Stradis Medical, LLC dba Stradis Healthcare: STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,

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: 100 units Lot/code info: UDI/DI (case) M75268219371, UDI/DI (kit)M75268219370, Serial/Lot Numbers: 22237490509

UPC codes

22237490509

Source

Official record: FDA (Device enforcement) ↗

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