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Recall Observatory FDA recall evidence

Device product

Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130 and 123132 Product Usage: To provide a patent airway for a patient with a blockage or potential blockage of the nasal cavity or nasopharynx.

Z-1519-2017

January 13, 2017

Class II

Product summary

Firm
Teleflex Medical
Event
Event 76263
Status
Terminated
Classification
Class II
Quantity
7,600 eaches
Official record key
device-enforcement:Z-1519-2017

Official wording

Reason: Labeling error

Code information: Lot/Batch Numbers 16A14 and 16A14

Distribution pattern: Worldwide Distribution - US Nationwide in the state of AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, and the countries of Canada and Mexico.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling error