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Class 2 Device Recall AMSCO C and AMSCO 400 Steam Sterilizers |
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Date Initiated by Firm |
February 12, 2013 |
Date Posted |
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
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Product Classification |
Sterilizer, steam - Product Code FLE
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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
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For Additional Information Contact |
440-392-7601
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = FLE and Original Applicant = STERIS Corporation
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