Events

Recall of NEEDLEZAP

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by E Med Future 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
    25039
  • Event Risk Class
    Class 2
  • Event Number
    Z-0624-03
  • Event Initiated Date
    2002-08-15
  • Event Date Posted
    2003-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25047
  • 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
    Sharps Needle Destruction Device - Product Code MTV
  • Reason
    Their needlezap devices were not manufactured in accordance with the quality system regulations, and were shipped without an approved pma.
  • Action
    On 8/15/2002, the firm contacted their largest distributor by telephone and instructed them to stop distribution and to place all remaining devices in quarantine until further notice. On 3/20/2003, the firm mailed recall notices to all direct accounts asking for the device to be returned.

Device

NEEDLEZAP
  • Model / Serial
    The devices are not identified with lot numbers or serial numbers.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The devices were shipped to customers located nationwide. The product was also distributed into Canada, Greece and Ireland.
  • Product Description
    NEEDLEZAP, a battery operated needle destruction device. || The product is labeled and marketed for use only in the law enforcement market or veterinary market.
  • Manufacturer
    E Med Future Inc

Manufacturer

E Med Future Inc
  • Manufacturer Address
    E Med Future Inc, 794 Morrison Road, Columbus OH 43230
  • Source
    USFDA