International safety notice
Alert 2887 (Technosurveillance) - Baxter Hospitalar - Equipo Prismaflex M60/M100 Possibility of access lines bending and preventing blood flow, causing the alarm to be triggered.
Brazil / Anvisa · BRA · May 29, 2019
Key facts
| Title | Alert 2887 (Technosurveillance) - Baxter Hospitalar - Equipo Prismaflex M60/M100 Possibility of access lines bending and preventing blood flow, causing the alarm to be triggered. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Prismaflex M60/M100 Equipment Technical Name: Hemodialise Equipment ANVISA registration number: 80145240431 Risk Class: III Affected model: EQUIPO PRISMAFLEX M100 Affected serial numbers: 18C1204 / 18C1403 / 18C2307 / 18D0303 / 18E0205 / 18E0302 / 18E0703 / 18F1103 / 18F1403 / 18F2001 / 18F2102 / 18F2204 / 18F2803 / 18G0505 / 18G0903 / 18G2606 / 18I0706 / 18I1205 / 18J0807/ 18J0906 / 18K0903 / 18K1604 |
| 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 GAMBRO INDUSTRIES 7 AVENUE LIONEL TERRAY BP126 69883 MEYZIEU CEDEX FRANÇA |
| Models | 18F1103, 18E0205, 80145240431, 18E0703, 18F2102, 18J0807, 18F2001, 18K0903, 18G0903, 18E0302, 18C2307, 18G0505 and 11 more |
| Date | May 29, 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