Cook Incorporated: COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791

Hazard

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Details from the source

Reason for recall: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Distribution: Worldwide distribution. Quantity: 49 units Lot/code info: Reference Part Number CMW-14-190-12G, UDI (01)00827002507876(17)260509(10)15885574X, Lot Number 15885574X; Reference Part Number CMW-14-190-12G, UDI (01)00827002507876(17)281203(10)15783003X, Lot Number 15783003X; Reference Part Number CMW-14-300-12G, UDI (01)00827002507913(17)260227(10)15416547, Lot Number 15416547.

UPC codes

00827002507876, 00827002507913

Source

Official record: FDA (Device enforcement) ↗

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