Recall Z-0541-06 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Bard Access Systems, Inc
Groshong NXT ClearVue 4 Fr Single-Lumen PICC, Bard Access Systems, Inc.
| Date | Mar 16, 2006 (initiated Dec 20, 2005) |
| Status | Terminated |
| Reason | Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions, possible complications, and insertion instructions. |
| Root cause | Other |
| Action | Consignees were notified by letter on 12/20/2005. |
| Quantity | 567 units |
| Distribution | Nationwide, including VA facilities in CA, FL and IL. No foreign or military distribution. |
| FDA record | Open on fda.gov |