Events

Recall of Siemens RAPIDLyte Arterial Blood Sampling Line Draw Syringes

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Smiths Medical ASD 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
    15856
  • Event Initiated Date
    2013-12-23
  • 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: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Reason
    The manufacturer has identied an issue with the abl syringes when used with radiometer brand blood gas analysers. the plunger tip in the abl syringe does not remain stationary when the probe of the analyzer extends into the syringe. this can result in difficulties aspirating the sample or the plunger may get pushed out of the syringe.
  • Action
    Manufacturer to issue advice regarding use

Device

Siemens RAPIDLyte Arterial Blood Sampling Line Draw Syringes
  • Model / Serial
    Model: Catalogue Numbers: 04180028, 00355281, 06194484, 06380806, Affected: Various lots
  • Manufacturer
    Smiths Medical ASD Inc

Manufacturer

Smiths Medical ASD Inc