Recall Z-0260-2007 ยท JOH Tube Tracheostomy And Tube Cuff
Smiths Medical ASD, Inc.
Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.
| Date | Dec 7, 2006 (initiated Nov 17, 2006) |
| Status | Terminated |
| Reason | Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm. |
| Root cause | Other |
| Action | The consignee was notified of the problem via recall letter sent on 11/17/06 and given the options of continuing to use the product or of returning it. |
| Quantity | 5 |
| Distribution | New York-single hospital consignee |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K923878 | BIVONA CUSTOMIZED TRACHEOSTOMY TUBES Bivona Medical Technologies, Dec 29, 1992 |