Events

Recall of Device Recall IV Flush LLC

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by IV Flush LLC.

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
    31082
  • Event Risk Class
    Class 1
  • Event Number
    Z-0546-05
  • Event Initiated Date
    2005-01-26
  • Event Date Posted
    2005-03-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37120
  • 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
    Sodium Chloride Injection - Product Code FOZ
  • Reason
    Device marketed without 510(k) clearance and is suspected to be contaminated with p. flourescens.
  • Action
    The firm initiated the recall by fax to distributors on 01/26/2005. On 2/16/2005 the firm faxed a second recall letter with return reciept response card to all consignees.

Device

Device Recall IV Flush LLC
  • Model / Serial
    All lots remaining on the market.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed nationwide.
  • Product Description
    Sodium Chloride Injection USP, manufactured by IV Flush LLC
  • Manufacturer
    IV Flush LLC

Manufacturer

IV Flush LLC
  • Manufacturer Address
    IV Flush LLC, 3905 Melcer, Suite 601, Rowlett TX 75088
  • Source
    USFDA