Recall – Washer/Disinfector software executes different cleaning cycle than selected

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

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