FDA-Device2021-03-03Class II
Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades.
DeRoyal Industries Inc
Hazard
Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
Sold states
Distributors in OK, MI, and TX.
Affected count
1084 packs
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1139-2021Don't want to check this manually?
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