Recall Z-0395-06 ยท JOH Tube Tracheostomy And Tube Cuff
Smiths Medical ASD, Inc.
Bivona brand Mid-Range Aire-Cuf Extra Length Fixed Hyperflex Adult Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 120 mm; REF 75FHXL80.
| Date | Jan 18, 2006 (initiated Dec 16, 2005) |
| Status | Terminated |
| Reason | Sterility is compromised by incomplete package seal. |
| Root cause | Other |
| Action | Certified letters were sent to each consignee on 12/ 16/05 and distributors were requested to notify their customers of the recall. |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922665 | BIVONA HYPERFLEX TRACHEOSTOMY TUBE Bivona Medical Technologies, Jan 7, 1993 |