Events

Recall of Device Recall 5/10/12 mm x 100mm Weck Vista Universal Cone Open Access

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
    67819
  • Event Risk Class
    Class 2
  • Event Number
    Z-1327-2014
  • Event Initiated Date
    2014-03-11
  • Event Date Posted
    2014-04-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126434
  • 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
    Laparoscope, general & plastic surgery - Product Code GCJ
  • Reason
    Complaints of leakage of insufflation gas through the device.
  • Action
    Letters were issued on March 11, 2014 to customers informing them of the recall. The letter asked the consignee to immediately discontinue use and quarantine any products on hand. The letter included a Recall Acknowledgement Form which is to be returned. A letter was also issued to distributors on March 11, 2014, requesting them to conduct a sub-recall.

Device

Device Recall 5/10/12 mm x 100mm Weck Vista Universal Cone Open Access
  • Model / Serial
    Lots - Catalog No. 405933 - 01L1200353, 01F1300080
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, OR, PA, SC, TN, UT, VA, WA, WV, WI and the countries of Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam.
  • Product Description
    5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. || An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
  • 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