Events

Recall of Device Recall AccuSure Insulin Syringe, 1cc, 28 guage, 1/2"

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Qualitest Pharmaceuticals 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
    32366
  • Event Risk Class
    Class 2
  • Event Number
    Z-0942-05
  • Event Initiated Date
    2005-06-14
  • Event Date Posted
    2005-06-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39893
  • 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, Piston - Product Code FMF
  • Reason
    Labeling error. there is a possibility that 1cc syringes are labeled at 1/2cc on the plastic inner wrap holding bundles of 10 syringes.
  • Action
    The firm initiated the recall on June 14, 2005 with a press release and followed with a letter initially sent via fax and then by letter requesting return of the product and posting of a copy of the press release at the retail level.

Device

Device Recall AccuSure Insulin Syringe, 1cc, 28 guage, 1/2"
  • Model / Serial
    All codes
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    AccuSure Insulin Syringe, 1cc, 28 guage, 1/2'', packaged in boxes of 100, each containing 10 bundles of 10 syringes, disposable, NDC 0603-6996-21.
  • Manufacturer
    Qualitest Pharmaceuticals Inc

Manufacturer

Qualitest Pharmaceuticals Inc
  • Manufacturer Address
    Qualitest Pharmaceuticals Inc, 130 Vintage Drive, Huntsville AL 35811-8216
  • Source
    USFDA