1 rue de l’Espoir 59260 LEZENNES France Tel +33 3 20 67 67 67 Fax + 33 3 20 67 67 68 Email [email protected]
FSN_ANIOS_SSP_DISTRIBUTORS_EN_EX EU
URGENT FIELD SAFETY NOTICE
Date: 07/11/19
Object: Batch recall Information and/or recommendations
Affected products:
Device Commercial Name Packaging Article Code SURFA’SAFE PREMIUM contained in
BACCIDE KIT PRO 12x750ML 2524326*
ECI MND PREMIUM 12x750ML 2722371 INSTRUNET 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
*diffused foam form products
Madam, Sir,
We have identified that you received products in the above table, and we are recalling all batches (Annex II) as they do not comply with our quality expectations. They may contain the opportunistic environmentalmicroorganism Burkholderia Cepacia.
Burkholderia cepacia poses little medical risk to healthy people. However, it is a known cause of infections in hospitalized patients. Patients who have certain health problems like weakened immune systems, especially immunocompromised patients or in neonatal care, or chronic lung diseases, particularly those with cystic fibrosis, are at higher risk of infection.
The products are available in a variety of packaging: foam sprays, diffused foam sprays (see indication in the above table) and dropping bottles. Depending on the indicated application of the products, the
FSN_ANIOS_SSP_DISTRIBUTORS_EN_EX EU
risks are different. When using a diffused foam form, the risk is higher for the at-risk population due to possible inhalation exposure. When using the product in a wiping action, the probability of the bacteria infecting the at-risk patient population is less important. Laboratory data indicates that in Surfa’Safe Premium the bacteria dies two and a half minutes after product use on surfaces (Annex III).
Corrective actions to eliminate the contamination source are being implemented. We have introduced additional hygiene security protocols which means that all our medical devices manufactured and delivered from our Sainghin-en-Mélantois plant will have successfully passed the test protocols.
For precautionary reasons, we ask that you stop immediately using the recalled products that you may have in stock, as there is a risk they may be contaminated.
We ask you to block and isolate these products. In addition, we need you to inform immediately your end customers and ask them to notify you of the quantities they have in stock. You will be required to collect the completed response form (Annex I) from your customers and share a consolidated form with us of all the products you have recalled to the following e-mail address: [email protected]. Any quantity declared can be subject of verification.
Please acknowledge receipt of this communication by returning at your earliest convenience - but no later than 05/12/2019 - the completed and signed reply form.
Your Anios representative will contact you to discuss the return of the recalled product you have in stock. We remain at your entire disposal for any question or assistance that you may need.
The undersigns confirm that this notice has been reported to the appropriate Regulatory Agency.
Please accept our apologies for the inconvenience it may have caused.
Yours faithfully
Isabelle Prévost
Quality Manager
Dr Monique Manche
Materiovigilance Contact Person Thomas Decoster
President
This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred.
This means, if you are a distributor, that this information has to be forwarded to any customers which was delivered with one of the affected batches.
Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action.
1 rue de l’Espoir 59260 LEZENNES - France Tel +33 3 20 67 67 67 Fax + 33 3 20 67 67 68 Email [email protected]
FSN_Annex 1_ANIOS_EN_EX EU
ANNEX I CUSTOMER REPLY FORM
1. Field Safety Notice (FSN)
FSN Reference:
FSN_ANIOS_SSP_DISTRIBUTORS_EN_EX EU
FSN Date: November 7, 2019
Affected products: Please refer to Annex II
2. Customer Details
Customer Number
Healthcare Organisation Name*
Organisation Address*
Department/Unit
Shipping address if different to above
Contact Name*
Title or Function
Telephone number*
Email*
Print Name*
Signature*
Date*
Mandatory fields are marked with *
FSN_Annex 1_ANIOS_EN_EX EU
3. Customer action undertaken on behalf of Healthcare Organisation
I confirm receipt of the Field Safety Notice (FSN) and that I read and understood its content.
