Gambro Renal Products, Incorporated: Medical Device Recalls in 2014

According to to data from the FDA, there were 18 medical device recalls made by Gambro Renal Products, Incorporated in 2014. See the details of the recalls below.

You can see similar recalls for other firms.

• Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box
• Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box
• Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box
• Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
• X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
• Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box
• Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box
• Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box
• Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box
• PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch
• Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box
• Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
• Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box
• 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.
• Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box
• Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box
• Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box
• Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box