• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Century Medium Sterilizer

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Century Medium Sterilizer
see related information
Date Posted August 23, 2007
Recall Status1 Terminated on September 28, 2010
Recall Number Z-1193-2007
Recall Event ID 38031
Product Classification Sterilizer, Steam - 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, Ohio 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
PRODUCTION CONTROLS: Process Control
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
-
-