Events

Recall of VISTEC X-RAY DETECTABLE SPONGES

According to Health Canada (via FOI), this recall involved a device in Canada 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
    18046
  • Event Risk Class
    II
  • Event Initiated Date
    2016-03-09
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Potential for the sterile barrier to be compromised at the package seal. the use of products with this condition may result in a potentially increased risk for infection.

Device

VISTEC X-RAY DETECTABLE SPONGES
  • Model / Serial
    Model Catalog: 7319 (Lot serial: >10. Contact mfr.); Model Catalog: 4031 (Lot serial: >10. Contact mfr.); Model Catalog: 8047 (Lot serial: >10. Contact mfr); Model Catalog: 4037 (Lot serial: >10. Contact mfr.); Model Catalog: 6056 (Lot serial: >10. Contact mfr.); Model Catalog: 6022 (Lot serial: >10. Contact mfr.); Model Catalog: 6545 (Lot serial: >10. Contact mfr.); Model Catalog: 6534 (Lot serial: >10. Contact mfr.); Model Catalog: 6522 (Lot serial: >10. Contact mfr.)
  • Product Description
    VISTEC X-RAY DETECTABLE SPONGES;KERLIX DISPOSABLE LAP SPONGES PREWASHED X-RAY;CURITY COVER SPONGES;CURITY DISPOSABLE LAP SPONGES PREWASHED X-RAY
  • Manufacturer
    COVIDIEN LLC

Manufacturer

COVIDIEN LLC
  • Manufacturer Address
    MANSFIELD
  • 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
    HC