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Recall Observatory FDA recall evidence

Device product

Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.

Z-1078-2015

January 09, 2015

Class II

Product summary

Firm
Teleflex Medical
Event
Event 70248
Status
Terminated
Classification
Class II
Quantity
300 units
Official record key
device-enforcement:Z-1078-2015

Official wording

Reason: Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; The correct product labeling is uncuffed nasal ET tube.

Code information: Catalog no. 5-22110, Lot no. 01M1300076.

Distribution pattern: Worldwide Distribution - US Distribution to the states of FL, GA, IL, KY, MA, MI, MO, MS, OH, TX, WA and WV., and to the countries of Canada and the Netherlands.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrectly labeled