Recall Z-0302-06 ยท BTO Tube, Tracheostomy (W/Wo Connector)
Smiths Medical ASD, Inc.
Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.
| Date | Dec 23, 2005 (initiated Feb 17, 2005) |
| Status | Terminated |
| Reason | The word PED was printed on the neckflange instead of the word NEO. |
| Root cause | Other |
| Action | Consignees were notified via 'product advisory letter' dated 2/17/05 and requested to either notify all users or to return the product for replacement. |
| Quantity | 26 |
| Distribution | Georgia, Illinois, Indiana, Maryland, Tennessee, Texas and Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K914088 | BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE Bivona Medical Technologies, Oct 23, 1991 |