Events

Recall of Baxter Self-Righting Luer Slip Tip Cap, Yellow

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Baxter Healthcare 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
    18088
  • Event Initiated Date
    2015-02-11
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Baxter Healthcare Ltd, 33 Vestey Drive, Mt Wellington, AUCKLAND
  • Reason
    Baxter healthcare identified that self-righting luer slip and luer lock tip caps in the discpac packaging were manufactured and shipped with inaccurate single and case labels, missing the latex symbol. the heat shrink tape used on the discpac package is the only product component that contains latex. the instructions for use (ifu) correctly identifies the content of latex.
  • Action
    Instructions for use to be updated

Device

Baxter Self-Righting Luer Slip Tip Cap, Yellow
  • Model / Serial
    Model: Product Code: H93866025, Affected: All lots. Expiration Date: 10/2014 to 10/2017
  • Manufacturer
    Baxter Healthcare Corporation

Manufacturer

Baxter Healthcare Corporation