Events

Recall of Device Recall medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with PreAttached Chronflex(R) Polyur

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
    56225
  • Event Risk Class
    Class 2
  • Event Number
    Z-2235-2010
  • Event Initiated Date
    2010-07-02
  • Event Date Posted
    2010-08-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93071
  • 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
    Implanted Subcutaneous Intravascular Port & Catheter - Product Code LJT
  • Reason
    Recalled product was packaged with the incorrect port and does not match the label. the kit is labeled as a 6.6f "dignity" low profile ct port. the kit contains a 6.6f "pro-fuse" low profile ct port.
  • Action
    Medcomp sales reps and foreign distributor were notified via email on 7/1/10. Product is to be returned to Medcomp.

Device

Device Recall medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with PreAttached Ch...
  • Model / Serial
    Lot #MAZL630, Exp. 04/2015
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA, including states of NC and TX and country of Israel.
  • Product Description
    medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with Pre-Attached Chronoflex(R) Polyurethane Catheter - 1 Unit. Catalog #MRCTI66841.
  • 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