Events

Avis De Sécurité sur curettes (flexible and rigid), uterine dilators (e.g. Laminaria), endometrial sampling sets, fetal blood samplers, fetal bladder drains, laparoscopy accessories, bone marrow needles, aspiration sets, biopsy pipettes, and harvesting pumps used in in-vitro fertilization

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par A & A 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
    Field Safety Notice
  • Numéro de l'événement
    SN2002(03)
  • Date
    2002-06-13
  • 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=/a-a-products&id=d19af825-9782-6eee-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
    Fda is alerting consumers and health care professionals of a nationwide/international recall of all medical devices labelled as sterile or ethylene oxide processed, manufactured by a&a of alpharetta, georgia.  the firm also does business as a&a medical/rocket usa, and lifequest.  some of the products manufactured by this company have been labelled and shipped as sterile but in fact may not have undergone any sterilization process.  this has the potential of causing death or serious injury such as infection, infertility, and miscarriage.  as a result, the company is recalling all products labelled as sterile and shipped nationwide and internationally to canada, egypt, italy and lebanon.
  • Action
    Do not use any A & A Medical, Inc., Rocket USA, or Lifequest products. Please ensure that those responsible for the purchase of these devices are made aware of this issue.

Device

curettes (flexible and rigid), uterine dilators (e.g. Laminaria), endometrial sampling sets, feta...
  • Modèle / numéro de série
  • Description du dispositif
    A&A; Products
  • Manufacturer
    A & A Medical

Manufacturer

A & A Medical
  • Source
    HPRA