I performed all actions requested by the FSN.
The information and required actions have been brought to the attention of all relevant users and
executed, including end customers in case of distribution of those products
I informed the supplier of the stock I have that is subject of the recall and needs to be returned
PERSON OF CONTACT FOR RETURN OF GOOD: _______________________________
EMAIL OF CONTACT: ______________________________________________________
PHONE NUMBER OF CONTACT: _____________________________________________
Device Commercial Name Article Code Batch N° Packages Quantity (units)
No affected devices are available for return
Other Action (Define):
4. Return acknowledgement to sender
Email [email protected] Postal Address Laboratoires ANIOS
Service qualité 1, rue de l’Espoir 59260 Lezennes - France
Fax +33 3 20 67 67 68Deadline for returning the customer reply form 05/12/2019
It is important that your organisation takes the actions detailed in the FSN and confirms that you have received the FSN. Your organisation's reply is the evidence we need to monitor the progress of the corrective actions
1. Field Safety Notice (FSN)
FSN Reference:
FSN_ANIOS_SSP_DISTRIBUTORS_EN_EX EU
FSN_ANIOS_SSP_DISTRIBUTORS_EN_EX NON EU
FSN Date: November 7, 2019
Reply form: Please refer to Annex I
2. Affected Products Batches
Device Commercial Name Packaging Article code Batch numberA01510SA13802SA26023SA34406SB17802SA03211SA04305SA13618SA15503SA16218SA17927SA19214SA23419SA26405SA29904SA33705SA34426SA36127SB01906SB02902SB04605SB05712SB08702SB10629SB13323SB14414SB16327SB17802S
1 rue de l’Espoir 59260 LEZENNES FranceTel +33 3 20 67 67 67Fax + 33 3 20 67 67 68E:mail [email protected]
ANNEX IIAFFECTED PRODUCTS BATCHES
SURFA'SAFE PREMIUMcontained in
BACCIDE KIT PRO
12x750ML 2524326
ECI MND PREMIUM 12x750ML 2722371
1/14 FSN_Annex 2_ANIOS_EN
Device Commercial Name Packaging Article code Batch numberB19604SB23213SB26920SW33210SW34906SA00807SA01510SA02505SA04322SA05308SA06406SA08805SA10013SA10123SA10303SA11002SA11204SA13713SA15503SA16218SA17106SA18508SA21915SA22213SA22907SA23419SA23703SA26803SA28403SA29211SA29904SA31018SA31309SA32204SA34106SB00406SB01405SB02902SB03721SB04807SB05712SB06909SB07719SB08702SB10101SB11318SB12808SB14828SB17118SB17803SB19126SB20807SB23213SB23907SB24304S
INTRUNET SURFA SAFE PREMIUM
12x750ML 2585544E2
2/14 FSN_Annex 2_ANIOS_EN
ECI MND PREMIUM 12x750ML 2722371
Device Commercial Name Packaging Article code Batch numberW30805SW31810SW32023SW35411SW36314SA01024SA01711SA02907SA04420SA05209SA05919SA08017SA08601SA10013SA11313SA11502SA11612SA13908SA14222SA15601SA15803SA16218SA16526SA16909SA17821SA18508SA19013SA20005SA21202SA22011SA26111SA26803SA27906SA28910SA29616SA31309SA32204SA33103SA34406SA35220SB00724SB01906SB03123SB03721SB05014SB06909SB07108SB07909SB08906SB09306SB11616SB13509SB14828SB15509SB17511S
