Baxter Healthcare Corporation - Phoenix Monitor - Class 2 Recall
Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 26, 2017 Category: Medical Equipment Source Type: alerts
Baxter Healthcare Corporation - Phoenix Monitor - Class 2 Recall
Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 26, 2017 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Renal Therapies Group, LLC - Fresenius Home Dialysis System - Class 2 Recall
Fresenius 2008K Series : Hemodialysis System (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 14, 2017 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Renal Therapies Group, LLC - Fresenius Home Dialysis System - Class 2 Recall
Fresenius 2008K@home Series : Hemodialysis System (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 14, 2017 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Renal Therapies Group, LLC - Fresenius Home Dialysis System - Class 2 Recall
Fresenius 2008K2 Series : Hemodialysis System (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 14, 2017 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Renal Therapies Group, LLC - Fresenius Home Dialysis System - Class 2 Recall
Fresenius 2008T Series Hemodialysis System (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 14, 2017 Category: Medical Equipment Source Type: alerts
ICU Medical, Inc. - Tego Connector - Class 2 Recall
Tego Connector, Item No. D1000, NM1000 The Tego¿ Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdrawal of fluids to a patient through a cannula or needle placed in the vein or artery. The Tego¿ is a needle-free capping device which closes the end of the catheter. The Tego¿ will permit access to the catheter without the use of needles and therefore passively aid in the reduction of needle stick injuries. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 11, 2017 Category: Medical Equipment Source Type: alerts
Baxter Healthcare Corp. - Polyflux(R) Revaclear MAX - Class 2 Recall
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 9, 2016 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Renal Therapies Group, LLC - Fresenius Crit Line in a Clip (CLiC) - Class 2 Recall
Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment. Used in conjunction with the Fresenius 2008T Hemodialysis Machines as follows: Model: 190895 2008T GEN 2 BIBAG w/o CDX 190713 2008T Hemodialysis SYS with CDX 190858 2008T Hemodialysis System w/o CDX 190766 2008T Hemodialysis System w/o CDX (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 22, 2016 Category: Medical Equipment Source Type: alerts
Dialog+ Hemodialysis Systems by B. Braun Medical: Class I Recall - Defective Conductivity Sensors
The presence of air in dialysis fluid may lead to improper blood filtration, causing serious adverse health consequences, including death. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - May 4, 2016 Category: American Health Source Type: alerts
B Braun Medical Inc - Dialog Hemodialysis machine: Dialog A 1 Blood Pump 120V - Class 1 Recall
Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2016 Category: Medical Equipment Source Type: alerts
B Braun Medical Inc - Dialog Hemodialysis machine: Dialog A 1 Blood Pump 120V - Class 1 Recall
Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2016 Category: Medical Equipment Source Type: alerts
B Braun Medical Inc - Dialog Hemodialysis machine: Dialog A HE/BIC - Class 1 Recall
Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2016 Category: Medical Equipment Source Type: alerts
B Braun Medical Inc - Dialog Hemodialysis machine: Dialog 120 V DFAdimeaWANBSL - Class 1 Recall
Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2016 Category: Medical Equipment Source Type: alerts
B Braun Medical Inc - Dialog Hemodialysis machine: Dialog A HE/BIC - Class 1 Recall
Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 4, 2016 Category: Medical Equipment Source Type: alerts
