Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube, Catalog # 5-10315 A tracheal tube is inserted into a patients mouth or nose for airway management
This recall has been terminated (originally issued February 9, 2017).
- Company
- Teleflex Medical
- Recall Initiated
- October 18, 2016
- Posted
- February 9, 2017
- Terminated
- August 25, 2017
- Recall Number
- Z-1177-2017
- Quantity
- 25,274 units
- Firm Location
- Research Triangle Park, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling inconsistency - units labeled with a 7mm tube may contain a size 6.5mm tube, and units labeled 7.5mm tube may contain a size 5.5mm tube.
Distribution
Worldwide Distribution - US including AL, AZ, ARK, CA, CO, CT, FL, GA. HI, KS, KY, IL, IN, IA, LA, MD, MA, MI, MN, MS, MO, MT, NE, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV and Internationally to Canada, Chile, & Japan
Lot / Code Info
Lots 73A1500461 & 73D1400082
Root Cause
Other
Action Taken
Teleflex sent an Medical Device Recall Notification letter dated October 18, 2016, to all affected customers. Customers were advised to immediately discontinue use and to quarantine product. The letter to distributors requested a sub-recall. Both letters included an acknowledgement form to be returned. Customers with questions were instructed to contact their local representative or Customer Service at 1-800-246-6990.