Recall Z-0338-06 ยท BTO Tube, Tracheostomy (W/Wo Connector)
Smiths Medical ASD, Inc.
Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70.
| Date | Jan 6, 2006 (initiated Apr 19, 2005) |
| Status | Terminated |
| Reason | The shaft was manufactured approximately 1 to 3 mm under the length specification, and may be 105 mm in length. |
| Root cause | Other |
| Action | Consignee was notified via recall letter dated April 19, 2005. |
| Quantity | 11 |
| Distribution | California, Indiana and North Carolina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922665 | BIVONA HYPERFLEX TRACHEOSTOMY TUBE Bivona Medical Technologies, Jan 7, 1993 |