Events

Recall of Device Recall 9.6F Plastic Dignity MidSized CT port w/PreAttached Silicone Catheter

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
    76625
  • Event Risk Class
    Class 2
  • Event Number
    Z-1536-2017
  • Event Initiated Date
    2017-02-23
  • Event Date Posted
    2017-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153698
  • 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
    The 9.6f port kits were packaged with the incorrect valved peelable introducer. the label states the kit contains a 10f valved peelable introducer. the kit is packaged with a 9f valved peelable introducer. the port lumen will not fit through the introducer during the insertion procedure.
  • Action
    Medcomp mailed a Customer Notification letter dated February 23, 2017, to all affected customers to inform them of the issue. Customers were asked to examine their inventory and return all unused product. Distributors were also asked to locate the end user/facility of where the affected product was sold and communicate the recall to them. Customers were instructed to contact their customer service representative for a Returned Goods Authorization (RGA) number if necessary at 215-256-4201. Customers were also instructed to complete and return page 2 of the letter by fax to 215-256-9191. For questions regarding this recall call 215-256-4201.

Device

Device Recall 9.6F Plastic Dignity MidSized CT port w/PreAttached Silicone Catheter
  • Model / Serial
    MRCTI96801 Lot# MHWQ060 S2 , UDI# 884908031232
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution to PR and Panama
  • Product Description
    9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter || The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media
  • Manufacturer
    Medical Components, Inc dba MedComp

Manufacturer

Medical Components, Inc dba MedComp
  • Manufacturer Address
    Medical Components, Inc dba MedComp, 1499 Delp Dr, Harleysville PA 19438-2936
  • Manufacturer Parent Company (2017)
    Medical Components Inc.
  • Source
    USFDA