International safety notice
Alert 2573 (Technovigilance) - America Medical Ltda - Sterile Operating Field - Reduction in the device's liquid retention capacity.
Brazil / Anvisa · BRA · May 23, 2018
Key facts
| Title | Alert 2573 (Technovigilance) - America Medical Ltda - Sterile Operating Field - Reduction in the device's liquid retention capacity. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Sterile Operating Drape Technical Name: Surgical Drape ANVISA registration number: 8003740007 Risk Class: II Affected model: sterile operating drape 25X28CM Affected serial numbers: LOT:034-2 FAB:19/03/2018. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO AMERICA MEDICAL LTDA CNPJ 01310212000138 AV SAROBÁ Nº35 BAIRRO MARIA AMÁLIA CURVELO MG TEL 38 37297427 EMAIL GQTAMERICAMEDICALNET FABRICANTE DO PRODUTO AMERICA MEDICAL AV SAROBÁ Nº35 BAIRRO MARIA AMÁLIA BRASIL |
| Models | 8003740007, 25X28CM, 034-2 |
| Date | May 23, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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