Events

Recall of ARGON Bone Marrow I-type aspirate/biopsy needles & ARGON Trap-Lok Bone Marrow biopsy needles

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Culpan Medical Pty Ltd.

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-2015-RN-00541-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00541-1
  • 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
    Some of these products may have a hole in the blister pack, which may compromise the sterility of the product inside the tray. invasive medical procedures conducted using non-sterile products could result in an infection for the patient. to date, there have been no reports of patient harm or infection attributed to this issue.
  • Action
    Customers are asked to check their inventory and place affected stock into quarantine. Culpan Medical will arrange to have quarantined stock collected. Unaffected products are available to replace any returned units. This action has been closed-out on 08/08/2016.

Device

ARGON Bone Marrow I-type aspirate/biopsy needles & ARGON Trap-Lok Bone Marrow biopsy needles
  • Model / Serial
    ARGON Bone Marrow I-type aspirate/biopsy needles & ARGON Trap-Lok Bone Marrow biopsy needlesProduct codes: BMHN1304VX, DBMNI1501, DBMNI1601, DBMNJ0804TL, DBMNJ1104TL, DBMNI1601Lot Numbers: 11095380, 11095842, 11098707, 11089370, 11096115, 11088295, 11094182, 11088597, 11090527ARTG Number: 223222
  • Manufacturer
    Culpan Medical Pty Ltd

Manufacturer

Culpan Medical Pty Ltd