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 - 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
NxStage Medical, Inc. - Class 2 Recall
NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis 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 - November 28, 2018 Category: Medical Devices Source Type: alerts
NxStage Medical, Inc. - Class 2 Recall
NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. 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 - November 28, 2018 Category: Medical Devices Source Type: alerts
NxStage Medical, Inc. - Class 2 Recall
NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis 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 - November 28, 2018 Category: Medical Devices Source Type: alerts
NxStage Medical, Inc. - Class 2 Recall
NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis 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 - November 28, 2018 Category: Medical Devices Source Type: alerts
NxStage Medical, Inc. - Class 2 Recall
NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis 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 - November 28, 2018 Category: Medical Devices Source Type: alerts
NxStage Medical, Inc. - Class 2 Recall
NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis 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 - November 28, 2018 Category: Medical Devices Source Type: alerts
NxStage Medical, Inc. - Class 2 Recall
NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis 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 - November 28, 2018 Category: Medical Devices Source Type: alerts
NxStage Medical, Inc. - Class 2 Recall
NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis 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 - November 28, 2018 Category: Medical Devices Source Type: alerts
Fresenius Medical Care Renal Therapies Group, LLC - 2008T BlueStar Hemodialysis Machine - Class 2 Recall
2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 20, 2018 Category: Medical Devices Source Type: alerts
Fresenius Medical Care Renal Therapies Group, LLC - 2008T BlueStar Hemodialysis Machine - Class 2 Recall
2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 20, 2018 Category: Medical Devices Source Type: alerts
Cardiovascular Systems Inc - Orbital Atherectomy System (OAS) Saline Infusion Pump - Class 2 Recall
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Usage: The pump is a component of the OAS that provides the pumping mechanism and power to the OAD. The pump does not have an indication independent from that of the systems. The Indications for Use for the peripheral and coronary systems are provided below: Peripheral: The DIAMONDBACK 360¿ and STEALTH Peripheral Orbital Atherectomy Systems are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and...
Source: Medical Device Recalls - September 12, 2018 Category: Medical Devices Source Type: alerts
Medical Components, Inc dba MedComp - American Access; Nikkiso; Lifeline - Class 2 Recall
Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 26, 2018 Category: Medical Devices Source Type: alerts
Medical Components, Inc dba MedComp - American Access; Nikkiso; Lifeline - Class 2 Recall
Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 26, 2018 Category: Medical Devices Source Type: alerts
