Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D. 8.7 mm, A 7.0 mm, B 0 mm, C 53.0 mm, Mfrd by Smiths Medical Cr
FDA device recall Z-0046-2007 · posted 2006-10-19 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- The length of the shaft is incorrectly stated as 7 mm, instead of the correct 17 mm, on the outer packaging, although the tray label is correct.
- Action taken
- Consignees were notified to cease using, and to return the product, by recall letter dated August 2006 and mailed on 8/11/06.
- Root cause
- Other
- Status
- Terminated
- Product code
- JOH
- Quantity affected
- 71 units.
- Distribution
- Nationwide.
- Date initiated
- 2006-08-11
- Date posted
- 2006-10-19
- Date terminated
- 2007-12-04
- Location
- Gary, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION (K913859) | Bivona Medical Technologies | 1992-01-30 |