International safety notice
Alert 2713 (Technovigilance) - Maquet Cardiopulmonary Do Brasil Indústria e Comércio Ltda - Quadrox-i Membrane Oxygenator - Possibility of leak in the blood input connector.
Brazil / Anvisa · BRA · Oct 30, 2018
Key facts
| Title | Alert 2713 (Technovigilance) - Maquet Cardiopulmonary Do Brasil Indústria e Comércio Ltda - Quadrox-i Membrane Oxygenator - Possibility of leak in the blood input connector. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Quadrox-i Membrane Oxygenator Technical Name: Oxygenators ANVISA registration number: 10390690071 Risk Class: II Affected model: Quadrox-i Neonatal Membrane Oxygenator Affected serial numbers: 92250538; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO MAQUET CARDIOPULMONARY DO BRASIL INDÚSTRIA E COMÉRCIO LTDA CNPJ 00944324000188 AV MARGINAL DO RIBEIRÃO DOS CRISTAIS 500 CAJAMAR SP TEL 1126087387 EMAIL GUILHERMEPACINIGETINGECOM FABRICANTE DO PRODUTO MAQUET CARDIOPULMONARY GMBH KEHLER STR 31 76437 RASTATT ALEMANHA |
| Models | 92201155, 92250538, 92225010, 92250547, 92227516, 92222964, 92178976, 92218969, 92236654, 92228009, 92250546, 92250548 and 17 more |
| Date | Oct 30, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 100–999 Matching device models in FDA data
- 10–99 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