Gambro Renal Products Inc - Polyflux Revaclear - Class 2 Recall
Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 2, 2014 Category: Medical Equipment Source Type: alerts
Argon Medical Devices, Inc - UltraStream Exchange Kit - Class 2 Recall
The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 25, 2014 Category: Medical Equipment Source Type: alerts
Argon Medical Devices, Inc - UltraStream Peel Away Kit - Class 2 Recall
UltraStream Peel Away Kit The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 25, 2014 Category: Medical Equipment Source Type: alerts
Argon Medical Devices, Inc - UltraStream Chronic Hemodialysis Catheter - Class 2 Recall
The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 25, 2014 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Holdings, Inc. - Fresenius Medical Naturalyte Liquid Bicarbonate Concentrate - Class 2 Recall
Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 24, 2014 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Holdings, Inc. - BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) - Class 2 Recall
BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 13, 2014 Category: Medical Equipment Source Type: alerts
Medical Components, Inc dba MedComp - Split Cath III - Class 2 Recall
Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is indicated for use in attaining long term vascular access for hemodialysis and apheresis in adult patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 5, 2014 Category: Medical Equipment Source Type: alerts
Cardiovascular Systems, Inc. - Diamondback 360 Peripheral Orbital Atherectomy System. - Class 1 Recall
CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DPB-125MICRO145, Part Number 7-10003. The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with oc...
Source: Medical Device Recalls - August 15, 2014 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Holdings, Inc. - NaturaLyte Liquid Bicarbonate Concentrate - Class 3 Recall
NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 10, 2014 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Holdings, Inc. - Naturalyte Liquid Bicarbonate Concentrate - Class 1 Recall
Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2014 Category: Medical Equipment Source Type: alerts
Gambro Renal Products, Incorporated - Polyflux(R) Revaclear Max, Capillary Dialyzer - Class 2 Recall
Polyflux(R) Revaclear Max, Capillary Dialyzer, 110634; Gambro Renal Products, Inc., 1101 Jeter Avenue, Opelika, AL 36801 Intended for the treatment of acute and chronic renal failure by hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2014 Category: Medical Equipment Source Type: alerts
Gambro Renal Products, Incorporated - Polyflux(R) Revaclear, Capillary Dialyzer - Class 2 Recall
Polyflux(R) Revaclear, Capillary Dialyzer, 110633; Gambro Renal Products, Inc., 1101 Jeter Avenue, Opelika, AL 36801 Intended for the treatment of acute and chronic renal failure by hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2014 Category: Medical Equipment Source Type: alerts
Gambro Renal Products, Incorporated - Polyflux Revaclear Max, Capillary Dialyzer - Class 2 Recall
Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2014 Category: Medical Equipment Source Type: alerts
Gambro Renal Products, Incorporated - Polyflux Revaclear, Capillary Dialyzer - Class 2 Recall
Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2014 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Holdings, Inc. - Fresenius 2008T Hemodialysis Machine - Class 2 Recall
Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 14, 2014 Category: Medical Equipment Source Type: alerts
