FDANovember 2, 2022device

HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

stradis medical llc dba stradis healthcarestradisstradis medical

UPCs

2224248958222242489505

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505 — Recall Details · AllClear