International safety notice
Alert 2838 (Technosurveillance) VR Medical Importadora e Distribuidora de Produtos Médicos Ltda Enflow Blood and Fluid Heating System Possibility of aluminum escaping from the disposable cartridge.
Brazil / Anvisa · BRA · Apr 8, 2019
Key facts
| Title | Alert 2838 (Technosurveillance) VR Medical Importadora e Distribuidora de Produtos Médicos Ltda Enflow Blood and Fluid Heating System Possibility of aluminum escaping from the disposable cartridge. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Enflow Blood and Fluid Warming System Technical Name: Fluid Heater ANVISA registration number: 80102511779 Risk Class: II Affected model: enFlow Disposable Cartridges with IV Extension Set - Model 202 (980202EU); Affected serial numbers: lot 17012002 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA CNPJ 04718143000194 RUA BATATAES 391 CONJUNTOS 11 12 E 13 SÃO PAULO SP TEL 11989257160 EMAIL CRISTIANEAGUIRREVRMEDICALCOMBR FABRICANTE DO PRODUTO CAREFUSION ESTADOS UNIDOS DA AMÉRICAVYAIRE 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 ESTADOS UNIDOS DA AMÉRICA |
| Models | 980202EU, 17012002, 980200EU, 80102511779 |
| Date | Apr 8, 2019 |
| 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