Events

Recall of 1000mL Receptal System (waste disposable suction system)

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-2013-RN-00413-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-05-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00413-1
  • 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
    Hospira have received customer reports where the 1000ml receptal system is not achieving vacuum and/or improper fit of the pvc liner.
  • Action
    Hospira is advising their customers to quarantine all 1000mL Receptal System units and use an alternative Receptal Liner (1500 mL or 2000 mL). If alternative devices are not available Hospira has provided work around instructions to reduce the safety risk to patients due to any reduction or failure of vacuum.

Device

1000mL Receptal System (waste disposable suction system)
  • Model / Serial
    1000mL Receptal System (waste disposable suction system)Canister 1000 mLInventory number: 434490411List number: 43449 PVC Liner 1000 mLInventory number: 0L2129701List number: L212A52
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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