Reported Nov 11, 2015 · Terminated
AMSCO 400 and AMSCO C Small Steam Sterilizers
Steris Corporation
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Steris Corporation · 5960 Heisley Rd · Mentor, OH · 44060-1834
Is this the product you have?
- AMSCO 400 and AMSCO C Small Steam Sterilizers
- Lot codes and dates
Serial #'s: 033331205033341248033351210033401221033411215033451217030741306031491314032381302032341304033281222030621412030871412030871410031751401031771425031781412031781414031911436R020141502R020151501R020191502R020201501R020261502R020261504R020271501030341514R020471501030501540030651519R021001503R021051501
- Amount recalled
- 32 units
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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