International safety notice
Alert 2636 (Technovigilance) - Asspress Cirúrgica Ltda - Ecoflan PTFE Tubular Graft / Ecoflon Inorganic Patch - Compliance with RE No. 1,724, of July 4, 2018 - Product recall.
Brazil / Anvisa · BRA · Aug 7, 2018
Key facts
| Title | Alert 2636 (Technovigilance) - Asspress Cirúrgica Ltda - Ecoflan PTFE Tubular Graft / Ecoflon Inorganic Patch - Compliance with RE No. 1,724, of July 4, 2018 - Product recall. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Ecoflan PTFE Tubular Graft / Ecoflon Inorganic Patch Technical Name: Cardiovascular Grafts / Prostheses ANVISA registration number: 27011500001 / 27011500002 Risk Class: IV Affected model: Bifurcated with external PTFE spiral reinforcement; Affected serial numbers: Registration #27011500001: 054032016 / Registration #27011500002: 197112015, 051032016, 195112015, 052032016. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ASSPRESS CIRÚRGICA LTDA RUA GÁVEA 35 LOJA 02 JARDIM AMÉRICA BELO HORIZONTE MINAS GERAIS TEL 31 33737744 EMAIL ASSPRESSASSPRESSCOMBR FABRICANTE DO PRODUTO SCIENTIFIC PRODUCTIVE COMPLEX ECOFLON 4A KOLOMENSKAYA STR SAINT PETERSBURG 191040 RUSSIA RÚSSIA FEDERAÇÃO RUSSA |
| Models | 27011500001, 195112015, 27011500002, 052032016, 054032016, 197112015, 051032016 |
| Date | Aug 7, 2018 |
| 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