Recall Z-1248-2017 ยท LRO General Surgery Tray
DeRoyal Industries Inc
SRHS DeRoyal Heart Tracecart REF 53-1913, 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 | 1157 units |
| Distribution | MS & LA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.