MalfunctionLRT
STERILIZATION INDICATOR STRIP
Received Sep 16, 1996
Report MW4001495 · MDR key 38043
Device
Generic name
Sterilization Indicator Strip
Manufacturer
Surgicot, Inc.Model number
*Catalog number
008060
Lot number
*
Product problems
- False Reading From Device Non-Compliance
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE STERILIZATION INDICATOR STRIPS (ETO) HAVE BEEN UNPREDICTABLE IN CHANGING COLOR WHEN EXPOSED TO ETHYLENE OXIDE. THIS HAS OCCURRED REPEATEDLY AND IN MULTIPLE LOTS. WHEN FOUR STRIPS WERE STERILIZED IN A SINGLE STERILIZATION CONTAINER, ALL FOUR SHOWED DIFFERENT COLOR CHANGES. ALL ETO STERILIZATION CRITERIA WAS MET AND ALL OTHER CHEMICAL AND BACTERIOLOGICAL INDICATORS ACCURATELY SHOWED THIS.