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Recall Observatory FDA recall evidence

Device product

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

Z-1177-2017

October 18, 2016

Class II

Product summary

Firm
Teleflex Medical
Event
Event 76133
Status
Terminated
Classification
Class II
Quantity
25,274 units
Official record key
device-enforcement:Z-1177-2017

Official wording

Reason: 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.

Code information: Lots 73A1500461 & 73D1400082

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.