Events

Avis De Sécurité sur MINISEND-LUER LOCK CAP

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Sendal S.L..

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
    Field Safety Notice
  • Numéro de l'événement
    SN201401
  • Date
    2014-02-11
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/minisend-luer-lock-cap&id=3579f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Notes supplémentaires dans les données
  • Cause
    A potential fault has been identified with the sealing of the primary packaging (blister) of the minisend luer lock cap, leading to a possible loss of sterility of the product. not all units are affected, only those with a small sealing surface.  the manufacturer has confirmed that devices on the irish market, with product reference codes tp-mf and tp-mf-a are affected by this action. refer to attached field safety notice (fsn).
  • Action
    Sendal S.L. requires that users check their inventory and quarantine all affected products/lots. In the absence of an alternative, it is recommended that users verify the integrity of the packaging and do not use units where the sealing appears defective.  Sendal requires that users return completed verification forms for this action to the Sendal representative.  The IMB recommends that users forward this safety notice to all those who need to be aware of this action within your organisation and to maintain awareness over this safety notice for an appropriate time period.

Device

MINISEND-LUER LOCK CAP
  • Modèle / numéro de série
  • Description du dispositif
    MINISEND-LUER LOCK CAP
  • Manufacturer
    Sendal S.L.

Manufacturer

Sendal S.L.