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This page shows you the most recent publications within this specialty of the MedWorm directory. This is page number 6.

Medtronic Sofamor Danek USA Inc - TIBIAL TRAY , SIZE 4, REF 90SRK200400 - Class 2 Recall
TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 24, 2016 Category: Medical Equipment Source Type: alerts

Medtronic Sofamor Danek USA Inc - RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 5R, REF 90SRK311500 - Class 2 Recall
RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R, (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 24, 2016 Category: Medical Equipment Source Type: alerts

GE OEC Medical Systems, Inc - OEC 9800 - Class 2 Recall
OEC 9800, fluoroscopic x-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 24, 2016 Category: Medical Equipment Source Type: alerts

GE OEC Medical Systems, Inc - OEC UroView 2800 - Class 2 Recall
OEC UroView 2800, fluoroscopic x-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 24, 2016 Category: Medical Equipment Source Type: alerts

Stryker Instruments Div. of Stryker Corporation - Stryker Neptune 3 Rover - Class 2 Recall
120 V Neptune 3 Rover, Model Number: 0703-001-000 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 24, 2016 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - SOMATOM Definition Flash - Class 2 Recall
SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 24, 2016 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - SOMATOM Definition Edge - Class 2 Recall
SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 24, 2016 Category: Medical Equipment Source Type: alerts

Siemens Medical Solutions USA, Inc - SOMATOM Definition AS - Class 2 Recall
SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 24, 2016 Category: Medical Equipment Source Type: alerts

Merge Healthcare, Inc. - RadSuite - Class 2 Recall
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 24, 2016 Category: Medical Equipment Source Type: alerts

Cook Inc. - White Lumax Guiding Coaxial Catheter - Class 2 Recall
White Lumax¿ Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of angioplasty balloons and other types of interventional devices. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2016 Category: Medical Equipment Source Type: alerts

Cook Inc. - Shuttle Select SlipCath - Class 2 Recall
Shuttle¿ Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2016 Category: Medical Equipment Source Type: alerts

Cook Inc. - Liver Access and Biopsy Needle Set - Class 2 Recall
Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver histology samples via a jugular vein approach. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2016 Category: Medical Equipment Source Type: alerts

Cook Inc. - Beacon Tip Royal Flush Plus HighFlow Catheter - Class 2 Recall
Beacon¿ Tip Royal Flush¿ Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2016 Category: Medical Equipment Source Type: alerts

Cook Inc. - FluoroSet Radiographic Tubal Assessment Set - Class 2 Recall
FluoroSet¿ Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the uterine cavity for radiographic evaluation of the uterine cavity and for injection of appropriate contrast media into the fallopian tubes for evaluation of tubal patency. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2016 Category: Medical Equipment Source Type: alerts

Cook Inc. - Beacon Tip Centimeter, White Vessel, and Vessel Sizing Catheter - Class 2 Recall
Beacon¿ Tip Centimeter Sizing Catheter Beacon¿ Tip White Vessel Sizing Catheter Beacon¿ Tip Vessel Sizing Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2016 Category: Medical Equipment Source Type: alerts

Cook Inc. - SlipCath Beacon Tip Catheter - Class 2 Recall
Slip-Cath¿ Beacon¿ Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2016 Category: Medical Equipment Source Type: alerts

Cook Inc. - Kumpe Access Catheter - Class 2 Recall
Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used in combination with a HiWire¿, Bentson, or other flexible-tipped wire guide to gain difficult ureteral access beyond a redundant or tortuous ureteral segment (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2016 Category: Medical Equipment Source Type: alerts

Cook Inc. - Beacon Tip Torcon NB Advantage Catheter - Class 2 Recall
Beacon¿ Tip Torcon NB¿ Advantage Catheter Catheter, Intravascular, Diagnostic (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2016 Category: Medical Equipment Source Type: alerts

Cook Inc. - Haskal Transjugular Intrahepatic Portal Access Set - Class 2 Recall
Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for transjugular liver access in diagnostic and interventional procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2016 Category: Medical Equipment Source Type: alerts

Cook Inc. - Selective Salpingography Catheter with Beacon Tip - Class 2 Recall
Selective Salpingography Catheter with Beacon¿ Tip Cannula, Manipulator/ Injector, Uterine Used for injection of contrast medium into the fallopian tube(s) for selective salpingography. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2016 Category: Medical Equipment Source Type: alerts

Cook Inc. - Aprima Access Nonvascular Introducer Set - Class 2 Recall
Aprima" Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2016 Category: Medical Equipment Source Type: alerts

Cook Inc. - Neff DAgostino Percutaneous Access Set - Class 2 Recall
Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2016 Category: Medical Equipment Source Type: alerts

Cook Inc. - Transluminal Biliary Biopsy Forceps Set - Class 2 Recall
Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue within the biliary ductal system (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2016 Category: Medical Equipment Source Type: alerts

Spacelabs Healthcare Inc - Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280 - Class 2 Recall
The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2016 Category: Medical Equipment Source Type: alerts

Baxter Healthcare Corp. - Baxter HomeChoice/HomeChoice Pro - Class 2 Recall
1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 23, 2016 Category: Medical Equipment Source Type: alerts

Siemens Healthcare Diagnostics Inc - Siemens RAPEDPoint500 - Class 3 Recall
Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

American National Mfg Inc - Panacea Air Pro Mattress Control Unit - Class 2 Recall
Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

Integra LifeSciences Corp. - Class 2 Recall
Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

