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Recall Observatory FDA recall evidence

Device product

Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated. A tracheal tube is inserted into a patients mouth or nose for airway management.

Z-1938-2016

May 05, 2016

Class II

Product summary

Firm
Teleflex Medical
Event
Event 74034
Status
Terminated
Classification
Class II
Quantity
6,390 ea.
Official record key
device-enforcement:Z-1938-2016

Official wording

Reason: The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm tracheal tube.

Code information: Lot 73F1500606

Distribution pattern: US Distribution to states of: AL, AZ, CO, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NY, NC, OK, PA, RI, TX and UT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm tracheal tube.