—#125118

Product

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, 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.

FDA product code: BTR — Tube, Tracheal (W/Wo Connector)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K091761
Affected lot / code info: Product Code: 5-13017, Lot numbers: 01L1000137, 01L1000160, 01A1100210, 01B1100506, 01D1100318, 01E1100525, 01E1100348, 01G1100439, 01G1100118, 01B1100199, 01L1100332, 01J1100026, 01C1200267, 01K1100240, 01D1200088, 01H1200524, 01G1200207, 01J1200353, 01D1300077, 01E1300117, 01K1300108 and 01K1300479.

Why it was recalled

The tracheal tube can kink during patient use.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 2917 Weck Dr., Research Triangle Park, North Carolina 27709

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2014-01-06
Posted by FDA: 2014-02-21
Terminated: 2016-06-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125118. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.