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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 Sterilizersee related information
Date Initiated by FirmMarch 22, 2007
Date PostedAugust 23, 2007
Recall Status1 Terminated 3 on September 28, 2010
Recall NumberZ-1193-2007
Recall Event ID 38031
510(K)NumberK010865 
Product Classification steam sterilizer - Product Code FLE
ProductAmsco 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 ContactHolly 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
ActionBy 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 Commerce78
DistributionWorldwide, including USA, Denmark, Belgium, Greece, India, and Russia.There are no Canadian accounts.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FLE
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