 5405, 5410, 5419, 5424, 5165, 5166, 5202, 5238, 5298, 5306, 5342, 5352, 5365, 5366, 5373, 5378, 5379, 5380, 5397, 5399, 5400, 5401, 5402, 5409, 5414, 5416, 5423 and 5425
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Concord , CA , 
REASON If a plan contains a sequence of beams, including at least 1 ARC treatment beam and if during the setup stage of a beam following an ARC beam in the delivery sequence a termination occurs, and the user selects the immediate resumption feature, syngo RT Therapist Express systems will display and record a second delivery of a prior beam and not the delivery of the current beam in certain circumstances.
VOLUME OF PRODUCT IN COMMERCE 36 units
DISTRIBUTION Nationwide and countries of Netherlands , Germany , Poland , Norway , Australia , Hungary , Belgium , New Zealand , France , Malaysia , Spain and Canada

PRODUCT GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure. 
CODE Software version 2.1.5.5 and 3.0.4 and higher
RECALLING FIRM/MANUFACTURER GE Healthcare Integrated IT Solutions, Barrington , IL ,
REASON There is a potential patient safety issue involving patient jacket content, which may result in unintended historical image(s) being displayed.
VOLUME OF PRODUCT IN COMMERCE 476 units
DISTRIBUTION Nationwide and Canada

PRODUCT Low Profile U-Joint Driver for the SynFix Mini-Open System, Catalog number 03.802.231. The Synthes SynFix LR is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the SynFix LR can be packed with autograft. 
CODE Lot numbers: 2317363, 2331806, 2331810, 2387975, 2387976, 2401982, 5637286, 5644605, 5660377, 5664629, 5826243, and 5826244
RECALLING FIRM/MANUFACTURER
Recalling Firm: Synthes Spine, West Chester , PA ,
Manufacturer: Synthes Gmbh, Oberdorf , Switzerland . 
REASON Screwdriver tip may break off and lodge in the screw head.
VOLUME OF PRODUCT IN COMMERCE 381 units
DISTRIBUTION Nationwide and countries of Canada and Switzerland

PRODUCT Ergolift 400 Lbs. Floor Lift, model/part numbers ERGOLIFT and ERGOLIFT-2. The equipment is intended to be used in hospitals, nursing homes, or other health care facilities by trained caregivers for the transfer of patients. 
CODE Serial numbers: ERLI-0001 through ERLI-1717, manufactured between 1995 and 1999
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle , IL , .
Manufacturer: B.H.M. Medical, Inc., Magog , Canada . 
REASON Report of structural failure of the mast during use.
VOLUME OF PRODUCT IN COMMERCE 220 lifts
DISTRIBUTION Nationwide

PRODUCT Posey Connecting Straps and Belts/Locking Cuffs. The device is used to limit the wearer's movement by securing cuffs to a connecting strap or belt. Catalog numbers: 2320, 2330, 2346, 2350, 2351, 2355, 2360, 2208, 2209, 2210, 2211, 2212 and 2213. 
CODE Unknown
RECALLING FIRM/MANUFACTURER J. T. Posey Company, Arcadia , CA 
REASON A patient may be able to catch the belt on a stationary object and use their body force to tear or break the strap, creating freedom of arm movement.
VOLUME OF PRODUCT IN COMMERCE 51,200 devices (approximately)
DISTRIBUTION Nationwide and countries of Australia , Belgium , Canada , France , Germany , Ireland , Italy , Korea , Lithuania and Netherlands

PRODUCT Stryker AVS AL Spacer Trial Inserter; Non Sterile. Catalog number: 48329800.
CODE Lot numbers: 056398 and 056399
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Spine, Allendale ,  NJ , 
Manufacturer: Stryker Spine, Cestas, Aquitane , France . 
REASON DESIGN FLAW: Issues were reported concerning fracture of handle, difficulty in removing inserter and inserter difficult to lock.
VOLUME OF PRODUCT IN COMMERCE 37 units
DISTRIBUTION Nationwide

PRODUCT
a) VOYAGER NC Coronary Dilatation Catheter, 4.5 X 8.0 mm. The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, (2) Balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, and (3) Balloon dilatation of a stent after implantation. Part Number: 1011759-08. ;
 
b) VOYAGER NC Coronary Dilatation Catheter, 4.5 X 12.0 mm. The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, (2) Balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, and (3) Balloon dilatation of a stent after implantation. Part Number: 1011759-12, 8061961 and Part Number: 1011750-12. 
CODE
a) Lot numbers: 8050961 and 8062361;
b) Lot Numbers: 8041051, 8050561, Lot Number 8100761
RECALLING FIRM/MANUFACTURER Abbott Vascular-Cardiac Therapies dba Guidant Corp., Temecula , CA , 
REASON The recall was initiated after Abbott Vascular received reports the protective, yellow balloon sheath of the 4.5mm diameter VOYAGER NC Coronary Dilatation Catheter has been tight. If unnoticed by the user, there is a potential to cause damage to the balloon dilatation catheter during removal of the sheath. The balloon sheath covers the balloon, maintaining the fold configuration and protects the balloon during shipment. It is disposed of during device preparation.
VOLUME OF PRODUCT IN COMMERCE 224 devices
DISTRIBUTION Nationwide and Internationally

PRODUCT IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Catalog numbers: E18R4000, L5NQJ000, L57OP000, LBCDB000, and E2ZCK000. IMPAX Cardiovascular is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. The IMPAX Centric Polling Procedure provides a mechanism to ensure that patient demographic and merge/split operations performed on the IMPAX database utilizing the IMPAX Service Tool are captured and applied to the IMPAX CV database, in order to keep patient updates from the IMPAX database synchronized with the IMPAX CV database. Equipment number: 15013696; Equipment number: 10281800; Equipment number: 10262174; Equipment number: 15003839; and Equipment number: 15009724. 
CODE Serial number: KQRCPF9; Serial number: BQWBZ81; Serial number: FB5C561; Serial number: USE708NBP3 and Serial number: GN6Z1E1
RECALLING FIRM/MANUFACTURER AGFA Corp., Greenville , SC , 
REASON Polling procedure may fail when multiple merge/split is carried out.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION Nationwide

PRODUCT Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor Cardiac Ablation Control System, Disposable connecting cable, accessory to the Epicor Cardiac Ablation Control System. The cable is used to connect the Epicor disposable tissue device (UltraCinch or UltraWand) to the Epicor Cardiac Ablation control System. 
CODE
All serial numbers affected, lot numbers 08051201, 08051504, 08052202, 08062605, 08070702, 08070704, 08071604, 08071801, 08072505, 08072506, 08080119, 08080801, 08082702, 08091112, 08092210, 08092608, 08100202, 08100703, 08101005, 08102006, 08102325, 08102805, 08110530, and 08111412. ***UPDATE 01/09/2009*** Serial numbers NS-10156, NS-10158, NS-10159, NS-10160 and NS-10161 were originally not included in the original submission. The lot number assigned to prior SN assignment adds 08052901, 08081801, 08091801, 08040701, 08071806, 08101326, and 08103001
RECALLING FIRM/MANUFACTURER St Jude Medical, Inc., Sunnyvale , CA ,
REASON Firm has received multiple reports of difficulties connecting the product and/or the presence of error code messages occurring with the use of the connecting cable and the Ablation Control System unit.
VOLUME OF PRODUCT IN COMMERCE 152 units
DISTRIBUTION Nationwide and country of Belgium

