Events

Recall of Split Cath III

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
    68993
  • Event Risk Class
    Class 2
  • Event Number
    Z-2592-2014
  • Event Initiated Date
    2014-08-04
  • Event Date Posted
    2014-09-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129216
  • 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
    The split cath iii trays were incorrectly labeled as 16f x 32cm split cath iii instead of 28cm.
  • Action
    Medcomp sent a Recall Notification letter, dated August 4, 2014, to all affected customers. The letter identified the affected product, problem, and action to be taken. Customers were requested to respond and return all affected product. For questions call contact Susan Smith at ssmith@medcompnet.com.

Device

Split Cath III
  • Model / Serial
    TRAY #55216-3; Lot numbers: MBTX960, exp. 10/2016; MBVA850, exp. 10/2016; MBVD080, exp. 01/2017; MBVG680, exp. 01/2017; MBVL020, exp. 01/2017.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Nationwide Distribution
  • Product Description
    Split Cath III Trays, 16F x 28CM || Product Usage: || The Split Cath III is indicated for use in attaining long term vascular access for hemodialysis and apheresis in adult patients.
  • 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