Events

Recall of Device Recall 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
    73121
  • Event Risk Class
    Class 2
  • Event Number
    Z-1212-2016
  • Event Initiated Date
    2016-01-22
  • Event Date Posted
    2016-03-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143251
  • 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
    Catheter, retention type, balloon - Product Code EZL
  • Reason
    Aplicare castile soap towelettes included in the foley trays and mid stream specimen kits are contaminated with bacteria.
  • Action
    Medtronic/Covidien notfiied customersl via Federal Express on January 22, 2016,, The letter instructs customers to not use the Castile Soap Towelettes contained in the product kits listed on Attachment 1 and discard the affected towelettes. The Castile Soap packet included in these kits does not impact the integrity of the remaining products in the kit. Questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878. For questions regarding this recall call 203-492-5000.

Device

Device Recall Covidien
  • Model / Serial
    Lot Codes: 513256264X 515358164X 517457064X 520550064X 520857464X 521058564X 522958064X 525153264X
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (nationwide) and to Canada.
  • Product Description
    Covidien Dover P400 PREM U/M 16FR SLVR FLY || Item Code: P4P16XSD || Castile soap towelettes are used to clean the genital area for male and female patients
  • 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