FDA-Device2022-12-21Class II
STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS
Stradis Medical, LLC dba Stradis Healthcare
Hazard
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Sold states
US nationwide distribution, and Canada.
Affected count
25 units
Manufactured in
3025 Northwoods Pkwy, N/A, Peachtree Corners, GA, United States
Products
STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0483-2023Don't want to check this manually?
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