Events

Recall of Device Recall Rusch, Latex Free Robertazzi Airway

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Teleflex Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76263
  • Event Risk Class
    Class 2
  • Event Number
    Z-1519-2017
  • Event Initiated Date
    2017-01-13
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152601
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Airway, nasopharyngeal - Product Code BTQ
  • 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.

Device

Device Recall Rusch, Latex Free Robertazzi Airway
  • Model / Serial
    Lot/Batch Numbers 16A14 and 16A14
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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 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.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA