Field Safety Notices (FSNs): 03/11/25 – 07/11/25

Manufacturers’ Field Safety Notices

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DL1 NHS Incidents and alerts Safety Officers

DL2 Local Authority Incidents and alerts Safety Officers

DL3 Specialist Liaison Group

DL4 Product Specialists

DL5 General list (internal)

DL7 General list (external)

Outlook tags     IRICSW$i0 (safety alert – general), IRICSW$i5 (field safety notices)

This message is sent to share information on manufacturers’ field safety notices (FSNs) which have been brought to our attention. Manufacturers have a legal duty to distribute these notices to affected customers.

This message does not affect the manufacturer’s FSN distribution, but it provides a reference source to check against.

You should always contact your supplier or the manufacturer if you are affected by a field safety notice listed below but have not received it from them. This will help ensure that you are not also missed from future FSN distributions. Note that field safety notices will only be listed in the sections below if we have been made aware of them.

Section 1 below lists selected FSNs and other relevant safety updates for estates, facilities or general products which have been brought to our attention through various sources including Office for Product Safety and Standards (OPSS). Section 2 lists FSNs for medical devices brought to our attention specifically by Medicines and Healthcare products Regulatory Agency (MHRA).

Section 1: estates, facilities or general products

1.     Product Safety Report: Audio-Technica Wireless Headphones ATH-CKS50TW2 (2507-0028)

2.     Product Recall: Valiant Radiator Fan sold via Amazon, eBay, Temu, B&Q, Debenhams, The Range and TikTok Shop (2510-0238)

3.     Product Safety Report: Borg & Overstrom E4 Range Water Dispenser (2510-0228)

4.     Product Recall: Stihl BR 800 Backpack Blower (2511-0019)

5.     Product Safety Report: Lila Grace Dots and Stripes Cherry Blossom Scented Hand Sanitiser sold by The Range (2510-0135)

Section 2: medical devices 03/11/25 – 07/11/25

1. AL.CHI.MI.A. S.r.l: GOT multi: Update to FSN 35236225 45957 Vitreous humour replacement medium, post-operative MHRA reference: 37531226 2025/004/003/601/027
2. Becton Dickinson: BD BACTE MGI 960 PZA Kit 45965 Multiple antibacterial minimum inhibitory concentr MHRA reference: 37532370 2025/011/003/601/017
3. C.R. Bard: InLay Optima Ureteral Stent 45967 Polymeric ureteral stent MHRA reference: 37522290 2025/010/031/601/029
4. Datascope: Cardiosave Intra-Aortic Balloon Pumps 45852 circulatory assist system, intra-aortic balloon MHRA reference: 37534784 2024/004/005/601/132
5. Hill-Rom: Accella 45964 Model: P006789A, P006792A, P006793A, P006788A60001, P006788A60002, P006788A60004 MHRA reference: 37533445 2025/010/030/601/084
6. Kerr Italia: ZenFlex Rotary File 45967 Rotary/reciprocating endodontic file, single-use MHRA reference: 37563156 2025/011/006/601/107
7. LivaNova: Symmetry VNS Therapy Generator 45952 Model: 8103 MHRA reference: 37521929 2025/010/023/601/001
8. Medtronic: Aurora EV-ICD MRI SureScan October 2025 FA1511 MHRA reference: 37519680 2025/010/010/601/059
9. Nexus Astraia B.V. (formerIy ICT Healthcare Technology Solutions B.V.): Mosos CTG 15000-25-01-EN MHRA reference: 37548911 2025/011/005/601/040
10. Tandem Diabetes Care: t:slim X2 Insulin Pump: Update to FSN 37303371 45964 Ambulatory Insulin Infusion pump, electronic MHRA reference: 37553272 2025/008/005/601/063
11. TEKNIMED: ESOBLOCK Ø12mm 45961 Polymer orthopaedic cement restrictor bioabsorbable MHRA reference: 37543594 2025/011/004/601/040
12. VIAM: Juvelook / Lenisna 45933 Model: Juvelook / Lenisna200 MHRA reference: 37529623 2025/010/020/601/001

The above list of FSNs for medical devices is copied from the relevant MHRA web page. If you wish to browse or search for FSNs on the MHRA website, please click here. 

Section 3: updates and changes to previously published medical device FSNs

Adverse Incidents

Incidents and near-misses should always be reported to local incident management systems (often referred to as Datix, Ullyses, SHE, etc.). However, IRIC also needs to be informed about incidents and near-misses when they involve:

• Medical devices, e.g. infusion pump, central line, hoist, care bed, x-ray machine, ventilator
• In vitro diagnostic devices or IVDs, e.g. blood analyser, reagent, SARS-CoV-2 test kit
• Estates and facilities, e.g. electrical installations, window restrictors, nurse call systems
• Social care equipment, e.g. mobile wheeled commode, powered rise and recline chair
• Personal protective equipment or PPE, e.g. visors, FFP3 respirators, aprons

We need incident reports so we can work with manufacturers and our partners to stop the same thing happening again. Health and care professionals can also report safety concerns about equipment and devices when an incident or near-miss has yet to occur. Information about how to report an incident to IRIC can be found here: https://www.nss.nhs.scot/health-facilities/incidents-and-alerts/report-an-incident/  

Kind regards

Incident Reporting & Investigation Centre (IRIC)

NHSScotland Assure

NHS National Services Scotland

Tel: 0131 275 7575 | nss.iric@nhs.scot 

IRIC operates incident learning and prevention systems for health and care technologies (medical devices, IVDs, estates, facilities, social care equipment and PPE). Find out more in CEL43 (2009), explore our educational content on Turas Learn or visit our website to: report an incident, find our safety alerts, or watch our short Intro to IRIC video

We are NHS National Services Scotland. We offer a wide range of services and together we provide national solutions to improve the health and wellbeing of the people of Scotland. Find out more in our NSS Strategic Framework 2024-2026

FAC406-212, 8B(i), Rev 7

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