Recall Z-0824-2019 ยท FLE Sterilizer, Steam
Steris Corporation
ATLAS Loading Car
| Date | Dec 26, 2018 |
| Status | Terminated |
| Reason | The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when the loading car is empty, potentially resulting in the loading car unexpectedly sliding forward or falling to one side. |
| Root cause | Device Design |
| Action | On December 20, 2018, the firm distributed Urgent Device Field Correction letters to its customers, informing them of the recall. Customers were advised of the following actions: 1. A Steris Service Technician will contact your facility to repair your units. 2. Users can continue to use the loading car and transfer carriage prior to repair. Users are advised to use caution when operating the loading car and transfer carriage, especially when the loading car is empty. If you have questions regarding this matter, please contact Sam Watkins, Senior Product Manager, at 440-392-7683, STERIS Cus |
| Quantity | 129 |
| Distribution | Nationwide domestic distribution. Foreign distribution to Canada, Costa Rica, Indonesia, South Korea, and Taiwan. |
| FDA record | Open on fda.gov |