Field Safety Notices (FSNs): 12/05/25 – 16/05/25

Manufacturers’ Field Safety Notices

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DL1 NHS Incidents and alerts Safety Officers

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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 12/05/25 – 16/05/25

1. Cook Incorporated: Cook Beacon® Tip 5.0 Fr Angiographic Catheter 45790 FSN & FSCA Ref: 2025FA0003 Angiographic catheter, single-use Model: Refer to Attachment 1 – Product Information Table MHRA reference: 35554112   Attachment 1 – Product Information Table MHRA reference: 35554112   Customer reply form MHRA reference: 35554112   FSN 2025/005/012/601/068
2. Copan Italia S.p.A.: BD BBL™ CultureSwab™ EZ Collection & Transport System 45779 FSN Ref: FSN-2025-0001 Model: 220144 MHRA reference: 35565678   Appendix 1 –  2025/005/013/601/060    MHRA reference: 35565678   FSN
3. GE Healthcare: MUSE 5 systems GE HealthCare Ref. # 30116 Cardiology information system application software Model: Refer to FSN MHRA reference: 35541456   2025/005/009/601/087
4. Löwenstein Medical SE: Leoni plus transport 45785 FSCA2025015 Baby Ventilator Model: Refer to FSN MHRA reference: 35543098   2025/005/009/601/027
5. Medtronic, Inc: Non-Implanted Medtronic Azure™ S DR Implantable Pulse Generators (IPGs) 45748 Medtronic Reference: FA1490 Model: W3DR01, GTIN 00763000956004 Serial Number: RNJ108800G, RNJ108808G, RNJ108810G MHRA reference: 35531854   Customer Contact Record MHRA reference: 35531854   FSN   – 2025/004/007/601/088
6. NHSBT Reagents: Copper Sulphate Solution for Blood Donor Haemoglobin Screening 45790 FSN Ref: QI44365 HAEMOGLOBIN (HB) Model: Refer to FSN MHRA reference: 35565448   2025/005/009/601/063
7. Peter Brehm GmbH: Impactor, iliac peg – MRS-TITAN Maximum 45796 FSCA-20250502 Prosthesis implantation instrument, orthopaedic Model: Refer to FSN MHRA reference: 35599227   2025/005/015/601/064
8. Rocamed France: Endoflow II – Irrigation and Warming System FSN Ref: FSN Endoflow CP22 ‘Instruction for use’ reinforcement Model: Refer to FSN MHRA reference: 35595209   2025/005/015/601/096
9. SHAOXING YIBON MEDICAL CO., LTD.: Cup 45757 Rev 1: September 2018 Medical container or receiver, for washing or holding liquid, instruments, dressings.. Model: Refer to FSN MHRA reference: 35558903   2025/002/025/601/001

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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