Events

Recall of ORS SLUSH DISC DRAPE

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

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
    126252
  • Event Risk Class
    II
  • Event Initiated Date
    2015-08-28
  • 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
    The reason for the recall is that the sterile packaging may contain small channels in the seal of the pouch. if channels are present the package integrity is compromised and there exists a remote chance that a non-sterile drape may be used during a surgical procedure. this issue was discovered during routine internal testing. no reports of patient injury or complaints have been received as a result of this issue. ecolab conducted a health risk assessment and determined the chance of serious adverse health consequences (infection) to be extremely unlikely.

Device

ORS SLUSH DISC DRAPE
  • Model / Serial
    Model Catalog: ORS-130 (Lot serial: > 10 numbers contact mfg.); Model Catalog: ORS-320 (Lot serial: > 10 numbers contact mfg.); Model Catalog: ORS-110 (Lot serial: > 10 numbers contact mfg.); Model Catalog: ORS-300 (Lot serial: > 10 numbers contact mfg.); Model Catalog: ORS-301 (Lot serial: > 10 numbers contact mfg.); Model Catalog: ORS-100 (Lot serial: > 10 numbers contact mfg.)
  • Product Description
    ORS SLUSH DISC DRAPE
  • Manufacturer
    ECOLAB CO.

Manufacturer

ECOLAB CO.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Ecolab Inc
  • Source
    HC