Safety Alert for Trade name: Askina Calgitrol Paste 15 gr and Askina Gel 15 gr. Technical name: Askina Calgitrol Paste 15 gr and Askina Gel 15 gr. ANVISA registration number: 80136990789. Risk class: III. Affected template: 6241505, 001419SBR and 001419S. Affected serial numbers: Code 001419S: 514031, 514033 and 518472 ;. Code 001419SBR: 485431, 504281, 485431 and 504281 ;. Code 6241505: P2408, P2460, P2469, P2481, P2524, P2528, P2549, P2552, P2556 and P2577. "

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Laboratórios B. Braun S.A.; B.Braun Melsungen AG.

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
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System (http: //portal.anvisa / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 04/23/2018 - Date of notification notice to Anvisa: 04/27/2018 "The company that owns the affected product is responsible for contacting its customers in a timely manner in order to guarantee the effectiveness of the Field Action underway.We highlight the joint responsibility of the chain of distribution and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art. 2. A holder of a product registration for health is the owner of the registration / registration of health product with Anvisa. , as well as the other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the products for health to the consumer Article 12 Distributors of health products shall forward the distribution map and other information required for the notification and execution of field actions to the registration holder in a timely manner. (...) ""
  • Reason
    The company b. braun hospicare informs that it verified that the dose of radiation applied in the process of sterilization of the batches of products referred to above was classified as low. it claims that, on the basis of that finding, the reduction of micro-organisms through gamma radiation may not have reached the established safety level of 10-6 on products belonging to the said manufacturing lots.
  • Action
    Action of field code: AC / 03/2018, triggered under the responsibility of the company Laboratorios B. Braun SA Recolhimento. Return to the manufacturer.