International safety notice
Alert 2564 (Technovigilance) - Laboratórios B. Braun S.A. - Askina Calgitrol Paste 15 gr and Askina Gel 15 gr - Possibility of ineffectiveness in reducing microorganisms in the sterilization process due to the low dose of gamma radiation.
Brazil / Anvisa · BRA · May 7, 2018
Key facts
| Title | Alert 2564 (Technovigilance) - Laboratórios B. Braun S.A. - Askina Calgitrol Paste 15 gr and Askina Gel 15 gr - Possibility of ineffectiveness in reducing microorganisms in the sterilization process due to the low dose of gamma radiation. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Good Calgitrol Paste 15 gr and Good Gel 15 gr Technical name: Good Calgitrol Paste 15 gr and Good Gel 15 gr ANVISA registration number: 80136990789 Risk class: III Affected model: 6241505, 001419SBR and 001419S Affected serial numbers: Code 001419S: 514031, 514033 and 518472; Code 001419SBR: 485431, 504281, 485431 and 504281; Código 6241505: P2408, P2460, P2469, P2481, P2524, P2528, P2549, P2552, P2556 e P2577." |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO LABORATÓRIOS B BRAUN SA AV EUGÊNIO BORGES 1092 E AV JEQUITIBÁ 9 CEP 24751000 SÃO GONÇALO RJ TEL 55 21 26023219 EMAIL ROSANERAMOSBBRAUNCOM FABRICANTE DO PRODUTO BBRAUN MELSUNGEN AG CARLBRAUNSTRABE 1 ALEMANHA |
| Models | 514031, P2549, P2469, P2577, P2528, 504281, P2460, 001419SBR, 514033, P2408, P2556, 001419S and 7 more |
| 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
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