Recall Z-1017-04 ยท JOH Tube Tracheostomy And Tube Cuff
Smiths Medical ASD, Inc
Portex Inner Cannula for Tracheostomy Tube, 8.0 mm, REF Code 566080
| Date | Jul 20, 2004 (initiated May 19, 2004) |
| Status | Terminated |
| Reason | Incompatible products may cause potential trachea trauma |
| Root cause | Other |
| Action | 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. |
| Quantity | 60,400 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K902180 | TRACHEAL TUBE STYLET Sims Surgical, Inc., Jul 19, 1990 |