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.
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) H65857027891, UDI/DI (kit)M75257027890, Serial/Lot Numbers: 22252491561
22252491561
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.