International safety notice
Technical name: Dilator Balloons
Brazil / Anvisa · BRA · Sep 6, 2016
Key facts
| Title | Technical name: Dilator Balloons |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial name: Zelos PTA Balloon Catheter /// Technical name: Dilation Balloons /// ANVISA registration number: 80134860129 /// Risk class: III - High Risk /// Affected model: 1740-1202, 1740-1204, 1740-1402, 1740-1404, 1740-1602, 1740-1604, 1740-1802, 1740-1804, 1740-2002, 1740-2004,1740-2202 , 1740-2204 , 1740-2402, 1740-2404, 1740-2602, 1740-2604, 1740-2802, 1740-2804 /// Affected lots: 6000120532; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO GRIFOLS BRASIL LTDA RUA UMUARAMA N 263 PINHAIS PR FABRICANTE OPTIMED MEDIZINISCHE INSTRUMENTE GMBH FERDINANDPORSCHESTRASSE ALEMANHA |
| Models | 6000133004, 1740-2402, 6000122608, 6000126658, 1740-1604, 6000123182, 6000086400, 1740-1202, 6000108952, 1740-2002, 6000121977, 6000128186 and 52 more |
| Date | Sep 6, 2016 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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