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Gambro Renal Products Inc

10 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear and Polyflux Reva recall (Z-0489-2015)Gambro Renal Products Inc2014-12-01
Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear and Polyflux recall (Z-0490-2015)Gambro Renal Products Inc2014-12-01
Gambro Cartridge Blood Set, 003410-510, is intended for single use in a hemodialysis treat recall (Z-1860-2008)Gambro Renal Products, Inc.2008-09-26
Gambro Cartridge Blood Set, 0141080XXXC, is intended for single use in a hemodialysis trea recall (Z-1861-2008)Gambro Renal Products, Inc.2008-09-26
Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3 ( recall (Z-1367-2008)Gambro Renal Products, Inc.2008-03-25
Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lu recall (Z-0695-2007)Gambro Renal Products, Inc.2007-03-31
Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Ga recall (Z-0200-2007)Gambro Renal Products, Inc.2006-11-21
Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, I recall (Z-0032-2007)Gambro Renal Products, Inc.2006-10-12
Gambro Prisma M100 preset, Part No. 8353486. recall (Z-0705-06)Gambro Renal Products, Inc.2006-04-05
Gambro Prisma HF1000 preset, Part No. 8399050. recall (Z-0706-06)Gambro Renal Products, Inc.2006-04-05

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