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U.S. Department of Health and Human Services

Class 3 Device Recall AMSCO

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  Class 3 Device Recall AMSCO see related information
Date Initiated by Firm September 03, 2015
Date Posted November 04, 2015
Recall Status1 Terminated 3 on January 22, 2016
Recall Number Z-0210-2016
Recall Event ID 72217
510(K)Number K111223  
Product Classification Sterilizer, steam - Product Code FLE
Product AMSCO 400 and AMSCO C Small Steam Sterilizers
Code Information Serial #'s: 033331205, 033341248, 033351210, 033401221, 033411215, 033451217, 030741306, 031491314, 032381302, 032341304, 033281222, 030621412, 030871412, 030871410, 031751401, 031771425, 031781412, 031781414, 031911436, R020141502, R020151501, R020191502, R020201501, R020261502, R020261504, R020271501, 030341514, R020471501, 030501540, 030651519, R021001503, R021051501
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact Ms. Kathryn E. Cadorette
440-392-7231
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Software design
Action On 9/21/2015 the firm sent Recall Correction Notices to their customers.
Quantity in Commerce 32 units
Distribution US nationwide distribution.
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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