Recall Z-0953-2014 ยท BTR Tube, Tracheal (W/Wo Connector)
Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, 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.
| Date | Feb 21, 2014 (initiated Jan 6, 2014) |
| Status | Terminated |
| Reason | The tracheal tube can kink during patient use. |
| Root cause | 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 affec |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091761 | TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT Teleflexmedical, Inc., Oct 29, 2009 |