Events

Recall of Device Recall Liberty

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Liberty Medical Supplies.

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
    25862
  • Event Risk Class
    Class 3
  • Event Number
    Z-0003-04
  • Event Initiated Date
    2003-02-24
  • Event Date Posted
    2003-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26623
  • 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
    The correct individual insulin syringe labeling size and guage may be different than what is on the incorrectly labeled shelf box .
  • Action
    The firm mailed a recall letter to accounts on 2/25/2003 informing the user patients of the labeling error and requesting they examine all syringes they have received from Liberty Medical for the indicated lot numbers and to call the recalling firm, Libery Medical at 800-762-8026 for replacements. Also the letter contained a mailing label for the patient to return any recalled syringes.

Device

Device Recall Liberty
  • Model / Serial
    Lot # 2IE03
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed directly to 1352 patients nationwide. No international or government accounts are involved.
  • Product Description
    Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
  • Manufacturer
    Liberty Medical Supplies

Manufacturer

Liberty Medical Supplies
  • Manufacturer Address
    Liberty Medical Supplies, 10045 S Federal Hwy, Port Saint Lucie FL 349525607
  • Source
    USFDA