FDA Recall Terminated

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.

Recall: Z-1519-2017 · Initiated January 13, 2017

Recall

Recall Number
Z-1519-2017
Event Number
76263
Firm
Teleflex Medical
FEI Number
3005747797
Product Code
BTQ
Status
Terminated
Root Cause
Unknown/Undetermined by firm
Initiated
January 13, 2017
Terminated
February 10, 2025
Address
2917 Weck Dr, Research Triangle Park, NC, 27709-0186

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

Labeling error

Action

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.

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.

Quantity

7,600 eaches