Events

Recall of COTTON BALLS STRUNG

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

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
    38433
  • Event Risk Class
    II
  • Event Initiated Date
    2016-11-10
  • 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
    Sterile packaging integrity/sterility assurance. a failure in the sterile peel pouch has been discovered during a quality control inspection. this failure may result in a small tear in the pouch of the device leading to a potential compromise of the sterile barrier. a leak in the sterile barrier may allow contamination of the device increasing the risk of infection. after the failure was identified a comprehensive investigation has shown an occurrence rate of less than 0.01% for the affected lots.

Device

COTTON BALLS STRUNG
  • Model / Serial
    Model Catalog: 30-03 (Lot serial: 2015/12 DA); Model Catalog: 70-02 (Lot serial: 2015/11 AN); Model Catalog: 80-05 (Lot serial: 2015/12 AD)
  • Product Description
    Cotton Balls Strung;Cylindrical sponge;TELFA;Telfa 3/8" x 3";Cotton Balls-Strung 3/4";Cylindrical Sponges-Strung
  • Manufacturer
    OSIS MEDICAL

Manufacturer

OSIS MEDICAL
  • Manufacturer Address
    BRADFORD
  • Source
    HC