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U.S. Department of Health and Human Services

Class 2 Device Recall Century Medium Sterilizer

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  Class 2 Device Recall Century Medium Sterilizer see related information
Date Initiated by Firm March 22, 2007
Date Posted August 23, 2007
Recall Status1 Terminated 3 on September 28, 2010
Recall Number Z-1193-2007
Recall Event ID 38031
510(K)Number K010865  
Product Classification steam sterilizer - Product Code FLE
Product Amsco Century Medium Steam Sterilizer (26" x 37.5") (660 x 950mm).
Code Information Prevac Steam Sterilizer, Model #'s V-136H, V-148H, V-160H, SV-148H, V-1264 & V-1263& SFPP Steam Sterilizer, Model #'s P-148H & P-160H.   Code # B093934202, B093924204, B09324223, B093924225, B093924227, B093924229, B093924233, B093924244, B093924246, B093924248, B093924250, B093924286, B093924288, B093924296, B093924307, B093924309, B093924310, B093924434, B093924476, B093927301, B093927302, B093927322, B300903936
Recalling Firm/
Manufacturer		 Steris Corp
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact Holly Wright Lee
440-392-7019
Manufacturer Reason
for Recall		 The cables inside the pump conduit box may be exposed (not covered with wire nut and/or electrical tape) that could cause a potential electrical shock hazard.
FDA Determined
Cause 2		 Employee error
Action By telephone 3/22/2007, customers were instructed to cease using the product and a service technician would be dispatched immediately to repair the unit.
Quantity in Commerce 78
Distribution Worldwide, including USA, Denmark, Belgium, Greece, India, and Russia.There are no Canadian accounts.
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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