Recall Z-0478-2014 ยท FLE Sterilizer, Steam
Steris Corporation
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.
| Date | Dec 11, 2013 (initiated Oct 18, 2013) |
| Status | Terminated |
| Reason | The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force. |
| Root cause | 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 | 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 |
| FDA record | Open on fda.gov |