Events

Recall of 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
    47881
  • Event Risk Class
    Class 2
  • Event Number
    Z-1808-2008
  • Event Initiated Date
    2008-04-10
  • Event Date Posted
    2008-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70434
  • 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
    Kit, surgical instrument, disposable - Product Code KDD
  • Reason
    Sterility compromised - component of convenience kit was recalled by its manufacturer for non-sterility.
  • Action
    Site Visit - There is only one consignee that received product. That single consignee was visited by Merit sales rep on 04/14/2008 with instructions to discontinue use and quarantine any affected product. No Hemovac inventory and no affected kits remained in Merit's inventory at the time of notification from Zimmer. The consignee site representative verified that all 60 of the affected kits received by them had already been used.

Device

Convenience Kit
  • Model / Serial
    Lot Number V477096
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Class II Recall - Nationwide Distribution --- including state of NY.
  • Product Description
    Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02160A, Sterile, Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan, Utah 84095. A combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the products' intended uses.
  • 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