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Manufacturers’ Field Safety Notices
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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
- ….
- ….
Section 2: medical devices 04/11/24 – 08/11/24
- SLE Ltd.: FLOW SENSORS 45572 Reusable and Single Use Flow Sensors Model: Refer to FSN MHRA reference: 33796938 2024/009/023/601/081
- Zimmer Biomet: JuggerLoc™ Disposable Cannula Kit – Drill Guide 45597 Disposable Cannula Kit Model: Refer to FSN MHRA reference: 33795671 2024/011/001/601/035
- Baxter: iLED 7 Surgical Lights – Updated FSN 45593 Operating Light Model: Refer to FSN MHRA reference: 33805454 2024/006/019/601/118
- Acumed: 3.5mm x 12mm Locking Hexalobe Screw 45587 Acumed Congruent Bone Plate System Model: 30-0234, 591015 MHRA reference: 33805426 2024/011/004/601/081
- Medtronic: Becker and Exacta External Drainage and Monitoring Systems 45597 External drainage and monitoring systems Model: Refer to FSN MHRA reference: 33812921 2024/011/004/601/022
- Siemens: Atellica CI Analyzer 45597 Specimen processing instrument IVD, automated Model: 10947347 MHRA reference: 33826782 2024/011/005/601/061
- Philips: MR system breast coils 45596 Magnetic Resonance Imaging (MRI) unit Model: Refer to FSN MHRA reference: 33824546 2024/011/005/601/072
- Abbott: 20/30 INDEFLATORTM Inflation Device, 20/30 Priority Pack Accessory Kit 45602 Catheter/over tube balloon inflator, single use Model: Refer to FSN MHRA reference: 33830685 2024/011/004/601/031
- Cordis: SELUTION SLRTM 018 PTA 3.0mm X 100mm Balloon Catheters 45594 Balloon Catheters Model: L92505, L92835, L93029, L93495 MHRA reference: 33851581 2024/011/007/601/083
- Baxter: AK 98 haemodialysis machines 45602 Haemodialysis system Institutional / Home-Use Model: Refer to FSN MHRA reference: 33846890 2024/010/025/601/085
- Boston Scientific: ACURATE neo2TM and ACURATE PrimeTM Aortic Valve Systems 45603 Aortic transcatheter heart Valve bioprosthesis, Model: Refer to FSN MHRA reference: 33854955 2024/011/007/601/078
- Beckman Coulter: Access Substrate 45597 Chemiluminescent substrate reagent IVD Model: Refer to FSN MHRA reference: 33846314 2024/002/029/601/013 MHRA reference: 33846314 Response form2024/011/001/501/002
- BioPlus Co. Ltd: 10ml Sterile Absorbable Hyaluronic Acid Dermal Fillers Ref: FSN-202401 Dermal filler Model: Refer to FSN MHRA reference: 33831005 2024/008/027/601/049
- Ultragel Medical Kft: Ebrington Medical AquaUltra clear Ultrasound Gel (Updated FSN) 45603 Topical skin coupling gel for use in ultrasound scanning procedures Lot No.: Refer to FSN MHRA reference: 33856044 2024/011/008/601/032
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 summary | Change(s) made |
| n/a | n/a |
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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