Events

Recall of Device Recall MynxGrip Vascular Closure Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AccessClosure, Inc., A Cardinal Health Company.

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
    74599
  • Event Risk Class
    Class 2
  • Event Number
    Z-2329-2016
  • Event Initiated Date
    2016-07-13
  • Event Date Posted
    2016-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148244
  • 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
    Device, hemostasis, vascular - Product Code MGB
  • Reason
    A total of 70 6f/7f mynx grip devices were shipped from a distributor using improper transport/packaging configurations.
  • Action
    Cardinal Health sent an Urgent Medical Device letters dated July 15, 2016 to affected customers. The letters provided the reason for recall and the exact lot number and quantity shipped to each location. Customers were instructed to quarantined affected products and complete and return the Field Action response form indicating the number of devices that will be returned. Instructions for returning the devices are included with an RMA number and Fed Ex airbill. Questions should be directed to Customer Advocacy at 408-610-6570 between 9 am and 5 pm PST.

Device

Device Recall MynxGrip Vascular Closure Device
  • Model / Serial
    Lot No: F1609702, Expiry 4/20/2018; Lot No. F1534302, Expiry 12/31/2016
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    US in the states of CA, and MS.
  • Product Description
    6F/7F MynxGrip Vascular Closure Device; || Product Model MX6721, || Product Usage: || The 6F/7F MynxGrip Vascular Closure Device is indicated for use to seal femoral arterial and femoral venous access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 6F or 7F procedural sheath. The 6F/7F MynxGrip Vascular Closure Device is designed to achieve femoral artery and femoral vein hemostasis via delivery of an extravascular, water-soluble synthetic sealant using a balloon catheter in conjunction with a standard procedural sheath. The sealant is comprised of a polyethylene glycol (PEG) material which expands upon contact with subcutaneous fluids to seal the arteriotomy or venotomy. The sealant is resorbed by the body within 30-days.
  • Manufacturer
    AccessClosure, Inc., A Cardinal Health Company

Manufacturer

AccessClosure, Inc., A Cardinal Health Company
  • Manufacturer Address
    AccessClosure, Inc., A Cardinal Health Company, 5452 Betsy Ross Dr, Santa Clara CA 95054-1101
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA