Events

Recall of Device Recall 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
    75127
  • Event Risk Class
    Class 2
  • Event Number
    Z-0002-2017
  • Event Initiated Date
    2016-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149424
  • 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
    Syringe, balloon inflation - Product Code MAV
  • Reason
    Merit medical systems, inc. announces a voluntary field action for merit inflation syring kit due to unit labels missing required device labeling information.
  • Action
    Merit Medical Inc. notified all affected customers on August 25, 2016, via verbal and written notification to return the affected units. The returned units will be re-labeled. For further questions, please call (801) 316-3690.

Device

Device Recall Convenience Kit
  • Model / Serial
    Lot Numbers: H959038, H970334, H984351.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    One consignee located in CA. No Canadian, other foreign or VA/govt/military consignees.
  • Product Description
    Merit Inflation Syringe Kit. Catalog Number KOS-02857
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Manufacturer Address
    Merit Medical Systems, Inc., 1600 W Merit Pkwy, South Jordan UT 84095-2416
  • Manufacturer Parent Company (2017)
    Merit Medical Systems Inc.
  • Source
    USFDA