Events

Recall of STERILE TRAM PACK

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARDINAL HEALTH 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
    136968
  • Event Risk Class
    II
  • Event Initiated Date
    2000-08-17
  • 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
    These products contain clinipad antiseptic components that are subject to a world wide recall because of possible microbial contamination in some lot numbers.

Device

STERILE TRAM PACK
  • Model / Serial
    Model Catalog: SBA30TRWCA (Lot serial: 250066 263464 269363); Model Catalog: SCV30CRRCB (Lot serial: 261751 265480); Model Catalog: SBA30MJWCC (Lot serial: 230732 295602 301472); Model Catalog: SBA30MJXXX (Lot serial: 230732 295602 301472); Model Catalog: SBA30MJWCC (Lot serial: 310252 320543 333712); Model Catalog: SBA30MJXXX (Lot serial: 310252 320543 333712); Model Catalog: SBA30MJWCC (Lot serial: 344959 356167.); Model Catalog: SBA30TRXXX (Lot serial: 401439 406373.); Model Catalog: SBA30TRWCA (Lot serial: 401439 406373.); Model Catalog: SBA30TRXXX (Lot serial: 353655 375610 385204); Model Catalog: SBA30TRWCA (Lot serial: 353655 375610 385204); Model Catalog: SBA30TRXXX (Lot serial: 337574 341751 350393); Model Catalog: SBA30TRWCA (Lot serial: 337574 341751 350393); Model Catalog: SBA30TRXXX (Lot serial: 208273 321546 333246); Model Catalog: SBA30TRWCA (Lot serial: 208273 321546 333246); Model Catalog: SBA30TRXXX (Lot serial: 280365 286162 292841); Model Catalog: SBA30TRWCA (Lot serial: 280365 286162 292
  • Product Description
    STERILE TRAM PACK
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    HC