EU issues 75 Product, Toy & Vehicle Recalls


European Union FlagBelgium/Brussels: The European Union issues Report 28/2020 of its Rapid Alert System containing seventy five (75) consumer, automotive, commercial and industrial-based product recalls; a must-read for parents, caregivers, drivers, health and safety workers, company owners, healthcare workers and others: http://ht.ly/afjI30qXHdZ

Direct link: https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/?event=main.weeklyOverview&web_report_id=10000002&Year=2020&lng=en

Additional information:

Among the seventy five (75) recalls the European Union has announced in its second report of July 2020, the following recall notification was made:

Elite branded Respirator Mask Recall [EU]

 Click to enlarge

Elite branded Respirator Masks, sold with a classification/rating of KN95, a model number of EB09.049 and a standard CE regulatory approval designation.

These products are marketed as low-end disposable KN95-class protective Masks used to reduce the chances of disease transmission through airborne spray and/or particulate transmission. These products are sold in white plastic sealed pouches with teal green accent striping, each containing one (1) Mask.

No barcodes, UPCs, DINs, item numbers, best-before date codes, manufacturing date codes, batch/lot designations, production dates, expiry dates, regulatory approval designations, registration numbers or other identification numbers were listed with this recall notification.

Please note: although these medical devices have been marked with the CE marking to indicate a registered certification mark that indicates formal conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (“EEA”), it is not certified as protective equipment by a relevant body.

The type of hazards presented in the recalled Elite branded Respirator Mask products include the reported finding that the particle/filter retention of the material used in the recalled Masks is insufficient to protect against disease spread (measured value ≤ 98.5 %) when operating and/or using the medical device in a reasonable manner expected with its intended use.

Consequently, an excessive amount of particles and/or microorganisms might pass through the Mask, increasing the risk of infection if not combined with additional protective measures. A wearer may consequently become ill when the Mask fails to protect him or her against microbial contamination. If used to prevent the spread against SARS-CoV-2, the virus that causes COVID-19 (i.e., Coronavirus), this operational failure may lead to pulmonary, cardiac, cerebral, hepatic and/or nephritic injuries could be life-changing and/or life-threatening.

Due to these defects and their associated risks, these Elite branded Respirator Mask products do not comply with the requirements set out in Europe’s Personal Protective Equipment Regulation and the relevant European standard EN 149.

Consequently, a recall of these Elite branded Respirator Masks and a withdrawal of the Masks from the European marketplace has been ordered.

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United Nations | World Health Organization___________________________________________________________

==> To see other recalls and notifications caused by faulty and/or dangerous Elite branded Respirator Mask products, please search for “mask” or more generically, “PPE” using the Search Box at the top of this page.

==> To see other recalls and notifications relating to products made, marketed and/or sold under the Elite brand, please search for “Elite” using the Search Box at the top of this page.

==> To see other recalls and notifications concerning Coronavirus hazards, please search for “COVID-19” using the Search Box at the top of this page.

==> To see other recalls and notifications concerning Infection hazards please search for “infection” using the Search Box at the top of this page.

==> To see other recalls and notifications relating to Concussion hazards, please search for “concussion” using the Search Box at the top of this page.

==> To see other recalls and notifications relating to Bone Fracture hazards, please search for “fracture” using the Search Box at the top of this page.

==> To see other recalls and notifications relating to Inhalation hazards, please search for “inhalation” using the Search Box at the top of this page.

==> To see other recalls and notifications relating to Injury hazards, please search for “injury” using the Search Box at the top of this page.

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More information about this recall:
European Union Rapid Alert “Rapex” Report: 28-2020
Recalls Direct RIN: 13238-2020
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/

We welcome your feedback:
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Legal notification:
The link to the above Web site is provided for informational use only. This recall notification should not be construed that the relevant EU institution endorses or supports the objectives or contents of this Web site or the organization managing it.

Additional terms and conditions concerning the use of this information can be found at: http://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/docs/notice_en.pdf

E. & O. E.

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