Z-1519-2017Class II

Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130 and 123132

Name: Z-1519-2017 Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130 and 123132
Creator: Teleflex Medical
Published: 2017-01-13
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2017-01-13 / Terminated / root cause: labeling and UDI

FDA source

Teleflex Medical began a recall of Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130 and 123132 Product Usage: To provide a patent airway for a patient with a... on 2017-01-13. FDA classified it as Class II and gives the reason as "Labeling error". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1519-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-13
Posted: 2017-03-21
Terminated: 2025-02-10
Recalling firm: Teleflex Medical
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.
Product code: BTQ Airway, Nasopharyngeal
Reason for recall: Labeling error
Root cause tag: labeling and UDI
FDA root cause: Unknown/Undetermined by firm
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.
Quantity in commerce: 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.
Product codes and lots: Lot/Batch Numbers 16A14 and 16A14

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1519-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1519-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-21

Product code BTQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)