Recall Z-0046-2007 ยท JOH Tube Tracheostomy And Tube Cuff
Smiths Medical ASD, Inc.
Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D. 8.7 mm, A 7.0 mm, B 0 mm, C 53.0 mm, Mfrd by Smiths Medical Critical Care; REF 60A160.
| Date | Oct 19, 2006 (initiated Aug 11, 2006) |
| Status | Terminated |
| Reason | The length of the shaft is incorrectly stated as 7 mm, instead of the correct 17 mm, on the outer packaging, although the tray label is correct. |
| Root cause | Other |
| Action | Consignees were notified to cease using, and to return the product, by recall letter dated August 2006 and mailed on 8/11/06. |
| Quantity | 71 units. |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K913859 | BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION Bivona Medical Technologies, Jan 30, 1992 |