PRODUCT iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3. Device is an image management system intended to be used by trained professionals, and is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage.
CODE Versions 4.1.x up to and including 4.1.51.3
RECALLING FIRM/MANUFACTURER Philips Healthcare Informatics, Inc., Foster City , CA , 
REASON Product may display clinical reports with the study date and time in GMT format, which may not be obvious to the end user, who may expect to see the local time in the report.
VOLUME OF PRODUCT IN COMMERCE 40 units
DISTRIBUTION Italy, Denmark, Germany, Netherlands, Sweden, Spain, Portugal, Switzerland, Spain, Turkey, France, Saudi Arabia, Australia, Thailand, New Zealand, Japan, Brazil

PRODUCT Artiste MV Digital Linear Accelerator System equipped with 160 MCL Accessory Holder. Medical charged-particle radiation therapy system. 
CODE All units of Part number: 8139789
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Concord , CA 
REASON The range of tolerance is too high for the accessory holder; therefore, Wedges and other accessories do not latch to the locking mechanism correctly. This issue represents a potential serious injury to a patient or operator.
VOLUME OF PRODUCT IN COMMERCE 43 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) HR90K Platinum Series Headpiece Model Number AB-7300-001. The HiRes90K headpiece is used in conjunction with speech processors. The Harmony HiResolution Bionic Ear System and Clarion Multi-Strategy Cochlear Implant are cochlear implant systems designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss. 
 
b) Platinum Series Headpiece Model Number AB-7300. The headpiece is used in conjunction with speech processors. The Harmony HiResolution Bionic Ear System and Clarion Multi-Strategy Cochlear Implant are cochlear implant systems designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss. 
 
c) S-Series Long Range Headpiece a) Model Number AB-5301-00 (beige) and b) AB-5301-10 (brown). The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics. 
 
d) S-Series Short Range Headpiece, a) Model Number MMT-5300-00 (beige) and b) MMT-5300-10 (brown). The headpiece is used in conjunction with speech processors. 
CODE
a) Serial Numbers: 167419, 167420, 169309, 169310, 169311, 170983, 170984, 170985, 172709, 172710, 174272, 174274, 174275, 174298, 175139, 175988, 175989, 175990, 175991, 177627, 177628, 177629, 177630, 177631, 177671, 177672, 177673, 178494, 179252, 181303, 181304, 183489, 184405 and 184694;
 
