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Gambro Renal Products, Incorporated

19 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, recall (Z-2193-2014)Gambro Renal Products, Incorporated2014-08-13
Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pou recall (Z-2194-2014)Gambro Renal Products, Incorporated2014-08-13
Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic recall (Z-2195-2014)Gambro Renal Products, Incorporated2014-08-13
Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouc recall (Z-2196-2014)Gambro Renal Products, Incorporated2014-08-13
Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 po recall (Z-2197-2014)Gambro Renal Products, Incorporated2014-08-13
Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches recall (Z-2198-2014)Gambro Renal Products, Incorporated2014-08-13
Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plasti recall (Z-2199-2014)Gambro Renal Products, Incorporated2014-08-13
Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plasti recall (Z-2200-2014)Gambro Renal Products, Incorporated2014-08-13
Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouc recall (Z-2201-2014)Gambro Renal Products, Incorporated2014-08-13
Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches recall (Z-2202-2014)Gambro Renal Products, Incorporated2014-08-13
Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches recall (Z-2203-2014)Gambro Renal Products, Incorporated2014-08-13
Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouc recall (Z-2204-2014)Gambro Renal Products, Incorporated2014-08-13
Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouc recall (Z-2205-2014)Gambro Renal Products, Incorporated2014-08-13
PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment K recall (Z-2206-2014)Gambro Renal Products, Incorporated2014-08-13
X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541 recall (Z-2207-2014)Gambro Renal Products, Incorporated2014-08-13
Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. I recall (Z-1643-2014)Gambro Renal Products, Incorporated2014-05-21
Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, In recall (Z-1644-2014)Gambro Renal Products, Incorporated2014-05-21
Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 1010 recall (Z-1455-2014)Gambro Renal Products, Incorporated2014-04-11
Prismaflex System, Catalog Number 107493, Indicated for continuous solute and/or fluid rem recall (Z-1901-2011)Gambro Renal Products, Incorporated2011-04-06

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Every clearance here is in the API, with alerts when new ones post.