Events

Recall of Device Recall PICC catheters

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
    34518
  • Event Risk Class
    Class 3
  • Event Number
    Z-0543-06
  • Event Initiated Date
    2005-12-20
  • Event Date Posted
    2006-03-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44018
  • 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
    Multiple pages in the instructions for use booklet were missing print. booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. these pages contain product description, indications, contraindications, warnings, precautions, possible complications, and insertion instructions.
  • Action
    Consignees were notified by letter on 12/20/2005.

Device

Device Recall PICC catheters
  • Model / Serial
    Product Code 7827508, Lot #REPI0650.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide, including VA facilities in CA, FL and IL. No foreign or military distribution.
  • Product Description
    Groshong NXT 5 Fr. Dual-Lumen Reverse Taper PICC.
  • Manufacturer
    Bard Access Systems, Inc

Manufacturer

Bard Access Systems, Inc
  • Manufacturer Address
    Bard Access Systems, Inc, 5425 Amelia Earhart Dr, Salt Lake City UT 84116-3713
  • Source
    USFDA