Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.
FDA device recall Z-0930-05 · posted 2005-06-25 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- The obturator may be 3.0 mm in length instead of the labeled 3.5 mm.
- Action taken
- Consignees were notified via letter dated 4/26/05.
- Root cause
- Other
- Status
- Terminated
- Product code
- JOH
- Quantity affected
- 48
- Distribution
- Connecticut, Georgia, Illinois, Indiana, Minnesota, Missouri, New Mexico, and North Carolina.
- Date initiated
- 2005-04-26
- Date posted
- 2005-06-25
- Date terminated
- 2005-10-26
- 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 AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE (K914088) | Bivona Medical Technologies | 1991-10-23 |