FDA-Device2022-12-21Class II

HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray

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
35 units
Manufactured in
3025 Northwoods Pkwy, N/A, Peachtree Corners, GA, United States
Products
HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0506-2023

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