Events

Alerte De Sécurité sur Sponge, Gauze: 2 x 2 inches 4-folds (1) MIRASORB, (2) NU GAUZE General use. Product Codes: (1) 602318, (2) 2338; Lots No (1) 2001 10 1 to 2001 10 3, (2) 2001 10 10 to 2001 10 3, 2001 10 A to 2001 10 D; units distributed during October 2001.

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 Johnson 740 Johnson Medical Inc A Division of Ethicon.

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
    403
  • Date
    2002-02-22
  • 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
    Some of the above gauze packets are improperly packed, which can potentially result in loss of sterility. due to the potential lack of integrity of the package, the manufacturer voluntarily initiated the correction by letter dated 26 october 2001 and on 10 december 2001.
  • Action
    Please verify that you have received the letter dated October 26, 2001 and December 10, 2001, UPS Shipping / Receiving Card. Identify and remove any product with the batch number above your inventory. Complete the pre-posted response card, attach the card with the affected product, and ship the product to Johnson 751 Johnson. You can receive credit for all returned material or receive product replacement by checking the appropriate line on the prepaid return / remittance card. For incomplete boxes, only credit may be requested. If you do not have any affected products, check the appropriate line on the prepaid shipping / return card, and return the card to Johnson 751 Johnson by mail at the address below, or fax to (1903) 891-6188. For more information, or to receive extra shipping labels, contact Johnson 751 Johnson or your local representative. For more information, contact the ANVISA Technovigilance Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485

Device

Sponge, Gauze: 2 x 2 inches 4-folds (1) MIRASORB, (2) NU GAUZE General use. Product Codes: (1) 60...

Manufacturer

Johnson 740 Johnson Medical Inc A Division of Ethicon
  • Source
    ANVSANVISA