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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
- Product Recall: NCC Type C Power Charger Plug (2501-0170)
- notices on products relevant to maternity and health visiting services – see links below (scroll to bottom)
Section 2: medical devices 24/03/25 – 28/03/25
- Abbott Molecular, Inc: Alinity m System 45735 Model: Refer to FSN MHRA reference: 35154752 Customer reply form – 2025/003/025/601/022 MHRA reference: 35154752 FSN
- Avanos Medical Inc: Ballard Closed Suction Systems 45737 Suction System Catheter, General Purpose Model: 198; 210; 20083; 220135; 2210-5; 2271418-5; 227-5 MHRA reference: 35145199 2025/003/024/601/057
- B. Braun Avitum AG: Single Needle Cross Over/Single Needle Bloodlines 45735 for Dialog+ and Dialog iQ dialysis machines Model: Refer to FSN MHRA reference: 35135270 2025/003/020/601/049
- Beckman Coulter: DxC 500i Clinical Analyzer 45730 Ref Number: FSN-25025 Analyzer Module: DxC 500 AU Module w/ISE, DxC 500i / DxC 500 AU Module, DxC 500i Software version: SW 1.3.0 and 1.3.2 MHRA reference: 35155883 FSN 2025/003/025/601/037 MHRA reference: 35155883 Vigilance response form
- Beckman Coulter: DxC 500i Clinical Analyzer 45730 Ref Number: FSN-25026 Analyzer Module: Access 2 Module, DxC 500i Software version: SW v1.3.0 and 1.3.2 MHRA reference: 35155351 FSN 2025/003/025/601/109 MHRA reference: 35155351 Vigilance response form
- Corin Limited: Trinity Acetabular Shells 45736 Ref: FA 2025 003 – FSN Rev: 1.0 Trinity 56mm Taper Size 4 Cluster Shell Model: 321.04.356 LOT: 568616 MHRA reference: 35133891 2025/003/020/601/095
- Covidien llc: Hugo™ Robotic-Assisted Surgery (RAS) Sterile Interface Module (SIM) Intermittent Connectivity 45717 Medtronic Reference: FA1473 Model: MRASA0003 MHRA reference: 35154949 2025/003/025/601/098
- Epocal Inc.: epoc® Blood Analysis System 45717 Multi blood gas/haem/electrolyte analyte IVD rgt Model: Refer to FSN MHRA reference: 35155552 2025/003/025/601/014
- Hill-Rom, Inc: Progressa Bed 25.03.2025 FA-2025-006 Basic electric hospital bed Model: refer to FSN MHRA reference: 35155002 – FSN 2025/003/025/601/136 MHRA reference: 35155002 – Customer reply form
- Waldemar Link GmbH: LinkSymphoKnee Femoral and Tibial Augments 24.03.2025 FSN Ref.: R-2025-02 Knee arthroplasty wedge Model: Refer to FSN MHRA reference: 35145588 2025/003/024/601/061
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
Product Safety Report: 0-12M Newborn Wrap Blanket Teddy Baby Sleeping Bag sold via eBay (2503-0101)
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