Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70.
FDA device recall Z-0301-06 · posted 2005-12-23 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- Instructions for use included in the package are for a different tracheostomy tube.
- Action taken
- Consignees were notified via 'precautionary product advisory notification' letter dated July 25, 2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTO
- Quantity affected
- 91
- Distribution
- Nationwide.
- Date initiated
- 2005-07-25
- Date posted
- 2005-12-23
- 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 AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE (K894614) | Bivona Medical Technologies | 1989-10-13 |