Date Initiated by Firm |
May 16, 2003 |
Date Posted |
July 19, 2003 |
Recall Status1 |
Terminated 3 on May 02, 2006 |
Recall Number |
Z-0992-03 |
Recall Event ID |
26394 |
Product |
Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised 3mm x 17cm Reference Number: 100/111/030 |
Code Information |
Lot Number: 161633 |
Recalling Firm/ Manufacturer |
Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom
|
For Additional Information Contact |
Timothy J. Talcott 603-358-1017
|
Manufacturer Reason for Recall |
Tracheal tubes may be non-sterile
|
FDA Determined Cause 2 |
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 in Commerce |
900 units |
Distribution |
Nationwide |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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