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U.S. Department of Health and Human Services

Class 1 Device Recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port

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  Class 1 Device Recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port see related information
Date Initiated by Firm January 06, 2014
Date Posted February 21, 2014
Recall Status1 Terminated 3 on June 17, 2016
Recall Number Z-0950-2014
Recall Event ID 67266
510(K)Number K091761  
Product Classification Tube, tracheal (w/wo connector) - Product Code BTR
Product ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx only,

Product Usage:
A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Code Information Product Code: 5-13012, Lot numbers: 01A1000055, 01B1000254, 01G1000275, 01J1000399, 01M1000285, 01A1100083, 01A1100448, 01E1100345, 01G1100116, 01B1100212, 01D1100297, 01C1200082, 01F1200369, 01E1200460, 01F1100482, 01F1200401, 01F1300054, 01H1200296, 01H1100157, 01E1300295 and 01F1300176.
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr.
Research Triangle Park NC 27709
For Additional Information Contact Michael T. Taggart
919-572-8014
Manufacturer Reason
for Recall		 The tracheal tube can kink during patient use.
FDA Determined
Cause 2		 Other
Action Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated January 6, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately discontinue use and quarantine any affected product. Return the product by completing the enclosed Recall Ackknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service to receive a Return Goods Authorization (RGA) number and instructions for the return of the affected product to Teleflex Medical. Consignees with no affected stock, should also complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881. Consignees with questions were instructed to call 1-866-246-6990. For questions regarding this recall call 919-572-8014.
Quantity in Commerce 190,871 each (148, 275 US)
Distribution Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = BTR and Original Applicant = Teleflex Medical, Inc.
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