FDA Recall
Terminated
Portex Tracheal Tube Profile Soft-Seal Cuff, Ivory Nasal 5 mmx 25cm Reference Number: 100/179/050
Recall: Z-0998-03
·
Initiated May 16, 2003
Recall
- Recall Number
- Z-0998-03
- Event Number
- 26394
- Firm
- Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom
- FEI Number
- 3002807908
- Status
- Terminated
- Root Cause
- Other
- Initiated
- May 16, 2003
- Posted
- July 19, 2003
- Terminated
- May 2, 2006
Description
Portex Tracheal Tube Profile Soft-Seal Cuff, Ivory Nasal 5 mmx 25cm Reference Number: 100/179/050
Reason
Tracheal tubes may be non-sterile
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.
Distribution
Nationwide
Quantity
110 units