b) Serial Numbers: 36241, 36242, 36243, 36244, 36245, 36246, 36247, 36248, 36249, 36250, 36251, 36252, 36253, 36254, 36255, 36256, 36257, 36258, 36259, 36260, 36261, 36262, 36263, 36264, 36265, 36266, 36267, 36268, 36269, 36270, 36271, 36272, 36273, 36274, 36275, 36276, 36291, 36292, 36293, 36295, 36297, 36298, 36299, 36300, 36324, 36325, 36326, 36327, 36328, 36329, 36330, 36331, 36332, 36333, 36334, 36335, 36336, 36338, 36339, 36340, 36341, 36342, 36343, 36344, 36345, 36346, 36347, 36348, 36349, 36350, 36351, 36352, 36353, 36354, 36355, 36356, 36357, 36358, 36359, 36360, 36481, 36482, 36483, 36484 36485, 36486, 36487, 36488, 36489, 36490, 36491, 36493, 36494, 36495, 36496, 36497, 36498, 36499, 36500, 36501, 36502, 36503, 36504, 36506, 36507, 36508, 36509, 36510, 36511, 36512, 36513, 36514, 36515 36516, 36517, 36518, 36519, 36520, 36521, 36522, 36523, 36524, 36525, 36526, 36527, 36528, 36529 36530, 36531, 36532, 36533, 36534, 36535, 36536, 36537, 36538, 36539, 36540, 36568, 36569, 36570, 36571, 36572, 36573, 36574, 36575, 36576, 36577, 36578, 36579, 36580, 36581, 36582, 36583 36584, 36585, 36586, 36587, 36588, 36589, 36590, 36591, 36592, 36593, 36594, 36595, 36596, 36597, 36598, 36599, 36600, 36601, 36602, 36603, 36604, 36605, 36606, 36607, 36608, 36609, 36610, 36611, 36612, 36613, 36614, 36615, 36616, 36617, 36618 36620, 36621, 36622, 36623, 36624, 36625, 36626, 36627, 36628, 36629, 36630, 36631, 36632, 36633, 36634, 36635, 36636, 36637, 36638, 36639, 36640, 36641, 36642, 36643, 36644, 36645, 36646, 36647, 36648, 36649, 36650, 36651, 36652, 36653, 36654, 36655, 36656, 36657, 36658, 36659, 36660, 36661, 36662, 36663, 36664, 36665, 36666, 36667, 36668, 36669, 36670, 36671, 36672, 36673, 36674, 36675, 36676, 36677, 36678, 36679, 36680, 36718, 36719, 36720, 36721, 36722, 36723, 36724, 36725, 36726, 36727, 36728, 36729, 36731, 36732, 36733, 36735, 36736, 36737, 36738, 36739, 36740, 36742, 36743, 36744, 36745, 36746, 36751, 36752, 36755, 36756, 36757, 36758, 36759, 36760, 36761, 36762, 36763, 36764, 36765, 36766, 36767, 36769, 36770, 36771, 36772, 36773, 36774, 36775, 36776, 36777, 36778, 36779, 36780, 36781, 36782, 36784, 36785, 36786, 36787, 36789, 36790, 36791, 36792, 36793, 36794, 36795, 36796, 36797, 36798, 36799, 36800, 36801, 36802, 36803, 36804, 36805, 36806, 36807, 36808, 36809, 36810, 36811, 36812, 36813, 36814, 36815, 36816, 36817, 36818, 36819, 36820, 36821, 36822, 36823, 36824, 36825, 36827, 36828, 36829, 36830, 36831, 36832, 36833, 36834, 36835, 36836, 36837, 36838, 36839, 36840, 36841, 36842, 36843, 36844, 36845, 36846, 36847, 36848, 36849, 36850, 36851, 36852, 36853, 36854, 36855, 36856, 36857, 36858, 36859, 36860, 36868, 36892, 36893, 36895, 36898, 36900, 36901, 36902, 36904, 36905, 36906, 36907, 36908, 36909, 36910, 36921, 36922, 36923, 36924, 36925, 36926, 36927, 36928, 36929, 36931, 36932, 36933, 36934, 36935, 36936, 36937, 36938, 36939, 36940, 36941, 36942, 36943, 36944, 36945, 36946, 36947, 36948, 36949, 36950, 36952, 36965, 36966, 36968, 36971, 36972, 36973, 36975, 36976, 36977, 36979, 36981, 36982, 36983, 36985, 36986, 36987, 36989, 36990, 36991, 36992, 36993, 36994, 36995, 36996, 36997, 36999, 37000, 37001, 37002, 37003, 37004, 37005, 37006, 37007, 37008, 37009, 37010, 37041, 37042, 37043, 37044, 37045, 37046, 37047, 37048, 37049, 37050, 37051, 37052, 37053, 37054, 37055, 37056, 37057, 37058, 37059, 37060, 37061, 37062, 37063, 37064, 37065, 37066, 37068, 37069, 37101, 37102, 37103, 37104, 37105, 37106, 37107, 37108, 37109, 37110, 37111, 37112, 37113, 37114, 37131, 37132, 37133, 37134, 37135, 37136, 37138, 37139, 37140, 37141, 37142, 37143, 37144, 37145, 37146, 37147, 37148, 37149, 37150, 37151, 37152, 37153, 37154, 37155, 37156, 37158, 37159, 37160, 37177, 37178, 37180, 37181, 37182, 37184, 37185, 37190, 37191, 37192, 37193, 37194, 37195, 37196, 37197, 37198, 37199, 37200, 37206, 37207, 37208, 37209, 37210, 37211, 37212, 37213, 37214, 37215, 37216, 37217, 37218, 37219, 37228, 37236, 37242, 37245, 37247, 37251, 37252, 37253, 37254, 37255, 37257, 37258, 37259, 37260, 37261, 37262, 37263, 37264, 37265, 37266, 37268, 37269, 37270, 37271, 37273, 37274, 37277, 37279, 37284, 37288, 37290, 37293, 37295, 37296, 37297, 37298, 37299, 37300, 37302, 37304, 37308, 37310, 37323, 37324, 37325, 37326, 37327, 37328, 37329, 37330, 37331, 37332, 37333, 37334, 37335, 37336, 37337, 37338, 37339, 37340, 37341, 37342, 37343, 37344, 37345, 37346, 37347, 37348, 37349, 37350, 37351, 37353, 37354, 37356, 37357, 37358, 37359, 37360, 37361, 37362, 37363, 37364, 37365, 37366, 37367, 37368, 37369, 37373, 37378, 37380, 37381, 37382, 37383, 37384, 37385, 37386, 37387, 37388, 37389, 37390, 37391, 37392, 37393, 37394, 37395, 37396, 37397, 37398, 37401, 37404, 37406, 37413, 37430, 37431, 37432, 37434, 37437, 37438, 37439, 37440, 37441, 37442, 37443, 37444, 37445, 37446, 37447, 37448, 37449, 37450, 37451, 37452, 37453, 37454, 37455, 37456, 37457, 37458, 37459, 37460, 37461, 37462, 37463, 37464, 37465, 37466, 37467, 37468, 37469, 37470, 37471, 37472, 37473, 37474, 37475, 37479, 37480, 37481, 37482, 37483, 37484, 37488, 37490, 37493, 37496, 37497, 37498, 37501, 37502, 37503, 37504, 37505, 37506, 37507, 37508 37509, 37510, 37511, 37512, 37513, 37514, 37515, 37516, 37517, 37518, 37519, 37520, 37522, 37523, 37524, 37525, 37526, 37527, 37528, 37532, 37534, 37535, 37536, 37537, 37540, 37542, 37543, 37544, 37546, 37547, 37549, 37551, 37552, 37553, 37554, 37555, 37556, 37557, 37558, 37559, 37572, 37573, 37574, 37575, 37576, 37577, 37578, 37579, 37580, 37581, 37582, 37583, 37584, 37585, 37586, 37587, 37588, 37589, 37592 37600, 37615, 37616, 37620, 37621, 37622, 37626, 37630, 37632, 37633, 37634, 37636, 37638, 37639, 37640, 37641, 37642, 37643, 37644, 37645, 37646, 37647, 37648, 37649, 37650, 37651, 37652, 37655, 37658, 37659, 37663, 37664, 37665, 37667, 37670, 37671, 37672, 37673, 37674, 37676, 37677, 37678, 37679, 37681, 37682, 37683, 37684, 37685, 37686, 37687, 37688, 37689, 37690, 37691, 37692, 37693, 37694, 37695, 37696, 37697, 37698, 37699, 37700, 37701, 37702, 37703, 37704, 37705, 37706, 37707, 37708, 37709, 37710, 37711, 37712, 37715, 37716, 37717, 37718, 37719, 37720, 37721, 37723, 37724, 37726, 37727, 37728, 37729, 37730, 37731, 37732, 37733, 37734, 37735, 37736, 37737, 37738, 37739, 37740, 37741, 37742, 37743, 37744, 37745, 37746, 37747, 37748, 37749, 37750, 37751, 37752, 37753, 37754, 37755, 37756, 37757, 37758, 37760, 37761, 37763, 37764, 37765 37766, 37767, 37768, 37770, 37771, 37772, 37774, 37775, 37776, 37777, 37778, 37779, 37780, 37781, 37782, 37783, 37784, 37785, 37786, 37787, 37788, 37789, 37791, 37792, 37793, 37795, 37796, 37797, 37798, 37800, 37801, 37802, 37803, 37804, 37805, 37806, 37807, 37808, 37809, 37810, 37811, 37812, 37813, 37814, 37815, 37816, 37817, 37818, 37819, 37820, 37821, 37822, 37823, 37824, 37825, 37826, 37827, 37828, 37829, 37830, 37832, 37833, 37834, 37835, 37836, 37837, 37838, 37839, 37840, 37841, 37842, 37843, 37844, 37845, 37846, 37847, 37848, 37849, 37850, 37851, 37852, 37853, 37854, 37855, 37856, 37857, 37858, 37859, 37860, 37861, 37862, 37863, 37864, 37865, 37866, 37867, 37868, 37869, 37870, 37871, 37872, 37873, 37874, 37875, 37876, 37877, 37878, 37879, 37880, 37881, 37882, 37883, 37884, 37885, 37886, 37887, 37888, 37889, 37890, 37891, 37892, 37893, 37894, 37895, 37896, 37897, 37898, 37899, 37900, 37901, 37902, 37903, 37904, 37905, 37906, 37907, 37908, 37909, 37910, 37912, 37913, 37914, 37915, 37916, 37917, 37918, 37919, 37920, 37921, 37922, 37923, 37924, 37925, 37926, 37929, 37930, 37931, 37932, 37933, 37934, 37935, 37936, 37937, 37938, 37939, 37940, 37941, 37942, 37943, 37944, 37945, 37946, 37947, 37948, 37949, 37950, 37951, 37952, 37953, 37954, 37955, 37956, 37957, 37958, 37959, 37960, 37961, 37962, 37963, 37964, 37965, 37966, 37967, 37968, 37969, 37970, 37971, 37972, 37973, 37974, 37975, 37976, 37977, 37978, 37979, 37980, 37981, 37982, 37983, 37984, 37985, 37986, 37987, 37988, 37989, 37990, 37991, 37993, 37994, 37995, 37996, 37997, 37998, 37999, 38000, 38001, 38002, 38003, 38004, 38005, 38006, 38007, 38010, 38011, 38014, 38015, 38016, 38017, 38018, 38019, 38020, 38021, 38022, 38023, 38024, 38025, 38026, 38027, 38028, 38029, 38030, 38031, 38032, 38033, 38034, 38035, 38036, 38037, 38038, 38039, 38040, 38041, 38042, 38043, 38044, 38045, 38046, 38047, 38048, 38049, 38050, 38051, 38052, 38053, 38054, 38055, 38056, 38057, 38058, 38059, 38060, 38061, 38062, 38063, 38064, 38065, 38066, 38067, 38068, 38069, 38070, 38071, 38072, 38073, 38074, 38075, 38076, 38077, 38078, 38079, 38080, 38081, 38082, 38083, 38084, 38085, 38086, 38087, 38088, 38089, 38090, 38091, 38092, 38093, 38094, 38095, 38096, 38097, 38098, 38099, 38100, 38101, 38102, 38103, 38105, 38106, 38109, 38110, 38111, 38112, 38113, 38114, 38115, 38116, 38117, 38119, 38120, 38121, 38122, 38123, 38124, 38125, 38126, 38127, 38128, 38129, 38132, 38133, 38134, 38135, 38137, 38138, 38139, 38140, 38142, 38143, 38144, 38146, 38147, 38148, 38149, 38150, 38151, 38153, 38154, 38155, 38156, 38157, 38159, 38160, 38186, 38187, 38188, 38189, 38190, 38191, 38192, 38194, 38195, 38196, 38197, 38198, 38199, 38200, 38201, 38202, 38203, 38204, 38205, 38206, 38207, 38208, 38209, 38210, 38211, 38212, 38213, 38214, 38215, 38216, 38217, 38218, 38220, 38221, 38222, 38223, 38225, 38226, 38227, 38228, 38229, 38230, 38231, 38232, 38233, 38234, 38235, 38236, 38237, 38238, 38239, 38240, 38242, 38243, 38244, 38245, 38246, 38247, 38248, 38249, 38250, 38251, 38252, 38253, 38254, 38255, 38256, 38257, 38258, 38259, 38260, 38261, 38262, 38263, 38264, 38265, 38266, 38267, 38268, 38269, 38270, 38271, 38272, 38273, 38274, 38275, 38276, 38277, 38278, 38279, 38280, 38281, 38283, 38284, 38285, 38286, 38287, 38288, 38289, 38290, 38292, 38293, 38294, 38295, 38296, 38297, 38299, 38300, 38301, 38302, 38303, 38304, 38305, 38308, 38309, 38310, 38311, 38312, 38313, 38314, 38315, 38316, 38317, 38318, 38319, 38320, 38321, 38322, 38323, 38324, 38325, 38326, 38327, 38328, 38329, 38330, 38331, 38332, 38333, 38334, 38335, 38336, 38337, 38338, 38339, 38340, 38341, 38342, 38343, 38344, 38345, 38346, 38347, 38348, 38349, 38350, 38351, 38352, 38353, 38354, 38355, 38356,38357, 38358, 38359 38360, 38361, 38362, 38363, 38364, 38365, 38366, 38367, 38368, 38369, 38370, 38371, 38372, 38373, 38374, 38375, 38376, 38377, 38378, 38379, 38380, 38381, 38382, 38383, 38384, 38385, 38386, 38387, 38388, 38390, 38391, 38392, 38393, 38394, 38395, 38396, 38397, 38398, 38399, 38400, 38401, 38402, 38403, 38404, 38405, 38406, 38407, 38408, 38409, 38410, 38411, 38412, 38413, 38414, 38415, 38416, 38417, 38418, 38419, 38420, 38421, 38422, 38423, 38424, 38425, 38426, 38427, 38428, 38429, 38430, 38456, 38457, 38458, 38459, 38460, 38461, 38462, 38463, 38464, 38465, 38466, 38467, 38469, 38470, 38471, 38472, 38473, 38474, 38475, 38476, 38477, 38478, 38479, 38480, 38481, 38482, 38484, 38485, 38486, 38487, 38488, 38489, 38490, 38491, 38492, 38493, 38494, 38495, 38496, 38497, 38498, 38499, 38500, 38501, 38502, 38503, 38504, 38505, 38506, 38507, 38508, 38509, 38510, 38511, 38512, 38513, 38514, 38515, 38516, 38517, 38518, 38519, 38520, 38521, 38522, 38523, 38524, 38525, 38526, 38527, 38528, 38529, 38530, 38531, 38532, 38533, 38534, 38535, 38536, 38537, 38538, 38539, 38540, 38541, 38542, 38543, 38544, 38545, 38547, 38548, 38549, 38550, 38551, 38552, 38553, 38554, 38555, 38556, 38557, 38558, 38559, 38560, 38561, 38562, 38563, 38564, 38565, 38566, 38567, 38568, 38569, 38570, 38571, 38572 38573, 38574, 38575, 38576, 38577, 38578, 38579, 38580, 38581, 38582, 38583, 38584, 38585, 38586 38587, 38589, 38590, 38591, 38592, 38593, 38594, 38595, 38596, 38597, 38598, 38599, 38601, 38602, 38603, 38604, 38605, 38606, 38607, 38608, 38609, 38610, 38611, 38612, 38613, 38614, 38615, 38616, 38617, 38618, 38619, 38620, 38621, 38622, 38623, 38625, 38626, 38627, 38628, 38629, 38630, 38631, 38632, 38633, 38634, 38635, 38636, 38637, 38638, 38639, 38640, 38641, 38642, 38643, 38644, 38645, 38646, 38647, 38648, 38649, 38650, 38651, 38652, 38653, 38654, 38655, 38656, 38657, 38658, 38659, 38660, 38661, 38662, 38663, 38664, 38665, 38666, 38667, 38668, 38669, 38671, 38672, 38673, 38674, 38675, 38676, 38678, 38679, 38680, 38681, 38682, 38683, 38684, 38685, 38686, 38687, 38688, 38691, 38692, 38693, 38695, 38696, 38697, 38698, 38699, 38700, 38701, 38702, 38703, 38704, 38705, 38706, 38707, 38708, 38709, 38710, 38711, 38712, 38713, 38714, 38715, 38716, 38717, 38718, 38719, 38720, 38721, 38722, 38723, 38724, 38725, 38726, 38727, 38728, 38729, 38730, 38732, 38733, 38734, 38735, 38736, 38737, 38738, 38739, 38740, 38741, 38743, 38744, 38745, 38746, 38747, 38748, 38749, 38752, 38753, 38754, 38756, 38759, 38761, 38762, 38763, 38764, 38765, 38766, 38767, 38768, 38769, 38770, 38771, 38772, 38773, 38774, 38775, 38777, 38778, 38779, 38780, 38781, 38782, 38783, 38784, 38785, 38786, 38787, 38788, 38789, 38790, 38791, 38792, 38793, 38794, 38795, 38796, 38797, 38798, 38799, 38800, 38801, 38802, 38803, 38804, 38805, 38806, 38807, 38808, 38809, 38810, 38811, 38812, 38813, 38814, 38815, 38816, 38817, 38818, 38819, 38820, 38821, 38822, 38823, 38824, 38825, 38826, 38827, 38828, 38829, 38830, 38831, 38832, 38833, 38834, 38835, 38836, 38837, 38838, 38840, 38841, 38842 38843, 38844, 38845, 38846, 38847, 38848, 38849, 38850, 38851, 38852, 38853, 38854, 38855, 38856, 38857, 38858, 38859, 38860, 38861, 38862, 38863, 38864, 38865, 38866, 38867, 38868, 38869, 38870, 38871, 38872, 38873, 38874, 38875, 38876, 38877, 38878, 38879, 38880, 38881, 38882, 38883, 38884, 38885, 38886, 38887, 38888, 38889, 38890, 38891, 38892, 38893, 38894, 38960, 38961, 38962, 38963, 38965, 38966, 38968, 38969, 38970, 38971, 38972, 38973, 38974, 38976, 38977, 38978, 38979, 38980, 38981, 38982, 38983, 38984, 38985, 38986, 38987, 38988, 38989, 39128, 39138, 39171, 39172, 39173, 39174, 39175, 39176, 39177, 39181, 39182, 39184, 39185, 39191, 39194, 39196, 39198, 39199, 39200, 39201, 39202, 39215, 39216, 39217, 39219, 39223, 39224, 39348, 39349, 39350, 39351, 39352, 39353, 39360, 39375, 39378, 39379, 39380, 39381, 39382, 39385, 39388, 39389, 39390, 39391, 39392, 39393, 39394, 39395, 39405, 39406, 39407, 39468, 39469, 39470, 39471, 39472, 39473, 39475, 39476, 39477, 39478, 39479, 39480, 39482, 39484, 39485, 39486, 39487, 39489, 39490, 39493, 39494, 39495, 39496, 39497, 39498, 39499, 39500, 39504, 39512, 39513, 39515, 39518, 39519, 39520, 39521, 39525, 39527, 39560, 39561, 39562, 39563, 39564, 39565, 39566, 39567, 39569, 39571, 39572, 39573, 39574, 39577, 39578, 39579, 39581, 39582, 39583, 39584, 39586, 39587, 39588, 39590, 39591, 39593, 39594, 39597, 39598, 39599, 39600, 39601, 39606, 39607, 39609, 39610, 39612, 39613, 39614, 39615, 39616, 39617, 39632, 39654, 39656, 39657, 39658, 39659, 39661, 39662, 39663, 39664, 39666, 39668, 39670, 39671, 39672, 39674, 39675, 39677, 39678, 39679, 39681 and 39682;
 
