Events

Recall of Device Recall NIOA / NIOP is an instant IO access device

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

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
    75008
  • Event Risk Class
    Class 2
  • Event Number
    Z-2680-2016
  • Event Initiated Date
    2016-08-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149107
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • Reason
    Waismed received a report in which during the operation of the nio-a, the needle was not released from the device as expected. the device was placed on the floor and after several minutes the needle was released spontaneously. nio-a and the nio-p models have the same activation mechanism. however, none of the affected lots of the nio-a are distributed in the us, and thus the company is only recalling a single lot of nio-p in the us.
  • Action
    The firm emailed the US Consignees on August 18, 2016 that they were conducting a recall on the NIO/A and NIO/P products. The US distributor shall contact the customers and will collect the products from each of the customers. The recalled products shall be moved to Storage quarantine within one week. The company shall keep track on the process and the recall efficacy.

Device

Device Recall NIOA / NIOP is an instant IO access device
  • Model / Serial
    1620005
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    WI, TX, CA, LA and the following countries: UK, Spain, Poland, Israel, Czech Republic, France, Belgium, Denmark, Italy, Cyprus, Austria, Greece, Slovenia, Australia, Germany, Estonia, New Zealand, Switzerland, Costa Rica, Guatemala, Canada, Malaysia, Poland, Singapore, Lithuania, Romania
  • Product Description
    NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle into the bone marrow of a patient and allows connection of syringe or IV administration set. || The NIO-A is intended for adults above 12 years old and the NIO-P is intended for pediatric patients 3 - 12 years of age.
  • Manufacturer
    Waismed Ltd

Manufacturer

Waismed Ltd
  • Manufacturer Address
    Waismed Ltd, 10, Amal St, Rosh Haayin Israel
  • Manufacturer Parent Company (2017)
    Waismed Ltd
  • Source
    USFDA