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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
None
Section 2: medical devices 26/06/23 – 30/06/23
- Acumed: 70.0mm Tension Band Kit 45099 Model: TB-1570K-S, 30-0095K-S MHRA reference: 5332199
- BD: Magic3 Go/Hydrosil Go Intermittent Silicone Catheter 45049 Single administration urethral drainage catheter MHRA reference: 5216505
- Boston Scientific: IntellaNav StablePoint Ablation Catheter 45009 Catheter, Cardiac Ablation MHRA reference: 5132942
- BVI: CryoTreQ 45006 Ophthalmic cryosurgical system, mechanical MHRA reference: 5324211
- Flexicare: BriteBlade Pro 45089 Laryngoscope Blade, Single Use MHRA reference: 5327028
- Getinge: Rotaflow II drive (flex); Rotaflow II drive (compact) 45098 Heart-lung bypass System Model: 701074622 MHRA reference: 5331928
- Hamilton Medical: HAMILTON-C1/HAMILTON-T1/HAMILTON-C2/HAMILTON-C3 45068 MHRA reference: 5241929 2023/005/025/601/043
- Integra: Codman Cranial Access Kit without drugs 45099 Craniotomy Kit MHRA reference: 5331908 2023/006/023/601/059
- Johnson & Johnson Vision: VERITAS Advanced Infusion & Fluidics Packs 45091 Ultrasonic Surgical System Tubing set Model: VRT-AI & VRT-AF MHRA reference: 5332289 2023/006/012/601/044
- LifeVac: LifeVac 45044 Airway Emergency Clearance/ Suction Plunger MHRA reference: 5216503 2023/005/003/601/013
- Medical Measurement Systems: Flowstar 44980 physiological monitoring. reusable urine flow meter Model: U2-1 MHRA reference: 5182895
- Optergo: Optical Ergonomic Solutions 45058 MHRA reference: 5241967
- Philips: Ingenia Elition, MR 7700 45082 Magnetic Resonance Imaging (MRI) unit Model: 781358, 782107, 782119, 782136, 781357, 782106, 782137, 782118, 782132, 782144, 782120, 782130, 782150, 782151 MHRA reference: 5331930
- Philips: Patient Information Center iX 45042 Model: 866389,866390 MHRA reference: 5326968
- Philips: IntelliVue MX40 Patient Monitor FSCA 2023-CC-HPM-014 Model: 865350, 865351, 867146, 865352 MHRA reference: 5323701
- QuidelOrtho: Quidel Triage Cardiac Panel 45071 MHRA reference: 5338144
- Randox: LIQUID URINE CONTROL LEVEL 2 45105 Multiple urine analyte IVD, control MHRA reference: 5337733
- Siemens Healthineers: ARTIS pheno/icono 45078 Stationary angiographic x-ray system, digital MHRA reference: 5332221
- ThermoFisher Scientific: EliA GliadinDP IgG Well Ref: QA2023-03 Gliadin antibody IVD, kit, fluorescent immunoassay Model: 14-5539-01 MHRA reference: 5228918
- UFSK-International OSYS: UFSK-OSYS 45043 Treatment Chair Model: 500 XLE MHRA reference: 5323076
- Vela Diagnostics: Sentosa SQ HIV Genotyping Reagents (4×16) 45104 HIV1 genotyping IVD, kit, nucleic acid technique MHRA reference: 5332538….
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.
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)
Health Facilities Scotland
NHS National Services Scotland
Tel: 0131 275 7575|nss.iric@nhs.scot | Report an incident | Find safety alerts
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
FAC406-015, 8B(i), Rev 6