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.
This recall has been terminated (originally issued February 21, 2014).
- Company
- Teleflex Medical
- Recall Initiated
- January 6, 2014
- Posted
- February 21, 2014
- Terminated
- June 17, 2016
- Recall Number
- Z-0953-2014
- Quantity
- 190,871 each (148, 275 US)
- Firm Location
- Research Triangle Park, NC
- Official Source
- View on FDA website ↗
Reason for Recall
The tracheal tube can kink during patient use.
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.
Lot / Code Info
Product Code: 5-13015, Lot numbers: 01A1000503, 01A1000056, 01B1000243, 01B1000023, 01B1000257, 01E1000404, 01E1000528, 01F1000093, 01G1000243, 01J1000253, 01G1000430, 01M1000283, 01M1000288, 01B1100010, 01C1100226, 01C1100151, 01C1100374, 01E1100100, 01E1100347, 01D1100358, 01C1100488, 01H1100354, 01E1100251, 01B1100463, 01J1100233, 01A1200448, 01C1200084, 01C1200384, 01B1200546, 01C1200467, 01K1100239, 01M1100365, 01E1200319, 01J1100379, 01H1200042, 01F1200035, 01E1200547, 01L1100370, 01J1200073, 01J1200198, 01E1300294, 01E1300322, 01E1300430, 01G1300424, 01G1300095 and 01H1300325, 01J1300002.
Root Cause
Other
Action Taken
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.