c) a) Serial Numbers: 14532, 14544, 14546, 14590, 14591, 14592, 14593, 14594, 14595, 14596, 14597, 14598, 14599, 14600, 14601, 14602, 14603, 14604, 14605, 14606, 14607, 14608, 14609, 14610, 14611, 14612, 14613, 14614, 14615, 14616, 14617, 14618, 14619, 14650, 14654, 14655, 14657, 14663, 14666, 14669, 14670, 14671, 14678, 14679, 14680, 14681, 14682, 14683, 14684, 14685, 14687, 14688, 14690, 14691, 14694, 14695, 14696, 14697, 14698, 14699, 14700, 14702, 14703, 14704, 14705, 14706, 14707, 14708, 14709, 15269, 15272, 15303, 15304, 15305, 15306, 15307, 15308, 15309, 15310, 15311, 15312, 15313, 15314, 15315, 15316, 15317, 15318, 15319, 15320, 15321, 15322, 15323, 15324, 15325, 15326, 15327, 15328, 15329, 15330, 15331, 15332, 15483, 15484, 15485, 15486, 15487, 15488, 15489, 15490, 15491, 15492, 15493, 15496, 15497, 15499, 15500, 15501, 15502 and 15504. b) Serial Numbers: 11112, 11113, 11114, 11115, 11121, 11123, 11124, 11125, 11126, 11129, 11160, 11161, 11163, 11164, 11165, 11166, 11167, 11169, 11170, 11171, 11172, 11173, 11174, 11175, 11176, 11177, 11178, 11179, 11180, 11181, 11182, 11183, 11184, 11185, 11186, 11188, 11189, 11190, 11191, 11196, 11201, 11208, 11215, 11216, 11217, 11218, 11250, 11251, 11254, 11255, 11256, 11257, 11259, 11260, 11261, 11262, 11263, 11265, 11267, 11269, 11270, 11271, 11272, 11273, 11274, 11275, 11277, 11278, 11280, 11281, 11282, 11283, 11284, 11285, 11286, 11287, 11288, 11289, 11290, 11291, 11292, 11293, 11294, 11295, 11296, 11297, 11298, 11299, 11300, 11301, 11302, 11303, 11304, 11305, 11306, 11307, 11308, 11309, 11324, 11325, 11326, 11327, 11328, 11329, 11330, 11331, 11332, 11333, 11334, 11406, 11413, 11414, 11416, 11418, 11430, 11432, 11435, 11437, 11438, 11439, 11443, 11445, 11446, 11449, 11452, 11453, 11454, 11499, 11501, 11508, 11510 and 11517;
 
