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All Recalls

Every Gambro Renal Products, Incorporated Recall

Sorted by most recent. Click any recall for full details.

14 recalls
High RiskFDA
Gambro Renal Products, Incorporated
Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box
Medical Devices·401,451 affected·Jul 18, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and...
Medical Devices·2,461,824 affected·Apr 16, 2014
High RiskFDA
Gambro Renal Products, Incorporated
Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and...
Medical Devices·306,525 affected·Dec 9, 2013