FDA Recall
Terminated
AMSCO 3000 Series Washer/Disinfector Model # 3052
Recall: Z-0995-2019
·
Initiated December 20, 2018
Recall
- Recall Number
- Z-0995-2019
- Event Number
- 82035
- Firm
- Steris Corporation
- FEI Number
- 1527821
- Product Code
- MEC
- Status
- Terminated
- Root Cause
- Software Manufacturing/Software Deployment
- Initiated
- December 20, 2018
- Terminated
- July 22, 2019
- Address
- 5960 Heisley Rd, Mentor, OH, 44060-1834
Description
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.
Action
Urgent Device Field Correction notification letters dated 12/20/18 were sent to customers.
Distribution
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.
Quantity
11