Events

Alerte De Sécurité sur Strykeflow Suction Irrigator II Irrigators. Parts No. 250-070-500; Lots Nos .: 00065812 and 0065832

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Stryker Endoscopy Div Stryker Corp.

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
  • ID de l'événement
    240
  • Date
    2000-12-22
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    The primary blister packaging of the mentioned units may have cracks that may compromise the sterility of the product. the manufacturer initiated a telephone recall on june 28, 2000 and by mail dated august 25, 2000.
  • Action
    Make sure that you have received the Medical Equipment Removal Notification correspondence dated August 25, 2000 and the Stryker Endoscopy Knowledge Receipt. Identify and isolate any affected product from your inventory. Return any affected product with return authorization, at no additional cost, to Stryker Endoscopy by mail at the above address. Contact your local representative or directly with the Stryker Endoscopy Customer Service Center by phone to receive a return authorization. Stryker Endoscopy states that upon receipt of the Receipt of Knowledge, it will automatically begin shipping the replacement product. Sign and complete the Knowledge Receipt and send it to Stryker Endoscopy by mail at the above address or by fax at 1 (408) 567-2505. For more information, contact your local representative or directly with Judy Toste, Stryker Endoscopy, by mail at the above address or fax 1 (408) 567-2505

Device

Strykeflow Suction Irrigator II Irrigators. Parts No. 250-070-500; Lots Nos .: 00065812 and 0065832

Manufacturer

Stryker Endoscopy Div Stryker Corp
  • Source
    ANVSANVISA