Device product
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.
Z-1140-2021
Product summary
- Event
- Event 87218
- Status
- Terminated
- Classification
- Class II
- Quantity
- 776 packs
- Official record key
device-enforcement:Z-1140-2021
Official wording
Reason: Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
Code information: a) 89-9194.07, Lot Numbers; 47782581 exp 5/1/2021 b) 89-9194.09, Lot Numbers: 50224694 exp 9/1/2023, 50326092 exp 9/1/2023, 50582301 exp 9/1/2023, 50795307 exp 11/1/2023, 51008862 exp 11/1/2023, 51153103 exp 11/1/2023 c) 89-9194-10, Lot Numbers: 51434221 exp 11/1/2023, 51881522 exp 11/1/2023 d) 89-9194-11, Lot Numbers: 52175785 exp 8/1/2022, 52849153 exp 11/1/2023, 53220664 exp 2/1/2025, 53327306 exp 2/1/2025, 53409521 exp 9/1/2023, 53565355 exp 12/1/2024
Distribution pattern: Distributors in OK, MI, and TX.
Derived failure modes
-
Unknown
Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.