Field Safety Notices (FSNs): 20/10/25 – 24/10/25

Manufacturers’ Field Safety Notices

Circulation

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 Recall: Q’STRAINT Wheelchair Securement Retractors (2510-0101)

2.     Product Safety Report: Knitted Baby Sleeping Bag sold via Grandado (2509-0205)

3.     Product Safety Report: BeyBee Baby Sleeping Bag sold via Desertcart

4.     Warning of new variant of dangerous baby self-feeding products

5.     Product Recall: Henry Quick Corded Vacuum (2510-0171)

6.     Product Recall: JoJo Maman Bébé Trousers and Rompers

7.     Product Recall: Curaprox Baby Soother (2509-0332)

Section 2: medical devices 20/10/25 – 24/10/25

1. Baxter Healthcare SA: EVO IQ Large Volume Pump 15th August 2025 Bedside infusion pump, single-channel Model: ELVP001UKI MHRA reference: 37397515  2024/011/028/601/018 MHRA reference: 37397515  2024/011/028/601/018 – Customer reply form
2. Bio-Rad: Genie Fast HIV ½ 9th October 2025 HIV1/HIV2 antibody IVD, kit, (ICT), rapid  MHRA reference: 37398742
3. Cardinal Health 200, LLC: Kendall SCD™ 700 Sequential Compression System 22nd October 2025 Pneumatic Compression Equipment MHRA reference: 37418709   2025/010/021/601/128
4. Cepheid AB : Xpert HIV-1 Viral Load XC  13th October 2025 MHRA reference: 37419965    2025/010/021/601/052 
5. Cepheid AB : Xpert CT/NG 20th October 2025 MHRA reference: 37436381  2025/010/010/601/056
6. Datex-Ohmeda, Inc: Giraffe Omnibed Carestation CS1; Giraffe Omnibed 21st March 2025 Incubator, infant, stationary MHRA reference: 37420686  2024/010/011/601/027 MHRA reference: 37438630  2024/010/011/601/027
7. (Both FSNs are different and each FSN requires attention.) GE Ultrasound Korea, Ltd: LOGIQ P9 and P10 FMI 74084 Ultrasound System Imaging, General Purpose MHRA reference: 37444100 
8. HUMAN Gesellschaft für Biochemica und Diagnostica mbH: AUTOCAL 16th October 2025 Multiple-type clinical chemistry analyte profile I MHRA reference: 37398566 MHRA reference: 37398566 – reply form
9. KANEKA Corporation: Senri ™ balloon dilatation catheter 9th October 2025 MHRA reference: 37397044    2025/010/006/601/017
10. LivaNova USA, Inc. : Symmetry™ VNS Therapy™ Generator 22nd October 2025 Model 8103 MHRA reference: 37444383  2025/010/023/601/001  
11. Medical (Heartsine Technologies Ltd.): HeartSine samaritan Pad-Pak and Pediatric-Pak 06th October 2025 MHRA reference: 37396940   2025/009/023/601/053 
12. Remote Diagnostic Technologies Ltd : Tempus Pro 9th October 2025 Transportable physiologic monitoring system Model: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R MHRA reference: 37411962  2025/004/017/601/037 
13. SCHILLER AG : EASY PULSE 17th October 2025 Cardiac resuscitator, battery-powered Model: 3.940409 (GTIN: 07613365001853) 3.940410 (GTIN: 07613365001679) MHRA reference: 37400930
14. Shenzhen Mindray bio-medical electronics, ltd: V90 electronic vaporizer 13th October 2025 MHRA reference: 37398834  
15. Synthes GmbH, Oberdorf : MatrixMIDFACE & MatrixMANDIBLE 15th October 2025 Craniofacial bone screw, non-bioabsorbable Model: NA546-31-0000546-31-2000546-31-4000546-31-6000546-31-8000546-32-0000 MHRA reference: 37425126  2025/010/014/601/087

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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