FDAFDA · Food and drugs·Recall number Z-0915-2013
AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
Published March 13, 2013 · Recall initiated: February 12, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Steris Corporation
- Distributor
- 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.
- Lot
- AMSCO C: Serial Numbers: 021911201 023461202 AMSCO 400: Serial Numbers: 030181215-030291310
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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