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 Car
FDA device recall Z-0339-2007 · posted 2007-01-05 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JOH
- Quantity affected
- 197
- Distribution
- Worldwide Distribution ---- including USA states of Arkansas, California, Georgia, Illinois, Kansas, Minnesota, Missouri, Ohio, Pennsylvania, Texas and countries of Canada and Netherlands.
- Date initiated
- 2006-08-31
- Date posted
- 2007-01-05
- Date terminated
- 2007-05-04
- 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 |