Events

Alerte De Sécurité sur Product name: RENASYS G - NEGATIVE PRESSURE THERAPY KIT Technical name: Healing ANVISA Registration Number: 80804050015 Hazard Class: III Affected Model: 66800494 - Renasys G Medium Drain Flat Kit and 66800496 - Renasys G Large Flat Drain Kit Numbers Affected lots 00815N, 01214G, 02214J, 05014F, 09014K, 09914K, 16014F, 17514T, 24114D, Affected batches Affected batches: 25214K, 28015M, 31714H.

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 Smith & Nephew Comércio de Produtos Médicos Ltda.; Smith & Nephew, Inc. Wound Management.

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
    2176
  • Date
    2016-08-19
  • 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
    Users are instructed to immediately check the RENASYS Sterile Transparent Film Part Number and Batch Number and RENASYS Clear Gauze Kits that contain the RENASYS Clear Film. Users are instructed to quarantine all RENASYS Transparent Films and RENASYS Gauze Dressing Kits that contain the affected RENASYS Transparent Folded Film. Users are instructed to return to Smith & Nephew all RENASYS Transparent Film and RENASYS Gauze Dressing Kits which contain the RENASYS Transparent Folded Film affected. Users should contact Smith & Nephew to coordinate any product replacement. Smith & Nephew will make every effort to provide replacement product. Users should ensure that this safety information is brought to all those who need to be aware of this information in their organization. Users should be kept informed of this warning and their resulting actions for the appropriate period to ensure effective remedial action.
  • Cause
    Voluntary field security corrective action (acsc) related to renasys sterile transparent film and renasys dressing kits which contains the renasys transparent film folded. the folded renasys clear film is used with the gaze healing kits and should be used in conjunction with smith & nephew's negative pressure wound therapy (npwi). smith & nephew has identified defects in the integrity of the internal packaging of renasys sterile transparent film folded during traffic tests. all sealing integrity failures identified during the test occurred at the time the internal packaging of renasys sterile transparent film was folded during the product packaging process. smith & nephew has identified that the folding process of renasys sterile transparent film inside packaging during packaging may damage the internal packaging seal, thus invalidating the sterilization of the product. a non-sterile product may contribute to a local infection.
  • Action
    Field Action Code 002/2016 triggered under the responsibility of Smith & Nephew Comércio de Produtos Médicos Ltda. Company will collect.

Device

Product name: RENASYS G - NEGATIVE PRESSURE THERAPY KIT Technical name: Healing ANVISA Registrati...

Manufacturer

Smith & Nephew Comércio de Produtos Médicos Ltda.; Smith & Nephew, Inc. Wound Management