Recall Z-1382-2024 ยท LRO General Surgery Tray
DeRoyal Industries Inc
GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
| Date | Mar 29, 2024 (initiated Feb 13, 2024) |
| Status | Open, Classified |
| Reason | DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled. |
| Root cause | Other |
| Action | DeRoyal Industries notified their sole consignee via email on 02/13/2024. The notice explained the reason for recall, risk, and requested that the affected product Nurse Assist 16F Urine Meter Foley, be removed from the tracecarts and returned. The consignee was instructed to complete the NOTICE OF RETURN FORM, indicating all affected products found in your inventory and return the completed form to DeRoyal via fax to 865- 362-3716 or recalls@deroyal.com. For questions regarding credit for the recall, email at recalls@deroyal.com or call 865-362-4203. |
| Quantity | 134 tracecarts |
| Distribution | Florida |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K842648 | GENERAL SURGERY TRAY Deroyal Industries, Inc., Sep 20, 1984 |