Merz North America, Inc. - Radiesse - Class 2 Recall
Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

Medtronic Neuromodulation - Medtronic, Lead Kit for DBS Stimulation - Class 2 Recall
Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V). (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

Richard Wolf Medical Instruments Corp. - Richard Wolf Instrument Corporation - Class 2 Recall
Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

Alere San Diego, Inc. - Alere INRatio/ INRatio2 PT/INR Test Strips - Class 1 Recall
Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 99008G7 Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with reagents that initiate coagulation. When the blood clots, changes in impedance in the sample are detected by the monitor. The monitor calculates the PT and INR results from this impedance change and reports them on the display. The Alere INRatio/INRatio2 PT/INR Monitoring Sy...
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

Alere San Diego, Inc. - Alere INRatio2 Replacement Monitor (Home) - Class 1 Recall
Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRatio 2 Home Monitor and INRatio PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin therapy on clotting time by properly selected suitably trained users (by prescription for home use or other order of a treating physician). Patients must be stabilized (>6 weeks) on warfarin therapy. The Alere INRatio¿2 PT/INR Ho...
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

Alere San Diego, Inc. - INRatio PT/INR Test Strips - Class 1 Recall
Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The INRatio/INRatio2 Test Strips perform a modified version of the one-stage Prothrombin Time test, using a recombinant human thromboplastin reagent. The clot formed in the Prothrombin Time reaction is detected by a change in the electrical impedance of the sample during the coagulation process. The system consists of a monitor and disposable test strips. The monitor measures impedance, heats the test strip to the proper reaction temperature, and provides a user interface. The blood sample is applied to the Test Strip and the clotting reaction o...
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

Alere San Diego, Inc. - Alere INRatio2 PT/INR Professional Monitoring System - Class 1 Recall
Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere INRatio ¿ 2 PT/INR Monitoring System (Professional Use): The Alere INRatio ¿ 2 PT/INR Monitoring System (Professional Use), consisting of the INRatio ¿ 2 Monitor and INRatio¿ 2 PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals. The Alere INRatio¿ 2 PT/INR Monitoring System (Professional Use) is intended for use outside of the body (in vitro diagnostic use). T...
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

Alere San Diego, Inc. - Alere INRatio Replacement Monitor - Class 1 Recall
Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purpose. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

Alere San Diego, Inc. - INRatio2 PT/INR Professional Testing System - Class 1 Recall
Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purpose. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

Alere San Diego, Inc. - INRatio2 PT/INR Professional Monitoring System - Class 1 Recall
Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with reagents that initiate coagulation. When the blood clots, changes in impedance in the sample are detected by the monitor. The monitor calculates the PT and INR results from this impedance change and reports them on the display. The Alere INRatio/INRatio2 PT/INR Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) i...
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

Alere San Diego, Inc. - INRatio2 PT/INR Home Monitoring System - Class 1 Recall
Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRatio 2 Home Monitor and INRatio PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin therapy on clotting time by properly selected suitably trained users (by prescription for home use or other order of a treating physician). Patients must be stabilized (>6 weeks) on warfarin therapy. The Alere INRatio¿...
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

Alere San Diego, Inc. - INRatio Prothrombin Time (PT) Monitoring System - Class 1 Recall
INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product Usage: The INRatio Prothrombin Time Monitoring System uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with reagents that cause coagulation to begin. The test strip area on the test strip is separated into three channels, each of which contains electrodes for detection of the blood clot. One channel contains the reagents to perform the Prothrombin time test on the blood sample. The other two channels contain the reagents. to perfom the Prothrombin time ...
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

Conmed Corporation - ThermoGard Dual Dispersive Electrodes - Class 2 Recall
Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710. Intended to be used for the dispersion and return to the electrosurgical generator. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

Conmed Corporation - ThermoGard Dual Dispersive Electrodes - Class 2 Recall
Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC¿ generators or conventional electrosurgery units with similar contact monitoring systems, 10' (3.05m) Cable, Catalog Number 7-383. Intended to be used for the dispersion and return to the electrosurgical generator. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

INNOKAS MEDICAL OY - CARESCAPE VC150 Vital Signs Monitor - Class 2 Recall
CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

Conmed Corporation - ThermoGard Dual Dispersive Electrodes - Class 2 Recall
Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable, Catalog Number 51-7310. Intended to be used for the dispersion and return to the electrosurgical generator. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

Conmed Corporation - ThermoGard Dual Dispersive Electrodes - Class 2 Recall
Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410. Intended to be used for the dispersion and return to the electrosurgical generator. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

Conmed Corporation - ThermoGard Dual Dispersive Electrodes - Class 2 Recall
Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC¿ generators or conventional electrosurgery units with similar contact monitoring systems, 10' (3.05m) Cable, Catalog Number 7-382. Intended to be used for the dispersion and return to the electrosurgical generator. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

Encore Medical, Lp - Bone Cement - Class 2 Recall
Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque, rapidly setting bone cement. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

Novus Scientific Ab - TIGR Matrix Surgical Mesh - Class 2 Recall
TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 20, 2016 Category: Medical Equipment Source Type: alerts

Avid Medical, Inc. - AVID TruCustom - Class 2 Recall
PEDIATRIC KIDNEY BIOPSY TRAY (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 19, 2016 Category: Medical Equipment Source Type: alerts

Avid Medical, Inc. - AVID TruCustom - Class 2 Recall
MAMMOGRAPHY (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 19, 2016 Category: Medical Equipment Source Type: alerts