Field Safety Notices (FSNs): 10/03/25 – 14/03/25

Manufacturers’ Field Safety Notices

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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: Emba Cast Iron Cookware (2502-0151)

2.     Product Recall: TOAST Organic Ticking Stripe Shower Curtain & Organic Pyjama Stripe Shower Curtain (2502-0126)

Section 2: medical devices 10/03/25 – 14/03/25

1. Baxter Medical: TruSystem 7500 surgical table systems 45728 Field Action Reference: FA-2025-004 Universal operating table, electromechanical Model: Refer to FSN MHRA reference: 34981921   2025/003/012/601/013
2. BD: 4Fr Single-Lumen PowerPICC Catheters – UPDATED FSN 45727 REF: MDS-24-5154-B UPDATE to FSN dated 30th October 2024 – 33739247 Peripherally-inserted central venous catheter (SOLO and non-SOLO versions) Type of Action: Product Removal Model: Refer to Appendix 1 of FSN MHRA reference: 34964943   2024/010/028/601/056
3. Beckman Coulter: Inhibin B Gen II Reagent 45709 REF: A81303 LOT/BN: Refer to FSN MHRA reference: 34945477   2025/003/007/601/062 – Customer response form MHRA reference: 34945477   2025/003/007/601/062 – FSN
4. Beckman Coulter: IRMA IGF-I 45709 REF: A15729 INDIVIDUAL AND SPECIFIED HORMONES / PROTEINS LOT/BN: Refer to FSN MHRA reference: 34944552   2025/003/007/601/069 – Customer response form MHRA reference: 34944552   2025/003/007/601/069 – FSN
5. Biosense Webster: VARIPULSE Bi-Directional Ablation Catheters 17.02.2025 Cardiac irreversible electroporation system catheter Model: Refer to FSN MHRA reference: 34992802   2025/002/017/601/049
6. DiaMed GmbH: Multiple products, see list below 13.03.2025 Bio-Rad Reference: FSCA 002-25 Model: Refer to “FSCA 002-25 product list_01” MHRA reference: 34992253   2025/003/013/601/105
7. GE HealthCare: MIM Software GE HealthCare Ref. # 21001 PACS, software Model: versions 7.2.0 through 7.2.6 MHRA reference: 34971272   2025/003/011/601/084
8. Limacorporate S.p.A: Guide for Locking Caps Insertion – Different sizes 45726 FSCA number: 20250001 Model: Refer to FSN MHRA reference: 34971207   2025/003/011/601/060
9. Medtronic: MiniMed™ Paradigm™, MiniMed™ 600 series, and MiniMed™ 700 series insulin pump system 45689 Medtronic reference: FA1446 Model: Refer to FSN MHRA reference: 34951064 – Diabetes Community letter MHRA reference: 34951064 – Healthcare professional letter 
10. Medtronic: NIM Vital™ Nerve Monitoring System Stimulus Artifact 45717 Medtronic Reference: FA1482 Nerve-locating system Model: Refer to FSN MHRA reference: 34971386   2025/003/011/601/024 – Customer ack form MHRA reference: 34971386   2025/003/011/601/024 – FSN
11. Philips: Philips DXR System 45723 DuraDiagnost, DuraDiagnost Compact Model: Refer to FSN MHRA reference: 34981628   2025/003/011/601/019
12. Straumann Ltd: TLX/TLX Guided Implant Driver 037.3002 03.03.2025 FSN Ref: ER25-0064 Dental implant holding endpiece, reusable LOT: GLKJ9 and LGMZ8 MHRA reference: 34945418   2025/003/006/601/065
13. Vygon UK Ltd: LIFECATH BIFLUX DOUBLE LUMEN CATHETER 45720 FSN – Identifier: 2503/51349/00 Product code: 00229370 Model: Refer to FSN MHRA reference: 34959188   2025/003/010/601/077
14. Zimmer Biomet: Comprehensive® Shoulder Primary Stem (5 mm Micro, 6 mm Micro, 7 mm Micro & 7 mm Mini) 45729 Comprehensive Shoulder System Model: Refer to FSN MHRA reference: 34992148   2025/003/013/601/057

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

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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