Events

Recall of Device Recall Churchill Medical Systems, Inc. a Vygon Company REF CMSCT6T225, 6F Triple Lumen CT PICC with M.S.T.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medical Components, Inc dba MedComp.

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
    64235
  • Event Risk Class
    Class 2
  • Event Number
    Z-0898-2013
  • Event Initiated Date
    2012-12-13
  • Event Date Posted
    2013-02-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116160
  • 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
    The affected 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
    Medcomp sent a notification letter dated December 13, 2012 via email to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions or concerns call 215-256-4201

Device

Device Recall Churchill Medical Systems, Inc. a Vygon Company REF CMSCT6T225, 6F Triple Lumen CT...
  • 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
    USA Nationwide Distribution including the state of PA.
  • Product Description
    REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components || Product Usage: Power injectable infusion PICC insertion kits
  • Manufacturer
    Medical Components, Inc dba MedComp

Manufacturer

Medical Components, Inc dba MedComp
  • Manufacturer Address
    Medical Components, Inc dba MedComp, 1499 Delp Dr, Harleysville PA 19438
  • Manufacturer Parent Company (2017)
    Medical Components Inc.
  • Source
    USFDA