Class 2 Device Recall AMSCO 3000 Series Washer/Disinfector Model 3052

• Date Initiated by Firm: December 20, 2018
• Create Date: March 09, 2019
• Recall Status: Terminated on July 22, 2019
• Recall Number: Z-0995-2019
• Recall Event ID: 82035
• Product Classification: Disinfector, medical devices - Product Code MEC
• Product: AMSCO 3000 Series Washer/Disinfector Model # 3052
• Code Information: Serial Numbers 3602014006 3631618006 3628818009 3629518008 3633018010 3626718010 3630918008 3630918010 3617717013 3620016019 3623516006
• Recalling Firm/ Manufacturer: Steris Corporation; 5960 Heisley Rd; Mentor OH 44060-1834
• For Additional Information Contact: Katie Bias; 440-392-7464
• Manufacturer 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.
• FDA Determined Cause: Software Manufacturing/Software Deployment
• Action: Urgent Device Field Correction notification letters dated 12/20/18 were sent to customers.
• Quantity in Commerce: 11
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.