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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 16, 2003
Date Posted July 19, 2003
Recall Status1 Terminated 3 on May 02, 2006
Recall Number Z-0991-03
Recall Event ID 26394
Product Portex Uncuffed Nasal Tracheal Tubes, Ivory
5mm x 25cm
Reference Number: 100/105/050
Code Information Lot number: 161614
Recalling Firm/
Portex Ltd.
Boundry Road
Hythe, Kent United Kingdom
For Additional Information Contact Timothy J. Talcott
Manufacturer Reason
for Recall
Tracheal tubes may be non-sterile
FDA Determined
Cause 2
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 10 units
Distribution Nationwide

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.