Events

Recall of Sterile ImPad Rigid Sole Foot Cover

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
    56565
  • Event Risk Class
    Class 2
  • Event Number
    Z-2656-2010
  • Event Initiated Date
    2010-08-11
  • Event Date Posted
    2010-10-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93976
  • 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
    Sleeve, Limb, Compressible - Product Code JOW
  • Reason
    Covidien issued an urgent product recall of the sterile impad rigid sole foot cover. the product is indicated for prevention of blood pooling in the limb. 120 cases of each lot code 6066 (right foot) and 6067 (left foot) were shipped to the distributor before sterilization. the customer is instructed to quarantine the product and return it to the manufacturer for replacement. if there are any.
  • Action
    Covidien issued an Urgent Product Recall of the Sterile ImPad Rigid Sole Foot Cover. The product is indicated for prevention of blood pooling in the limb. 120 cases of each Lot code 6066 (right foot) and 6067 (left foot) were shipped to the distributor before sterilization. The customer is instructed to quarantine the product and return it to the manufacturer for replacement. If there are any questions please contact, Covidien Customer Service at (800) 962-9888, Option 1.

Device

Sterile ImPad Rigid Sole Foot Cover
  • Model / Serial
    Lot Numbers: 010/09, 011/09, 012/09
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    AVI Sterile Impad Rigid Sole Foot Cover, Right Foot || Product Code:6066
  • 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