Events

Recall of Green RuschLite Disposable Metal Larynogoscope Blade.

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
    66640
  • Event Risk Class
    Class 2
  • Event Number
    Z-0366-2014
  • Event Initiated Date
    2013-10-15
  • Event Date Posted
    2013-11-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122874
  • 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
    Rigid Laryngoscope - Product Code CCW
  • Reason
    Labeling inconsistency.
  • Action
    Recall letters were sent to customers and distributors on 10/15/2013 via courier. The letter indicated that the consignee was to immediately discontinue use and quarantine any products with the affected catalog numbers. The letter also included a Recall Acknowledgment Form which was to be faxed back to the firm.

Device

Green RuschLite Disposable Metal Larynogoscope Blade.
  • Model / Serial
    Product Code 004551004; Lot 1305342
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: AL, AZ, CA, CO, FL, GA, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV and WI.
  • Product Description
    Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement of tracheal tube.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA