Recall of SENSICARE GREEN WITH ALOE SURGICAL GLOVES

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

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
    107805
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-27
  • Event Country
  • 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
    The reason for this recall is the result of a confirmed us customer complaint of an open seal on the top portion of the package. medline confirmed the customer complaint and promptly put all other inventory with this lot number on quarantine for further investigation. no other packages from this lot were confirmed to have open seals during the investigation. as a precautionary measure medline is issuing a recall for this specific lot of gloves.

Device

  • Model / Serial
    Model Catalog: MSG1285 (Lot serial: 701893369485)
  • Product Description
    SENSICARE GREEN WITH ALOE SURGICAL GLOVES
  • Manufacturer

Manufacturer