International Medical Devices Database

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

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Type of Event
Safety alert
Event ID
1449
Date
2014-10-24
Event Country
Brazil
Event Source
ANVISA
Event Source URL
http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
Notes / Alerts

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Extra notes in the data

Terumo asks distributors to block the remaining units in their inventory, and immediately communicate their customers so that users stop using the APC-60SA product, lot A60SA0002. End users should be reported to Terumo for arrangements. Distributors must collect the units present on their customers. All affected units (from stock or collection) must be segregated for local rework, or by Terumo.
Reason
Label placed on the product may contain incorrect information of 3/3/2016 validity, when the correct date is 03/31/2015.
Action
Collecting and correcting incorrect labels.

Device

APC + Harvest Plate Concentrate System. Anvisa Registry n ° 80012280135.

Model / Serial
Manufacturer
Terumo Medical do Brasil Ltda

Manufacturer

Terumo Medical do Brasil Ltda

Manufacturer Parent Company (2017)
Terumo Corp.
Source
ANVSANVISA

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Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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Safety Alert for APC + Harvest Plate Concentrate System. Anvisa Registry n ° 80012280135.

What is this?

Device

APC + Harvest Plate Concentrate System. Anvisa Registry n ° 80012280135.

Manufacturer

Terumo Medical do Brasil Ltda