Events

Recall of BARD URINE METER FOLEY TRAY

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

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
    52290
  • Event Risk Class
    III
  • Event Initiated Date
    2017-09-19
  • 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
    Contained within certain medical device kits manufactured by c.R. bard inc is a bard statlock stabilization device sub-assembly which includes a skin protectant prep pad component that is manufactured by aplicare inc. aplicare is changing its labeling to no longer identify the prep pad as sterile. however bard trays containing the prep pad indicate that components within the kit packaging are sterile. the recall will inform bard customers of the conflict between bard's and aplicare's labels. no product return is required.

Device

BARD URINE METER FOLEY TRAY
  • Model / Serial
    Model Catalog: A902914 (Lot serial: ALL); Model Catalog: A902418 (Lot serial: ALL); Model Catalog: A902416 (Lot serial: ALL); Model Catalog: A800366 (Lot serial: ALL); Model Catalog: A800365 (Lot serial: ALL); Model Catalog: A800364 (Lot serial: ALL); Model Catalog: A902918 (Lot serial: ALL); Model Catalog: A902916 (Lot serial: ALL); Model Catalog: A902414 (Lot serial: ALL); Model Catalog: A119418M (Lot serial: ALL); Model Catalog: A119416M (Lot serial: ALL); Model Catalog: A897514 (Lot serial: ALL); Model Catalog: A897516 (Lot serial: ALL); Model Catalog: A897518 (Lot serial: ALL); Model Catalog: A303418A (Lot serial: ALL); Model Catalog: A303416A (Lot serial: ALL); Model Catalog: NG0100 (Lot serial: ALL); Model Catalog: A303414A (Lot serial: ALL); Model Catalog: 303118A (Lot serial: ALL); Model Catalog: 303116A (Lot serial: ALL); Model Catalog: 399100A (Lot serial: ALL); Model Catalog: 304100A (Lot serial: ALL); Model Catalog: A319518AM (Lot serial: ALL); Model Catalog: A319516AM (Lot serial: ALL); Model C
  • Product Description
    BARD URINE METER FOLEY TRAY;BARDEX LUBRICATH TEMPERATURE SENSING FOLEY TRAY W/BARD HYDROGEL;DRAINAGE BAG FOLEY TRAY W/ANTI-REFLUX CHAMBER;LUBRI-SIL COMPLETE CARE STATLOCK URINE METER FOLEY TRAY;STATLOCK NASOGASTRIC STABILIZATION DEVICE;INFECTION CONTROL A
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.