Medical Device Alert

Ref: MDA/2011/043 Issued: 11 May 2011 at 15:30

Device Surgical gloves Biogel Eclipse Reveall(608) Manufactured by Molnlycke Health Care. Specific lots and NHS Supply codes (see appendix). Problem
The manufacturer issued a Field Safety Notice (FSN) for this product in April 2011, but has not had sufficient confirmation from users that they have received and acted on this information. A copy of the FSN is in the appendix of this alert, and it is available on the MHRA website. This alert has been issued in support of the manufacturers actions.

Action
Ensure that relevant members of staff are aware of the problem. Carry out the actions described in the manufacturers FSN, including sending any confirmation requests. Customers in England may also have received a Customer Notice from NHS Supply Chain Ref ICN 2011/152

Action by
All staff using these gloves, suppliers and distributors

CAS deadlines
Action underway: 25 May 2011 Action complete: 10 June 2011

Contact
Manufacturer Caroline Price Molnlycke Healthcare Tel: 0161 777 2679 Fax: 0161 777 2601 Email: caroline.price@molnlycke.com

Medicines and Healthcare products Regulatory Agency

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Ref: MDA/2011/043

Distribution
This MDA has been sent to: NHS trusts in England (Chief Executives) Care Quality Commission (CQC) (Headquarters) for information HSC trusts in Northern Ireland (Chief Executives) NHS boards in Scotland (Equipment Co-ordinators) NHS boards and trusts in Wales (Chief Executives) Primary care trusts in England (Chief Executives)

Onward distribution
Please bring this notice to the attention of relevant employees in your establishment. Below is a suggested list of recipients. Trusts
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including: Accident and emergency All departments All staff All theatres All wards Ambulance staff Clinical pathology directors Day surgery units Dental departments Infection control nurses Medical directors Nursing executive directors Purchasing managers Risk managers Supplies managers

Primary care trusts

CAS liaison officers for onward distribution to all relevant staff including: Community hospitals District nurses General dental practitioners General practitioners Health protection units Health visitors Infection control nurses NHS walk-in centres Practice managers Practice nurses

Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by: Clinics Hospices Hospitals in the independent sector Independent treatment centres Private medical practitioners

Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Healths Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Medicines and Healthcare products Regulatory Agency

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Contacts
Manufacturer Caroline Price Molnlycke Health Care Two Omega Drive Irlam Greater Manchester M44 UK 5BJ Tel: 0161 777 2679 Fax: 0161 777 2601 Email: caroline.price@molnlycke.com

England
If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2011/043 or 2011/004/026/081/013 The NHS Supply Chain issued a Customer Notice on April 21 2011 about the recall and can give advice on alternative suppliers; contact your local customer services representative, quoting reference ICN 2011/152 Technical aspects Mojisola Ajeneye or Sally Mounter Medicines & Healthcare products Regulatory Agency Floor 4 151 Buckingham Palace Road London SW1W 9SZ Tel: 020 3080 7271 / 7168 Email: mojisola.ajeneye@mhra.gsi.gov.uk sally.mounter@mhra.gsi.gov.uk

Clinical aspects Jonathan Plumb Medicines & Healthcare products Regulatory Agency Floor 4 151 Buckingham Palace Road London SW1W 9SZ Tel: 020 3080 7128 Email: jonathan.plumb@mhra.gsi.gov.uk

How to report adverse incidents

Please report via our website http://www.mhra.gov.uk Further information about CAS can be found at https://www.cas.dh.gov.uk/Home.aspx

Medicines and Healthcare products Regulatory Agency

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Northern Ireland
Alerts in Northern Ireland will continue to be distributed via the NI SABS system. Enquiries and adverse incident reports in Northern Ireland should be addressed to: Northern Ireland Adverse Incident Centre Health Estates Investment Group Room 17 Annex 6 Castle Buildings Stormont Estate Dundonald BT4 3SQ Tel: 02890 523 704 Fax: 02890 523 900 Email: NIAIC@dhsspsni.gov.uk http://www.dhsspsni.gov.uk/index/hea/niaic.htm In Northern Ireland the Regional Procurement Pharmacist (Pharmacy & Medicines Management Centre) and/or Procurement and Logistics Service (Pals) can give advice on alternative suppliers if appropriate.

How to report adverse incidents in Northern Ireland

Please report directly to NIAIC, further information can be found on our website http://www.dhsspsni.gov.uk/niaic Further information about SABS can be found at http://sabs.dhsspsni.gov.uk/

Scotland
Enquiries and adverse incident reports in Scotland should be addressed to: Incident Reporting and Investigation Centre Health Facilities Scotland NHS National Services Scotland Gyle Square 1 South Gyle Crescent Edinburgh EH12 9EB Tel: 0131 275 7575 Fax: 0131 314 0722 Email: nss.iric@nhs.net http://www.hfs.scot.nhs.uk/online-services/incident-reporting-and-investigation-centre-iric/ In Scotland the National Distribution Centre (NDC) and/or National Procurement can give advice on alternative suppliers if appropriate.

