Events

Recall of Device Recall Premicath 28G

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

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
    32997
  • Event Risk Class
    Class 2
  • Event Number
    Z-0090-06
  • Event Initiated Date
    2005-06-27
  • Event Date Posted
    2005-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41186
  • 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
    Guidewire protuding from tip of the catheter.
  • Action
    The recalling firm issued a recall letter via fax to the distributors on 6/27/05. The letter informed the distributors of the problem and to notify any hospital accounts of the problem and the need to trim the catheter prior to implantation.

Device

Device Recall Premicath 28G
  • Model / Serial
    Lot numbers 014434 and 012615
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The product was shipped to distributors in CA, CO, FL, IL, MD, NJ, NY, OH, PA, TX and WA.
  • Product Description
    Premicath 28G PICC Catheter
  • Manufacturer
    Vygon Corporation

Manufacturer

Vygon Corporation
  • Manufacturer Address
    Vygon Corporation, 2495 General Armistead Ave, Norristown PA 19403
  • Source
    USFDA