Avis De Sécurité sur Capio SLIM Open Access suture collection unit Capio SLIM Open Access suture collection unit (Box 5), Capio Open Access suture collection unit (Box 4), Capio Value suture collection unit (Box 4), Capio RP suture collection unit, uphold LITE Capio SLIM vaginal support system, Pinnacle repair kit for the anterior pelvic Pinnacle LITTLE posterior with Capio SLIM repair kit for the pelvic floor

Selon Swedish Medical Products Agency, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Sweden qui a été fabriqué par Boston Scientific Corporation.

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

Device

Manufacturer

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    SMPA