Respiratory masks

Recall

Filtering Half-Masks - FFP 2 / 3 - In accordance with DIN 149

SQ Deutschland GmbH informs about a voluntary, purely preventive product recall of some batches of articles of FFP2 masks produced by manufacturer SHENGQUAN. Affected products can be returned - if they have not yet been used and can be clearly identified as concerned – to the company they have been bought from.

I today´s course, we will inform our distributors after having evaluated all information available.

In case you have bought FFP2 masks with the relevant marking ( see below) directly from SQ Deutschland, we will take back those und will replace them against a different batch without any additional cost for you. All important information about this recall can be found here:

What happened?

During routine quality controls, the following has been found by a market surveillance authority despite the most careful manufacturing and testing processes: ‘The particle/filter retention of the material is insufficient (measured value as low as 89%). Consequently, an excessive amount of particles or microorganisms might pass through the mask, increasing the risk of infection if not combined with additional protective measures. As a result of the labelling, the mask may be worn in areas where hazardous substances are in use or during activities involving asbestos; since the mask fails to offer sufficient protection, this could lead to asbestosis with fatal consequences. The product does not comply with the Personal Protective Equipment (PPE) Regulation and with the relevant European standard EN 149.’

The products must not be used.

The articles in question were delivered to retailers in the period 4th quarter 2020 / 1st quarter 2021 without any recognisable regional restriction, i.e. nationwide. The products in question can be identified by the following data on the packaging or the product itself:

type / model: SNN70369B
batch number: EXP 2023/10 – batch to be determined
barcode: 6970266961305
CE marking: 2834

We plan to inform our business partners which have received the relevant batch on August 23rd about further details.

What is to be done?

Only the listed products of the manufacturer SHENGQUAN are being recalled. All other FFP2 masks, also from the manufacturer SHENGQUAN, are not affected by the recall.

The quality of the products and thus the safety of the consumers is the top priority for SQ Deutschland GmbH. Customers who have purchased the affected items or have concerns about reselling them can contact the following numbers: 05692 99707-0/1/2.

We also have arranged a special email address maskenrueckruf@sq-deutschland.com

FAQs

1. What are the reasons for the recall?

Tests by a market surveillance authority revealed that excessive particles or microorganisms can pass through the affected masks. Thus, the products do not meet our internal safety requirements. In order to exclude any risks for our customers, SQ Deutschland GmbH has decided to recall all possibly affected products as a precautionary measure.

2. Which product batches are affected?

The following batches and articles are affected::
category: protective equipment
product: particle filter mask
type / model: SNN70369B
batch number: EXP 2023/10 - batch to be determined
barcode: 6970266961305
CE marking: 2834

3. How exactly are the masks concerned damaged?

According to the tests of the market surveillance authority, the particle and filter retention of the material is insufficient (measured value only 89 %). The products must therefore not be used.

4. Can the consumer detect the damage?

The possible inadequacies of the masks cannot be detected. However, affected mask batches can be identified from the data mentioned under 2.

5. If the outer packaging has been discarded: How can it be determined if the masks are affected?

Although there are identification data on each individual mask, the exact allocation to the production period is no longer possible. Therefore, it is not possible to take back unpacked masks.

6. What is the impact of the problem in normal use?

Excessive particles or microorganisms can pass through the mask and increase the risk of infection if not combined with additional protective measures.

7. Have there been previous quality problems?

No. This is the first recall at SQ Deutschland GmbH.

8. At which production site were the affected masks manufactured?

All masks were manufactured entirely by the manufacturer SHENGQUAN in China.

9. Can I be sure that an FFP2 mask I bought from a retailer today is safe??

Yes, all product batches that may be affected have been recalled by retailers and a production stop has been imposed. However, to be on the safe side, we recommend that you compare the identification data on the product itself or on the packaging of the masks you have with the announced data to rule out the possibility that they are affected.

12. Why should the affected masks be sent in and not simply thrown away?

We want to reliably ensure that any inadequate masks are disposed of and not accidentally used.