International safety notice
Hemodialysis device
Brazil / Anvisa · BRA · Mar 28, 2017
Key facts
| Title | Hemodialysis device |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Prismaflex Technical name: Hemodialysis Device ANVISA registration number: 80145240438 Risk class: III Affected serial numbers: 107493 / 113082/ 114489 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BAXTER HOSPITALAR ENDEREÇO RUA HENRI DUNAT Nº 1383 TORRE B 12º ANDAR TELEFONE 11 56948496 FABRICANTE GAMBRO LUNDIA AB SUÉCIA SUÉCIA BOX 10101 MAGISTRATSVÄGEN 16 SE220 10 LUND SUÉCIA |
| Models | 113082, 80145240438, 114489, 107493 |
| Date | Mar 28, 2017 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 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