Events

Recall of Device Recall Kendall/Tyco Monoject

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
    47436
  • Event Risk Class
    Class 2
  • Event Number
    Z-1596-2008
  • Event Initiated Date
    2008-03-28
  • Event Date Posted
    2008-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69494
  • 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
    Scientific protein laboratories (spl), disclosed that two lots of heparin sodium, usp active pharmaceutical ingredient has a heparin-like contaminant.
  • Action
    Tyco Healthcar notifed customers by letter sent via US Postal Service beginning 3/28/08, through 4/1/08. The letter requests that they immediately stop using and return the product. Distributors are requested to in-turn notify their customers. An instruction sheet was attached for product return and replacement. All customers are required to respond to the notice regardless of remaining inventory. .

Device

Device Recall Kendall/Tyco Monoject
  • Model / Serial
    Lot Numbers: 7051524; 7082274; 7113164; 7113174
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Tyco Healthcare Tyco HealthcareMonoject Prefill 10U/mL Heparin || Lock Flush Syringe 5mL || REF # 8881580125Tyco Healthcare, Mansfield, MA 02048
  • 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