Events

Alerte Ou Avis De Sécurité sur Safety blood collection and infusion sets

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 Greiner Bio-One.

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/2013/047
  • Numéro de l'événement
    CON287019
  • Date
    2013-06-27
  • Date de publication de l'événement
    2013-06-27
  • 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/CON287019?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 of blood or infusion fluid, or under-filling of evacuated blood collection tubes or blood culture bottles. this product is being recalled due to potential cracking of the luer connector on these devices.
  • Action
    Identify and quarantine affected products. Greiner Bio-One issued a Field Safety Notice (FSN) in March 2013 recalling affected products. Confirm receipt of the FSN to Greiner Bio-One and arrange for the return and replacement of unused affected devices.

Device

Safety blood collection and infusion sets
  • Modèle / numéro de série
  • Description du dispositif
    Safety blood collection and infusion sets. Various item and lot numbers. The affected devices are illustrated below.  The area where the crack may occur is circled.  A list of the affected item codes and lot numbers are provided in the FSN .  The NHS Supply Chain codes (England only) corresponding to the manufacturer’s item codes are given as below. Safety infusion sets Greiner Bio-One code NHS supply chain code LOT numbers 450092 KFK 024 12H23 Safety blood collection sets with Luer adapter Greiner Bio-One code NHS supply chain code LOT numbers 450081 KFK 134 12H23, 12H24, 12I17, 12I26, 12H30 450082 KFK 136 12H21, 12H22, 12H30 450083 none 12I16 450084 none 12H29 450095 KFK 302 12H19, 12I22 450099 none 12H26 Safety blood collection sets with Luer adapter and holder Greiner Bio-One code NHS supply chain code LOT Numbers 450086 KFK 138 12H28, 12H25, 12H27, 12I26, 12I24, 12I25 Safety blood collection sets with blood culture holder Greiner Bio-One code NHS supply chain code LOT Numbers 450182 KFK 416 12H21, 12H30, 450184 KFK 418 12H22, 12H23, 450185 KFK 419 12H24, 12H23, 12I20
  • Manufacturer
    Greiner Bio-One

Manufacturer

Greiner Bio-One