Baxter Healthcare Corporation - REVACLEAR 400 - Class 2 Recall
REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 2, 2019 Category: Medical Devices Source Type: alerts
Baxter Healthcare Corporation - REVACLEAR 300 - Class 2 Recall
REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 2, 2019 Category: Medical Devices Source Type: alerts
Cook Inc. - ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER - Class 1 Recall
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35252 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the cerebral or coronary vasculature. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 18, 2019 Category: Medical Devices Source Type: alerts
Cook Inc. - ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER - Class 1 Recall
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the cerebral or coronary vasculature. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 18, 2019 Category: Medical Devices Source Type: alerts
Cook Inc. - ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER - Class 1 Recall
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the cerebral or coronary vasculature. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 18, 2019 Category: Medical Devices Source Type: alerts
NxStage Medical, Inc. - NxStage PureFlow B Solution - Class 2 Recall
NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2019 Category: Medical Devices Source Type: alerts
NxStage Medical, Inc. - NxStage PureFlow B Solution - Class 2 Recall
NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2019 Category: Medical Devices Source Type: alerts
Fresenius Medical Care Renal Therapies Group, LLC - Class 3 Recall
2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2019 Category: Medical Devices Source Type: alerts
Medical Components, Inc dba MedComp - 14F SLX Double Lumen Full Tray - Class 2 Recall
14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 17, 2019 Category: Medical Devices Source Type: alerts
BrosMed Medical Co.,Ltd. - Hermes NC PTA Balloon Dilation Catheter - Class 2 Recall
Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 28, 2019 Category: Medical Devices Source Type: alerts
Baxter Healthcare Corporation - Kaguya Automated Peritoneal Dialysis System - Class 2 Recall
Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2019 Category: Medical Devices Source Type: alerts
Baxter Healthcare Corporation - AMIA Automated Peritoneal Dialysis Cycler - Class 2 Recall
AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2019 Category: Medical Devices Source Type: alerts
Fresenius Medical Care Renal Therapies Group, LLC - Granuflo Dry Acid Concentrate - Class 3 Recall
Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 30, 2018 Category: Medical Devices Source Type: alerts
Fresenius Medical Care Renal Therapies Group, LLC - Granuflo Dry Acid Concentrate - Class 3 Recall
Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 30, 2018 Category: Medical Devices Source Type: alerts
Fresenius Medical Care Renal Therapies Group, LLC - Fresenius Granuflo Dry Acid Concentrate - Class 3 Recall
Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 30, 2018 Category: Medical Devices Source Type: alerts
