International safety notice
Alert 2560 (Technosurveillance) Terumo BCT - Spectra Optia Apheresis System Safety alert on the risk of air infusion in a patient when using the device in conjunction with a blood warmer.
Brazil / Anvisa · BRA · May 4, 2018
Key facts
| Title | Alert 2560 (Technosurveillance) Terumo BCT - Spectra Optia Apheresis System Safety alert on the risk of air infusion in a patient when using the device in conjunction with a blood warmer. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial name: Spectra Optia Apheresis System Technical name: Apheresis System ANVISA registration number: 80554210002 Risk class: III Affected Model:- Affected Lot/Serial Numbers: All devices. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO TERUMO BCT TECNOLOGIA MÉDICA LTDA CNPJ 10141389000149 RUA DO RÓCIO 220 CONJUNTO 41 SÃO PAULO SP TEL 11 28992612 28992620 EMAIL MAYRABAPTISTATERUMOBCTCOM LENITAGNOCHITERUMOBCTCOM FABRICANTE TERUMO BCT INC 10811 W COLLINS AVENUE LAKEWOOD COLORADO ZIP CODE 80215 ESTADOS UNIDOS DA AMÉRICA |
| Models | 80554210002 |
| Date | May 4, 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