SURFA'SAFE PREMIUM 12x750ML 2419326
3/14 FSN_Annex 2_ANIOS_EN
INTRUNET SURFA SAFE PREMIUM
12x750ML 2585544E2
Device Commercial Name Packaging Article code Batch numberB17826SB19126SB20510SB23213SB23424SB24716SB25008SB26920SB27424SW31203SW32206SW33925SW34906SW35411SA02505SA08017SA08601SA11313SA11502SA13908SA14911SA18508SA22011SA28227SA32320SA34106SB01906SB06323SB06909SB10724SB12606SB14414SB15509SB18102SB19718SB22416SB25008SW32206SW34809SW34906SA05209SA08017SA13802SA18401SA21202SA28227SA28910SA31309SB00406SB02902SB04605SB06909SB08906SB14414SB19604S
2419326EZ
2419326HQ
4/14 FSN_Annex 2_ANIOS_EN
SURFA'SAFE PREMIUM 12x750ML 2419326
Device Commercial Name Packaging Article code Batch numberB22416SB26920SW31203SW36314SA00408SA00807SA00928SA01024SA01510SA01711SA02404SA02505SA02907SA03613SA04322SA04420SA04606SA05209SA05308SA05720SA05919SA06406SA06816SA07424SA08017SA08210SA08601SA08805SA09420SA09520SA10013SA10123SA10303SA11002SA11204SA11313SA11612SA13202SA13417SA13618SA13713SA13802SA14222SA15211SA15503SA15601SA15703SA15803SA16909SA17106SA17404SA17613SA17715SA17821SA17927S
2419544
5/14 FSN_Annex 2_ANIOS_EN
SURFA'SAFE PREMIUM 12x750ML 2419326HQ
Device Commercial Name Packaging Article code Batch numberA18401SA18601SA19013SA19214SA19408SA20005SA20615SA21202SA21403SA21915SA22213SA22613SA22907SA23419SA23703SA24309SA24610SA26405SA26803SA26827SA27906SA28227SA28314SA28403SA28417SA28910SA29211SA29616SA29810SA29904SA31018SA31309SA31412SA31706SA31819SA32204SA32320SA32501SA32620SA32905SA33103SA34106SA34406SA34426SA34619SA34722SA34905SA35220SA35324SB00406SB00724SB00827SB01016SB01714SB01906S
6/14 FSN_Annex 2_ANIOS_EN
SURFA'SAFE PREMIUM 12x750ML 2419544
Device Commercial Name Packaging Article code Batch numberB02902SB03123SB03721SB04605SB04807SB05014SB05301SB05507SB05712SB07318SB07719SB07909SB08016SB08702SB08906SB09306SB10101SB10521SB10724SB11208SB11318SB11616SB12312SB12606SB12808SB12919SB13323SB13509SB14716SB15102SB15509SB15701SB16427SB17118SB17511SB17803SB17826SB18102SB18604SB19032SB19126SB19916SB20310SB20529SB20807SB21121SB21228SB21403SB21924SB23907SB24118SB24304SB24716SB25008SB25326S
7/14 FSN_Annex 2_ANIOS_EN
SURFA'SAFE PREMIUM 12x750ML 2419544
Device Commercial Name Packaging Article code Batch numberB25609SB26109SB27424SB28014SB28203SW30618SW30805SW31105SW31203SW31810SW32023SW32206SW32510SW32810SW33422SW33925SW34701SW34809SW34906SW35309SW35612SW36314SA04305SA08017SA13802SA17927SA21202SA22613SA10123SA14222SA16909SA17927SA31004SA31018SA31309SB04605SB07108SB08702SB10629SB20807SB23907SB25609SW31810SA05308SA06816SA11204SA12712SA13802SA20005SA22213SA26803SA28314SA31819SA32501SB10521S
2419544BA
2419544BR
2419544D2
8/14 FSN_Annex 2_ANIOS_EN
SURFA'SAFE PREMIUM 12x750ML 2419544
