Events

Recall of Device Recall Churchill Medical Systems, Inc. A Vygon Company All sizes of CMSCT6T225 6F Triple Lumen CT PICC

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
    64458
  • Event Risk Class
    Class 2
  • Event Number
    Z-0937-2013
  • Event Initiated Date
    2012-12-17
  • Event Date Posted
    2013-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116180
  • 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
    PICC - Product Code LJS
  • Reason
    Product was packaged with the incorrect introducer needle. the kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.
  • Action
    Churchill Medical Systems sent a letter to their consignees on December 19, 2012.

Device

Device Recall Churchill Medical Systems, Inc. A Vygon Company All sizes of CMSCT6T225 6F Triple...
  • Model / Serial
    Lots numbers MBKQ640, exp 05/2015; MBKZ720, exp 05/2015; MBLJ290, exp 06/2015; MBLR100, exp 07/2015; MBLZ350, exp 09/2015; and MBMG250, exp 10/2015.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania
  • Product Description
    Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.
  • Manufacturer
    Vygon Corporation

Manufacturer

Vygon Corporation