Events

Recall of RAPIDLyte Arterial Blood Sampling Line Draw Syringes3 mL Line Draw, 70 IU, Aspirating, L/L

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Ltd Diagnostics Division.

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
    RC-2013-RN-01310-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-12-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01310-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Siemens is advising of an issue with rapidlyte arterial blood syringes when used with radiometer brand blood gas analysers. the plunger tip in the rapidlyte 3ml arterial draw line does not remain stationary when the probe of the analyser extends into the syringe. this can result in difficulties aspirating the sample or the plunger may get pushed out of the syringe.
  • Action
    Siemens is advising their customers to cease using RAPIDLyte syringes on Radiometer Blood Gas systems. The syringes can continue to be used on any Siemens Blood Gas Analysers.

Device

RAPIDLyte Arterial Blood Sampling Line Draw Syringes3 mL Line Draw, 70 IU, Aspirating, L/L
  • Model / Serial
    RAPIDLyte Arterial Blood Sampling Line Draw Syringes3 mL Line Draw, 70 IU, Aspirating, L/LReference number: 04180028Siemens Part Number: 103202963 mL Line Draw, 21 IU, Aspirating, L/LReference number: 06194484Siemens Part Number: 103239253 mL Line Draw, 70 IU, Aspirating, L/LReference number: 06380806Siemens Part Number: 104909663 mL Line Draw, 70 IU, Aspirating, L/SReference number: 00355281Siemens Part Number: 10313293Multiple lot numbers affected
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA