Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70.
FDA device recall Z-0338-06 · posted 2006-01-06 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- The shaft was manufactured approximately 1 to 3 mm under the length specification, and may be 105 mm in length.
- Action taken
- Consignee was notified via recall letter dated April 19, 2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTO
- Quantity affected
- 11
- Distribution
- California, Indiana and North Carolina.
- Date initiated
- 2005-04-19
- Date posted
- 2006-01-06
- Date terminated
- 2007-12-06
- 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 HYPERFLEX TRACHEOSTOMY TUBE (K922665) | Bivona Medical Technologies | 1993-01-07 |