Events

Recall of Device Recall StatLock PICC Plus Crescent Foam

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bard Access Systems.

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
    75908
  • Event Risk Class
    Class 2
  • Event Number
    Z-0981-2017
  • Event Initiated Date
    2016-12-09
  • Event Date Posted
    2017-01-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151675
  • 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
    Bard access systems announces a voluntary field action for the statlock¿ catheter stabilization devices because some single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.).
  • Action
    Bard sent an Urgent Customer Notification letter dated December 12, 2016. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory and identify any product subject to the notification. Please direct any return requests and/or questions to Shelly Gilbert at 1-800-290-1689.

Device

Device Recall StatLock PICC Plus Crescent Foam
  • Model / Serial
    Lot Number: JUZGF345 & JUAQF020
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    StatLock¿ PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 50 pouches per carton and 10 cartons per case. Other configurations may contain additional components such as a foam pad with a pigtail clip. || Product Usage: || The StatLock¿ PICC Plus and StatLock¿ CV Plus catheter stabilization devices are suture-free stabilization devices for peripherally inserted central catheters (PICCs) and central venous catheters (CVCs) respectively.
  • Manufacturer
    Bard Access Systems

Manufacturer

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