Events

Recall of Device Recall UltraStream Chronic Hemodialysis Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Argon Medical Devices, Inc.

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
    68521
  • Event Risk Class
    Class 2
  • Event Number
    Z-2696-2014
  • Event Initiated Date
    2014-06-05
  • Event Date Posted
    2014-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128132
  • 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
    Ultrastream chronic hemodialysis catheter may develop cracks on the red (arterial) luer during attachment or manipulation.

Device

Device Recall UltraStream Chronic Hemodialysis Catheter
  • Model / Serial
    Lot Numbers: 11034387, 11034915, 11039525, 11045439, 11057890, 11059625, 11027376, 11034000, 11035976, 11036453, 11038334, 11041518, 11044383, 11047511, 11049668, 11052111, 11054546, 11059459, 11060050, 11033757, 11041251, 11044868, 11050693, 11054199, 11059627, 11061874, 11067035, 11021364, 11034424, 11059468, 11034914, 11035965.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (36 cm) and 32102540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure.
  • Manufacturer
    Argon Medical Devices, Inc

Manufacturer

Argon Medical Devices, Inc