Events

Recall of Device Recall Heparin I.V. Flush Syringe

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

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
    67562
  • Event Risk Class
    Class 3
  • Event Number
    Z-1149-2014
  • Event Initiated Date
    2014-02-19
  • Event Date Posted
    2014-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125720
  • 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
    Heparin, vascular access flush - Product Code NZW
  • Reason
    The bar code that is printed on the master carton label does not correspond to the product code fully displayed on the master carton label. the non-matching information can only be detected by using a bar code reader. the defective bar codes will be read as product no. mih-3335 ( heparin i.V. flush syringe 100 units/ml; 5 ml fill in 12 ml syringe) whereas this product is actually product no. mih-3333 (heparin i.V. flush syringe 100 units/ml; 3 ml fill in 12 ml syringe).
  • Action
    URGENT MEDICAL DEVICE CORRECTION letters dated February 19, 2014 were sent to all direct accounts. The letters included instructions to: quarantine the recalled products; and,complete and return the attached customer response form (via Fax to 630-681-9100 or via mail to Medefil Inc., 250 Windy Point Drive, Glendale Heights, IL 60139) so that the correct number of replacement labels can be sent from Medefil.

Device

Device Recall Heparin I.V. Flush Syringe
  • Model / Serial
    Product Number: MIH-3333;  NDC Number: 64253-333-33;  Lot Numbers and Expiration Dates: Lot H114120N, Expires 12/15; Lot H113403N, Expires 11/15; Lot H113369N, Expires 10/15; Lot H113327N, Expires 8/15; Lot H113291N, Expires 7/15; Lot H113266N, Expires 6/15; Lot H113232N, Expires 5/15; Lot H113185N, Expires 3/15.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, SC, TX, UT, and WI, and the country of Canada.
  • Product Description
    Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.
  • Manufacturer
    Medefil Incorporated

Manufacturer

Medefil Incorporated
  • Manufacturer Address
    Medefil Incorporated, 250 Windy Point Dr, Glendale Heights IL 60139-3805
  • Manufacturer Parent Company (2017)
    Medefil Inc.
  • Source
    USFDA