Events

Recall of STERILE PENROSE DRAIN

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
    41189
  • Event Risk Class
    II
  • Event Initiated Date
    2009-04-01
  • 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
    A drain placed by a surgeon and an x-ray ordered the drain did not show up on x-ray although the packaging states the product is x-ray opaque. two lots of product are affected in this issue.

Device

STERILE PENROSE DRAIN
  • Model / Serial
    Model Catalog: DYND50420 (Lot serial: 05AA0001-09CA9999); Model Catalog: DYND50426 (Lot serial: 05AA0001-09CA9999); Model Catalog: DYND50425 (Lot serial: 05AA0001-09CA9999); Model Catalog: DYND50421 (Lot serial: 05AA0001-09CA9999); Model Catalog: DYND50423 (Lot serial: 05AA0001-09CA9999); Model Catalog: DYND50422 (Lot serial: 05AA0001-09CA9999); Model Catalog: DYND50424 (Lot serial: 05AA0001-09CA9999)
  • Product Description
    MEDLINE PENROSE DRAIN
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION