International safety notice
Alert 2653 (Technovigilance) - Ethica Medical Comércio e Importação de Produtos Médicos e Hospitalares Ltda - Circular Stapler with REACH Staples - Possibility of divergence in the instructions for use and labeling.
Brazil / Anvisa · BRA · Aug 28, 2018
Key facts
| Title | Alert 2653 (Technovigilance) - Ethica Medical Comércio e Importação de Produtos Médicos e Hospitalares Ltda - Circular Stapler with REACH Staples - Possibility of divergence in the instructions for use and labeling. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Circular Stapler with Reach Staples Technical Name: Surgical Stapler ANVISA registration number: 80702890001 Risk Class: III Affected model: RCS25C, RCS28C, RCS31C, RCS34C, RCS25D, RCS28D, RCS31D, RCS34D, RCS25E, RCS28E, RCS31E, RCS34E, RCS25F, RCS28F. Affected serial numbers: RCS25C - batch no.: 150120; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ETHICA MEDICAL COMÉRCIO E IMPORTAÇÃO DE PRODUTOS MÉDICOS E HOSPITALARES LTDA CNPJ 11708510000134 AVENIDA LEDIO JOAO MARTINS 935 SALA 202 KOBRASOL CEP 88102001 SÃO JOSÉSC SÃO JOSÉ SC TEL 48 3047 2525 EMAIL JOSIANEETHICAMEDICALCOMBR FABRICANTE DO PRODUTO REACH SURGICAL TIANJIN INC 5 FOURTH STREET BLDG B 4TH FLOOR TEDA 300457 CHINA |
| Models | 160116, RCS34E, RCS31E, RCS25E, RCS31C, RCS25D, 1704201660, RCS28F, 160137, 150120, RCS25C, 160118 and 10 more |
| Date | Aug 28, 2018 |
| 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