d) a) Serial Numbers:14122, 14124, 14125, 14126, 14127, 14128, 14129, 14130, 14132, 14133, 14134, 14135, 14137, 14138, 14139, 14141, 14142, 14143, 14144, 14145, 14147, 14148, 14149, 14150, 14151, 14152, 14153, 14155, 14156, 14157, 14158, 14159, 14160, 14161, 14162, 14163, 14164, 14166, 14168, 14169, 14170, 14171, 14715, 14716, 14717, 14718, 14719, 14720, 14721, 14722, 14723, 14724, 14725, 14726, 14727, 14730, 14732, 14735, 14736, 14741, 14742, 14743, 14800, 14955, 14956, 14964, 14971, 15105, 15106, 15107, 15110, 15111, 15112, 15117, 15118 and 15120. b) Serial Numbers: 10250, 10251, 10252, 10254, 10255, 10256, 10289, 10290, 10291, 10292, 10293, 10294, 10295, 10296, 10297, 10298, 10299, 10300, 10301, 10302, 10303, 10304, 10305, 10306, 10307, 10308, 10309, 10310, 10311, 10312, 10313, 10314, 10315, 10316, 10317, 10318, 10319, 10320, 10321, 10322, 10323, 10324, 10325, 10326, 10327, 10328, 10329, 10330, 10331, 10332, 10333, 10334, 10335, 10336, 10337, 10338, 10339, 10340, 10341, 10342, 10344, 10345, 10346, 10348, 10352, 10354, 10362, 10367, 10374, 10375, 10378, 10559, 10561, 10566, 10572, 10573, 10577, 10578, 10582, 10583, 10586, 10587, 10588, 10649, 10650, 10651, 10652, 10653, 10654, 10655, 10656, 10657, 10658, 10659, 10660, 10661, 10663, 10664, 10665, 10666, 10668, 10669, 10670, 10673, 10674, 10675, 10676, 10677, 10678, 10682, 10684, 10702, 10705, 10769, 10770, 10771, 10773 and 10774
RECALLING FIRM/MANUFACTURER Advanced Bionics LLC, Sylmar , CA ,
REASON Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Potential clinical symptoms include: -No lock -Intermittent lock -Implant locks, but cannot measure impedances -Reduction in battery life, primarily for C1 patients with thick flaps.
VOLUME OF PRODUCT IN COMMERCE Approximately 4,617 units
DISTRIBUTION Nationwide

PRODUCT
a) PROMOS Releasing Clamp (3 parts), REF 420 189, S&N 75006600, Rx only, QTY (1), non-sterile Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer. 
 
