Recall Z-1247-2017 ยท LRO General Surgery Tray
DeRoyal Industries Inc
DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
| Date | Jan 25, 2017 |
| Status | Terminated |
| Reason | DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage product which was subsequently recalled due to the current packaging configuration of the Atrium Ocean, Oasis, Express and Express Mini chest drainage products. |
| Root cause | Other |
| Action | DeRoyal issued their recall on 01/25/17 to the end-user level by sending overnight letters to its direct accounts and hospitals. Distributors and hospitals were instructed to return the tracecarts to DeRoyal. |
| Quantity | 849 units |
| Distribution | MS & LA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K842648 | GENERAL SURGERY TRAY Deroyal Industries, Inc., Sep 20, 1984 |