Events

Alerte Ou Avis De Sécurité sur Receptal 1 litre canisters, 1 litre PVC liners, 1 litre PE 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/2013/048
  • Numéro de l'événement
    CON289464
  • Date
    2013-07-02
  • Date de publication de l'événement
    2013-07-02
  • 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/CON289464?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 loss of suction. hospira has issued an updated field safety notice (dated 7 june 2013) to extend the recall of 1 litre devices to those marked with abbott labels, and to instruct customers to seek alternatives.  this mda is an extension of mda/2013/026 published in may 2013 to include these additional devices. the vacuum needed to generate 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. hospira is unable to trace customers who purchased products marked with abbott labels.
  • Action
    Identify affected devices. Ensure that users are aware of the manufacturer’s updated 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 must 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

Receptal 1 litre canisters, 1 litre PVC liners, 1 litre PE liners
  • Modèle / numéro de série
  • Description du dispositif
    Update to MDA/2013/026 Recall of Hospira 1 litre suction canisters and liners - additional products recalled. Suction canisters and liners with Abbott labels and list numbers are now included in the recall. One litre suction canisters - Abbott list number 770462. One litre suction liners - Abbott list numbers L212A52 and L213A52. All batch numbers are affected. The affected products are part of a closed, disposable suction system that is used to isolate suction waste.  They are used for adult, paediatric and neonatal patients. Hospira has issued an updated Field Safety Notice (dated 7 June 2013) to extend the recall detailed in MDA/2013/026 , to include 1 litre devices supplied under the legacy Abbott model numbers. The Abbott labelled products are no longer in production, but may still be in stock. The Abbott and Receptal products are manufactured to the same design and both are, therefore, affected.  To clarify, the full list of devices affected by this problem is: Receptal 1 litre canisters (List number 43449), previously marketed as Abbott 1L suction canisters (List number 770462) Receptal 1 litre PVC liners (List number OL212), previously marketed as Abbott 1L suction liners (List number L212A52) Receptal 1 litre PE liners (List number OL213), previously marketed as Abbott 1L suction liners (List number L213A52).
  • Manufacturer
    Hospira (formerly manufactured by Abbott)

Manufacturer

Hospira (formerly manufactured by Abbott)
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    MHRA