FDA-Device2017-02-15Class II
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
Teleflex Medical
Hazard
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.
Sold states
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
Affected count
25,274 units
Manufactured in
2917 Weck Dr, N/A, Research Triangle Park, NC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1177-2017Don't want to check this manually?
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