International safety notice
Alert 2889 (Technosurveillance) Baxter Hospitalar Prismaflex TPE 1000/2000 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 2889 (Technosurveillance) Baxter Hospitalar Prismaflex TPE 1000/2000 Possibility of access lines bending and preventing blood flow, causing the alarm to be triggered. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Prismaflex TPE 1000/2000 Technical Name: Dialyzers ANVISA registration number: 80145240418 Risk Class: III Affected model: Prismaflex TPE 1000/2000 Affected serial numbers: 18E2804, 18F1104, 18G1203, 18I0304, 18I1804, 18K2005 |
| 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 | 18K2005, 18G1203, 18E2804, 80145240418, 18I0304, 18F1104, 18I1804 |
| 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