Device Commercial Name Packaging Article code Batch numberB12312SW36314SA00807SA18601SB15505SA15503SA21202SB17802SA01024SA05209SA05308SA05919SA06406SA09420SA09520SA11204SA13618SA13802SA15803SA17927SA18601SA21915SA26111SA28403SA29616SA29810SA31819SA32501SA33705SA34619SB00406SB00827SB00909SB01405SB04105SB05712SB06909SB07909SB08702SB10724SB12919SB15509SB16327SB16906SB17802SB19126SB19206SB19604SB19916SB20529SB21924SB23424SB24716SB26109SW31203S
2419544GA
2419544HA
2419544HD
9/14 FSN_Annex 2_ANIOS_EN
SURFA'SAFE PREMIUM 12x750ML 2419544D2
Device Commercial Name Packaging Article code Batch numberW33210SW35612SA05209SA12712SA15503SA19013SA22907SA29211SA31018SA34106SB04105SB04605SB10724SB11616SB15102SB16327SB19206SB22416SW31810SW33210SW34701SA05919SA26111SA28314SB01714SB19126SA01711SA06406SA19214SA22213SA34619SB01906SB02902SB04605SB07108SB10724SB15102SB19126SB21924SW31810SW36314SA04322SA13202SA19214SA23419SA34722SB07318SB15102SB19206SB23424SW30805SW32023SB11616SB23907SB24304S
2419544T4
2419544UE
2419544UO
2419544UY
2419544S6
10/14 FSN_Annex 2_ANIOS_EN
SURFA'SAFE PREMIUM 12x750ML 2419544HD
Device Commercial Name Packaging Article code Batch numberB26920SA02907SA05919SA08805SA11002SA15503SA15803SA18401SA21403SA22907SA26111SA28403SA28417SA31018SA33705SA34619SB00406SB00909SB03123SB04105SB08421SB08702SB10101SB10724SB12919SB16906SB18102SB20807SB28014SW33210SW33422SW33925SW36314SA00415A01911
A03613SA05380SA06816SA08210SA11502SA12712SA14911SA15803SA16307SA16526SA17106SA17927SA18508SA20005SA21212SA21502SA23320SA23703SA26503SA28314S
2419544UZ
16X500ML 2419105
11/14 FSN_Annex 2_ANIOS_EN
SURFA'SAFE PREMIUM 12x750ML 2419544UY
Device Commercial Name Packaging Article code Batch numberA31004SA31309SA33103SA34106SA35513SA36127SB00827SB01714SB02207SB03028SB05121SB06323SB07318SB08421SB10629SB12312SB13509SB14414SB15505SB16327SB19206SB19718SB20510SB21121SB23213SB25326SB25915SW31810SW32206SW33210SW34906SW35411SA00415
A06816SA23320SB01714SB15505SB16327SB23213SA03613SW34906S
1X5L 2419922 W31810SA01024SA01510SA01711SA02907SA06406SA08805SA10013SA10303SA11002SA13202SA13618SA14222SA15503S
1X500ML 2419982
1X50ML 2419874
1X750ML 2419890
12/14 FSN_Annex 2_ANIOS_EN
SURFA'SAFE PREMIUM 16X500ML 2419105
Device Commercial Name Packaging Article code Batch numberA18601SA21403SA22213SA24309SA26405SA27906SA28227SA28403SA31018SA33103SB03721SB07719SB09306SB12808SB14716SB15701SB18604SB21403SB25609SW30618SW30805SW31105SW33925SW34809S
2419890UY W34809SA00928SA01024SA01711SA02907SA05919SA08805SA15601SA26111SA31309SB06909SB08906SB17511SW30618SW30805SW31105SW33925SW34809SA01711SW30618SW31203SW36314SA03211SA10815SA16307SA19408SA21502SA30910SA34406SB02207SB09202S
4X5L 2419028
2419892
2419892HQ
13/14 FSN_Annex 2_ANIOS_EN
SURFA'SAFE PREMIUM 1X750ML 2419890
Device Commercial Name Packaging Article code Batch numberB10629SB12606SB17826SB19718SB24304SW31810SA23320SB02207SB24304S
2419028HR
14/14 FSN_Annex 2_ANIOS_EN
SURFA'SAFE PREMIUM 4X5L 2419028