Z-0995-2019 Class II Terminated
FDA device recall Z-0995-2019 was initiated by Steris Corporation on Dec 20, 2018 and is designated Class II. 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… The recall status is terminated (terminated Jul 22, 2019). Affected quantity: 11.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 20, 2019
- Initiation Date
- Dec 20, 2018
- Termination Date
- Jul 22, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11
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.
Distribution Pattern
The products were distributed to the following US states: AL, AR, CA, CO, FL, GA, IL, LA, MA, MD, ME, MI, NC, NJ, NM, NY, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The products were distributed to the following foreign countries: Bahrain, Brazil, Canada, China, Saudi Arabia, South Korea, and Taiwan.
Code Information
Serial Numbers 3602014006 3631618006 3628818009 3629518008 3633018010 3626718010 3630918008 3630918010 3617717013 3620016019 3623516006
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0995-2019
- openFDA file date
- Oct 19, 2026
- Loaded by RegDataLab
- Oct 21, 2026