Recall Z-0409-05 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Boston Scientific Corporation
VAXCEL WITH PASV PICC, 3F, single lumen. CUSTOM KIT - UNIVERSITY OF NEW MEXICO HOSPITAL, Catalog # 60M210624, UPN #M00160M2106240. Firm on label: Boston Scientific Corp, NAMIC Technology Center, 10 Glens Falls Technical Park, Glens Falls, NY . DEVICE DESCRIPTION: Each kit contains a radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapt
| Date | Jan 20, 2005 (initiated Nov 22, 2004) |
| Status | Terminated |
| Reason | Catheter separation immediately distal to the nose of the suture wing. |
| Root cause | Other |
| Action | Letters dated 11/22/2004 issued via Certified Mail. Customers instructed to return units in inventory. Patients with implanted units are to be evaluated. |
| Quantity | 68 kits |
| Distribution | 75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021704 | VAXCEL PICC WITH PASV VALVE TECHNOLOGY Catheter Innovations, Inc., Jun 6, 2002 |