Events

Recall of MiniCap with Povidone-Iodine Solution

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Baxter Healthcare 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-00058-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-01-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00058-1
  • 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
    Baxter received complaints indicating that the iodine sponge of the minicap was fully separated from the cap, partially protruding from the cap, or missing.This may give rise to infusion of micro-organisms or by-products of microbes or other foreign materials into the peritoneal cavity, which may lead to bacterial or fungal peritonitis and/or infusion of inert foreign material into the peritoneal cavity which may lead to tissue injury or peritoneal membrane injury.These events are considered as catastrophic, however, the likelihood of this occuring has been calculated by the manufacturer as improbable (less than one in one million chance).
  • Action
    Users are advised to inspect the product to ensure there is no damage to the MiniCap and that the sponge is fully within the cap. Do not use the product if the sponge is protruding or missing from the cap, and obtain a new MiniCap. For further information please see https://www.tga.gov.au/alert/minicaps-povidone-iodine-solution-used-peritoneal-dialysis.

Device

MiniCap with Povidone-Iodine Solution

Manufacturer

Baxter Healthcare Pty Ltd