Events

Recall of Merit Custom Kits

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
    57176
  • Event Risk Class
    Class 2
  • Event Number
    Z-0557-2011
  • Event Initiated Date
    2010-10-25
  • Event Date Posted
    2010-12-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95527
  • 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
    Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. the valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.
  • Action
    Merit issued an Urgent Product Recall Notice letter dated October 25, 2010 to consignees. Copnsignees were instructed to quarantine the product immediately for return and to notify customers of recall activity and instruct them to return product.. All distributors and customers are to complete and return a Recall Notification Form. For further information about this recall, contact Merit at 800 356-3748.

Device

Merit Custom Kits
  • Model / Serial
    Lot No.: H137939, H147372, H151609, H158544
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution in the states of CA, IL, IN, and UT.
  • Product Description
    Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09815, Manufacturer: Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

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