International safety notice
Alert 2655 (Technosurveillance) - Ethica Medical - Endo Reach Endoscopic Linear Cutting Stapler with Individual Use Charging Unit - Possibility of divergence in instructions for use and labeling.
Brazil / Anvisa · BRA · Aug 28, 2018
Key facts
| Title | Alert 2655 (Technosurveillance) - Ethica Medical - Endo Reach Endoscopic Linear Cutting Stapler with Individual Use Charging Unit - Possibility of divergence in instructions for use and labeling. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: ENDO REACH Endoscopic Linear Cutting Stapler with Single Use Charging Unit Technical Name: Surgical Stapler ANVISA registration number: 80702890003 Risk Class: III Affected model: ENDO RLC S, ENDO RLC, ENDO RLC L, ENDO RLC 3020L, ENDO RLC 3025L, ENDO RLC 3035L, ENDO RLC4525L, ENDO RLC4535L, ENDO RLC 3040L, ENDO RLC 3048L, ENDO RLC 4520L, ENDO RLC 4540L, ENDO RLC 4548L, ENDO RLC 6020L, ENDO RLC 6025L, ENDO RLC6035L, ENDO RLC 6040L, ENDO RLC6048L, ENDO RLC 3020R, ENDO RLC 3025R, ENDO RLC 3035R, ENDO RLC 4525R, ENDO RLC 4535R, ENDO RLC 45 40R, ENDO RLC 4548R, ENDO RLC 6025R, ENDO RLC 6035R, ENDO RLC 6040R, ENDO RLC 6048R. Affected serial numbers: ENDO RLC batch #: 1706080042; |
| 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 | 6040L, RLC4535L, 1709070019, 1706080042, 4520L, 4535R, 6025R, 1704181586, 3025R, 80702890003, RLC6035L, 3035L and 26 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