Portex Ltd.
Portex Tracheal Tube Profile Soft-Seal Cuff, Ivory Nasal 5 mmx 25cm Reference Number: 100/179/050
| Date | Jul 19, 2003 (initiated May 16, 2003) |
| Status | Terminated |
| Reason | Tracheal tubes may be non-sterile |
| Root cause | Other |
| Action | Portex Inc. Keene,NH initiated the recall by telephone to direct accounts on 5/16/03. A follow-up Recall Notification letter was issued by Federal Express on May 17, 2003. Dealers were asked to provide a consignee list or contact their accounts directly. Unused product is requested to be returned from the distributors and medical facilities. |
| Quantity | 110 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.