International safety notice
Alert 2581 (Technosurveillance) - Bard do Brasil Industria e Comercio de Produtos para Saude Ltda.
Brazil / Anvisa · BRA · Jun 4, 2018
Key facts
| Title | Alert 2581 (Technosurveillance) - Bard do Brasil Industria e Comercio de Produtos para Saude Ltda. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Bardport Port Fully Implantable in Titanium and Silicone; Technical Name: Infusion Catheter; ANVISA registration number: 80689090126; 80689090128; 80689090136; 80689090103; 80689090105 Risk Class: IV Affected model: Titanium Ports (base diameter: 31.7 mm; height: 14.5 mm; weight: 15.4 g); Affected serial numbers: Code Lot Number: 0602240 REBT0050; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BARD DO BRASIL INDUSTRIA E COMERCIO DE PRODUTOS PARA SAUDE LTDA CNPJ 10818693000188 RUA ALEXANDRE DUMAS 2100 10 ANDAR CHACARA SANTO ANTONIO SÃO PAULO SP TEL 1151800222 EMAIL SANDRABRAMUCCICRBARDCOM FABRICANTE DO PRODUTO BARD ACCESS SYSTEMS INC 605 NORTH 5600 WEST SALT LAKE CITY UTAH ESTADOS UNIDOS |
| Models | 8808561, REBT2330, 0602850, 80689090126, 80689090105, 0607555, REBU0499, 80689090103, 80689090128, REBT2153, REBT0050, 8808061 and 6 more |
| Date | Jun 4, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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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.
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