Events

Recall of Device Recall Angiographic Convenience Kit

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
    25605
  • Event Risk Class
    Class 2
  • Event Number
    Z-0622-03
  • Event Initiated Date
    2003-02-13
  • Event Date Posted
    2003-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26182
  • 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
    Catheter, Intravascular, Diagnostic - Product Code DQO
  • Reason
    A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.
  • Action
    Consignees were notified by phone and FAX on 2/12/2003.

Device

Device Recall Angiographic Convenience Kit
  • Model / Serial
    Model Number: K11-MPT2023/D. Lot Numbers: A145200, A156200, A191561.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    FL and Japan.
  • Product Description
    Custom Angiographic Kit
  • Manufacturer
    Merit Medical Systems, Inc

Manufacturer

Merit Medical Systems, Inc
  • Manufacturer Address
    Merit Medical Systems, Inc, 1600 West Merit Parkway, South Jordan UT 84095
  • Source
    USFDA