Events

Alerte De Sécurité sur Soluset 100 Burette IV Set

Selon Food and Drug Administration Philippines, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Philippines qui a été fabriqué par Hospira de Costa Rica Ltd..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Numéro de l'événement
    2013-048
  • Pays de l'événement
    Philippines
  • Source de l'événement
    FDAP
  • URL de la source de l'événement
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/119167-fda-advisory-no-2013-048
  • Notes / Alertes
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, 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 Philippines.
  • Notes supplémentaires dans les données
  • Cause
    Fda advisory no. 2013-048 quality hold on soluset tm 100 burette iv (intravenous) set imported by hospira philippines, inc.  in the interest of public health and safety, the food and drug administration (fda) and hospira philippines, inc. will jointly undertake a quality hold of the product solusettm 100 burette iv (intravenous ) set, with its clamp and secure lock.  hospira philippines, inc., as part of their due diligence responsibility, will do a quality check on solusettm 100 burette iv (intravenous) set found in the market, specifically those with batch numbers 1707456 and 1707856. solusettm 100 burette iv (intravenous) set is manufactured by hospira de costa rica ltd., costa rica and registered in the philippines with fda registration no. dvr-2362. all consumers and health professionals are advised not to use the said batches of solusettm 100 burette iv (intravenous) set until such time that the fda and hospira philippines, inc. shall have issued an advisory that the quality hold has been lifted.  likewise, distributors and drug outlets are ordered to remove the stocks from their shelves and hold the said stocks until the fda and hospira philippines, inc. shall have conducted the quality check.  for inquiries, email us at this email address is being protected from spambots. you need javascript enabled to view it. . for strict compliance of all concerned. attachments: fa2013-048 - quality hold on soluset 100 burette iv set imported by hospira phil.

Device

Soluset 100 Burette IV Set

Manufacturer

Hospira de Costa Rica Ltd.
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    FDAP