—#116145

Product

AMSCO C and AMSCO 400 Steam Sterilizers 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, K112403
Affected lot / code info: AMSCO C: Serial Numbers: 021911201 023461202 AMSCO 400: Serial Numbers: 030181215-030291310

Why it was recalled

The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during operation. When this alarm occurs, the sterilizer locks up and cannot be used until serviced, causing Customer nuisance.

Root cause (FDA determination)

Software design

Action the firm took

Steris Corporation initiated their recall on February 12, 2013. They will notify customers via onsite visits by STERIS Field Service Technicians to each affected Customer site. For further questions, please call (440) 392-7601.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA including Canada and the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, SK, TN, TX, UT, VA, VT, WA, WI, and WV.

Timeline

Recall initiated: 2013-02-12
Posted by FDA: 2013-03-06
Terminated: 2013-12-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #116145. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.