Recall Z-0930-05 ยท JOH Tube Tracheostomy And Tube Cuff
Smiths Medical ASD, Inc.
Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.
| Date | Jun 25, 2005 (initiated Apr 26, 2005) |
| Status | Terminated |
| Reason | The obturator may be 3.0 mm in length instead of the labeled 3.5 mm. |
| Root cause | Other |
| Action | Consignees were notified via letter dated 4/26/05. |
| Quantity | 48 |
| Distribution | Connecticut, Georgia, Illinois, Indiana, Minnesota, Missouri, New Mexico, and North Carolina. |
| 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 |