b) PROMOS Reverse, Glenosphere Loosening Adapter, REF 24 000 047, S&N 75005271, Rx only, QTY (1), non-sterile Instrument for prosthesis, shoulder, semi-constrained, metal/polymer cementer. 
CODE
a) Lot numbers: A1, A1B1107, A2, A3B1107, A3, A3B1107, A4, A4/I, A51767, A51767B706, B57815, B58460, B60400, and B62141;
 
b) Lot numbers: A55827, A59222, A62005, A62127, A62349, A63526, and A63779
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew Inc., Memphis ,  TN , 
Manufacturer: Smith & Nephew Orthopaedics Ag, Rotkreuz , Switzerland . 
REASON The product was breaking during use.
VOLUME OF PRODUCT IN COMMERCE 159 Clamps and 51 Adapters
DISTRIBUTION International distribution only. Germany , France , Italy Austria , Switzerland , Belgium , United Kingdom , Greece , Australia , South Africa , Spain , and Cypress

PRODUCT Biomet Oxford Unicompartmental Knee, Phase 3, Right Medical Tibial Tray, Standard Size B, CoCr, sterile. Unicompartmental knee joint replacement system. Designed to allow for motion between the plastic tibial bearing and metal tibial baseplate components of a unicompartmental knee prosthesis. 
CODE Lot number: 1563796
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomet, Inc., Warsaw , IN , 
Manufacturer: Biomet U.K. , Ltd, Bridgend, South Wales, UK . ng.
REASON Packages labeled as “right” actually contain a “left” component.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION MA and WV

PRODUCT
a) NFix II System 150 mm, Catalog number NX60150-1 spinal fusion surgery.
 
b) NFix II System 200 mm, Catalog number NX60200-1. Spinal fusion surgery. 
 
c) N-Hance System 150 mm, Catalog number NH60150-1. Spinal fusion surgery, 
 
d) TI N-Hance Rod 150 mm Sterile, Catalog number 04.600.715.02S Spinal fusion surgery. 
 
e) NFlex Stabilization System 200 mm, Catalog number NF60020-1. Spinal fusion surgery. 
 
f) NFlex Stabilization System 150 mm, Catalog number NF60150-1. Spinal fusion surgery. 
CODE
a) Lot numbers: P06J01 exp 9/30/07; P06J02 exp 9/30/07; P06M01 exp 12/31/07; P06M02 exp 12/31/07; P07D02 exp 4/30/08; P07H01 exp 8/31/08; and P07J01 exp 9/30/08;
 
b) Lot number: P07G01 exp 7/31/08;
 
c) Lot number: P07M01 exp 12/31/08;
 
d) Lot number: 5764185 exp 5/20/2013;
 
e) Lot number: NF60003 exp 3/31/07;
f) Lot numbers: P07M01 exp 12/31/08; P07M03 exp 12/31/08; P06H01 exp 8/31/07; P06M01 exp 12/31/07; and P06J01 exp 9/30/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Synthes Spine, West Chester ,  PA , 
Manufacturer: Synthes ( USA ), Monument, CO. . 
REASON The dimensional specifications are incorrect.
VOLUME OF PRODUCT IN COMMERCE 1,508 units
DISTRIBUTION Nationwide and countries of Germany , Denmark , Switzerland and Korea

PRODUCT GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). The Centricity PACS (Picture Archiving and Communication System) Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.
CODE Software versions 2.1.X and 3.0.X and higher with Talk Extend
RECALLING FIRM/MANUFACTURER GE Healthcare Integrated IT Solutions, Barrington , IL , 
REASON Unread exams may inadvertently get marked as dictated in PACS workstation when the user signs off the report in Talkstation and opens the next exam.
VOLUME OF PRODUCT IN COMMERCE 22 units
DISTRIBUTION CA, FL, IL, IA, LA, OR, PA, TX, UT, VA, and WI

WEEK ENDING FEBRUARY 28

PRODUCT
a) MicroScan Synergies Plus Dried Overnight Gram Negative MIC/Combo Panels, 20 panels per box. Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria. Catalog numbers B1016-100, B1016-101, B1016-102, B1016-105, B1016-107, B1016-108, B1016-109, B1016-119, B1016-120, B1016-121, B1016-122, B1016-126, B1016-127, B1016-128, B1016-129, B1016-131, B1016-132, B1016-61a, B1016-62a, B1016-64a, B1016-65a, B1016-80, B1016-82, B1017-300, B1017-301, B1017-302, B1017-303, B1017-304, B1017-305, B1017-306, B1017-307, B1017-308, B1017-309, B1017-312, B1017-313, B1017-315, B1017-400, B1017-401, B1017-402, B1017-403, B1017-404, B1017-405, B1017-406, B1017-407, J1016-311c, J1016-312c, J1016-611c, J1016-611j, J1016-612b, J1016-612J, J1016-632J, J1016-623m, J1016-631J, J1016-632J, J1016-65c, J1016-66J, J1025-311, J1025-312, J1025-333, and J1025-611. 

b) MicroScan Synergies Plus Negative Panels, 20 panels per box Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria. Catalog numbers: B1016-200, B1016-201, B1016-202, B1016-203, B1025-103, B1025-104, B1025-105, B1025-106, B1025-107, B1025-108, B1025-109, B1025-112, and B1027-101. CODE Unknown
RECALLING FIRM/MANUFACTURER Siemens Microscan, West Sacramento, CA, 
REASON Falsely lowered imipenem MICs may result, leading to major errors in results.
VOLUME OF PRODUCT IN COMMERCE 569,375 panels
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Ossur 3'" Titanium Skull Pin, 1 pack, Model Number: 516V2S. 
b) Ossur 3" Ceramic Tip Pin, 4 pack, Model Number: 517DS. 
c) Ossur 2 1/4" Ceramic Tip Pin, 4 pack, Model Number: 522CS. 
CODE
a) Lot Number: 08060410;
b) Lot Number: 08060408;
c) Lot Number: 08060305
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ossur, Reykjavik, Ireland,
Manufacturer: Ossur Engineering, Inc., Albion, MI. 
REASON The firm is unable to guarantee the sterility of the affected products.
VOLUME OF PRODUCT IN COMMERCE 43 pins
DISTRIBUTION Nationwide

PRODUCT
a) ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-8-038, 8.5 F, Sterile EO. Used for drainage of bile within the biliary system. 

b) ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-10-038, 10F, Sterile EO. Used for drainage of bile within the biliary system. 

c) ReSolve Hydrophilic Coated Locking Biliary Catheter, 12F, REF RBC-12-038, Sterile EO. Used for drainage of bile within the biliary system. 

d)  ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-14-038, 14F, Sterile EO. Used for drainage of bile within the biliary system
CODE
a) Lot numbers: G543418, MR604367, and MR607897;

b) Lot numbers: G543416, G625227, MR604361, MR604362, MR604363, MR604364, and MR607895;

c) Lot numbers: G543417, MR604365, and MR607896;

d) Lot numbers: G543419, G625228, and MR604366
RECALLING FIRM/MANUFACTURERN Merit Medical Systems, Inc., South Jordan, UT,
REASON Biliary drainage catheter tips may separate from the catheter shaft after placement.
VOLUME OF PRODUCT IN COMMERCE 1,164 units
DISTRIBUTION Nationwide and countries of Canada, Colombia, France, Germany, Mexico, Ireland, Netherlands, South Korea, and UK