Medicines and Healthcare products Regulatory Agency

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Wales
Enquiries in Wales should be addressed to: Dr Sara Hayes Senior Medical Officer Medical Device Alerts Welsh Assembly Government Cathays Park Cardiff CF10 3NQ Tel: 029 2082 3922 Email: Haz-Aic@wales.gsi.gov.uk

MHRA is an executive agency of the Department of Health Crown Copyright 2011 Addressees may take copies for distribution within their own organisations

Medicines and Healthcare products Regulatory Agency

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Appendix
April 2011

Voluntary Product Recall - Biogel Eclipse Reveal (608)

We have received a small number of reports from customers overseas that pinholes have been found on the package seal of the Biogel Eclipse Reveal gloves. No reports have originated from the UK. Furthermore, no pinholes have been found on any other Biogel brand within our wide assortment of surgical gloves. Mlnlycke Health Care acknowledges these customer reports and takes the issue very seriously and we are devoting a large amount of our resources to find the root cause of this issue. We have therefore decided to carry out a voluntary recall for all affected batch numbers of Biogel Eclipse Reveal System gloves that have been delivered to customers in the UK since September 2010. We have decided to take this precautionary measure as a responsible course of action to assure you the highest possible standard of quality. The appropriate health authorities have been informed and we are asking customers to contact their relevant distributor in the UK to return any remaining stock of the affected batch numbers, which your distributor will be able to advise you. All affected stock in our central warehouse has been quarantined, however, we are immediately able to supply unaffected replacement stock to customers to ensure continuation of supply. Mlnlycke Health Care has a wide range of surgical products and we focus on operating room efficiency where safe and effective procedures are the most important aspect to us for patients and health care workers. Our Biogel surgical gloves are designed to meet the highest quality specification for a surgical glove, above the various regulatory standards required for surgical gloves. We are the only major surgical glove manufacturer to test every single glove for holes by air inflation and visually inspect for quality and user confidence. Finally, your distributor should be in contact with you shortly to arrange collection of any remaining batches within your facility and delivery of replacement stock. Thank you for your co-operation in this matter. Yours sincerely, Mlnlycke Health Care

Torbjrn Turland Biogel Product Manager UK email: torbjorn.turland@molnlycke.com

Medicines and Healthcare products Regulatory Agency

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Biogel Eclipse Reveal Size 5.5 6.0 6.5 7.0 7.5 8.0 8.5 Code 60855 60860 60865 60870 60875 60880 60885

Ref: MDA/2011/043
NHS SC Code FTE695 FTE697 FTE698 FTE700 FTE703 FTE704 FTE705

Medicines and Healthcare products Regulatory Agency

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Important CustomerNotice
NHS Supply Chain recall ref: 004
Ref:ICN2011/152 21stApril2011

VoluntaryProductRecallBiogelEclipseReveal(608)
NHSSupplyChainwishestonotifycustomersthatMlnlyckeHealthCarehavereceivedasmallnumberof reports from customers overseas that pinholes have been found on the package seal of the Biogel Eclipse Reveal gloves. No reports have originated from the UK. Furthermore, no pinholes have been found on any other Biogel brand within their wide assortment of surgical gloves. Please click here for copy of supplierletter Mlnlycke Health Care acknowledges these customer reports and take the issue very seriously and is devoting a large amount of resource to find the root cause of this issue. Mlnlycke Health Care have therefore decided to carry out a voluntary recall for all affected batch numbers of Biogel Eclipse Reveal System gloves that have been delivered to customers in the UK since September 2010. Mlnlycke Health Care has decided to take this precautionary measure as a responsible course of action to assure you the highestpossiblestandardofquality. MlnlyckeHealthCareisimmediatelyabletosupplyunaffectedreplacementstocktocustomerstoensure continuationofsupply.PleasecontactyourNHSSupplyChainCustomerServiceAdvisor. TheBiogelsurgicalglovesaredesignedtomeetthehighestqualityspecificationforasurgicalglove,above the various regulatory standards required for surgical gloves. Mlnlycke Health Care is the only major surgical glove manufacturer to test every single glove for holes by air inflation and visually inspect for qualityanduserconfidence. Pleasenotethatthisrecallislimitedtothespecificcodesandlotnumbersonly,noothercodessuppliedby MlnlyckeHealthCareareaffected. Foraffectedlotnumberspleaseclickhere Please pass this notice on to all those who need to be aware within your organisation or to any organisationwherethepotentiallyaffecteddeviceshavebeentransferred.

Medicines and Healthcare products Regulatory Agency Page 8 of 9

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ActionRequired

Ref: MDA/2011/043

1) Identifyifyouhaveanyofthepotentiallyaffecteddevices 2) Quarantinetheproduct 3) ContactyourlocalNHSSupplyChainCustomerServiceTeamtoarrangereturnquotingReason Code7SupplierRecall 4) AllreturnstobebackbyFriday20thMay2011forbothfullandpartpacks

BiogelEclipseReveal Size 5.5 6.0 6.5 7.0 7.5 8.0 8.5 Code 60855 60860 60865 60870 60875 60880 60885 NHSSCCode FTE695 FTE697 FTE698 FTE700 FTE703 FTE704 FTE705

Forfurtherinformation,pleasecontactyourlocalNHSSupplyChainCustomerServiceTeam(clickherefor contactdetail).

Medicines and Healthcare products Regulatory Agency

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