Events

Recall of IV Flush

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nurse Assist, Inc.

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
    75348
  • Event Risk Class
    Class 1
  • Event Number
    Z-0926-2017
  • Event Initiated Date
    2016-10-04
  • Event Date Posted
    2017-01-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150104
  • 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
    Potential contamination with b. cepacia.
  • Action
    Nurse Assist, Inc. sent an Urgent Medical Device Recall letter dated October 4, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately discontinue use, a Returned Goods Authorization would be provided for return of the affected product. If product was further distributed consignees were instructed to make every effort to retrieve any of the unused product. For questions consignees should call 800-649-6800 or email productremovalinfo@nurseassist.com. For questions regarding this recall call 817-231-1300.

Device

IV Flush
  • Model / Serial
    Item Number 1203: 1511075, 1604273; Item Number 1205: 1511001, 1602028, 1603060; Item Number 1210: 1509282, 1511328, 1511329, 1512048, 1512053, 1512072, 1601355, 1602048, 1602137, 1602178, 1603029, 1605387, 1606076; Item Number 1210-BP: 1604431,1604432, 1604433, 1606254, 1607018, 1607195, 1607418 (All lots within expiry)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide), St. Thomas, US Virgin Islands, and Internationally to Canada.
  • Product Description
    Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP || Product usage: Saline flush
  • Manufacturer
    Nurse Assist, Inc

Manufacturer

Nurse Assist, Inc
  • Manufacturer Address
    Nurse Assist, Inc, 4409 Haltom Rd, Haltom City TX 76117-1207
  • Manufacturer Parent Company (2017)
    Nurse Assist Inc.
  • Source
    USFDA