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Stradis Medical, LLC dba Stradis Healthcare recalls HENRY SCHEIN, ENT PACK, Item No.570-2718
Recalled December 21, 2022 · FDA recall Z-0511-2023 · Stradis Medical, LLC
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. · FDA Class II
Units
104 units
Sold at
US nationwide distribution, and Canada.
Description
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.
Product
HENRY SCHEIN, ENT PACK, Item No.570-2718
Manufacturer(s)
Stradis Medical, LLC dba Stradis Healthcare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →