Events

Recall of Device Recall Safedraw Venous Close Loop System

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
    61832
  • Event Risk Class
    Class 2
  • Event Number
    Z-1946-2012
  • Event Initiated Date
    2012-05-04
  • Event Date Posted
    2012-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109201
  • 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
    Computer, blood pressure - Product Code DSK
  • Reason
    Some of the kits may exhibit a potential defect with the pouch seal. the pouch issue may compromise the sterile barrier.
  • Action
    Argon Medical Devices sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 4, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Recall Response Form was attached to the letter for customers to complete and return to the firm via fax to 903-577-9393. Contact the firm at CRS@argonmedical.com for questions regarding this recall.

Device

Device Recall Safedraw Venous Close Loop System
  • Model / Serial
    Lot Number 204889, Expiration Date March 2017
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed only in Missouri.
  • Product Description
    Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte. Ltd., 198 Yishun Avenue 7, Singapore 768028. || The blood sampling set is intended to be used for closed-loop blood sampling from the patient without the system being exposed to the outside environment.
  • Manufacturer
    Argon Medical Devices, Inc

Manufacturer

Argon Medical Devices, Inc