Company: Steris Corporation
Date of Enforcement Report: 3/20/2019
Class II:
PRODUCT
AMSCO 3000 Series Washer/Disinfector Model # 3052
Recall Number: Z-0995-2019
REASON
The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinfector or potential for inadequate cleaning or disinfection.
RECALLING FIRM/MANUFACTURER
Steris Corporation on 12/20/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
11
DISTRIBUTION
US Nationwide and International