—#170619

Product

AMSCO 3000 Series Washer/Disinfector Model # 3052

FDA product code: MEC — Disinfector, Medical Devices
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Serial Numbers 3602014006 3631618006 3628818009 3629518008 3633018010 3626718010 3630918008 3630918010 3617717013 3620016019 3623516006

Why it was 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.

Root cause (FDA determination)

Software Manufacturing/Software Deployment

Action the firm took

Urgent Device Field Correction notification letters dated 12/20/18 were sent to customers.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

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.

Timeline

Recall initiated: 2018-12-20
Terminated: 2019-07-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #170619. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.