ClearanceBrief
Recall Z-1519-2017 ยท BTQ Airway, Nasopharyngeal

Teleflex Medical

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.

DateJan 13, 2017
StatusTerminated
ReasonLabeling error
Root causeUnknown/Undetermined by firm
ActionConsignees 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.
Quantity7,600 eaches
DistributionWorldwide 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.