International safety notice
Alert 2931 Second Update (Technovigilance) - JP Indústria Farmacêutica S.A. - Equipment for separating Blood Components Recall of units sold in violation of RDC 25/2001.
Brazil / Anvisa · BRA · Jul 31, 2019
Key facts
| Title | Alert 2931 Second Update (Technovigilance) - JP Indústria Farmacêutica S.A. - Equipment for separating Blood Components Recall of units sold in violation of RDC 25/2001. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Equipment for separating Blood Components. Technical Name: Cell separation device. ANVISA registration number: 80146150065. Product Type: Equipment. Risk Class: II. Affected model: Giotto. Affected serial numbers: 2226915; Update Alert: serial number 2225214 instead of 2226214. Access the full content of Alert 2931 with the respective annexes on the ANVISA Portal (http://portal.anvisa.gov.br/alertas). |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO JP INDÚSTRIA FARMACÊUTICA SA CNPJ 55972087000150 AVENIDA PRESIDENTE CASTELO BRANCO 999 RIBEIRÃO PRETO SP TEL 1635123500 EMAIL GARANTIAJPFARMACOMBR FABRICANTE DO PRODUTO DELCON VIA MATTEUCCI 2527 ITÁLIA |
| Models | 2226214, 2225314, 2226915, 2226715, 2225414, 2225214, 2227115, 80146150065, 2231117, 2225814 |
| Date | Jul 31, 2019 |
| 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