Events

Recall of Medline Cardiac Pack (which includes Edwards LifeSciences Suction Wand)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medline International Two Australia 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-2013-RN-00706-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-07-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00706-1
  • 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
    Edwards lifesciences has notified medline that they are conducting a recall of certain lot numbers of the edwards lifescience suction wand, which is included in medline's cardiac pack. edwards discovered plastic particulate inside the sterile pouch and within the internal diameter of the rigid suction wands. the particulate ranged from 0.26 to 0.41 (6.6 to 10.4mm) in size. particulate not detected during the preparation of the device may pose a risk as it may enter into the pericardium and could cause abrasions to the surface of the heart.
  • Action
    Customers are asked to inspect all inventory and return affected packs to Medline.

Device

Medline Cardiac Pack (which includes Edwards LifeSciences Suction Wand)
  • Model / Serial
    Medline Cardiac Pack (which includes Edwards LifeSciences Suction Wand) Product Code: SCVPEMO01H (which includes Suction Wand Model Code: S099)Lot Numbers: CS1273342, CS1274530, CS1275921, CS1276983, CS1277145, CS1279180, CS1279527, CS1381863, CS1381982, CS1383487, CS1384082, CS1384586 and CS1385127ARTG Number: 136870
  • Manufacturer
    Medline International Two Australia Pty Ltd

Manufacturer

Medline International Two Australia Pty Ltd