International safety notice
Sets Prismaflex, Oxiris, Septex y Kit MARS, utilizados con la unidad de control continuo PRISMAFLEX. Ver códigos afectados en la nota de aviso de la empresa.
Spain / AEMPS · ESP · May 28, 2019
Key facts
| Title | Sets Prismaflex, Oxiris , Septex y Kit MARS, utilizados con la unidad de control continuo PRISMAFLEX. Ver códigos afectados en la nota de aviso de la empresa. |
|---|---|
| Regulator | Spain / AEMPS |
| Country | ESP |
| Brand | Sets Prismaflex, Oxiris , Septex y Kit MARS, utilizados con la unidad de control continuo PRISMAFLEX. Ver códigos afectados en la nota de aviso de la empresa. |
| Manufacturer | • GAMBRO LUNDIA AB, Suecia (instalaciones: GAMBRO ROSTOCK GMBH, Alemania): Kit MARS. • GAMBRO INDUSTRIES, Francia: Sets Prismaflex, Septex y Oxiris. |
| Models | 107140, HF1000, 107144, HF1400, 109990, 46394, ST150, 107142, 106697, ST100, 114877, 800540 and 17 more |
| Event type | Safety Notice |
| Date | May 28, 2019 |
At a glance
- No Recall
- Yes Field safety notice
- 1–9 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