Events

Recall of Device Recall Heparin I.V. Flush Syringe 10 units/mL

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
    47378
  • Event Risk Class
    Class 2
  • Event Number
    Z-1544-2008
  • Event Initiated Date
    2008-03-20
  • Event Date Posted
    2008-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69522
  • 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 Access Flush - Product Code NZW
  • Reason
    The heparin lock flush solution was manufactured from contaminated heparin sodium usp active pharmaceutical ingredient (api). the fda has received reports of serious injuries and/or deaths in patients administered finished heparin injectable products manufactured from heparin api containing this contaminant.
  • Action
    Medefil telephoned the direct accounts on 3/20/08, e-mailed them a copy of the 3/20/08 recall letter on 3/21/08, and sent the accounts a hard copy of the recall letter on 3/24/08. The accounts were informed of Medefil's recall of 19 lots of Heparin I.V. Flush Syringes produced from the active pharmaceutical ingredient (API) Heparin Sodium, USP, lot 1035-0773, that has been recalled by the manufacturer, Scientific Protein Laboratories, due to the presence of a contaminant in the recalled lot of API. The accounts were instructed to stop use of the 19 lots of Heparin I.V. Flush Syringes immediately, place them under quarantine, and contact all customers to whom they further distributed the product, telling them to stop use of the product and return the product to Medefil through their supplier. The accounts were requested to complete and return to Medefil via fax the enclosed response form, indicating the quantity on hand of each recalled lot. Any questions were directed to Pradeep Aggarwal, President at 630-682-4600.

Device

Device Recall Heparin I.V. Flush Syringe 10 units/mL
  • Model / Serial
    catalog #MIH-2235: lot H07325, exp. date 11/09, H08113, exp. date 12/09;  catalog #MIH-2233: lot H08124, exp. date 01/10
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Nationwide Distribution --- including states of Arizona, Florida, Illinois, Massachusetts, Pennsylvania, and Texas.
  • Product Description
    Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 10 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc., Glendale Heights, IL 60139 || The pre-filled syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: || a) NDC #64253-222-35, catalog #MIH-2235: 5 mL fill in 12 mL syringe || b) NDC #64253-222-33, catalog #MIH-2233: 3 mL fill in 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