Recall Z-1140-2021 ยท LRO General Surgery Tray
DeRoyal Industries Inc
Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including sternum saw blades.
| Date | Jan 25, 2021 |
| Status | Terminated |
| Reason | Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker. |
| Root cause | Process control |
| Action | DeRoyal issued their recall on 01/25/2021 to the end user level by emailing recall letters to its direct accounts. The direct accounts were instructed to forward our recall notification to their customers. The direct accounts and their customers were asked to identify the affected products and return the provided notice of credit form back to DeRoyal. |
| Quantity | 776 packs |
| Distribution | Distributors in OK, MI, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K842648 | GENERAL SURGERY TRAY Deroyal Industries, Inc., Sep 20, 1984 |