Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
Check against the official notice below — it lists the full affected range.
Stradis Medical, LLC is recalling 348 units of the Coryell Memorial Hospital Total Joint Pack surgical kit due to potential perforations or tears in the outer bag that could compromise the sterility of the kit. The affected products have SKU/Part Number 690-260 and UDI M7526902600, with 18 specific lot numbers identified. The recalled kits were distributed nationwide in Indiana, Texas, and Pennsylvania.
The source document does not specify a remedy or corrective action for consumers who may have obtained affected units.
Written by software from the official notice below. Not reviewed by a lawyer.
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Reason for recall: The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. Distribution: US Nationwide distribution in the states of IN, TX, and PA. Quantity: 348 units Lot/code info: SKU/Part Number 690-260; UDI M7526902600 Lot Numbers: 1912331779, 1914333072, 1915433813, 1915634371, 1919334769, 1923436351, 1930338689, 1935342884, 2006644326, 2007745836, 20149461110, 20241463865, 20303466242, 20328467437, 20356468152, 21033468960, 21050471039, 21270476822
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.