Events

Recall of UltraSafe Dental Needle Guard, P/N: 401801 Lot:T20201501

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Safety Syringes 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
    25313
  • Event Risk Class
    Class 2
  • Event Number
    Z-0444-03
  • Event Initiated Date
    2002-09-05
  • Event Date Posted
    2003-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25582
  • 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
    Syringe, Antistick - Product Code MEG
  • Reason
    Package integrity not validated. sterility not assured.
  • Action
    Firm initiated recall on 9/5/2002. Visits, telephone calls and letters were the tools used to implement the recall. Unused recalled units were retrieved from customers. This recall is complete.

Device

UltraSafe Dental Needle Guard, P/N: 401801 Lot:T20201501

Manufacturer

Safety Syringes Inc
  • Manufacturer Address
    Safety Syringes Inc, 1939 Palomar Oaks Way #A, Carlsbad CA 92009
  • Source
    USFDA