—#135639

Product

AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. Designed for sterilization of heat and moisture-stable materials used in healthcare facilities.

FDA product code: FLE — Sterilizer, Steam
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K111223, K112055
Affected lot / code info: AMSCO 400 Units: Serial #'s: 030051501 - 033641440; AMSCO C Units: Serial #'s: R020051501 - R023641403.

Why it was recalled

STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will interrupt and cancel a processing cycle should the selected sterilizer shutdown time coincide with a processing cycle. This may result in a procedure delay.

Root cause (FDA determination)

Software design (manufacturing process)

Action the firm took

On 3/9/2015, the firm sent Urgent Field Correction Notices, to their customers. The letter identified the affected product and gave a description of the problem. The letter states that the control software is being revised to ensure the utility shutdown feature will not interrupt an ongoing processing cycle. STERIS Field Representatives will contact customers to schedule installation of the new control board on affected units. Customers may direct questions regarding the issue to STERIS Customer Service at 1-800-548-4873; Marie LaFrance, Product Manager, at 440-392-7648, or their local sales representative.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, I, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY; and, the countries of Afghanistan, Canada, Japan, Kuwait, Mexico, Republic of Korea, & United Arab Emirates.

Timeline

Recall initiated: 2015-02-19
Posted by FDA: 2015-04-30
Terminated: 2016-01-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #135639. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.