Events

Safety Alert for PREP-KIT for CAPD-SDD ANVISA registration no. 10068390336.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Baxter Hospitalar Ltda (Baxter Healthcare Corporation)..

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
    844
  • Date
    2006-11-29
  • 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
    The Company recommends that thyroid function be monitored in patients with small volumes of peritoneal dialysate filling. To minimize exposure to iodine, drain the contents of the peritoneal cavity into the drainage receptacle prior to the start of the next filling cycle, where possible clinically. ****** Company Letter: http: //www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2006/844.pdf
  • Reason
    Possibility of changes in the thyroid function of patients using prep-kit, a health product containing povidone-iodine, used in hemodialysis and peritoneal dialysis procedures.
  • Action
    Baxter has forwarded a Safety Alert to clients informing them of potential changes in thyroid function in their patients with CKD undergoing hemodialysis and peritoneal dialysis.

Device

PREP-KIT for CAPD-SDD ANVISA registration no. 10068390336.

Manufacturer

Baxter Hospitalar Ltda (Baxter Healthcare Corporation).
  • Source
    ANVSANVISA