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
In November we issued recalls for Surfa’Safe Premium and its equivalents, for Opaster Anios and its equivalent and for a single batch of Aniosyme DD1 (B28123S), manufactured in our plant in northern France where we had 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 from these bacteria.
Field Safety Notices (FSNs) were sent by registered post to all our customers, asking customers to immediately stop using the recalled products they might have in stock, as there was a risk they could be contaminated.
In response we immediately moved to put in place additional hygiene security protocols which led to the suspension of the production and distribution of our products from November 9 to 17 while we carried out a remediation of our plant. Following that remediation effort we re-started production in our plant in Sainghin-en-Melantois which has since been running effectively. As part of these protocols we also continued to do extensive microbiological testing both on finished goods and the water. This stringent release process has sometimes hampered the release of products but has enabled us to ensure that all the products that we have been shipping to customers since the re-start are safe.
We continue to implement corrective measures to ensure we are returning to normal supply situation.
| 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.
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.
We have announced the recall of Surfa’Safe Premium and its equivalent, Opaster Anios, as well as a single batch of Aniosyme DD1.
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).
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.
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.
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.
For precautionary reasons, we ask that users immediately stop using the recalled products that they may have in stock and contact their supplier.
Tel : +33 3 20 67 67 67
Email : vigilance@anios.com
Tel : +44 7795 300 685
Email : laetitia.tettamanti@ecolab.com