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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: Lila & Jack Christmas Pacifier Clip & Teether sold by TK Maxx (2312-0126)
Section 2: medical devices 18/12/23-22/12/23
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- B Braun: LEONARD BUTTON EYELET WIRING TI (PAK 10) 45274 Craniofacial bone wire/bar Model: HS-075-01-W MHRA reference: 27714304
- Cardinal Health: Kangaroo Enteral Feeding Pump Sets 45240 Enteral Feeding non-invasive component set MHRA reference: 27724006
- Evolan Pharma: Viscopaste PB7 45280 Dressing, wound non-adherent permeable MHRA reference: 27739599
- GE Healthcare: Ultrasound System type 2300 Ref. # 87010 MHRA reference: 27723262
- Getinge: HLS Set Advanced 5.0 / 7.0 45281 Tubing set, heart-lung bypass Model: 701069076, 701069073, 701077943, 701069077, 701069068, 701069078, 701069065, 701069083, 701069063 MHRA reference: 27734388
- Lowenstein: elisa 300, elisa 500, elisa 600, elisa 800 45280 Critical Care Ventilator MHRA reference: 27734972
- Medex: Secufill 45279 Low pressure extension line Model: 218684 (SECU002); 240134 (SECU005) MHRA reference: 27723346
- Merit Medical: Merit Maestro, Merit Pursue, Fountain Infusion 45267 MHRA reference: 27717752
- Nova Biomedical: PRIME Plus, PRIME Plus Vet 45182 MHRA reference: 27701086
- Occlutech: Figulla Flex II ASD Procedure Pack 45278 MHRA reference: 27732483
- OriGen Biomedical: Accessory Sets 45279 Blood collection tubing set MHRA reference: 27730253
- Philips: Azurion 45268 Interventional Fluoroscopic X-Ray System Model: 722063, 722221, 722064, 722222, 722227, 722228, 722067, 722225, 722068, 722226, 722078, 722223, 722079, 722224, and 722280 MHRA reference: 27714302
- Philips: Spectral CT 7500/China, Spectral CT on Rails 45273 Model: 728334, 728333, 728340 MHRA reference: 27717074
- QuidelOrtho: VITROS Anti HBs Reagent/Calibrator 45261 Hepatitis B virus surface total antibody IVD, kit MHRA reference: 27719457
- Samsung: GM85 FSN-GM85-231117-1 Mobile Digital Batteries X-ray Units MHRA reference: 27717462
- Siemens: ARTIS pheno / icono 45261 Stationary angiographic x-ray system, digital MHRA reference: 27721232
- Smiths Medical: Medfusion Syringe Infusion Pump 45281 MHRA reference: 27723265
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)
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 6