Recall Z-0714-06 ยท BTO Tube, Tracheostomy (W/Wo Connector)
Smiths Medical ASD, Inc.
Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080
| Date | Apr 6, 2006 (initiated Mar 7, 2006) |
| Status | Terminated |
| Reason | Mislabeled Product labeled as 8.0mm inner cannula, may contain a 9.0mm |
| Root cause | Other |
| Action | Smiths Medical ASD, Inc. notified US customers by letter dated 3/7/06. Accounts are requested to return inventory. |
| Quantity | 5350 units (107 cases) |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030381 | PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA Portex , Ltd., Aug 27, 2003 |