Events

Recall of Connection Tube

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

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
    53557
  • Event Risk Class
    Class 2
  • Event Number
    Z-0510-2010
  • Event Date Posted
    2009-12-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85855
  • 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
    Connection Tube - Product Code DQO
  • Reason
    Potential sterility breach caused by excessive shipment damage.
  • Action
    Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365.

Device

Connection Tube
  • Model / Serial
    Lot #: F709636
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (AL, LA, MO, KY, TN, GA). No military, government or foreign distribution.
  • Product Description
    Merit Medical Systems, Inc. Connection Tube label reading in part: CONNECTING TUBE 12" STERILE K10-04129, CATALOG NUMBER K10-04129 Connection tubing can be used with any drainage catheter and drainage bag
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Manufacturer Address
    Merit Medical Systems, Inc., 1600 Merit Pkwy, South Jordan UT 84095
  • Manufacturer Parent Company (2017)
    Merit Medical Systems Inc
  • Source
    USFDA