Events

Recall of UNIVERSAL ELECTROSURGICAL PATIENT PLATES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by 3M CANADA COMPANY.

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
    100634
  • Event Risk Class
    II
  • Event Initiated Date
    2016-11-09
  • 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
    This voluntary recall follows confirmation of a single user report from outside of canada which resulted in 3m identifying an unintended material (process liner) in the product. the presence of a process liner may prevent or impede the safe return of electrosurgical current following electrosurgical unit (esu) activation. this defect has the potential to increase the risk of a patient burn directly under the pad or at an alternate site of the body due to increased impedance at the pad application site.

Device

UNIVERSAL ELECTROSURGICAL PATIENT PLATES
  • Model / Serial
    Model Catalog: 9135-LP (Lot serial: 2019-02DB); Model Catalog: 9135-LP (Lot serial: 2019-02CY); Model Catalog: 9130 (Lot serial: 2019-02CY); Model Catalog: 9130 (Lot serial: 2019-02DT); Model Catalog: 9130 (Lot serial: 2019-02DB); Model Catalog: 9135-LP (Lot serial: 2019-03DU); Model Catalog: 9130 (Lot serial: 2019-03DU); Model Catalog: 9135-LP (Lot serial: 2019-02DT)
  • Product Description
    UNIVERSAL ELECTROSURGICAL PAD
  • Manufacturer
    3M CANADA COMPANY

Manufacturer

3M CANADA COMPANY
  • Manufacturer Address
    LONDON
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    HC