DeRoyal Industries Inc recalls Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure pack

Recalled March 3, 2021 · FDA recall Z-1140-2021 · DeRoyal Industries

Hazard

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

Units

776 packs

Sold at

Distributors in OK, MI, and TX.

Description

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

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.

Manufacturer(s)

DeRoyal Industries Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →