Bivona brand Mid-Range Aire-Cuf Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 6.0 mm O.D. 8.7 mm length 110 m
FDA device recall Z-0394-06 · posted 2006-01-18 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- Sterility is compromised by incomplete package seal.
- Action taken
- Certified letters were sent to each consignee on 12/ 16/05 and distributors were requested to notify their customers of the recall.
- Root cause
- Other
- Status
- Terminated
- Product code
- JOH
- Distribution
- Nationwide and Canada.
- Date initiated
- 2005-12-16
- Date posted
- 2006-01-18
- Date terminated
- 2007-02-08
- 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 |