Field Safety Notices (FSNs): 19/01/26 – 23/01/26

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)

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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

None

Section 2: medical devices 19/01/26 – 23/01/26

1. Acumed: Olecranon Plates 46021 MHRA reference: 38187950 2025/012/031/601/013
2. Beckman Coulter: CellMek SPS 45992 AUTOSAPLERS MHRA reference: 38153357 2025/012/022/601/155
3. Boston Scientific: AXIOS Stent and Delivery System 45992 Transenteric Drainage Tube MHRA reference: 38244929 2025/012/017/601/078
4. Datascope: CS100 and CS300 Intra-Aortic Balloon Pumps 46023 Circulatory assist system, intra-aortic balloon Model: 0998-XX-3013-XX; 0998-XX-3023-XX MHRA reference: 38302275 2026/001/023/601/098
5. Datex-Ohmeda: Carestation 600 and 700 Series Ref. # 34143 Anaesthesia workstation, general-purpose MHRA reference: 38231974 2025/012/009/601/071
6. Drägerwerk: Set2go Ventilation 50 (A)nd 46023 MHRA reference: 38282849 2026/001/021/601/061
7. Derma Sciences: Dry skin moisture barrier dressing 46030 MHRA reference: 38172860 2026/001/007/601/024 Distributor letter MHRA reference: 38172860 2026/001/007/601/024 Medical facilities letter
8. Fannin/Poly Medicure: Fannin Double chambered Blood Sets 46037 MHRA reference: 38231351 2026/001/013/601/029
9. Instrumentation Laboratory: GEM Premier 5000 PAK 46042 Multiple blood gas/haemoximetre MHRA reference: 38256700 2026/001/020/601/116
10. JRI Orthopaedics: ACE Cup Introducer M7 46008 Orthopaedic implant inserter/extractor, reusable MHRA reference: 38275501 2025/012/017/601/060
11. Microbiologics: KWIK-STIK and LYFO DISK controls 46038 Multiple bacteria species identification control Model: KWIK-STIK 2-Pack Campylobacter jejuni subsp. jejuni derived MHRA reference: 38236216 2025/012/030/601/061
12. Olympus: CleverCut and FlowCut Sphincterotomes 46045 MHRA reference: 38245079 2026/001/019/601/073
13. Olympus: High Flow Insufflation Unit 46050 Laparoscopic insufflators Model: UHI, UHI-2, UHI-3 MHRA reference: 38302144 2026/001/023/601/087
14. Stryker: STRYKEFLOW2 46023 STRYKEFLOW2 WITH /without DISPOSABLE TIP MHRA reference: 38233287
15. SunTech UK: eFOLDi Powerchair 46043 Model: HBLD3-D MHRA reference: 38306008 2026/001/023/601/030

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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