—#140236

Product

AMSCO 400 and AMSCO C Small Steam Sterilizers

FDA product code: FLE — Sterilizer, Steam
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K111223
Affected lot / code info: Serial #'s: 033331205, 033341248, 033351210, 033401221, 033411215, 033451217, 030741306, 031491314, 032381302, 032341304, 033281222, 030621412, 030871412, 030871410, 031751401, 031771425, 031781412, 031781414, 031911436, R020141502, R020151501, R020191502, R020201501, R020261502, R020261504, R020271501, 030341514, R020471501, 030501540, 030651519, R021001503, R021051501

Why it was recalled

In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator to open and close the sterilizer door.

Root cause (FDA determination)

Software design

Action the firm took

On 9/21/2015 the firm sent Recall Correction Notices to their customers.

Recalling firm

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

Distribution

Distribution pattern: US nationwide distribution.

Timeline

Recall initiated: 2015-09-03
Posted by FDA: 2015-11-04
Terminated: 2016-01-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #140236. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.