The FDA has issued a Class III recall for Gunther Tulip Vena Cava Filter Sets due to voluntary termination by Cook Medical Incorporated.
How to tell if you have it
- Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach
- Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917
The hazard
The specific hazard details are not provided in the current fact pack; the recall is classified as Class III and initiated voluntarily by the firm.
Context
This recall involves Gunther Tulip Vena Cava Filter Sets with UPCs 10827002529165, 10827002529172, and 10827002529189. Cook Medical Incorporated has other recalls on record since 2018-09-25.