Recall Z-0586-2020 ยท FLE Sterilizer, Steam
Steris Corporation
Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam
| Date | Oct 22, 2019 |
| Status | Terminated |
| Reason | The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain full y engaged with the transfer carriage and result in the transfer carriage and loading car unexpectedly falling forward |
| Root cause | Process control |
| Action | Steris Corp. issued URGENT DEVICE FIELD CORRECTION dated 10/22/19 informing users reason for recall, and action to take: A STERIS Service Technician will contact your facility to repair your unit(s). Users can continue to use the transfer carriage prior to this repai r. Users are advised to use caution when operating the transfer carriage, and avoid bumping into other equipment or rolling over uneven surfaces. If you have questions regarding this matter, please contact STERIS Technical Support, at 800-333-8828, STERIS Customer Service at 1-800-548-4873, or your local STERIS Representative. |
| Quantity | 237 units |
| Distribution | Nationwide Foreign: Canada, Peru, Mexico, Brazil, Saudi Arabia, Columbia |
| FDA record | Open on fda.gov |