Recall Z-2191-2008 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Cook Vascular Inc.
Vital Port Vascular Access System Polysulfone Petite with detached 1.0mm catheter
| Date | Sep 17, 2008 (initiated Apr 24, 2008) |
| Status | Terminated |
| Reason | mislabeled - wrong size catheter was packaged in the box |
| Root cause | Packaging process control |
| Action | The recalling firm issued an Urgent Product Recall letter dated 4/30/08 to inform their customers of the problem and the need to return the product. The letter also instructed the customers to notify sub accounts. Contact Cook Vascular at 1-724-845-8621 for assistance. |
| Quantity | 20 units |
| Distribution | The products were shipped to distributors in Japan and Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924748 | VITAL-PORT VASC ACCESS 901OP/911OP/9012P/9112P Med Institute, Inc., Jul 28, 1993 |