Events

Recall of Device Recall Modular Verres Body/Obturator

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
    73267
  • Event Risk Class
    Class 2
  • Event Number
    Z-1178-2016
  • Event Initiated Date
    2015-01-08
  • Event Date Posted
    2016-03-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143661
  • 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
    Needle, aspiration and injection, reusable - Product Code GDM
  • Reason
    Packaging error in which customers who ordered product code 140880 (verres cannula for use with a separately available needle tip) were incorrectly provided with product code 140878 (verres cannula with integral needle tip).
  • Action
    Teleflex sent an Medical Device Advisory Notification letter dated January 8, 2016, to all affected customers notifying them of the packaging error. Our records indicate that you have received products that are subject to this notification. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at recalls@teleflex.com or 1-866-246-6990.

Device

Device Recall Modular Verres Body/Obturator
  • Model / Serial
    Lot K3
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to the state of : UT
  • Product Description
    Pilling Modular Verres Body/Obturator, Product Code 140880
  • 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