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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: Fast Charge Jump Starter 260 & 9000mAH Power Bank (2402-0097)
- Product Recall: Cuqoo Home Double Electric Blanket sold via Amazon (2310-0284)
- Product Recall: Ideal Heating Logic 2 Combi & System Boiler Range (2401-0138)
Section 2: medical devices 26/02/24 – 01/03/24
- Aidence: Veye Lung Nodules 45349 Model: 3.22.0 MHRA reference: 28038186 2024/002/027/601/027
- Arjo: IndiGo Intuitive Drive Assistance 45336 Accessory for basic electric hospital beds Model: INDI-XXX MHRA reference: 28028412 2023/012/013/601/033
- Baxter: Flo-Rester, Flo-Thru, Vascular Probe, Ma Recette 45351 Surgical intravascular shunt MHRA reference: 28043281 Letter 2024/002/029/601/026 MHRA reference: 28043281 FSN 2024/002/029/601/026
- BD: BodyGuard MicroSet 45348 Electric infusion pump admin set,single use MHRA reference: 28028023 2024/002/023/601/063
- Beckman Coulter: DxA Automation System / DxA Aliquoter 23 February 2024 FSN-24006 Specimen processing instrument IVD, automated MHRA reference: 28043275 2024/002/029/601/015
- Beckman Coulter: Access Substrate 45345 Chemiluminescent substrate reagent IVD Model: 81906 MHRA reference: 28043269 2024/002/029/601/013
- bioMérieux: BIOFIRE Pneumoniaplus (PNplus) Panel 45330 Multiple-type respiratory pathogen nucleic acid Model: RFIT-ASY-0142 (PNplus, 30-pack), RFIT-ASY-0143 (PNplus, 6-pack) MHRA reference: 27943715 2024/002/006/601/040
- bioMérieux: MUELLER HINTON E AGAR 44952 Mueller-Hinton agar antimicrobial susceptibility MHRA reference: 27942675 2023/001/025/601/009
- BVI: 581012 – IRRIGATION HANDLE (20/SP) 45335 MHRA reference: 28029327 2024/002/016/601/074
- CONMED: HIP PRESERVATION SYSTEM SIGNATURE SERIES 45331 Arthroscopic shaver system blade, single-use MHRA reference: 28043125 2024/002/007/601/091
- Cook: Dilators – Coons Taper, EntuitSecure Adjustable Gastrointestinal Suture Anchor Sets, Chiba Biopsy NeedlesBrand 45350 Model: JCD22.0-38-20-COONS, GIAS-SRM-ADJ-2, DCHN-22-15.0, DCHN-22-15.0-U MHRA reference: 28028797 2024/002/023/601/141
- LINK: OptiStem, Rasp Handle Stainless Steel 45349 Model: 17-5220/01 MHRA reference: 28040570 2024/002/028/601/044
- Luminex: NxTAG Respiratory Pathogen Panel 45316 MHRA reference: 28038177 Letter 2024/002/015/601/039 MHRA reference: 28038177 FSN 2024/002/015/601/039
- Medicina: ENFit double-lumen polyurethane “Replogle” tube 45334 Model: NF02L MHRA reference: 28030507 2024/002/026/601/060
- Olympus: SOLTIVE SuperPulsed Laser System 45350 General/multiple surgical solid-state laser system Model: TFL-PLS, TFL-SLS MHRA reference: 28029779 2024/002/026/601/051
- Randox: MICROALBUMIN CALIBRATOR SERIES (mALB CAL) 45322 Microalbumin IVD, calibrator MHRA reference: 28028402 2024/002/023/601/050
- RaySearch Laboratories: RayStation 45345 Model: 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A MHRA reference: 28043273 2024/002/029/601/025
- Roche: t 511/ t 711: PT-aPTT 45017 MHRA reference: 27919638
- Siemens Healthineers: ACUSON Redwood ultrasound system US005-24-S + US011-12-24-S General-purpose ultrasound imaging system Model: 11503314 MHRA reference: 28037799 2024/002/027/601/062
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 |
| None | 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/
Incident Reporting & Investigation Centre (IRIC)
Facilities Division
NHSScotland Assure
NHS National Services Scotland
Tel: 0131 275 7575|nss.iric@nhs.scot | Report an incident | Find safety alerts | IRIC | Turas Learn
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 about our services at www.nss.nhs.scot
FAC406-212, 8B(i), Rev 7
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