International safety notice
Alert 2676 (Technosurveillance) - Respiratory Care Hospitalar Ltda - Infusion Pump - Possibility of rupture of the S5 transmission spring, which may result in clinically significant over-infusion.
Brazil / Anvisa · BRA · Sep 18, 2018
Key facts
| Title | Alert 2676 (Technosurveillance) - Respiratory Care Hospitalar Ltda - Infusion Pump - Possibility of rupture of the S5 transmission spring, which may result in clinically significant over-infusion. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Infusion Pump Technical Name: Infusion Pump ANVISA registration number: 80113010024 Risk Class: III Affected model: GH Plus Infusion Pump / PK Infusion Pump Affected serial numbers: See attachment List of serial numbers at risk |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO RESPIRATORY CARE HOSPITALAR LTDA CNPJ 02126465000119 RUA PADUR ABES 118 CENTRO JUQUITIBA SP TEL 1146821200 EMAIL CELSODIASEQUIPAMEDCOMBR FABRICANTE DO PRODUTO BD SWITZERLAND SARL TERRE BONNE PARK A4 ROUT DE CRASSIER 17 CH SWITZERLAND |
| Models | 80113010024 |
| Date | Sep 18, 2018 |
| 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