Portex Inner Cannula for Tracheostomy Tube, 8.0 mm, REF Code 566080
FDA device recall Z-1017-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc
- Reason for recall
- Incompatible products may cause potential trachea trauma
- Action taken
- Smiths Medical ASD notified the consignees by letter, dated 5/21/04. All responses to the notification are to be completed by fax and directed to Smiths Medical Regulatory Affairs Departement. The recalled products are to be returned and scrapped by Smiths Medical.
- Root cause
- Other
- Status
- Terminated
- Product code
- JOH
- Quantity affected
- 60,400
- Distribution
- Nationwide
- Date initiated
- 2004-05-19
- Date posted
- 2004-07-20
- Date terminated
- 2006-05-02
- Location
- Keene, NH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRACHEAL TUBE STYLET (K902180) | Sims Surgical, Inc. | 1990-07-19 |