Stradis Medical, LLC dba Stradis Healthcare: STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,

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: 10 units Lot/code info: UDI/DI (case) M752682334R11, UDI/DI (kit)M752682334R10, Serial/Lot Numbers: 22231489619

UPC codes

22231489619

Source

Official record: FDA (Device enforcement) ↗

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