PRODUCT
a) Terumo TenderFlow Pediatric Arterial Cannulae, 2.0 mm (6Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813567. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. 

b) Terumo TenderFlow Pediatric Arterial Cannulae, 2.0mm (6Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813568. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. 

c) Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8 Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813569. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

d) Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813570. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. 

e) Terumo TenderFlow Pediatric Arterial Cannulae, 3.3 mm (10Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813571. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. 

f) Terumo TenderFlow Pediatric Arterial Cannulae, 3.3mm (10 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813572. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. 

g) Terumo TenderFlow Pediatric Arterial Cannulae, 4.0 mm (12 FR) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813573. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. 

h) Terumo TenderFlow Pediatric Arterial Cannulae, 4.0mm (12 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813574. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. 

i) Terumo TenderFlow Pediatric Arterial Cannulae, 4.7 mm (14Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813575. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. 

 j) Terumo TenderFlow Pediatric Arterial Cannulae, 4.7mm (14 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813576. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. 

k) Terumo TenderFlow Pediatric Arterial Cannulae, 5.3 mm (16 Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813577. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. 

l) Terumo TenderFlow Pediatric Arterial Cannulae, 5.3mm (16 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813578. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. 
CODE
a) Lot numbers: 0501557 and 0512008;
b) Lot numbers: 0501639 and 0512002;
c) Lot numbers: 0502199, 0513068, and 0517852;
d) Lot numbers: 0502200 and 0513069;
e) Lot numbers: 0507120, 0512919, and 0518680;
f) Lot numbers: 0507121 and 0512918;
g) Lot numbers: 0509238 and 0517874;
h) Lot number: 0509240;
i) Lot numbers: 0500759 and 0513331;
j) Lot number: 0509241;
k) Lot number: 0502878;
l) Lot number: 0500760
RECALLING FIRM/MANUFACTURER Terumo Cardiovascular Systems Corp., Ann Arbor, MI, 
REASON The introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.
VOLUME OF PRODUCT IN COMMERCE 2,892 units
DISTRIBUTION Nationwide and countries of Australia, Belgium and Canada

PRODUCT Drive Belt for Radiation Therapy Simulation systems SIMVIEW 3000 and SIMVIEW NT with CT option or IDI. Radiation therapy simulation system. NT with model numbers 1957153, 1957161, 5496992, 5497016, 5496984. 
CODE All drive belts in SIMVIEW 3000 and NT Models.
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Concord, CA,
REASON Excessive wear on drive belts used for Image Intensifier and/or X-ray head drive mechanisms may result in uncontrolled movement, which may cause injury.
VOLUME OF PRODUCT IN COMMERCE 223 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Philips M8000-64100 Table Mount Shipped standard with all IntelliVue Patient Monitors MP40-70, Gas Modules Gl and G5 and certain options of the IntelliVue Patient Monitors MP5 MPST and MP20/30. Product shipped between 6/03/08 and 9/12/08 as follows: M1013A IntelliVue G1 Gas Module M1019A IntelliVue GS Gas Module M8001A option E22 Quick release mount for IntelliVue MP20 M8002A option E22 Quick release mount for IntelliVue MP30 M8003A IntelliVue MP40 M8004A IntelliVue MPSO M8005A IntelliVue MP60 M8007A IntelliVue MP70 M8105A option E22 IntelliVue MP5 Quick Release Mount M8105AT option E22 IntelliVue MPST Quick Release Mount M8040A option U02 U02 Table top mount kit M8040A option E22 Quick release kit for MP20MP30 The Philips IntelliVue Patient Monitors are intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, X2, MP5, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. 
CODE Product shipped between 6/03/08 and 9/12/08. A list of S/N's can be obtained from the recalling firm.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, Andover, MA, 
Manufacturer: Philips Medizin Systeme Boblingen Gmbh, Boblingen, Germany. 
REASON Table Mounts assembled with incorrect length hardware may fall.
VOLUME OF PRODUCT IN COMMERCE 14,292 table mounts
DISTRIBUTION Nationwide, Canada, Argentina, Aruba, Australia, Austria, Bahain, Bangladesh, Belgium, Bosnia, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Egypt, Finland, France, Gabon, Germany, Great Britain, Greece, Hong Kong, Iceland, India, Iraq, Ireland , Italy, Japan, Korea, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Namibia, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovenia South Africa, Spain, Srilinka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Uganda, UAE, Uzbekistan, Venezuela, Vietnam, and Zambia

PRODUCT Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456, manufactured by Boston Scientific Corporation, Fremont, CA. Medical device, intended for ultrasound examination of peripheral pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. 
CODE Batch/lot numbers: 11420600, 11420601, 11420602, 11611665, 11716746, 11720663, 11721240, 11722752, 11727107, 11727873, 11727874, 11728458, 11731354, 11732665, 11735762, 11736559, 11739563, 11742590, 11754455, 11758051, 11764281, 11777994, 11788045, 11790848, 11820112, 11897802, 11897904, and 11904295
RECALLING FIRM/MANUFACTURER Boston Scientific Corp., Fremont, CA, 
REASON Product is mislabeled as having a shelf life of 3 years, where the actual shelf life is 1 year.
VOLUME OF PRODUCT IN COMMERCE 1,033 units
DISTRIBUTION Nationwide, PR and Panama

