Events

Alerte Ou Avis De Sécurité sur Hudson RCI nebulizer adaptors and Aquapak sterile water with nebulizer adaptors

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 Teleflex Medical.

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/2014/042
  • Numéro de l'événement
    CON471141
  • Date
    2014-11-03
  • Date de publication de l'événement
    2014-11-03
  • 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/CON471141?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
    The packaging of these devices might not be sealed properly. however, the adaptors are used as part of a non-sterile system, so there is minimal risk of infection to patients. teleflex sent an amended field safety notice (dated 19 september 2014) to its customers recalling affected products but hasn’t had enough replies to know that users have received and acted on this information.
  • Action
    Identify and quarantine the affected devices using the codes in the FSN. Return affected devices and arrange for replacements from Teleflex. Return the acknowledgement form to the manufacturer.

Device

Hudson RCI nebulizer adaptors and Aquapak sterile water with nebulizer adaptors
  • Modèle / numéro de série
  • Description du dispositif
    Hudson RCI © nebulizer adaptors and Aquapak sterile water with nebulizer adaptors. Specific product and lot numbers. Check Appendix 2 of the FSN for the full list of affected product codes. If relevant to you, the national supply codes are as follows: England NPC: NHS Supply chain code Manufacturer’s part number Product description FDE115 4044-28 AQUAPAK 428 SW,440 ML W/028 ADAPTOR,INTL FDE130 403128 ADAPTOR,028 NEB,INTL FDE369 403728 AQUAPAK 728 SW,760 ML W/028 ADAPTOR,INTL FDE384 404128 AQUAPAK 1028 SW,1070 ML W/028 ADAPTOR,IN Northern Ireland: The products identified in the FSN are not on regional contract within Northern Ireland but may have been acquired as non-stock items. Scotland SKU: Supply chain code Manufacturer’s part number Product description 031498 403128 ADAPTOR, 028 NEB, INTL
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical