International safety notice
Alert 2566 (Technovigilance) Laboratórios B. Braun S.A. - Aesculap single-use bipolar instrument Possibility of arc formation (carbonization) at the tip of the Caiman 5 product, which can cause failures during use.
Brazil / Anvisa · BRA · May 7, 2018
Key facts
| Title | Alert 2566 (Technovigilance) Laboratórios B. Braun S.A. - Aesculap single-use bipolar instrument Possibility of arc formation (carbonization) at the tip of the Caiman 5 product, which can cause failures during use. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Aesculap single-use bipolar instrument Technical name: Aesculap single-use bipolar instrument ANVISA registration number: 80136990832 Risk class: III Affected model: Caiman 5 mm Affected Lot/Series Numbers: See attachment List of Lots at Risk |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO LABORATÓRIOS B BRAUN SA CNPJ 31673254000102 AV EUGÊNIO BORGES 1092 E AV JEQUITIBÁ 9 CEP 24751000 SÃO GONÇALO RJ TEL 21 26023219 EMAIL ROSANERAMOSBBRAUNCOM FABRICANTE AESCULAP AG POSTFACH 40 78501 TUTTLINGEN ALEMANHA |
| Models | 80136990832 |
| Date | May 7, 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