Events

Recall of MedComp 8F Plastic ProFuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Cathet

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
    62238
  • Event Risk Class
    Class 2
  • Event Number
    Z-1868-2012
  • Event Initiated Date
    2012-04-02
  • Event Date Posted
    2012-06-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-05-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110003
  • 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
    Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
  • Reason
    Product was packaged with the incorrect port and does not match the label. the kit is labeled as an 8f low profile pro-fuse ct port. the kit contains an 8f midsize dignity ct port.
  • Action
    MedComp sent a "PRODUCT ALERT" letter dated April 2, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The firm requested the return of all affected product. Contact the firm at 215-256-4201 ext. 2225 for questions regarding this notice.

Device

MedComp 8F Plastic ProFuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Cathet
  • Model / Serial
    Catalog number MRCTT80041, Lot # MDNK860, Exp 02/2015
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of GA and WA and the countries of Ireland and Turkey.
  • Product Description
    MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. || Power Injectable Implantable Infusion Port insertion kit.
  • 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