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Cook Medical Incorporated recalls Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C ELECT
Recalled March 27, 2019 · FDA recall Z-1026-2019 · Cook Medical Incorporated
Hazard
Updates to the Instructions for Use. · FDA Class III
Units
91731 total
Sold at
The products were distributed US Nationwide Distribution
Description
Updates to the Instructions for Use.
Product
Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C ELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: Pulmonary thromboembolism when anticoagulant therapy is contraindicated; Failure of anticoagulant therapy in thromboembolic diseases; Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Filter implant may be retrieved if clinically indicated. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.
Manufacturer(s)
Cook Medical Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →