Field Safety Notices (FSNs): 16/12/24 – 20/12/24

Manufacturers’ Field Safety Notices

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DL1 NHS Incidents and alerts Safety Officers

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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: Oscha Slings Onbuhimo Baby Carrier (2410-0036)

Section 2: medical devices 16/12/24-20/12/24

1. Bayer: Medrad Centargo CT Injection System 45642 CT Contrast medium injection system, line-powered MHRA reference: 34219607   2024/012/016/601/015
2. Becton Dickinson: BD PCR Cartridge 45644 MHRA reference: 34235097   2024/012/013/601/040
3. Boston Scientific: please refer to the Field Safety Notice (FSN) 45638 Please refer to section 8 Model: please refer to the FSN MHRA reference: 34219135   2024/012/012/601/078
4. GE Healthcare: Tec 6 Plus, Tec 820, Tec 850 FMI 34139 Vaporizer, anaesthesia MHRA reference: 34224209   2024/012/016/601/013 – Letter 
5. GE HealthCare: Certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Ref. # 40910 Nuclear Medicine systems Model: Refer to FSN MHRA reference: 34245892   2024/012/018/601/088
6. Greiner Bio-One: HOLDEX® Single-Use Holder PP single-packed,sterile 45645 Model: Refer to FSN MHRA reference: 34261451   2024/012/019/601/128
7. Nobel Biocare: N1 TiUltra TCC Implants 45642 Dental Implants Model: Refer to FSN MHRA reference: 34253185   2024/012/018/601/103
8. Occlutech: Figulla Flex II ASD Occluder 45637 Cardiac occlude MHRA reference: 34234498    2024/012/012/601/023 
9. Siemens: Atellica CH Analyzer, Atellica CI Analyzer – Follow up 45627 Immunoglobulin M_2 LOT number: 242315 and above MHRA reference: 34246039   2023/012/021/601/016 MHRA reference: 34246039   – Response letter
10. Stryker: Neptune S and Neptune 3 Rover Waste Management Systems 45637 Collect and dispose of surgical fluid waste Model: Refer to FSN MHRA reference: 34235661   2024/012/009/601/041
11. ThermoFisher: ThermoScientific™ Oxoid™ Levofloxacin Antimicrobial Susceptibility Discs 45645 Antimicrobial Susceptibility Discs Model: Refer to FSN MHRA reference: 34262136   2024/012/019/601/138
12. Touchstone: Linear Stapler and Reloads 45636 Open-surgery manual linear stapler, single-use Product Code: LS9048 LOT/BN: Refer to FSN MHRA reference: 34238060   2024/010/028/601/020
13. Vernacare Limited: Procedure Packs 45644 Single-use components in one sterile pack to be used as an ancillary pack during a range of surgical procedures Model: Refer to FSN MHRA reference: 34250943   2024/012/018/601/106

Section 3: medical devices 20/12/24

14. Ultragel Medical Kft: AquaUltra Basic Ultrasound Transmission Gel 45646 Topical skin coupling gel for use in ultrasound scanning procedures Products: Trimbio Ultra Gel Ultrasound Transmission Gel TECNO.CARTA Gel for Ultrasonic Transmission Lot No: 2024.04 to 2024.10 MHRA reference: 34265566   2024/012/020/601/108

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 4: updates and changes to previously published medical device FSNs

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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