Events

Recall of Device Recall IntelliSystem25 Inflation Device and Fluid Dispensing Syringe

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
    27525
  • Event Risk Class
    Class 2
  • Event Number
    Z-0138-04
  • Event Initiated Date
    2003-10-01
  • Event Date Posted
    2003-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30008
  • 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
    Injector And Syringe, Angiographic - Product Code DXT
  • Reason
    There is a potential for the petg blister trays to bond together with varying degrees of attachment. the potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.
  • Action
    Merit notified sales representatives, domestic and international accounts and dealers immediately by letter dated October 3, 2003. The manufacturer requests that the use of the affected inventory should immediately cease and that on-hand units should be promptly isolated from general inventory for simultaneous inspection by a site representative and a Merit sales representative.

Device

Device Recall IntelliSystem25 Inflation Device and Fluid Dispensing Syringe
  • Model / Serial
    Lot # A285003.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed nationwide. International distribution includes Canada, Japan, Korea, England and France.
  • Product Description
    IntelliSystem25 Inflation Device and Fluid Dispensing Syringe - Label on package reads in part: ''INTELLISYSTEM 25 WITH MAP152 MAP152 CONTAINS: MERIT ACCESS PLUS LARGE BORE HEMOSTASIS VALVE, TORGUE DEVICE AND METAL GUIDE WIRE INSERTION TOOL...MERIT MEDICAL'', Latex free. Sterile if package is unopened or undamaged. Part # 1525/B
  • Manufacturer
    Merit Medical Systems, Inc

Manufacturer

Merit Medical Systems, Inc
  • Manufacturer Address
    Merit Medical Systems, Inc, 1600 Merit Pkwy, South Jordan UT 84095-2416
  • Source
    USFDA