DeRoyal Industries Inc Recall 87218
Description: Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades.
DeRoyal Industries Inc Recall 87218 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1139-2021 |
| Event ID | 87218 |
| Event Description | Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades. |
| Product Type | Devices |
| Distribution | Distributors in OK, MI, and TX. |
| Quantity | 1084 packs |
| Recall Reason | Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker. |
| Device Classification | 20210303 |
| Device Code Info | a) 89-7483.07, Lot Numbers: 48535952 exp 3/1/2021, 48613789 exp 3/1/2021, 49330297 exp 7/1/2021, 49529669 exp 8/1/2021, 49852263 exp 9/1/2021 b) 89-7483.08, Lot Numbers: 50033361 exp 11/1/2021, 50404628 exp 12/1/2021, 50783200 exp 12/1/2021 c) 89-7483.09, Lot Numbers: 51021872 exp 12/1/2021, 51121460 exp 4/1/2022, 51284373 exp 4/30/2022, 51458898 exp 4/1/2022, 51701317 exp 7/1/2022 d) 89-7483.10, Lot Numbers: 51954402 exp 9/1/2022, 52183224 exp 9/1/2022, 52413069 exp 10/1/2022, 53117579 exp 10/1/2022, 53311005 exp 11/1/2022 |
| Center Classification Date | 20210219 |
| Recall Initiation Date | 20210125 |
| Recalling Firm | DeRoyal Industries Inc |
| Initial Notification | |
| Similar To |