Events

Recall of 0.9 Sodium Chloride Injection, USP, PreFilled Flush Solution, 3 mL in 12 mL Single Use Syringe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Amsino Medical USA.

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
    63105
  • Event Risk Class
    Class 3
  • Event Number
    Z-2393-2012
  • Event Initiated Date
    2012-08-15
  • Event Date Posted
    2012-09-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112553
  • 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
    One lot of 0.9% sodium chloride flush syringe, 3 ml in 12 ml may be mislabeled as 0.9% sodium chloride flush syringe, 10 ml in 12 ml.
  • Action
    The firm, Amusa, notified their sole consignee of the mislabeled product via e-mail and telephone on August 15, 2012. An "URGENT-CLASS II MEDICAL DEVICE RECALL" letter dated August 22, 2012 was sent to the customer. The letter identified the product, problem, and actions to be taken by the customer. A Response Form was included for the customer to complete and return. Contact the firm at 615-521-2723 for questions regarding this recall.

Device

0.9 Sodium Chloride Injection, USP, PreFilled Flush Solution, 3 mL in 12 mL Single Use Syringe
  • Model / Serial
    KH03752
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to one customer in Illinois.
  • Product Description
    0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. || Flush syringe.
  • Manufacturer
    Amsino Medical USA

Manufacturer

Amsino Medical USA
  • Manufacturer Address
    Amsino Medical USA, 5209 Linbar Dr, Suite 640, Nashville TN 37211-1026
  • Source
    USFDA