International safety notice
Alert 2792 (Technovigilance) - CMS Produtos Hospitalares Ltda - Silk 4.0x20 Intracranial Stent - Balt - Possibility that the size of the introducer for SILK+ stents is incorrect.
Brazil / Anvisa · BRA · Jan 31, 2019
Key facts
| Title | Alert 2792 (Technovigilance) - CMS Produtos Hospitalares Ltda - Silk 4.0x20 Intracranial Stent - Balt - Possibility that the size of the introducer for SILK+ stents is incorrect. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: Stent Intracraniano Silk 4.0x20 - Balt Technical Name: Intracranial Stent ANVISA registration number: 80065320147 Risk Class: IV Affected model: SILK4.0X20 Affected serial numbers: 00327700 and 00327114 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO CMS PRODUTOS HOSPITALARES LTDA CNPJ 03301390000128 RUA 06 C RUA 18 C RUA 19 QD21 LTS1A44 POLO EMPRESARIAL DE GOIÁS APARECIDA DE GOIÂNIA GO TEL 6236255018 EMAIL SORAYACRISTINACMSMEDICALCOMBR FABRICANTE DO PRODUTO BALT EXTRUSION 10 RUE DE LA CROIX VIGNERON 95160 MONTMORENCY FRANÇA |
| Models | 80065320147, 00327700, SILK4, 00327114, 4.0x20 |
| Date | Jan 31, 2019 |
| 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.
Source: National medical device regulators (as listed), compiled by Orca1