Asahi Am-Bio Series Dialyzers (Wet Models)& (Dry Models), Models Am-Bio-50, Am-Bio-65, Am-Bio-75, and Am-Bio-100, Am-Bio-

• 2 recalls, same reason

  • Terminated Z-0173-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006
  • Terminated Z-0174-2007 FDA Unclassified (pre-2012) ·initiated 12 Oct 2006

  There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle.

• • Terminated Z-0788-05 FDA Unclassified (pre-2012) ·initiated 31 Mar 2005 ·on shared 510(k) K983720

  Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K983720 ↗

FDA Product Code

MSE

Models / Variants

Am-Bio-50

Am-Bio-65

Am-Bio-75

Am-Bio-100

Am-Bio-

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Modified Sepacell Pl-Series Leukocyte Removal Filt

  Class II

  FDA 510(k) K896664 Active Cleared 24 Jan 1990

• Asahi AM-R Series Dialyzers

  Class II

  FDA 510(k) K970650 Active Cleared 30 Sep 1997

• Asahi Hollow Fiber Kidneys, Excel

  Class II

  FDA 510(k) K833150 Active Cleared 15 Nov 1983

• Asahi New Pan-Series Hemofilters

  Class II

  FDA 510(k) K844663 Active Cleared 18 Jan 1985

• High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models Aps-R, -M, -S, -E, and -Ex

  Class II

  FDA 510(k) K041726 Active Cleared 23 Jul 2004

• Modified Am-Series Dialyzers

  Class II

  FDA 510(k) K854575 Active Cleared 2 Dec 1985

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