Field Safety Notices (FSNs): 30/01/23 – 03/02.23

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

1. None

Section 2: medical devices 30/01/23 – -3/02/23

1    Abbott: Alinity m HBV AMP Kit 44938 MHRA reference: 5028007

2. Abbott: FreeStyle Libre 2 Sensors 44958 MHRA reference: 5044080
3. Aidapt Bathrooms: Wheelchair attendant\occupant driven collapsible 44938 Model: VA170 & VA165Silver MHRA reference: 5023437
4. Aspire Pharma: Epimax 44946 MHRA reference: 5032139
5. B Braun: INF.SP.LINE,TRANS,PVC,LL,250CM-EU 44951 MHRA reference: 5037381
6. BD: Venovo Venous Stent System 44936 MHRA reference: 5044151
7. Bio-Rad: IH-1000 44952 MHRA reference: 5036802
8. DeVilbiss Healthcare: 5L Oxygen Concentrator 44918 Model: 525 MHRA reference: 5036698
9. GE Healthcare: NM/CT 850 44913 MHRA reference: 5026862
10. Ivoclar: VivaPen Snap-On Cannulas 44866 MHRA reference: 5041158
11. Leica Biosystems: BOND tm Ready-to-Use Primary Antibody Bcl-6 (LN22) 44848 MHRA reference: 5029948
12. Medtronic: Affinity Fusion Oxygenator TMA 44896 Model: BB811, BB841, CB811, CB841 MHRA reference: 5028041
13. Medtronic: Vanta Clinician Programmer Application FA1260, January 2023 Model: A71200 MHRA reference: 5041176
14. Medtronic: Vanta / Sequentia LT Clinician Programmer Application FA1266, January 2023 Model: A71200 MHRA reference: 5038274
15. Medtronic: Vanta LT Clinician Programmer Application FA1292, January 2023 Model: A71200 MHRA reference: 5037448
16. Medtronic: Tri-Staple 2.0 Black Intelligent Reload 44927 Model: SIG60AXT MHRA reference: 5036699
17. Objective Imaging: Glissando 20SL 44959 Model: 20SL 40X CE-IVD MHRA reference: 5044043
18. Peninne: Link Yankauer Sets and Suction Connecting Tubing 44936 MHRA reference: 5041304
19. Randox: CRP 44958 MHRA reference: 5041191
20. Schiller Medical: DEFIGARD Touch-7 44896 MHRA reference: 5033044
21. Seegene: Allplex RV Essential Assay 44909 MHRA reference: 5026060
22. Siemens Healthineers: ARTIS pheno, ARTIS icono biplane/icono floor 44958 MHRA reference: 5044037
23. Siemens Healthineers: Atellica CH 930 Analyzer 44927 MHRA reference: 5041193
24. Teleflex: Rüsch EndoGuide T 44927 MHRA reference: 5029894
25. ThermoFisher Scientific: Thermo Scientific Oxoid MacConkey Agar without Salt 44957 MHRA reference: 5038225
26. Zimmer Biomet: Oxford Fixed Lateral 44901 Model: 154341 MHRA reference: 5041242

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

Contact us:

IRIC Email         nss.iric@nhs.scot

Helpline             0131 275 7575

Web                 https://www.nss.nhs.scot/browse/health-facilities/incidents-and-alerts

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