Recall Z-0875-2022 · DTK Filter, Intravascular, Cardiovascular
Cook Medical Incorporated
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IGTCFS-65-1-UNI-TULIP G52918
| Date | Feb 14, 2022 |
| Status | Terminated |
| Reason | IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events |
| Root cause | Labeling design |
| Action | Cook issued Urgent Medical Device Correction letter on February 14, 2022 via courier to US consignees. Letter states reason for recall, health risk and action to take: 1. Please read the new IFU in entirety. 2. The electronic versions of the IFUs can be found on the Cook Medical website by Catalogue Number (RPN): https://ifu.cookmedical.com/ifuPub/searchIfu.jsf 3. Your Cook Medical Sales Representative can facilitate delivery of new IFUs for your inventory upon request. 4. Please complete and return the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless |
| Quantity | 24,641 units |
| Distribution | US Nationwide - Worldwide Distribution Foreign: Canada, Bahamas ,Chile Guam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211874 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approa William Cook Europe Aps, Jul 28, 2021 |