Events

Recall of Device Recall T/S2 0.9 Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL

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
    70974
  • Event Risk Class
    Class 2
  • Event Number
    Z-1808-2015
  • Event Initiated Date
    2015-02-09
  • Event Date Posted
    2015-06-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135755
  • 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 labeling of the expiration date.
  • Action
    The firm, AMUSA, Inc., initiated the recall by telephone to the sole consignee on 02/09/2015. The consignee were informed of product, the problem and actions to be taken. The consignees verified that they were in possession of the product and that all the product has been destroyed. If you have any questions, call 513-235-1940 or email: qadirector@amusa.us.

Device

Device Recall T/S2 0.9 Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL ...
  • Model / Serial
    KH04090
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution to CA only.
  • Product Description
    T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 || 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