PRODUCT Varian Medical Systems Eclipse treatment planning system, Model Number H48, versions 6.5/7.x and Inspiration 8.0. 
CODE
Serial numbers: H480002 H481912 H483369 H484526 H485316 H485593 H485859 H486079 H486328 H486602 H480005 H482181 H483429 H484532 H485334 H485594 H485862 H486086 H486330 H486606 H480016 H482186 H483471 H484587 H485338 H485603 H485867 H486089 H486331 H486613 H480092 H482192 H483485 H484593 H485340 H485615 H485871 H486092 H486332 H486617 H480112 H482194 H483488 H484635 H485342 H485629 H485873 H486094 H486336 H486618 H480114 H482250 H483560 H484661 H485345 H485632 H485874 H486097 H486338 H486629 H480132 H482270 H483566 H484663 H485347 H485633 H485875 H486108 H486342 H486633 H480169 H482294 H483570 H484692 H485352 H485642 H485883 H486120 H486346 H486639 H480293 H482324 H483586 H484709 H485359 H485646 H485901 H486121 H486348 H486641 H480294 H482427 H483715 H484763 H485362 H485648 H485912 H486123 H486349 H486642 H480300 H482462 H483724 H484767 H485363 H485656 H485913 H486127 H486356 H486653 H480427 H482523 H483731 H484791 H485370 H485668 H485918 H486128 H486369 H486665 H480433 H482528 H483756 H484813 H485374 H485669 H485926 H486130 H486385 H486667 H480446 H482541 H483764 H484838 H485375 H485670 H485933 H486132 H486411 H486680 H480467 H482557 H483769 H484841 H485380 H485671 H485934 H486134 H486412 H486685 H480481 H482579 H483797 H484847 H485382 H485672 H485936 H486136 H486440 H486686 H480514 H482677 H483799 H484857 H485388 H485676 H485941 H486138 H486444 H486689 H480570 H482678 H483800 H484866 H485391 H485681 H485946 H486140 H486445 H486694 H480583 H482699 H483808 H484875 H485393 H485694 H485947 H486143 H486451 H486700 H480670 H482706 H483827 H484876 H485414 H485699 H485948 H486188 H486452 H486701 H480723 H482710 H483879 H484950 H485421 H485701 H485949 H486198 H486457 H486703 H480759 H482722 H483921 H484954 H485433 H485703 H485953 H486202 H486473 H486707 H480780 H482725 H483937 H484970 H485437 H485709 H485963 H486205 H486474 H486708 H480789 H482727 H483964 H484975 H485441 H485715 H485964 H486206 H486481 H486715 H480809 H482761 H483980 H484977 H485443 H485717 H485966 H486207 H486488 H486717 H480822 H482769 H484013 H484979 H485447 H485739 H485967 H486223 H486490 H486721 H480889 H482821 H484103 H484988 H485449 H485749 H485971 H486224 H486498 H486724 H480890 H482848 H484186 H485014 H485454 H485751 H485972 H486228 H486500 H486756 H480996 H482892 H484200 H485024 H485463 H485753 H485981 H486230 H486501 H486758 H481003 H482920 H484235 H485026 H485468 H485771 H485983 H486233 H486503 H486759 H481154 H482934 H484250 H485035 H485472 H485776 H485987 H486236 H486509 H486766 H481165 H482970 H484256 H485039 H485475 H485778 H485988 H486247 H486520 H486793 H481193 H482997 H484263 H485043 H485477 H485789 H486003 H486257 H486522 H486803 H481203 H483060 H484283 H485081 H485485 H485794 H486008 H486260 H486525 H486804 H481215 H483070 H484294 H485098 H485488 H485795 H486010 H486271 H486531 H486805 H481220 H483086 H484308 H485129 H485489 H485798 H486016 H486273 H486541 H486806 H481296 H483109 H484311 H485136 H485491 H485802 H486023 H486276 H486543 H486809 H481308 H483146 H484317 H485143 H485517 H485804 H486024 H486278 H486549 H486820 H481309 H483176 H484323 H485148 H485519 H485805 H486025 H486288 H486550 H486826 H481445 H483178 H484332 H485165 H485533 H485806 H486029 H486289 H486555 H486831 H481497 H483182 H484336 H485193 H485537 H485812 H486032 H486292 H486556 H486840 H481551 H483200 H484346 H485236 H485538 H485815 H486034 H486294 H486558 H486848 H481562 H483203 H484377 H485240 H485541 H485816 H486038 H486295 H486561 H486856 H481667 H483210 H484419 H485243 H485543 H485820 H486040 H486298 H486566 H486866 H481685 H483243 H484430 H485291 H485545 H485823 H486046 H486299 H486567 H486871 H481737 H483248 H484439 H485292 H485546 H485827 H486058 H486300 H486570 H486872 H481744 H483273 H484450 H485297 H485550 H485828 H486062 H486301 H486579 H486875 H481787 H483279 H484472 H485301 H485551 H485831 H486066 H486313 H486589 H486893 H481835 H483321 H484475 H485308 H485556 H485834 H486067 H486316 H486592 H486899 H481870 H483327 H484506 H485309 H485564 H485844 H486072 H486317 H486597 H486902 H481906 H483329 H484510 H485310 H485568 H485850 H486075 H486327 H486600 H486907 H486908 H486914 H486924 H486949 H486973 H486975
RECALLING FIRM/MANUFACTURER Varian Medical Systems oncology Systems, Palo Alto, CA, 
REASON Possible incorrect wedge orientation in treatment: Software labeling was issued without warning message relating to preservation of user selected values for Siemens wedge orientation, wedge limits and SAD values for Elekta machines, and collimator operating limits for Saturne Machines when the software version is upgraded.
VOLUME OF PRODUCT IN COMMERCE 516 units
DISTRIBUTION Nationwide, Austria, Belgium, Canada, Czech Republic, Finland, France, Germany, Greece, Hungary, Italy, Ireland, Lithuania, Norway, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, Netherlands, Turkey and the United Kingdom.

PRODUCT Stainless Steel Surgical Blades Part number: 4-312B. The product is supplied sterile, individually packaged in boxes containing 100 blades. 
CODE Lot number: S07C06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Miltex, Inc., York, PA, 
Manufacturer: Kai Surgical Instrument Co., Ltd., Seki City, Japan. 
REASON Blade may break; Over milling of the blade resulted in tip more narrow than specified.
VOLUME OF PRODUCT IN COMMERCE 200 boxes
DISTRIBUTION CA, FL, GA, IN, NE, NJ, NY, PA, SC, TN, TX and Canada

PRODUCT Monitor portion of the LifeVest device – specifically the Defibrillator printed circuit assembly (PCA) within the monitor. The LifeVest is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator. Model numbers: WCD3000 and WCD3100. 
CODE Unknown
RECALLING FIRM/MANUFACTURER Zoll Lifecor Corp., Pittsburgh, PA, 
REASON The charging circuit will not shut down properly.
VOLUME OF PRODUCT IN COMMERCE 1,685 units
DISTRIBUTION Nationwide, Germany, United Kingdom, Italy and France

PRODUCT Regenesis Biomedical PROVANT Wound Therapy System, Model 4201 - The Provant Wound Therapy System is a solid-state, fixed-power output radio frequency generator and transmitter designed to operate at the FCC authorized medical device frequency of 27.12 MHz. Provant transmits a fixed dose of non-ionizing, non-thermal RF energy via an applicator pad that is placed adjacent to the patient's dressed wound. The Provant Wound Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. 
CODE Serial numbers: 704, 920, 460, 709, 711, 714, and 727
RECALLING FIRM/MANUFACTURER Regenesis Biomedical, Inc., Scottsdale, AZ, .
REASON In the course of device testing, the firm determined that the affected devices may, under certain unusual clinical circumstance, be unable to generate a therapeutic dose of radio frequency energy. As such, for these few devices, the effectiveness of Provant therapy may be impaired.
VOLUME OF PRODUCT IN COMMERCE 7 units
DISTRIBUTION WY, VA and NC

PRODUCT
a) Femoral Array, Model number: 0150ARR00001 and b) Tibial Array, Model number: 0150ARR00002. The devices are accessories used with MAKO's Tactile Guidance System (TGS). The Tactile Guidance System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. 
CODE
a) Lot Number/Quantity: 0609038 (6), 06051107 (4), 01010806 (4), 09010108 (2), 06040707-01 (1), 01010107 (3), 01010607 (1), 01010106 (1) and 06040707 (2) and
b) Lot Number/Quantity: 06060308 (6), 06061107 (7), 01020866 (2), 01010507 (1), 01020806 (1), 01020107 (3), 09081107 (2) and 01020607 (2)
RECALLING FIRM/MANUFACTURER Mako Surgical Corp., Davie, FL, 
REASON The product in its current state may fail during use, which would cause the instrument to be in-accurate.
VOLUME OF PRODUCT IN COMMERCE 44 units
DISTRIBUTION Nationwide