Events

Recall of STATLOCK - IV

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
    153492
  • Event Risk Class
    III
  • Event Initiated Date
    2017-09-07
  • 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
    Bard is informing customers of a label change to a component in the listed bard access systems (bas) trays and/or kits. the component skin prep pad (part number p-1010) manufactured by aplicare inc. will no longer be labeled as sterile (new non-sterile part number p-1030). over the next several months bas will deplete inventory of the sterile-labeled product and transition to the modified labeled product in its trays and/or kits. no product return is required.

Device

STATLOCK - IV
  • Model / Serial
    Model Catalog: VITML6AV (Lot serial: ALL); Model Catalog: 1173118 (Lot serial: ALL); Model Catalog: VIDTML4 (Lot serial: ALL); Model Catalog: VIDML6 (Lot serial: ALL); Model Catalog: VIDML12 (Lot serial: ALL); Model Catalog: IV0572 (Lot serial: ALL); Model Catalog: IV0571 (Lot serial: ALL); Model Catalog: IV0564 (Lot serial: ALL); Model Catalog: IV0541 (Lot serial: ALL); Model Catalog: IV0525 (Lot serial: ALL); Model Catalog: 3194155 (Lot serial: ALL); Model Catalog: 3194135 (Lot serial: ALL); Model Catalog: 9386118Q (Lot serial: ALL); Model Catalog: 3386118Q (Lot serial: ALL); Model Catalog: 3396355 (Lot serial: ALL); Model Catalog: 3396335 (Lot serial: ALL); Model Catalog: 3395335Q (Lot serial: ALL); Model Catalog: 3395355Q (Lot serial: ALL); Model Catalog: 9396118 (Lot serial: ALL); Model Catalog: 9395118Q (Lot serial: ALL); Model Catalog: 9295118 (Lot serial: ALL); Model Catalog: 9194118 (Lot serial: ALL); Model Catalog: 1386118 (Lot serial: ALL); Model Catalog: 1385118Q (Lot serial: ALL); Model Catalog:
  • Product Description
    STATLOCK - IV;POWERPICC SV CATHETER W/SHERLOCK 3CG TPS STYLET BASIC TRAY;POWERPICC SOLO CATHETER SL SS GUIDEWIRE;POWERPICC CATHETER SHORT TAPER SHERLOCK TLS;POWERPICC CATHETER SHORT TAPER MICROEZ;POWERPICC SOLO CATHETER TL NITINOL GUIDEWIRE;POWERPICC SOLO
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.