Stradis Medical, LLC dba Stradis Healthcare: STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431

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: 80 kits Lot/code info: a) 9430: UDI/DI (case) M75294301, UDI/DI (kit)M75294301, Serial/Lot Numbers: 22270492023 b) 9431: UDI/DI (case) M75294301, UDI/DI (kit)M75294301, Serial/Lot Numbers: 22255491774, 22255491484

UPC codes

22270492023, 22255491774, 22255491484

Source

Official record: FDA (Device enforcement) ↗

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