Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Smith & Nephew Comércio de Produtos Médicos Ltda.; Smith & Nephew, Inc. Wound Management.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2176
  • Date
    2016-08-19
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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