Events

Recall of Receptal System Liners and Canisters

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

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-2014-RN-00509-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-05-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00509-1
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
  • Reason
    Through customer complaints, hospira has become aware of customers using the incorrect size receptal liners with their receptal canisters, e.G., 2l liner or 3l liner with a 1.5l canister, which has resulted in a report of one death to date. there have been no reports of death or serious injury in australia. it is possible that if an incorrectly sized liner is used with a different size canister the lid may not fit and the vacuum/suction will not be sufficient and/or consistent. hospira advises users to not use incorrectly sized receptal liners with receptal canisters. all receptal liner and canister list numbers are affected by this action.
  • Action
    Hospira is advising hospitals to only use the correct size liners are used with the corresponding canister and to ensure that the liner is fully extended in the liner.

Device

Receptal System Liners and Canisters

Manufacturer

Hospira Pty Limited
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    DHTGA