Events

Recall of 0.9 Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile

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
    71175
  • Event Risk Class
    Class 2
  • Event Number
    Z-1709-2015
  • Event Initiated Date
    2015-04-27
  • Event Date Posted
    2015-06-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136366
  • 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
    Incorrect expiration date on label.
  • Action
    The firm, AMUSA, sent a "Voluntary Recall Notification" dated 4/24/2015 to their consignees via Fed Ex on 04/27/2015. The letter described the product, problem and actions to be taken. The consignees were instructed to return any product remaining in the distribution channel to AMUSA; check with your product representative to determine if you have any of the listed products; if any product is located, call (615) 833-2633 from 8:30 am to 5:00 pm (Eastern Time) to receive instructions as to how to return the product; follow the enclosed Steps for Voluntary Recall in their entirety, and complete and return the enclosed Product Tracking and Verification Form. Please contact your AMUSA customer service representative if you have any questions regarding this correction, any of our products, or would like assistance with the corrections. Customers can also contact the Director, Quality Assurance at 513-325-1940 or email qadirector@amusa.us.

Device

0.9 Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile
  • Model / Serial
    CODES: KH04103, KH04104, KH04105
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution in states of:OH, PA, AL, IL, TN, and CT.
  • Product Description
    0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 || Usage: Flush syringe.
  • 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