International safety notice
Alert 2708 (Technovigilance) - Baxter Hospitalar Ltda - Empty Exactamix EVA bag - Possibility of leakage during use, compromising the sterility of the prepared solution.
Brazil / Anvisa · BRA · Oct 25, 2018
Key facts
| Title | Alert 2708 (Technovigilance) - Baxter Hospitalar Ltda - Empty Exactamix EVA bag - Possibility of leakage during use, compromising the sterility of the prepared solution. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Exactamix Empty EVA Pouch Technical Name: Sterile solution mixing bag ANVISA registration number: 80145240404 Risk Class: II Affected model: H938740 Affected serial numbers: 60049816 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BAXTER HOSPITALAR CNPJ 49351786000180 AVENIDA DR CHUCRI ZAIDAN Nº 1240 TORRE B 12º ANDAR VILA SÃO FRANCISCO SÃO PAULO SP TEL 11 56948877 EMAIL CINTIAGUEDESBAXTERCOM FABRICANTE DO PRODUTO BAXTER HEALTHCARE CORPORATION ONE BAXTER PARKWAY DEERFIELD IL 60015 ESTADOS UNIDOS |
| Models | H938740, 60049816, 80145240404 |
| Date | Oct 25, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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