Events

Recall of AccuSure U100 29 Gauge, 1cc

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
    53709
  • Event Risk Class
    Class 2
  • Event Number
    Z-0572-2010
  • Event Initiated Date
    2009-10-27
  • Event Date Posted
    2009-12-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86396
  • 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 are becoming dislodged from the barrels.
  • Action
    The recall is being conducted to the Consumer level. A Press Release was issued on October 27, 2009 stating that Qualitest Pharmaceuticals was issuing a nationwide recall of all Accusure ¿¿ Insulin Syringes. The consignees were asked to post a copy of the press release in their retail stores and to alert patients of this action. Also, Recall Notifications were sent to all of the firm's consignees by First Class Mail on October 30, 2009. The consignees were instructed to notify their customers or sub accounts who may have been sold or dispensed the affected syringes starting in 2002, and to return the affected product. Questions are directed to the firm at telephone number 800-444-4011.

Device

AccuSure U100 29 Gauge, 1cc

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