International safety notice
Alert 2605 (Technovigilance) - Gadali Medical Comercio de Produtos Médico Hospitalar LTDA - Valved Introducer Kit Failure in the production process may result in the valve not adhering effectively to the sheath.
Brazil / Anvisa · BRA · Jul 9, 2018
Key facts
| Title | Alert 2605 (Technovigilance) - Gadali Medical Comercio de Produtos Médico Hospitalar LTDA - Valved Introducer Kit Failure in the production process may result in the valve not adhering effectively to the sheath. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Valve Introducer Kit Technical Name: Introducers ANVISA registration number: 80984190018 Risk Class: II Affected model: 09212- Valve Introducer Kit 6 Fr x 11 cm Affected serial numbers: Lot: 31707013B |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO GADALI MEDICAL COMERCIO DE PRODUTOS MÉDICO HOSPITALAR LTDA CNPJ 06143957000173 RUA LOPES TROVÃO 302 CAMPINAS SP TEL 1932913882 EMAIL DALIZECOLAGADALIMEDICALCOMBR FABRICANTE DO PRODUTO UMBRA MEDICAL PRODUCTS INC 8930 ROAN LANE EAST INVERNESS FLORIDA 34450 USA ESTADOS UNIDOS DA AMÉRICA |
| Models | 31707013B, 80984190018, 09212 |
| Date | Jul 9, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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