Recall Z-1340-04 ยท JCT Prosthesis, Tracheal, Expandable
Boston Scientific Scimed
WALLSTENT Endoprostheses with UNISTEP Plus Delivery System.
| Date | Aug 13, 2004 (initiated Jul 9, 2004) |
| Status | Terminated |
| Reason | Specific lots of the WALLSTENT Endoprosthesis with UNISTEP Plus Delivery System were packaged without one of the three required directions for use. |
| Root cause | Other |
| Action | Boston Scientific is notifying sales representatives and customers of recall along with instructions regarding the return of potentially affected product. |
| Quantity | 82 units (H965402100) aa7 units (H965402100) |
| Distribution | Inside the US only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992510 | WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM Boston Scientific Corp, Nov 18, 1999 |