Enforcement Report - Week of March 13, 2013
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Product Detail
| Product Description | AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities. |
|---|---|
| Recall Number | Z-0915-2013 |
| Classification | Class II |
| Code Info | AMSCO C: Serial Numbers: 021911201 023461202 AMSCO 400: Serial Numbers: 030181215-030291310 |
| Product Distributed Qty | 395 Units |
| Reason For Recall | 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. |
Event Detail
| Event Id | 64440 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Steris Corporation |
| City | Mentor |
| State | OH | Country | US |
| Voluntary / Mandated | |
| Recall Initiation Date | 2013-02-12 |
| Initial Firm Notification of Consignee or Public | Visit |
| 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. |
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