Events

Recall of AccuSure

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals.

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
    51817
  • Event Risk Class
    Class 2
  • Event Number
    Z-1504-2009
  • Event Initiated Date
    2009-04-09
  • Event Date Posted
    2009-06-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81329
  • 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
    insulin syringe - Product Code FMF
  • Reason
    Needles separate from the barrel of the syringes.
  • Action
    On 04/09/2009, Qualitest issued a press release and sent out recall notifications to their consignees by US Mail. The recall was extended to the User level. Qualitest will send a second letter to all non-responders after thirty days. Thirty days after the second letter, Qualitest will perform a recall effectiveness check by telephone on a percentage of non-responders (in accordance with FDA request).

Device

AccuSure

Manufacturer

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
  • Manufacturer Address
    Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, 120 Vintage Dr Ne, Huntsville AL 35811-8216
  • Manufacturer Parent Company (2017)
    Endo International plc
  • Source
    USFDA