Events

Recall of Covidien

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

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
    65978
  • Event Risk Class
    Class 2
  • Event Number
    Z-2181-2013
  • Event Initiated Date
    2013-08-16
  • Event Date Posted
    2013-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121126
  • 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
    Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin.
  • Action
    Covidien sent an Urgent Medical Device Recall letter dated August 16, 2013 via Federal Express to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter requested that customers immediately quarantine and discontinue use of the affected products, return any affected product by following the instructions provided in the letter, and complete and return the Recalled Product Return Form to Covidien. The letter states that if the affected products have been distributed, assure that all customers are notified and affected product is removed from the distribution channel as well as from customer stock. Questions or concerns, please do not hesitate to contact your Covidien representative or Covidien Customer Service, Monday through Friday, 8am- 6:30pm ET, at (800) 962-9888, option 1, and then option 2. Firm issued Press on 8/19/13

Device

Covidien
  • Model / Serial
    Lot Numbers:  13A0084N
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and the country of Bermuda
  • Product Description
    Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill || Product ID: 8881590123 || Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • Manufacturer Address
    Covidien LLC, 15 Hampshire Street, 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