Stradis Medical, LLC dba Stradis Healthcare: HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891

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.

Details from the source

Reason for recall: 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. Distribution: US nationwide distribution, and Canada. Quantity: 144 units Lot/code info: UDI/DI (case) H65857028911, UDI/DI (kit)M75257028910, Serial/Lot Numbers: 22252491813

UPC codes

22252491813

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.