Devices

Device Recall Polyflux Revaclear

  • Model / Serial
    Lot No. C412120501 to C412127501, C413100101 to C413129601, C414100101 to Lots C414119301 and Lot C414120001
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.
  • Product Description
    Polyflux Revaclear Dialyzer, Model Number 110633. || The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
  • Manufacturer
    Gambro Renal Products Inc
  • 1 Event

Manufacturer

Gambro Renal Products Inc
  • Manufacturer Address
    Gambro Renal Products Inc, 1101 Jeter Ave, Opelika AL 36801-3885
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA

One device with a similar name

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Device Recall Polyflux Revaclear
  • Model / Serial
    Lot No C412207001 to C412209101, C413200101 to C413206001, C414200101 to C414206001
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.
  • Product Description
    Polyflux Revaclear Max Dialyzer, Model Number 110634. || The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
  • Manufacturer
    Gambro Renal Products Inc