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Field Safety Notices (FSNs): 12/01/26 – 16/01/26

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)

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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

1.     Product Safety Report: Dummy Clips sold via Amazon (2601-0146)

Section 2: medical devices 12/01/26 – 16/01/26

  1. Abaxis: Piccolo Xpress Chemistry Analyzer REF: 3006510 Clinical chemistry analyser Model: 1100-1001 MHRA reference: 38210770 2025/012/022/601/058
  2. Bard: Hickman/ Broviac Central Venous Catheters 46035 Centrally-inserted central venous catheter MHRA reference: 38161948 2025/012/019/601/106
  3. bioMérieux: VITEK 2 AST Test Kit 46037 General-microorganism antimicrobial susceptibility MHRA reference: 38200339 2026/001/013/601/022
  4. EVER Neuro Pharma: EVER Pharma D-mine Pump Reservoir 45986 MHRA reference: 38164857 2025/011/026/601/038
  5. Fysicon: DataLinQ (MDR Class I) 46000 Cardiology information system Model: DataLinQ 2PAD MHRA reference: 38185689
  6. Gambro: Prismaflex Sets 46034 Haemofilter, Apheresis filter MHRA reference: 38184515 2026/001/009/601/014
  7. Hamilton Medical: HAMILTON-C2 46035 Neonatal/adult intensive-care ventilator MHRA reference: 38217449 2026/001/015/601/061
  8. ICU Medical: Tego 46037 Haemodialysis tubing valve-connector Model: D1000 MHRA reference: 38183507 2026/001/012/601/013
  9. Klaxon Mobility: Klick REF: FSCA-01-2025 Wheelchair electric-motor-driven propulsion system MHRA reference: 38216973 2026/001/015/601/021
  10. Lifeaz: Clark 45992 MHRA reference: 38175265 2026/001/008/601/064
  11. Medline: sterile surgical drapes and sterile surgical gowns REF: FSN-26/01 MHRA reference: 38208808 2026/001/014/601/039
  12. Olympus: Outer sheath, 22.5 Fr. 46043 Cystoscopes, Rigid Model: WA22810A MHRA reference: 38217024 2026/001/015/601/041
  13. Roche Diagnostics: cobas c 703 analytical unit 46000 Multiple clinical chemistry analyser IVD, laborat Model: 09502971001 MHRA reference: 38210828 2025/012/009/601/088
  14. Roche Diagnostics: cobas HbA1c Test Gen. 2 46014 Glycated haemoglobin (HbA1c) IVD, reagent MHRA reference: 38197756 2025/012/023/601/093
  15. Waldemar Link: Connection component; Knee Joint component 46034 Rotating hinged total knee prosthesis Model: 15-0027/11, 15-0027/12, 15-0027/15, 15-0027/16, 15-2835/12, 15-2836/11, 15-8030/12, 15-8521/09, 15-8521/11, 15-8521/15, 16-2840/02, 16-2840/05, 16-2840/07, 11C010360 313-09079 MHRA reference: 38197444 2026/001/013/601/055

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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