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
Date
2018-02-02
Event Country
Peru
Event Source
Digemid
Event Source URL
http://www.diresalima.gob.pe/diresa/descargar/DIRECCION%20EJECUTIVA%20DE%20MEDICAMENTOS%20Y%20DROGAS/EVALUACION-PRODUCTOS/2018/memorando_058-2018-DIREMID.pdf
Notes / Alerts

Peruvian data is current through August 2018. All of the data comes from Digemid, 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 recall data from the U.S. and Peru.
Extra notes in the data
Reason
Non conforming to the corrosion test.

Device

Sterile Scalpel Blade N ° 20

Model / Serial
Lot B2036 / Sanitary Registration # DM3167E
Product Description
Scalpel blade
Manufacturer
STERILANCE MEDICAL (SUZHOU) INC

Manufacturer

STERILANCE MEDICAL (SUZHOU) INC

Manufacturer Parent Company (2017)
Sterilance Medical (Suzhou) Inc.
Manufacturers representative
DROGUERÍA IMPORT ALKHOFAR S.A.C.
Source
Digemid

About this database

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 Sterile Scalpel Blade N ° 20

What is this?

Device

Sterile Scalpel Blade N ° 20

Manufacturer

STERILANCE MEDICAL (SUZHOU) INC