Events

Recall of ONE LINK NON-DEHP MICROBORE CATHETER EXTENSION SET BONDED NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT POWER INJECTABLE

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
    73374
  • Event Risk Class
    II
  • Event Initiated Date
    2014-11-26
  • 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 corporation is notifying customers of an incompatible product that should not be used with specific one-link devices. customers have reported no-flow and restricted flow situations when attempting to connect the microclave device to the male luer lock adapter of the one-link catheter extension set in product code 7n8371. baxter's investigation has determined that the microclave dimensions are not compatible with the iso-compliant male luer lock adapter dimensions of the affected one-link product codes. under-infusion or interruption of therapy could result.

Device

ONE LINK NON-DEHP MICROBORE CATHETER EXTENSION SET BONDED NEEDLE-FREE IV CONNECTOR WITH NEUTRAL F...
  • Model / Serial
    Model Catalog: 7N8390 (Lot serial: ALL LOTS); Model Catalog: 7N8300 (Lot serial: ALL LOTS); Model Catalog: 7N8371 (Lot serial: ALL LOTS)
  • Product Description
    BONDED ONE-LINK NON-DEHP MICROBORE SETS
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION