International safety notice
Alert 2489 (Technosurveillance) - HP Bioprosthesis - Atrial Catheter - Possibility of rupture due to low tensile strength
Brazil / Anvisa · BRA · Feb 23, 2018
Key facts
| Title | Alert 2489 (Technosurveillance) - HP Bioprosthesis - Atrial Catheter - Possibility of rupture due to low tensile strength |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Atrial Catheter Technical name: Catheters ANVISA registration number: 10166360031 Risk class: IV Affected model: AC, AE, AH Affected serial number: AC code: lot 06 series 01 to 10, lot 07 series 01 to 10 AE code: lots 17 to 29 series 01 to 10 Code AH: lot 04 series 01 to 10 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO HP BIOPROTESES LTDA RUA MARIA JOSÉ RANGEL 83 SÃO PAULO SP FABRICANTE HP BIOPROTESES LTDA CNPJ 54801196000142 RUA MARIA JOSÉ RANGEL 83 TELEFONE 11 38537625 FAX 11 38537626 EMAIL MARCIAHPBIOCOMBR |
| Models | 10166360031 |
| Date | Feb 23, 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