Events

Recall of 15 L CYCLER DRAINAGE BAG

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BAXTER 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
    21125
  • Event Risk Class
    III
  • Event Initiated Date
    2013-12-09
  • 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
    Baxter has identified an issue with the large clamp that is used to close the drain tube on the 15l cycler drainage bag. the large clamp may not fully close the drain tube and may result in leakage. if leakage occurs there is a potential risk of contamination or infection to a patient/caregiver and a possibility of a slipping hazard if there is a fluid spill. there have been no injuries reported for this issue.

Device

15 L CYCLER DRAINAGE BAG
  • Model / Serial
    Model Catalog: 5C4145P (Lot serial: >10 NUMBERS (CONTACT MFR))
  • Product Description
    15 L CYCLER DRAINAGE BAG
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION