Events

Safety Alert for KIMBERLY-CLARK STERILE SURGICAL CLOTHING MODEL: EXTRA GRAND ULTRA-REINFORCED APRON. Registro Anvisa n ° 80357219002. Affected lots: all lot numbers starting with: AH9284 *** a AH9356 ***; AH0007 *** a AH0356 ***; AH1008 *** to AH1364 ***; AH2006 *** to AH2146 ***.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Kimberly-Clark Brasil Indústria e Comercial de Produtos de Higiene Ltda..

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
    1198
  • Date
    2012-11-12
  • 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
    Check for additional information in the Kimberly-Clark Customer Letter document. The document is available at http://portal.anvisa.gov.br/wps/wcm/connect/496126804d6f9bcdbea8ffc116238c3b/Carta_ao_Cliente_1198.pdf?MOD=AJPERES. The Technovigilance Unit is following up on this case.
  • Reason
    Primary packaging of the product may be open, which compromises its sterility.
  • Action
    The product in question is being collected by the registration holder. If you have any affected product, segregate it (identify it appropriately to avoid inadvertent use), and contact the company to report the fact through the Product Field Action Response Form. The form and the contact phone number of the company are available in the Letter to Customers document.

Device

KIMBERLY-CLARK STERILE SURGICAL CLOTHING MODEL: EXTRA GRAND ULTRA-REINFORCED APRON. Registro Anvi...

Manufacturer

Kimberly-Clark Brasil Indústria e Comercial de Produtos de Higiene Ltda.