FDA-Device2022-12-21Class II
STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,
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
10 units
Manufactured in
3025 Northwoods Pkwy, N/A, Peachtree Corners, GA, United States
Products
STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0548-2023Don't want to check this manually?
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