Recall Z-1068-2016 ยท DTK Filter, Intravascular, Cardiovascular
Bard Peripheral Vascular Inc
Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J; Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.
| Date | Feb 9, 2016 |
| Status | Terminated |
| Reason | Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and Denali Filter-Femoral Delivery System because of the stop cocks potentially cracking. |
| Root cause | Component design/selection |
| Action | The firm sent customer notification letters on 02/09/16. The following instructions were provided to customers: 1. Do not use or further distribute any affected product. 2. Check all inventory locations within the institution for affected product code/lot number combination listed in the recall notice. If further distributed any of the product code/lot numbers, immediately contact that location, advise them of the recall, forward these instructions and have them return the affected product to BPV. 3. Remove any identified product from your shelves. 4. If have used the affected product, |
| Quantity | 2904 |
| Distribution | Worldwide Distribution-US (nationwide) including DC and PR, and the states of MN, TX, PA, OH, IL, OR, CA, SC, NC, AK, NY, MD, GA, NJ, AZ, KY, OH, WI, AL, AR, MO, FL, MA, MT, TN, LA, CT, NE, WV, VA, NV, ME, UT, CO, WY, AR, DE, NM, IN, MN, MS, NH, IA, MI, WA, VA, KS, HI, RI, SD, VT, and the countries |
| 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 |