Events

Safety Alert for Non-Sterile Surgical Glove With Powder, Registration No. 80950310009, Lots: 171114-LV; 181114-LV; 191114-LV; 211114-LV; 241114-LV-210115-LV; 020215-LV; 030215-LV; 040215-LV; 090215-LV; 030315-LV; 050315-LV; 060315 - LV; 100315-LV; 130315-LV; 160315-LV; 230315-LV; 240315 - LV; 250315-LV; 270315-LV, 020415-LV; 080415-LV

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Indústria de Artefatos de Borracha Inovatex Ltda.

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.

Learn more about the data here

Type of Event
Safety alert
Event ID
1589
Date
2015-05-26
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

The semi-annual maintenance tests indicated that the sample analyzed did not meet the certification criteria, being rejected in the impermeability attribute.
Reason
Suspension of the authorization for use of the product identification identification seal (ocp) due to the failure to perform the semi-annual maintenance tests on the impermeability attribute (check of holes) as evidenced by reports ela / l 260.333 / 3 / 15 (proof) and ela / l 261.498 / 15 (against proof).
Action
The company is carrying out Field Action for the collection of products manufactured from the date of the last certification

Device

Non-Sterile Surgical Glove With Powder, Registration No. 80950310009, Lots: 171114-LV; 181114-LV;...

Model / Serial
Manufacturer
Indústria de Artefatos de Borracha Inovatex Ltda

Manufacturer

Indústria de Artefatos de Borracha Inovatex Ltda

Source
ANVSANVISA

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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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