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Manufacturers’ Field Safety Notices
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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 Recall: Colson X-Cel Limited – BHSX Ball Valves (2411-0125)
2. Product Safety Report: Laser Elec EV Safety Boot (2409-0148)
3. Product Safety Report: ARMA A18-Lightning Safety Boots (2411-0046)
Section 2: medical devices 25/11/24 – 29/11/24
- Siemens: epoc® Blood Analysis System 45597 epoc NXS Host Model: Refer to FSN MHRA reference: 34048116 2024/011/026/601/090
- PAJUNK® : NRFit Rectus Sheath 45588 Peripheral anaesthesia catheter set, non-medicated Model: Refer to FSN MHRA reference: 34045564 2024/010/022/601/072
- Beckman Coulter: Access hsTnI Reagent Kit 45615 Troponin I IVD, kit, Chemiluminescent Immunoassay Model: B52699 LOTS: All Lots MHRA reference: 34057680 2024/011/026/601/089 MHRA reference: 34057680 Response form
- Philips: Turbo Elite Laser Atherectomy Catheter 45597 Peripheral Atherectomy System Model: Refer to FSN MHRA reference: 34059930 2024/011/026/601/039
- Medtronic: Progrip™ Self-Gripping Polyester Mesh 45597 Surgical meshes, more than one component Model: TEM1509G, TEM1515G Lot: SYF0106X; SYF0272X MHRA reference: 34072504 2024/011/028/601/050
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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