Recall Z-0737-2016 ยท DTK Filter, Intravascular, Cardiovascular
Bard Peripheral Vascular Inc
Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.
| Date | Feb 1, 2016 (initiated Mar 13, 2015) |
| Status | Terminated |
| Reason | IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys. |
| Root cause | Labeling Change Control |
| Action | The firm sent out Medical Device Recall customer notification letters on 03/13/15. The notification letter stated that there is no required action on the customer's part. Customers were told that if the device did not meet their needs then the firm will provide a replacement unit. Effective immediately the firm is implementing a change in the ordering code for the device to accurately reflect the approved information with the IFU and corresponding retrieval kit. Any questions the firm states to call Bard Canada: 1-800-268-2862 Western Canada 1-800-387-9473 Ontario 1-800-387-7851 Eastern |
| Quantity | 1,183 units |
| Distribution | Distributed to CA only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130366 | BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT C.R. Bard, Inc., May 15, 2013 |