PlainRecalls
FDA Devices Moderate Class II Terminated

AMSCO 5000 Series Washer/Disinfector Model # 5052

Reported: March 20, 2019 Initiated: December 20, 2018 #Z-0996-2019

Product Description

AMSCO 5000 Series Washer/Disinfector Model # 5052

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.

Details

Recalling Firm
Steris Corporation
Units Affected
68
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.
Location
Mentor, OH

Frequently Asked Questions

What product was recalled?
AMSCO 5000 Series Washer/Disinfector Model # 5052. Recalled by Steris Corporation. Units affected: 68.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 20, 2019. Severity: Moderate. Recall number: Z-0996-2019.