Events

Safety Alert Or Field Safety Notices for Receptal suction canisters and liners

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Hospira (formerly manufactured by Abbott).

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2013/077
  • Event Number
    CON330878
  • Date
    2013-10-31
  • Event Date Posted
    2013-10-31
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON330878?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Potential for failure or loss of suction if a canister and liner of different sizes are used in combination. due to a number of customer complaints, hospira has issued a field safety notice (dated 6 september 2013) to advise customers of appropriate use and combination of liners and canisters. the mhra is not confident that hospira has been able to reach all affected customers.
  • Action
    Identify affected devices. Ensure that the correctly sized liner is used with the canister. Obtain a copy of the revised instructions for use from Hospira when this is made available. Use only Receptal liners with Receptal canisters in the following combinations: 1.5 litre liner with a 1.5 litre canister 2 litre liner with a 2 litre canister 3 litre liner with a 3 litre canister Please note that all 1 litre liners and canisters have been recalled. See MDA/2013/048 for further information.

Device

Receptal suction canisters and liners
  • Model / Serial
  • Product Description
    Receptal suction canisters and liners. All Abbott and Hospira list numbers are affected. All lot numbers and sizes are affected. This is a closed, disposable system that is used to isolate suction waste. It is used with adult, paediatric and neonatal patients. Hospira has only been able to provide the Abbott list numbers for the 1 litre liners and canisters.
  • Manufacturer
    Hospira (formerly manufactured by Abbott)

Manufacturer

Hospira (formerly manufactured by Abbott)
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    MHRA