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DeRoyal Industries Inc recalls CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.
Recalled March 3, 2021 · FDA recall Z-1138-2021 · 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
309 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
CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 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 →