Recall Z-1522-2012 ยท FLE Sterilizer, Steam
Steris Corporation
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 lo
| Date | May 11, 2012 (initiated Mar 23, 2012) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |