International safety notice
Alert 2803 (Technovigilance) - Tecmedic Comércio de Produtos Médicos Ltda - ALN Vena Cava Filter and ALN Vena Cava Filter Extraction Catheter - Recall determined by Resolution RE No. 503, OF FEBRUARY 21, 2019.
Brazil / Anvisa · BRA · Mar 7, 2019
Key facts
| Title | Alert 2803 (Technovigilance) - Tecmedic Comércio de Produtos Médicos Ltda - ALN Vena Cava Filter and ALN Vena Cava Filter Extraction Catheter - Recall determined by Resolution RE No. 503, OF FEBRUARY 21, 2019. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: ALN Vena Cava Filter (registration 80202910017); Technical Name: Intravascular Filter (80202910017); ANVISA registration number: 80202910017; Risk Class: IV Affected model: Registration 80202910017: FF.HOOK, FJ.HOOK, FP.HOOK, FB.HOOK, FJ.120096, FF.010995, FB.010500 AND FP.012013; Affected serial numbers: All lots. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO TECMEDIC COMÉRCIO DE PRODUTOS MÉDICOS LTDA CNPJ 05638301000169 RUA BRASILIO CUMAN 566 SÃO BRÁZ CURITIBA PARANÁ TEL 41 32337887 EMAIL REGULATORIOCONTECSERVCOMBR FABRICANTE DO PRODUTO ALN IMPLANTS CHIRURGICAUX 589 CHEMIN DU NIEL BORMES LES MIMOSAS 83230 FRANÇA FRANÇA |
| Models | 80202910018, FJ.120096, FB.010500, 80202910017, FT.200001, FF.010995, FP.012013, FT.902010 |
| Date | Mar 7, 2019 |
| 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