Recall Z-1519-2017

Teleflex Medical · initiated January 13, 2017

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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.

Codes / lots: Lot/Batch Numbers 16A14 and 16A14

Reason for recall

Labeling error

FDA-determined cause: Unknown/Undetermined by firm

Action taken

Consignees were notified of the recall by letter on 1/13/2017. The letter requested that they immediately discontinue use and quarantine the recalled product. Distributors were requested to conduct a sub-recall. The letter included a reply form which was to be returned to Teleflex.

Details

Recall number
Z-1519-2017
Initiated
January 13, 2017
Terminated
February 10, 2025
Product code
BTQ – Airway, Nasopharyngeal
Quantity
7,600 eaches
Distribution
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.
Recalling firm
Teleflex Medical, Research Triangle Park, NC

Official FDA recall record