Events

Recall of Device Recall Titan Hemodialysis 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
    58975
  • Event Risk Class
    Class 2
  • Event Number
    Z-2693-2011
  • Event Initiated Date
    2011-05-19
  • Event Date Posted
    2011-06-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100757
  • 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, Hemodialysis, Implanted - Product Code MSD
  • Reason
    Product was packaged with the incorrect valved peelable introducer. the catheter sized is 15.5f and the introducer packaged in the kit is a 15f. the kit should contain a 16f introducer.
  • Action
    Medcomp sent a "PRODUCT ALERT" letter dated May 19, 2011 to all affected customers. The letter described the product, problem, and actions to be taken. The letter is requesting the return of all affected product. Customers are instructed to contact their customer service representative for an RGA (returned good authorization) number. If you have any questions or concerns contact Medcomp at 215-256-4201 ext. 2225.

Device

Device Recall Titan Hemodialysis Catheter
  • Model / Serial
    Lot # MAZX990; Catalog # THD155428, Exp Date 2013/03
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA (nationwide) including states of AZ, CA, CO and RI and countries of Australia, Brazil, and Netherlands
  • Product Description
    THD155428- 15.5F X 28cm Titan HD(TM) Catheter Kit || Product Usage: Hemodialysis catheter 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