Z-1519-2017 Class II Terminated

Recalled by Teleflex Medical — Research Triangle Park, NC

FDA device recall Z-1519-2017 was initiated by Teleflex Medical on January 13, 2017 and is designated Class II. Reason for recall: Labeling error The recall status is terminated (terminated February 10, 2025). Affected quantity: 7,600 eaches.

Recall Details

Product Type
Devices
Report Date
March 29, 2017
Initiation Date
January 13, 2017
Termination Date
February 10, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7,600 eaches

Product Description

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.

Reason for Recall

Labeling error

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.

Code Information

Lot/Batch Numbers 16A14 and 16A14