Alerte De Sécurité sur Trade name: Infusion Pump. Technical Name: Infusion Pump. ANVISA registration number: 80113010024. Risk class: III. Model Affected: Infusion Pump GH / Infusion Pump PK. Serial numbers affected: pumps manufactured prior to September / 2008 - attached list.

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.

If a pl3 alarm occurs the syringe pump should be immediately withdrawn from clinical use and should be referred for repair by qualified service personnel or authorized technical assistance. Additional information: - Date of identification of the problem by the company: 06/11/2017 - Date of notification notice to Anvisa: 11/16/2017 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain 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 registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as 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 health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "