Stradis Medical, LLC dba Stradis Healthcare recalls HENRY SCHEIN, OMFS, Item No.570-2779,

Recall date

November 2, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0515-2023

FDA classification

Class II

Brand / firm

Stradis Medical, LLC dba Stradis Healthcare

Sold / distributed

US nationwide distribution, and Canada.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HENRY SCHEIN, OMFS, Item No.570-2779,