Events

Recall of Device Recall MONOJECT Prefill Heparin Lock Flush Syringe

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

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
    57315
  • Event Risk Class
    Class 2
  • Event Number
    Z-0568-2011
  • Event Initiated Date
    2010-11-15
  • Event Date Posted
    2010-12-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95829
  • 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
    Saline, vascular access flush - Product Code NGT
  • Reason
    The heparin sodium usp used to manufacture was produced with crude heparin containing over-sulfated chondroitin sulfate.
  • Action
    COVIDEN sent an URGENT PRODUCT RECALL letter dated November 12, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and in-use stock to determine if they had any units of the affected product and quarantine the product immediately. Distributors were instructed to notify their customers immediately of the URGENT PRODUCT RECALL letter. Customers were to fill out the enclosed response form and return it by fax to (203) 822-6009 or email to adfeedback@coviden.com following the instructions on the form. For questions customers were to contact Customer Service at 1-800-962-9888

Device

Device Recall MONOJECT Prefill Heparin Lock Flush Syringe
  • Model / Serial
    Lot # 9082094
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, LA, KS, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and Bermuda
  • Product Description
    MONOJECT Prefill Heparin Lock Flush Syringe || 100 Unit Heparin, 3 ml in 12 ml syringe || Item code 8881590123
  • Manufacturer
    Covidien LP

Manufacturer

Covidien LP
  • Manufacturer Address
    Covidien LP, 15 Hampshire St, Mansfield MA 02048-1113
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA