Recall Z-0378-2007 ยท KAC Tube, Laryngectomy
Smiths Medical ASD, Inc.
Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm, Mfrd by Smiths Medical Critical Care; REF BOSL1L.
| Date | Jan 25, 2007 (initiated Dec 15, 2006) |
| Status | Terminated |
| Reason | The label incorrectly states the outer diameter of the tube is 20.0 mm when it is actually 12.0 mm. |
| Root cause | Other |
| Action | Consignees were notified via recall letter dated 12/15/06. Distributors were requested to provide the firm with final user name and address information so that they could notify them of the recall. The firm is advising users that they can either return the product for replacement or continue to use it now that they are aware of the labeling error. |
| Quantity | 117 |
| Distribution | Worldwide, including USA, Canada, Netherlands and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.