Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0995-2019 — AMSCO 3000 Series Washer/Disinfector Model # 3052

U.S. FDA — Device Enforcement · United States · 2018-12-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0995-2019
Date of alert
2018-12-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Steris Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
3602014006
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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