Fresenius Medical Care Holdings, Inc. - Revision K Actuator Test Boards - Class 2 Recall
Revision K Actuator Test Boards 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
Gambro Renal Products, Incorporated - Gambro Cartridge Blood Set - Class 2 Recall
Gambro Cartridge" Blood Set blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extracorporeal blood transport circuit for hemodialysis treatments for Gambro Phoenix and COBE Centrisystem 3 (and 3+) Dialysis Delivery Systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 12, 2014 Category: Medical Equipment Source Type: alerts
Mar Cor Purification - Mar Cor Purification Millenium HX Portable Reverse Osmosis System. - Class 2 Recall
Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment.. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 15, 2014 Category: Medical Equipment Source Type: alerts
NxStage Medical, Inc. - NxStage PureFlowB Solution - Class 2 Recall
NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. The 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 - February 25, 2014 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Holdings, Inc. - Fresenius Bicarbonate Jug Adapter - Class 2 Recall
Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 4, 2014 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Holdings, Inc. - Fresenius 2008 Series Hemodialysis Machines - Class 2 Recall
Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. Hemodialysis is indicated for patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate. The dialysate delivery machine is used for hemodialysis in hospital, dialysis centers, and at home. The 2008K, 20081(2 and 2008T hemodialysis machines are designed to perform hemodialysis in hospitals and dialysis clinics. They can be used for patients suffering chronic or acute renal failure. The 2008K, 2008K2 and 20...
Source: Medical Device Recalls - January 7, 2014 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Holdings, Inc. - 2008K Home Blood lines Combiset True Flow Series - Class 2 Recall
2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 9, 2013 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Holdings, Inc. - Combiset Blood Line with BVM - Class 2 Recall
Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 9, 2013 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Holdings, Inc. - Combiset Blood Line - Class 2 Recall
Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 9, 2013 Category: Medical Equipment Source Type: alerts
Mesa Laboratories, Inc. - pH 7.0 Buffer Solution - Class 2 Recall
pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints and 02.0031 for Quarts. Packaged in Plastic Bottles. Can be sold individually or in cartons with 6 bottles per box (for quart bottles only). Used in the hemodialysis setting to calibrate pH meters. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 8, 2013 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Holdings, Inc. dba Renal Solutions - 2008 MeDS Pump, Venofer(R) Pump - Class 2 Recall
2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer, in conjunction with hemodialysis, is prescribed by a physician. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 27, 2013 Category: Medical Equipment Source Type: alerts
Fresenius Medical Care Holdings, Inc. - Class 2 Recall
Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 12, 2013 Category: Medical Equipment Source Type: alerts
NxStage Medical, Inc. - NxStage PureFlowB Solution - Class 2 Recall
NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The 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 - May 3, 2013 Category: Medical Equipment Source Type: alerts
Molded Products Inc - Sterile Access & Return Line Set - Class 2 Recall
Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 19, 2013 Category: Medical Equipment Source Type: alerts
Medisystems a NX Stage Company - Medisytems - Class 2 Recall
Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 25, 2013 Category: Medical Equipment Source Type: alerts
