medical Class II Updated 2021-03-03

DeRoyal Industries Inc recalls Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 8

Recalled 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.


Hazard / Issue

Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.

Issued by

FDA

Affected States: OK, MI, TX
Lot/Code Info: 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
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