Events

Safety Alert Or Field Safety Notices for Suction canisters and liners, Receptal system

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/2013/026
  • Event Number
    CON270677
  • Date
    2013-05-01
  • Event Date Posted
    2013-05-01
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON270677?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 failure or loss of suction. due to a number of customer complaints, hospira has issued a field safety notice (dated 12 april 2013) to recall all 1 litre devices and instruct customers to seek alternatives. the mhra is not confident that hospira has sufficient alternative stock available to supply the demand during a recall. the vacuum needed to create the suction cannot be created if the hard canister and the single-use liner are not properly seated during use, or if the liner separates from the canister during use. hospira has not yet identified the root cause of this failure. an investigation is ongoing. hospira cannot guarantee that the pre-use checks (listed below) will identify all defective units. therefore, a unit could pass the pre-use checks and still fail during use.
  • Action
    Identify affected devices. Ensure that users are aware of the manufacturer’s Field Safety Notice. Seek alternative devices immediately and return affected devices to the manufacturer. Until alternative devices are available: Perform pre-use checks (see below).  If defective units are identified, remove from use. Exercise caution in use as failure can occur despite the pre-use checks. Ensure that a back-up suction device is available at all times. Until alternatives are made available, the following pre-use checks should be carried out: During assembly, check the underside of the liner lid to ensure that the liner is not misaligned and there is a flush connection. Verify that the correct vacuum pressure can be achieved and that there is no loss of suction.

Device

Suction canisters and liners, Receptal system
  • Model / Serial
  • Product Description
    Suction canisters and liners. All Receptal: 1 litre canisters (List number 43449), 1 litre PVC liners (List number OL212) and 1 litre PE liners (List number OL213). All batch numbers are affected. The Receptal system is a closed, disposable suction system that is used to isolate suction waste. It is used with adult, paediatric and neonatal patients.
  • Manufacturer
    Hospira (formerly manufactured by Abbott)

Manufacturer

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