InjuryFLF

CASTLE ETHYLENE OXIDE GAS STERILIZER

Received Jul 2, 1996

Report 35307 · MDR key 35307

Device

Generic name

Ethylene Oxide Sterilizer

Manufacturer

Castle Mdt Technology For Life

Model number

Catalog number

Lot number

Patient

Narrative

Description of Event or Problem

GAS STERILIZER MALFUNCTIONED, RESULTING IN 3 ITEMS BEING USED IN CARE OF THREE PTS NOT BEING COMPLETELY STERILIZED. CO EXAMINED, REPAIRED AND TESTED THE STERILIZER TO VERIFY APPROPRIATE OPERATION.