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
    71893
  • Event Risk Class
    Class 2
  • Event Number
    Z-2525-2015
  • Event Initiated Date
    2015-08-06
  • Event Date Posted
    2015-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139286
  • 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
    Sterility may be compromised.
  • Action
    Medtronic/Covidien sent an Urgent Medical Device Recall letter August 7, 2015 to affected customers via Federal Express. The letter identified the affected product, problem and actions to be taken. The letter instructs customers to quarantine, discontinue use and return the affected product as instructed in the letter. For questions contact your Medtronic representative or Customer Service at (800)-882-5878

Device

Covidien
  • Model / Serial
    Lot Numbers: P15035 P15036 P15037 P15041 P15042 P15046 P15047 P15048 P15049 P15056 P15057 P15058 P15059 P15063 P15064 P15069 P15070 P15071 P15078 P15079 P15080 P15081 P15091
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Monoject 0.9% Saline Flush Prefill Double Pouch || Item Code: 8881570129 || Product Usage: || Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • Manufacturer Address
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • 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