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U.S. Department of Health and Human Services

Class 2 Device Recall AMSCO Evolution steam sterilizer Transfer Carriage

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  Class 2 Device Recall AMSCO Evolution steam sterilizer Transfer Carriage see related information
Date Initiated by Firm October 18, 2013
Date Posted December 11, 2013
Recall Status1 Terminated 3 on May 13, 2014
Recall Number Z-0478-2014
Recall Event ID 66874
510(K)Number K082435  K091136  
Product Classification Sterilizer, steam - Product Code FLE
Product AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage.

Product Usage:
Mobile, wheeled transportation unit utilized to carry, load, & unload the Loading Car into and out of steam sterilizer units.
Code Information Serial Number Range: 030061103 - 0535531220
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact Mrs. Lindsey M. McGowan
440-392-7519
Manufacturer Reason
for Recall		 The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force.
FDA Determined
Cause 2		 Device Design
Action Steris sent an Urgent Voluntary Field Correction Notice letter dated October 18, 2013 to their customers. The letter identified the affected product, problem, and actions to be taken. The letter informed customers that a Steris Service Representative will contact affected facility to arrange for Steris to upgrade the Transfer Carriage(s). For questions contact Steris Field Service Dispatch at 1-800-333-8828.
Quantity in Commerce 936 units
Distribution Worldwide Distribution - USA Nationwide in the states of: AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MI, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and the District of Columbia including the countries of: Brazil, Canada, Chile, Guam, Mexico, Saudi Arabia, United Arab Emirates & Venezuela.
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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