Events

Recall of CARESITE LUER ACCESS DEVICE

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
    47582
  • Event Risk Class
    III
  • Event Initiated Date
    2013-10-16
  • 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
    B. braun medical inc. (bbmi) has identified the instruction for use (ifu) on the caresite luer access device (product 415128) exhibits translated instructions in the incorrect section and/or partially missing translation instructions. specifically the french section is primarily spanish and the spanish section is primarily italian. it should be noted all other content information including the warning section is translated correctly and accurate on the ifu. at this time no patient harm or adverse impact has been noted as a result of this issue.

Device

CARESITE LUER ACCESS DEVICE
  • Model / Serial
    Model Catalog: 415128 (Lot serial: 0061254182); Model Catalog: 415128 (Lot serial: 0061254309)
  • Product Description
    Caresite Luer Access Device
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

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