DeRoyal Industries Inc: Medical Device Recall in 2021 - (Recall #: Z-1140-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 25, 2021

Date Posted: March 3, 2021

Recall Number: Z-1140-2021

Event ID: 87218

Reason for Recall:

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

Status: Terminated

Product Quantity: 776 packs

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.

Voluntary or Mandated:

Voluntary: Firm initiated