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U.S. Department of Health and Human Services

Class 2 Device Recall Evolution steam sterilizers

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  Class 2 Device Recall Evolution steam sterilizers see related information
Date Initiated by Firm March 23, 2012
Date Posted May 11, 2012
Recall Status1 Terminated 3 on June 11, 2013
Recall Number Z-1522-2012
Recall Event ID 61786
510(K)Number K082435  K091136  
Product Classification Sterilizer, steam - Product Code FLE
Product The Evolution steam sterilizers, manufactured by Steris Corporation, utilize a loading system to assist the operator in transporting, loading and unloading items to be sterilized. It consists of two major components:
-Loading Car: Shelving unit which holds the items to be sterilized; and the
-Transfer Carriage: Wheeled unit which loads/unloads the loading car and transports it from one location to another. Product shipped in crate.

Product Usage:
The Evolution Transfer Carriage is a wheeled unit which loads/unloads the sterilizer loading car and transports it from one location to another.
Code Information Model #: M4012097, M4012098, M4011084, M4011085 & M4011090; Seral #s: 030400905 thru 030381235.
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact Molly Conway
440-392-7771
Manufacturer Reason
for Recall		 Through Customer feedback and field service experience, STERIS learned that operators may experience difficulty when inserting or removing equipment from the Evolution sterilizer using the transfer carriage due to the following issues with the transfer carriage. 1) Deformation of the latch pin or cracked ball bearings preventing the roller from turning. 2) The rollers on the ends of the pivot a
FDA Determined
Cause 2		 Device Design
Action Steris Corporation sent an Urgent Voluntary Field Correction Notice dated March 23, 2012 via FedEx with tracking numbers for delivery confirmation to each affected customer. The letter identified the affected product, problem and actions to be taken. The letter stated a STERIS Field Service Representatives will contact each affected customer to schedule a service visit to upgrade the transfer carriages. For technical questions or questions regarding STERIS visit to your facility, please contact STERIS Field Service Dispatch at 1-800-333-8828.
Quantity in Commerce 523
Distribution Worldwide Distribution - USA Nationwide including AL, AZ, CA, CO, CN, DE, FL, GA, IL, IN, KA, KY, LA, MD, MA, MI, ME, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, & WY and the countries of Brazil and Canada.
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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