Events

Recall of IV EXTENSION SET

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
    132388
  • Event Risk Class
    III
  • Event Initiated Date
    2010-09-07
  • 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
    Baxter has identified a labeling issue affecting all lots of extension sets 2n3347 and 2n3350 whereby the product configuration and label illustration have the slide clamp above the filter but the written instructions tell the user to close the clamp below filter when set is not in use. the current clamp configuration could result in the unintended fluid administration of approximately 0.2ml.

Device

IV EXTENSION SET
  • Model / Serial
    Model Catalog: 2N3347 (Lot serial: UE103267); Model Catalog: 2N3350 (Lot serial: UR09F04083); Model Catalog: 2N3350 (Lot serial: UR09E12013); Model Catalog: 2N3350 (Lot serial: UR192179X); Model Catalog: 2N3350 (Lot serial: UR242057); Model Catalog: 2N3350 (Lot serial: UR07I25092); Model Catalog: 2N3350 (Lot serial: UR261362); Model Catalog: 2N3350 (Lot serial: UR08B04109); Model Catalog: 2N3350 (Lot serial: UR08B09058); Model Catalog: 2N3350 (Lot serial: UR253450)
  • Product Description
    MICRO-VOLUME EXTENSION SETS WITH FILTER
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION