International safety notice
OffRoad Product - Reintroduction Catheter - Registration 10341350691 - Risk Class II (Medium risk) - Technical name: Catheters
Brazil / Anvisa · BRA · Sep 18, 2014
Key facts
| Title | OffRoad Product - Reintroduction Catheter - Registration 10341350691 - Risk Class II (Medium risk) - Technical name: Catheters |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | OffRoad - Reintroduction Catheter - Registration 10341350691 - Risk Class II (Medium risk) - Technical name: Catheters - Model H74939202100540 - Affected batches 16514006 (DISTRIBUTION MAP ATTACHED) |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO NO BRASIL BOSTON SCIENTIFIC DO BRASIL LTDA CNPJ 01513946000114 AV DA NAÇÕES UNIDAS 21476 SANTO AMARO VILA ALMEIDA SÃO PAULOSP REGAFFAIRSBRAZILBSCICOM FABRICANTE BOSTON SCIENTIFIC CLONMEL LIMITED BALLYBRIT BUSINESS PARK GALWAY IRLANDA |
| Models | H74939202100540, 16514006, 10341350691 |
| Date | Sep 18, 2014 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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