Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medi
FDA device recall Z-0260-2007 · posted 2006-12-07 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.
- Action taken
- The consignee was notified of the problem via recall letter sent on 11/17/06 and given the options of continuing to use the product or of returning it.
- Root cause
- Other
- Status
- Terminated
- Product code
- JOH
- Quantity affected
- 5
- Distribution
- New York-single hospital consignee
- Date initiated
- 2006-11-17
- Date posted
- 2006-12-07
- Date terminated
- 2007-01-12
- 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 CUSTOMIZED TRACHEOSTOMY TUBES (K923878) | Bivona Medical Technologies | 1992-12-29 |