International safety notice
Alert 2656 (Technovigilance) - Ethica Medical Ltda - Linear Reach Stapler with Charging Unit for Individual Use - Possibility of divergence in instructions for use and labeling.
Brazil / Anvisa · BRA · Aug 29, 2018
Key facts
| Title | Alert 2656 (Technovigilance) - Ethica Medical Ltda - Linear Reach Stapler with Charging Unit for Individual Use - Possibility of divergence in instructions for use and labeling. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: REACH Linear Stapler with Single Use Charging Unit Technical Name: Surgical Stapler ANVISA registration number: 80702890004 Risk Class: III Affected Model: RLS3035S, RLS3048S, RLS4535S, RLS4548S, RLS6035S, RLS6048S, Charging Unit Models: RLS3035L, RLS3048L, RLS4535L, RLS4548L, RLS6035L, and RLS6048L Affected serial numbers: RLS6035S batch #: 160207; |
| 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 TEL 48 3047 2525 EMAIL JOSIANEETHICAMEDICALCOMBR FABRICANTE DO PRODUTO REACH SURGICAL TIANJIN INC 5 FOURTH STREET BLDG B 4TH FLOOR TEDA 300457 CHINA |
| Models | RLS3035S, 160209, RLS3035L, RLS4535S, RLS4548S, 1706150018, RLS6035S, RLS4535L, 80702890004, RLS3048L, RLS6048L, 1711220059 and 12 more |
| Date | Aug 29, 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