International safety notice
Alert 2522 (Technovigilance) - Baxter - Homechoice for peritoneal dialysis and Homechoice Claria - Alert for users to correctly open the Equipo Cassette packaging
Brazil / Anvisa · BRA · Mar 16, 2018
Key facts
| Title | Alert 2522 (Technovigilance) - Baxter - Homechoice for peritoneal dialysis and Homechoice Claria - Alert for users to correctly open the Equipo Cassette packaging |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome comercial: Homechoice para dialise peritonial Technical name: Homechoice Automated PD Cycle ANVISA registration number: 10068390123 Risk class: III Affected model: 5C4471 Affected serial number: 115V Trade name: Homechoice Claria Technical name: Homechoice Claria APD System ANVISA registration number: 80145240442 Risk class: III Affected model: 5C6M10 Affected serial number: 115V/230V |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BAXTER HOSPITALAR CNPJ 49351786000180 AVENIDA DR CHUCRI ZAIDAN Nº 1240 TORRE B 12º ANDAR VILA SÃO FRANCISCO SÃO PAULO SP FABRICANTE BAXTER HEALTHCARE CO 2 WOODLANDS INDUSTRIAL PARK STREET 2 SINGAPURA |
| Models | 5C6M10, 80145240442, 10068390123, 5C4471 |
| Date | Mar 16, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1