Recall Z-2080-2019 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Bard Peripheral Vascular Inc
POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 8F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; NAUTILUS DELTA Tip Confirmation Sys
| Date | Jun 25, 2018 |
| Status | Completed |
| Reason | Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement procedures when used in combination with the NAUTILUS DELTA" TCS. |
| Root cause | Device Design |
| Action | On June 25, 2018 Bard sent recall notifications to all their customers informing them of the following: "This letter is to inform you of a voluntary product recall issued by Bard Peripheral Vascular, Inc. (BPV), a wholly owned subsidiary of Becton, Dickinson and Company. Specific product code / lot number combinations of the NAUTILUS DELTA" Port Kits are affected as outlined in Attachment 3. These product code / lot number combinations cannot be used with the NAUTILUS DELTA" Tip Confirmation System (TCS), product code 9770323. All other product code / lot number combinations not listed in Att |
| Quantity | 95 units |
| Distribution | US Nationwide Distribution in the states of FL, CO, WI, OH, IL, KS, AZ, WV, CT, PA, AL, MI and VA |
| FDA record | Open on fda.gov |