Recall Z-0301-06 ยท BTO Tube, Tracheostomy (W/Wo Connector)
Smiths Medical ASD, Inc.
Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70.
| Date | Dec 23, 2005 (initiated Jul 25, 2005) |
| Status | Terminated |
| Reason | Instructions for use included in the package are for a different tracheostomy tube. |
| Root cause | Other |
| Action | Consignees were notified via 'precautionary product advisory notification' letter dated July 25, 2005. |
| Quantity | 91 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K894614 | BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE Bivona Medical Technologies, Oct 13, 1989 |