Events

Recall Or Safety Alert for Set of peritoneal dialysis lines "Sleep-Safe Set Plus", reference 5016931 and "Sleep Safe Set Paed", reference 5017391.

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain that was produced by Fresenius Medical Care AG & Co.

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
    Recall / Safety Alert
  • Date
    2016-12-23
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 recall data from the U.S. and Spain.
  • Extra notes in the data
  • Action
    Removal from the market of certain batches of the sets of the peritoneal dialysis lines "Sleep-Safe Set Plus", reference 5016931 and "Sleep Safe Set Paed", reference 5017391, manufactured by Fresenius Medical Care AG & Co, Germany, due to the possibility of leakage and damage to the line.

Device

Set of peritoneal dialysis lines "Sleep-Safe Set Plus", reference 5016931 and "Sleep Safe Set Pae...

Manufacturer

Fresenius Medical Care AG & Co