Events

Alerte De Sécurité sur Central venous access kits MAC 2-Lumen with long obturators .. Catalog number: (1) AK-11142, (2) SI-11142; Lot. Numbers: (1) RF1020751, RF1031739, RF1031850, RF1033089, RF1043328, RF1044374; (2) RF0126277, RF1031741, RF1043329.

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 Arrow International Inc.

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
    244
  • Date
    2001-09-28
  • 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 above sets may leak fluid or air when the long obturator is inserted into the hemostasis valves. assemblies distributed after may 31, 2001 have a shorter shutter and are risk free. the manufacturer initiated the removal by means of a letter dated july 23, 2001.
  • Action
    Check receipt of the letter dated July 23, 2001 from the manufacturer Arrow International. Identify and isolate any affected product in inventory. Return any affected product to the above address to the care of Scott Carlisle, Quality Control Manager, Arrow International. The freight of the products will be free. The product exchange will be automatically posted at no cost upon presentation of return receipts. For further clarification or adjustments, please contact your local representative or telephone (610) 378-0131 (calls from outside the United States ).

Device

Central venous access kits MAC 2-Lumen with long obturators .. Catalog number: (1) AK-11142, (2) ...

Manufacturer

Arrow International Inc
  • Source
    ANVSANVISA