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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMay 16, 2003
Date PostedJuly 19, 2003
Recall Status1 Terminated 3 on May 02, 2006
Recall NumberZ-0998-03
Recall Event ID 26394
ProductPortex Tracheal Tube Profile Soft-Seal Cuff, Ivory Nasal 5 mmx 25cm Reference Number: 100/179/050
Code Information Lot Number: 153163
Recalling Firm/
Manufacturer		 Portex Ltd.
Reachfields
Boundry Road
Hythe, Kent United Kingdom
For Additional Information ContactTimothy J. Talcott
603-358-1017
Manufacturer Reason
for Recall		Tracheal tubes may be non-sterile
FDA Determined
Cause 2		Other
ActionPortex 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 Commerce110 units
DistributionNationwide
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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