Field Safety Notices (FSNs): 17/02/25 – 21/02/25

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: Stokke® YOYO 3 Pram (2410-0182)

Section 2: medical devices 17/02/25 – 21/02/25

1. Abbott: Assurity, Endurity 45689 Dual -chamber impl. pm Model: PM1140, PM1152, PM1160, PM1162, PM1172, PM1272, PM2140, PM 2152, PM2162, PM2172, PM2240, PM2272 MHRA reference: 34767642   2025/002/014/601/040
2. Baxter: Welch Allyn non-automated blood pressure gauges 19th February 2025 Model: See Attachment A MHRA reference: 34773300
3. BD: BD PCR Cartridge 15th January 2025 See comments Model: < Add model (normal style)> MHRA reference: 34747586   2024/012/013/601/040
4. Beckman Coulter: DxI 9000 Access Immunoassay Analyzer 7th February 2025 See Section 8 MHRA reference: 34764500   2025/002/018/601/065
5. Beckman Coulter: DxI 9000 Access Immunoassay Analyzer 7th February 2025 Chemiluminescent Immunoassay Model: < Add model (normal style)> MHRA reference: 34787668   2025/002/019/601/140
6. Cook Medical: Hemospray Endoscopic Hemostat 12th February 2025 Non-organic haemostatic agent, sterile MHRA reference: 34776985   2024/010/023/601/109 MHRA reference: 34776985   2024/010/023/601/109  
7. GCE: GCE Combi valve 22nd July 2022  MHRA reference: 34786931   2025/002/013/601/070
8. Human Care: Altair Lifting Solutions 26th November 2025 Overhead track patient lifting/transfer system MHRA reference: 34783023   2025/002/018/601/033
9. Medtronic: Microstream Advance and Luer Sampling Lines  FA1432 Class I: R9099, Class IIa: R03010204, R9099 Model: < Add model (normal style)> MHRA reference: 34774533   2025/002/019/601/080
10. Siemens Healthineers: Atellica CH Diluent 45689 Buffered sample diluent IVD Model: N/A MHRA reference: 34747627   2025/002/017/601/033 MHRA reference: 34747627   2025/002/017/601/033 – Customer letter
11. Smiths Medical: Intubation ORAL/NASAL Endotracheal Tube 19th February 2025 Basic endotracheal tube, single-use Model: See FSN MHRA reference: 34737817   2025/002/014/601/038

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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