Recall Z-1668-2022 ยท LRO General Surgery Tray
DeRoyal Industries Inc
DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
| Date | Aug 12, 2022 |
| Status | Terminated |
| Reason | Procedure packs contained a recalled product. |
| Root cause | Material/Component Contamination |
| Action | DeRoyal issued their recall notification on 08/12/2022 to the end user level by emailing recall letters to affected consignees. The consignees are asked to identify the affected products and return any affected product and to complete the return form back to DeRoyal. |
| Quantity | 1306 kits |
| Distribution | US Nationwide distribution in the states of OH and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K842648 | GENERAL SURGERY TRAY Deroyal Industries, Inc., Sep 20, 1984 |