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
FDA Recall Z-1177-2017 · Posted 2017-02-09
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Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeBTR
Date Initiated2016-10-18
Date Terminated2017-08-25
Product Quantity25,274 units
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.
Firm Action
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.
Root Cause
Other
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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