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U.S. Department of Health and Human Services

Class 2 Device Recall AMSCO C and AMSCO 400 Steam Sterilizers

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  Class 2 Device Recall AMSCO C and AMSCO 400 Steam Sterilizers see related information
Date Initiated by Firm February 12, 2013
Date Posting Updated March 06, 2013
Recall Status1 Terminated 3 on December 05, 2013
Recall Number Z-0915-2013
Recall Event ID 64440
510(K)Number K112403  K111223  
Product Classification Sterilizer, steam - Product Code FLE
Product AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
Code Information AMSCO C: Serial Numbers: 021911201  023461202, AMSCO 400: Serial Numbers: 030181215-030291310.
Recalling Firm/
Manufacturer
Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact
440-392-7601
Manufacturer 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.
FDA Determined
Cause 2
Software design
Action 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.
Quantity in Commerce 395 Units
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FLE and Original Applicant = STERIS Corporation
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