FDANovember 2, 2022device

STRADIS HEALTHCARE, Endo Pack, Item No.682-509,

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

22256490827

Recall history

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

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