International safety notice
Alert 2815 (Technovigilance) - CMS Produtos Hospitalares Ltda - Hanarostent - Biliary Stent - Failure to assemble repositionable blocks from specific batch units incorrect block size.
Brazil / Anvisa · BRA · Mar 12, 2019
Key facts
| Title | Alert 2815 (Technovigilance) - CMS Produtos Hospitalares Ltda - Hanarostent - Biliary Stent - Failure to assemble repositionable blocks from specific batch units incorrect block size. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Hanarostent - Biliary Stent. Technical Name: Biliary Stent. ANVISA registration number: 80065320113. Risk Class: III. Affected model: SHS-10-060-180. Affected serial numbers: 18060022, 18060023, 18060024, 18060025, 18060026, 18060027, 18060028, 18060101, 18060102, 18060103, 18081624, 18081 625, 18081626, 18081627, 18081628. |
| 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 MI TECH 174 HABUK2GIL JINWIMYEON PYEONTAEKSI 451864 GYEONGGIDO CORÉIA DO SUL CORÉIA DO SUL |
| Models | 18060027, 18081628, SHS-10-060-180, 18081627, 18060025, 18081624, 18060102, 18060024, 18060023, 18060022, 18060101, 80065320113 and 5 more |
| Date | Mar 12, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers 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