Events

Recall of StatLock IV Premium Catheter Stabilization Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bard Access 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
    77132
  • Event Risk Class
    Class 2
  • Event Number
    Z-2120-2017
  • Event Initiated Date
    2017-04-25
  • Event Date Posted
    2017-05-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155010
  • 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, intravascular catheter securement - Product Code KMK
  • Reason
    Statlocktm iv premium catheter stabilization device may contain an incorrectly sized retainer clip.
  • Action
    Bard Access sent an Urgent: Product Recall letter dated May 15, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please immediately examine your inventory and quarantine any product subject to this notification. Please complete and return the enclosed response form as soon as possible. Bard Access Systems will provide instructions for returning impacted product for credit or replacement upon receipt of the response form. If you have further distributed this product, please identify your customers and inform them of this notification at once. You may include a copy of this letter in your notification to your customers. Please direct all return requests or other questions to our coordinator for credit or replacement product at 1-800-290-1689. We sincerely regret any inconvenience this may cause to you or your facility. For further questions, please call (801) 522-5000.

Device

StatLock IV Premium Catheter Stabilization Device
  • Model / Serial
    Lot Number JUAQF675, Exp 2/28/2019
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution - Internationally to Canada. No govt/VA/Military consignees.
  • Product Description
    StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices.
  • Manufacturer
    Bard Access Systems Inc.

Manufacturer

Bard Access Systems Inc.
  • Manufacturer Address
    Bard Access Systems Inc., 605 N 5600 W, Salt Lake City UT 84116-3738
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA