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Field Safety Notices (FSNs): 26/01/26 – 30/01/26

IRICIncident Reporting &
Investigation Centre

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 Recall: Counterfeit SOPPYCID Refillable Water Balloon sold via Fruugo (2505-0031) updated

2.     Product Safety Report: Ethan the Fox Teether (2507-0081)

Section 2: medical devices 26/01/26 – 30/01/26

  1. Andersen Caledonia: Sharp Safe Intravitreal Injection Needle 46015 Model: SPY 712 MHRA reference: 38285567 2025/012/024/601/039
  2. Baxter: EVO IQ Large Volume Pump 46050 Model: ELVP002UKI and 04400121200 MHRA reference: 38329736 2026/001/019/601/021
  3. BD: Alaris VP Infusion Sets 46043 Infusion Pump Administration Set MHRA reference: 38309876 2026/001/014/601/056
  4. Cepheid: Xpert Carba-R 46031 MHRA reference: 38324139 2026/001/027/601/045
  5. Edan Instruments: Patient Monitoring and Fetal Monitoring Devices 46049 MHRA reference: 38324626 2026/001/027/601/003
  6. Hologic: Brevera® Breast Biopsy System Disposable 9 Gauge N 46029 Mammographic stereotactic biopsy system Model: BREVDISP09 SDM-SYS-9000-3D MHRA reference: 38246814 2025/012/019/601/061
  7. Medtronic: Vanta with AdaptiveStim Technology 45992 Model: 977006 MHRA reference: 38189539 2022/004/001/291/003
  8. Merit Medical Systems: BasixCOMPAK Inflation Device 45986 Catheter-balloon inflator, single-use MHRA reference: 38308879 2025/012/011/601/068
  9. OrthoPediatrics: Rail Drive Mechanism 46037 Model: 20-2012 MHRA reference: 38332647 2026/001/028/601/071
  10. QIAGEN: QIAstat-Dx Respiratory SARS-CoV-2 Panel 45988 A collection of reagents and other associated MHRA reference: 38324901 2026/001/027/601/118
  11. Zhermack: Aquasil Putty Hard and Aquasil Putty Soft 46048 MHRA reference: 38347191 2026/001/029/601/156 Customer letter MHRA reference: 38347191 2026/001/029/601/156 Distributor letter

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

Page summaryChange(s) made
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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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