FDAFDA · Food and drugs·Recall number Z-1177-2017
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
Published February 15, 2017 · Recall initiated: October 18, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teleflex Medical
- Distributor
- 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
- Lots 73A1500461 & 73D1400082
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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