Assert Eo Biological Test Pack

• • Terminated Z-0605-2014 FDA Class II ·initiated 10 Sep 2013

  STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM sterilization cycles does not meet specifications for Lot # 131004 of the Verify Dual Species Self-Contained Biological Indicators. As a result the spore count on the affected product is lower than the labeled minimum and the product may incorrectly indicate that a 5-log spore kill was achieved.

510(k) Number

K854631 ↗

FDA Product Code

FRC

Device Class

Class II

Regulation

21 CFR Part 880.2800

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Universal Mouthpiece, #750

  Class I

  FDA 510(k) K770586 Active Cleared 5 Apr 1977

• Surgicot Steam Test Pack Open recall

  Class II

  FDA 510(k) K854902 Active Cleared 20 May 1986

• Ventilator Adaptor, #751

  Class I

  FDA 510(k) K770587 Active Cleared 5 Apr 1977

• Surgipeel Self-Seal Packaging System

  Class II

  FDA 510(k) K820302 Active Cleared 24 Feb 1982

• Corrugated Tubing #770 & 771

  Class I

  FDA 510(k) K770593 Active Cleared 19 Apr 1977

• Aerosol T Adapter, #752

  Class I

  FDA 510(k) K770585 Active Cleared 5 Apr 1977

See all devices from Surgicot, Inc. →