Recall Z-0339-2007 ยท JOH Tube Tracheostomy And Tube Cuff
Smiths Medical ASD, Inc.
Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd by Smiths Medical Critical Care; Product code 670185.
| Date | Jan 5, 2007 (initiated Aug 31, 2006) |
| Status | Terminated |
| Reason | Mislabeled- The outer diameter (OD) of the shaft is labeled as 11.0 m on the inner, outer and tray label in error. The OD is actually 11.8 mm. |
| Root cause | Other |
| Action | Distributors and hospital consignees were notified via recall letter dated 8/25/06 to return all unused product to the firm. Distributors were asked to notify their customers of the recall. |
| Quantity | 197 |
| Distribution | Worldwide Distribution ---- including USA states of Arkansas, California, Georgia, Illinois, Kansas, Minnesota, Missouri, Ohio, Pennsylvania, Texas and countries of Canada and Netherlands. |
| 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 |