Events

Recall of Device Recall 0.9 Sodium Chloride Injection, USP

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

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
    71735
  • Event Risk Class
    Class 2
  • Event Number
    Z-2476-2015
  • Event Initiated Date
    2015-07-02
  • Event Date Posted
    2015-08-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138868
  • 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
    Saline, vascular access flush - Product Code NGT
  • Reason
    Procedures for the acceptance and control of in-process product have not been adequately established.
  • Action
    The firm notified their consignees of the recall by Fed Ex on 07/02/2015. The firm requested the return of the product. Distributors were instructed to notify their customers.

Device

Device Recall 0.9 Sodium Chloride Injection, USP
  • Model / Serial
    KH04143,exp. 07/2016; KH04145, exp. 08/2016; KH04153, exp. 11/2016; KH04155, exp. 12/2016
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of CA. PA, VA, TX, MA, MD, WV, UT, FL, and TN.
  • Product Description
    0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
  • Manufacturer
    MRP, LLC dba AMUSA

Manufacturer

MRP, LLC dba AMUSA
  • Manufacturer Address
    MRP, LLC dba AMUSA, 5209 Linbar Dr Ste 640, Nashville TN 37211-1026
  • Manufacturer Parent Company (2017)
    Amusa Inc.
  • Source
    USFDA