Recall Z-0995-2019— Steris Corporation
Class II · Terminated
Class II FDA medical device recall by Steris Corporation, initiated 2018-12-20, terminated 2019-07-22. FDA's recall record names no specific 510(k) clearance for this event. Product: AMSCO 3000 Series Washer/Disinfector Model # 3052. 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
- Steris Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-20
- Terminated
- 2019-07-22
- Firm location
- Mentor, OH, United States
Product description
AMSCO 3000 Series Washer/Disinfector Model # 3052
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.