The ANSM, the French Health authority that regulates medical devices has published an information and a health policy decision which outlines the measures that Laboratoires Anios has committed to implement, in order to ensure the compliance and quality of the products distributed on the market. – Read the decision

PRODUCT RECALL INFORMATION

We are currently recalling Surfa’Safe Premium and its equivalent, Opaster Anios and a single batch of Aniosyme DD1 (B28123S), manufactured in our plant in northern France where we have identified the presence of bacteria. These bacteria are commonly found in water and pose little risk to the general population. However, immunocompromised patients are at higher risk of infection.

Field Safety Notices (FSNs) are currently being sent by registered post to all our customers. We ask that you immediately stop using the recalled products that you may have in stock, as there is a risk they may be contaminated.

With an abundance of caution, and in collaboration with the French health authorities, we have suspended the production and distribution of our products from the plant. We have been decontaminating our plant and we have re-started production. We have put in place corrective measures, including additional hygiene safety protocols, in order to ensure the quality of our products and to restart production.

We are taking these precautionary measures to ensure patient safety and will continue to work with the local health authorities on this matter.

Products affected by recall

Device Commercial Name Packaging Article Code FSN TO DOWNLOAD
BACCIDE KIT PRO 12x750ML 2524326 FSN_ANIOS_SSP_DISTRIBUTORS_EN_EX EU.pdf
ECI MND PREMIUM 12x750ML 2722371
INTRUNET SURFA SAFE PREMIUM 12x750ML 2585544E2
SURFA'SAFE PREMIUM 12x750ML 2419326, 2419326EZ, 2419326HQ, 2419544, 2419544BA, 2419544BR, 2419544D2, 2419544GA, 2419544HA, 2419544HD, 2419544S6, 2419544T4, 2419544UE, 2419544UO, 2419544UY, 2419544UZ
16X500ML 2419105
1X500ML 2419982
1X50ML 2419874
1X5L 2419922
1X750ML 2419890, 2419890UY, 2419892, 2419892HQ
4X5L 2419028, 2419028HR
DENTASEPT SH PRO 12x750ML 2462326R8 FSN_DMD_SSP_DISTRIBUTORS_EN_EX EU.pdf
1X5L 2462042R8
1X750ML 2462892
DISINFECTANT DETERGENT SPRAY 12x750ML 2654241HU
1X5L 2654042HU
KIT FLACON 12x750ML 2514440
KLINION DESINFECTANT 6X750ML 2518443
NORMOBIOT PS NF 12x750ML 2544241EZ
VAPOSEPT ZERO 1X5L 2763047
6X750ML 2763382T1
UNISEPTA FOAM 2 12x750ML 2458241__L3, 2458241GM FSN_USF_SSP_DISTRIBUTORS_EN_EX EU.pdf
1X750ML 2458953
2X5L 2458539__L3
OPASTER ANIOS 4X5L 2504028C6, 2504028HA, 2504028OB, 2504028E2, 2643028BR, 2504028YS, 2504318UE, 2504028UO, 2504028G4, 2504028Z8, 2504028DL, 2504028JC, 25040282Q FSN_ANIOS_OPASTER_DISTRIBUTORS_EN_EX EU.pdf
ANIOSYME DD1 – LOT B28123S 4X5L 1200036 FSN_ANIOS_DD1_DISTRIBUTORS_EN_EX EU.pdf
12X1L 1200095
INSTRUNET INIBSA ALTA DESINFECCION
Batch A06711S
1x5L 2888208P2 FSN_ANIOS_INSTRUNET INIBSA ALTA DESINFECCION_ES.pdf

PRECAUTION OF USE ANIOSYME DD1 AND ITS EQUIVALENTS

We are recalling a single batch of Aniosyme DD1 (B28123S). However, with an abundance of caution, we ask you to limit the use of other batches of this product and its equivalents to the treatment of medical devices that will go through a sterilization. This precaution of use notice is applicable to Aniosyme DD1 and equivalent products (also sold under commercial licence as Dentasept Enzymatique, Actanios P2, Micro 10 Enzyme, Septol Instruments Enzymatique and Aniosyme DD1+) that you might have in stock as of November 16, 2019. Newly manufactured products that will be delivered to you are not impacted by this restriction, as we will conduct microbiological tests on every batch to ensure the quality of the products before distribution. – For more information, please download the Anios, DMD and USF letters.

Background information

These bacteria found in the products are commonly found in water. The risk of infection for the general population is very low, but these bacteria can cause infection in immunocompromised people. Patients most at risk of infection are:

Data from laboratory analysis indicate that the bacteria Burkholderia cepacia, if present in Surfa’Safe Premium and its equivalent, dies two minutes and 30 seconds after the product is used on surfaces. The study is available in the attached Field Safety Notices (FSN).

As a precaution, the French health authorities (Département General de la Santé) is advising users of other Anios products around at-risk patients, in particular immunocompromised patients, to use alternative products to the Anios portfolio, until we can restart our plant.

Patients that do not have the above conditions are therefore not at increased risk of infection.

Questions and Answers

Q: How widespread is the recall?

We have announced the recall of Surfa’Safe Premium and its equivalent, Opaster Anios, as well as a single batch of Aniosyme DD1.

Q: What batches of the products recalled do I need to stop using and notify Anios about?

All batches available on the market of the Surfa’Safe Premium and Opaster ranges dated November 11, 2019 and earlier are recalled until new batches will be manufactured and released on the market. We are also recalling a single batch of Aniosyme DD1 (B28123S).

Q: Does this recall apply to other products in the Anios product portfolio?

The recall applies only to Surfa’Safe Premium and its equivalent, Opaster Anios and a single batch of Aniosyme DD1.

As a precaution, the French health authorities (Département General de la Santé) is advising users of other Anios products around at-risk patients, in particular immunocompromised patients, to use alternative products to the Anios portfolio, until we can restart our plant which should take place this week.

Q: How should I inform Anios about the product I have in stock?

When you receive the official FSN, you need to complete and sign the reply form (Annex I), indicating the name of the recalled product and quantity you have in stock. You then need to share the form with your supplier, as indicated in the letter you have received.

After receipt of your reply form, you will be contacted shortly to finalize the recall process.

Q: How long will it be before Anios is in a position to resume production and distribution of product?

With an abundance of caution, and in collaboration with the French health authorities, we have suspended the production and distribution of our products from the plant. We have been decontaminating our plant and we have re-started production. We have put in place corrective measures, including additional hygiene safety protocols, in order to ensure the quality of our products and to restart production.

Q: What steps should hospitals and healthcare facilities take regarding the recalled products?

For precautionary reasons, we ask that users immediately stop using the recalled products that they may have in stock and contact their supplier.

CONTACT

Customers and distributors in France:

Tel : +33 3 20 67 67 67
Email : vigilance@anios.com

Media :

Tel : +44 7795 300 685
Email : laetitia.tettamanti@ecolab.com