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
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
Labeling error