Events

Alerte Ou Avis De Sécurité sur Stopcocks (catalogue numbers W20058 and W21372) and specific products containing non-lipid resistant stopcocks

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 Arrow® International.

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/2009/047
  • Numéro de l'événement
    CON052020
  • Date de publication de l'événement
    2009-07-27
  • 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/CON052020?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
    Risk of leakage or air embolism due to hub cracking at the female luer connector during delivery of infusions containing lipids.Teleflex medical has determined that the material used in the manufacture of these stopcocks is not lipid resistant and could be weakened during the administration of lipid solutions. these stopcocks, and the kits containing them, should be used only to administer non-lipid containing solutions. teleflex originally issued a field safety notice (fsn) in march 2009 that highlighted these risks. however, the sample product label in this fsn carried an extra warning not to use 70% isopropyl alcohol on the stopcocks. after further testing, teleflex has determined that these stopcocks (distributed in the united kingdom) can in fact be wiped with 70% isopropyl alcohol solutions without harmful effects. as a consequence, teleflex has now issued an amended fsn in july 2009 with a revised product label.This medical device alert has been issued due to the widespread use of these stopcocks and to ensure that all users are aware of this amended field safety corrective action.

Device

Stopcocks (catalogue numbers W20058 and W21372) and specific products containing non-lipid resist...
  • Modèle / numéro de série
  • Description du dispositif
    Stopcocks (catalogue numbers W20058 and W21372) and specific products containing non-lipid resistant stopcocks, manufactured by Arrow® The stopcocks are manufactured by Arrow® International, which is a subsidiary of Teleflex Medical. Product codes AH-05050-G, AI-07077-G, AH-05050-PU, AI-07077-PU (regardless of batch number) contain non-lipid resistant stopcocks.  Only product codes with batch numbers ZFxxxxxxx contain lipid resistant stop cocks. This is summarised in the table below: Product codes Lipid resistant batches Non-lipid resistant batches AH-05050-G None All AH-05050-PU AI-07077-G AI-07077-PU All product codes listed in Appendix A of the Field Safety Notice Lot numbers beginning with the letter ZF and followed by seven digits, e.g. ZFxxxxxxx. All other Lot numbers
  • Manufacturer
    Arrow® International

Manufacturer

Arrow® International