Recall Z-1022-2019 ยท DTK Filter, Intravascular, Cardiovascular
Cook Medical Incorporated
Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number IGTCFS-65-1-JUG-TULIP Product Usage: The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: (1) Pulmonary thromboembolism when anticoagulant therapy is contraindicated; (2) Failure of anticoagulant therapy in thromb
| Date | Feb 25, 2019 |
| Status | Terminated |
| Reason | Updates to the Instructions for Use. |
| Root cause | Labeling Change Control |
| Action | Cook Medical sent an Urgent Medical Device Correction notification letters dated February 25, 2019 to customers. Additional customers identified later were sent letters on 3/8/19. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return it via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). For questions or conc |
| Quantity | 91731 total |
| Distribution | The products were distributed US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172557 | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approa William Cook Europe Aps, Nov 20, 2017 |