Recall Z-0496-03 ยท BSY Catheters, Suction, Tracheobronchial
Sorenson Medical, Inc.
Trach-Eze Closed Suction System Endotracheal Start Kit *** 16F *** REF 220070 *** Catheter Length: 571 mm *** STERILE ***.
| Date | Jan 30, 2003 (initiated Nov 25, 2002) |
| Status | Terminated |
| Reason | Catheters have 2 unvalidated seal product configurations to produce a new hybrid seal that had not been verified or validated. |
| Root cause | Other |
| Action | On 10/25/2002, all consignees were notified by letter. |
| Quantity | 2790 units |
| Distribution | Distributors in IL, OH, PA. Foreign distribution to Brazil, Czech Republic, Denmark, Guatemala, Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961707 | TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM Sorenson Critical Care, Mar 11, 1997 |