Events

Alerte Ou Avis De Sécurité sur Receptal suction canisters and liners

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Hospira (formerly manufactured by Abbott).

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2013/077
  • Numéro de l'événement
    CON330878
  • Date
    2013-10-31
  • Date de publication de l'événement
    2013-10-31
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON330878?tabName=allTabs
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    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)
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    MHRA