Events

Recall of Device Recall Groshong PICC

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
    57457
  • Event Risk Class
    Class 2
  • Event Number
    Z-0865-2011
  • Event Initiated Date
    2010-12-10
  • Event Date Posted
    2011-01-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96273
  • 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
    Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
  • Reason
    Prepackaged sterile latex gloves beyond their expiration date were packaged in surgical kits.
  • Action
    BARD Access Systems sent an URGENT: GROSHON* 3 FR SINGLE-LUMEN PICC INTERMEDIATE TRAY WITH SAFETY INTRODUCER RECALL letter dated December 10, 2010. The letter identified the product, the problem,and the action to be taken by the customer. Customers were instructed to examine their inventory and quarantine the product subject to recall, discontinue use, and cease further distribution of any the affected product. If the product was further distributed, those customers were to be notified immediately with a copy of the recall notification letter. Any remaining product was to be returned to Bard. For information regarding this recall call 800-290-1689.

Device

Device Recall Groshong PICC
  • Model / Serial
    Lot numbers: REUF1011, REUF1303.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including AL, AZ, CA, GA, IA, MN, MO, NE, NJ, NY, OH, OR, SD, and WI.
  • Product Description
    Groshong 3 Fr. Single-Lumen PICC Intermediate Tray with Safety Introducer, Reorder Number 7717300, Bard Access Systems, Inc., Salt Lake City, UT 84116. || The Groshong is a family of single and dual -lumen peripherally placed mid-line and central catheters made from specially formulated and processed medical grade materials, in a tray with accessories for reliable long (greater than 30 days) or short term (less than 30 days) vascular access.
  • Manufacturer
    Bard Access Systems

Manufacturer

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