International safety notice
Alert 2617 (Technovigilance) - Fresenius Hemocare Brasil Ltda - Filter for removing leukocytes from packed red blood cells, for use at the bedside - FILTER BIOR 01 PLUS BS PF - Possibility that the filter penetrator is loose from the tube.
Brazil / Anvisa · BRA · Jul 18, 2018
Key facts
| Title | Alert 2617 (Technovigilance) - Fresenius Hemocare Brasil Ltda - Filter for removing leukocytes from packed red blood cells, for use at the bedside - FILTER BIOR 01 PLUS BS PF - Possibility that the filter penetrator is loose from the tube. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Filter for removing leukocytes from packed red blood cells, for use at the bedside Technical Name: Filter for Leukocyte Removal (Transfusion) ANVISA registration number: 10154450115 Risk Class: III Affected model: BIOR 01 PLUS BS PF Affected serial numbers: 71LM08GB00 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO FRESENIUS HEMOCARE BRASIL LTDA CNPJ 49601107000184 RUA ROQUE GONZALEZ 128 ITAPECERICA DA SERRA SP TEL 11 2504 1481 EMAIL CINTIAGARCIAFRESENIUSKABICOM FABRICANTE DO PRODUTO FRESENIUS HEMOCARE BRASIL LTDA RUA ROQUE GONZALEZ 128 BRASIL |
| Models | 10154450115, 71LM08GB00 |
| Date | Jul 18, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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