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Field Safety Notices (FSNs): 06/10/25 – 10/10/25

IRICIncident Reporting &
Investigation Centre

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: Joolz Hub Pram (2510-0023)

2.     Product Recall: Blue and White Teddy Bear Wrap Baby Sleeping Bag sold via Etsy (2503-0106) updated

3.     Product Safety Report: First Kick Baby Sleeping Bag sold via Desertcart (2412-0067)

4.     Product Safety Report: BRANDONN Baby Sleeping Bag sold via Desertcart (2412-0065)

5.     Product Safety Report: Beybee Sleeping Bag sold via Desertcart (2412-0064)

Section 2: medical devices 06/10/25 – 10/10/25

  1. Abbott: Eterna™ SCS IPG 45931 Spinal Cord, electrical stimulation system. Model: 32400 MHRA reference: 37299359   2025/010/008/601/007
  2. Abbott Ireland: FreeGo Enteral Feeding Sets 45936 Ref. PA09-2025-01 Enteral feeding non-invasive component set Model: Refer to FSN MHRA reference: 37284286   2025/009/025/601/079
  3. Astor Bannerman: Charder Lift Scales used in combination with Carlo Eco Classic Mobile Hoist (also known as Astor Mobile Hoist and Olympic Pro 185) 45938 FSN-001-2025 Model: Refer to FSN MHRA reference: 37298372   2025/010/008/601/061
  4. Biomet Sports Medicine: ZipTight™, Acute AC Joint Implant, Single Ziploop® 45936 Model: 904834 Batch Number: 0002587666 MHRA reference: 37265896   2025/010/006/601/049
  5. Cardiac Pacemakers, Inc/Boston Scientific: ACCOLADE™ Pacemakers and CRT-Ps devices 45901 Reference: 97125289F-FA Pacemakers Model: Refer to FSN MHRA reference: 36701449   2025/008/014/601/067
  6. CareFusion 303, Inc.: BD Alaris™ Syringe Pumps 45938 Infusion syringe pumps Model: Refer to FSN MHRA reference: 37254135   2025/010/003/601/059
  7. Fisher & Paykel Healthcare Ltd: AirvoTM 2 and myAirvoTM 2 Disinfection Kit F&P Reference: FA-2025-001 Professional high-flow respiratory unit, humidify Model: Refer to FSN MHRA reference: 37238419   2025/009/005/601/030
  8. GE Medical Systems: AW Server Ref. # 80192 Picture Archiving and Communication System, Software Model: Refer to FSN MHRA reference: 37298317   2025/010/008/601/070
  9. Howmedica Osteonics/Stryker: EXETER V40 STEM 45870 Model: Refer to FSN MHRA reference: 37283889   2025/009/005/601/067
  10. Intersurgical Ltd: Various Clear-Therm™ Mini HMEF FSN Ref: 491800 45908 Model: Refer to FSN MHRA reference: 37298149   2025/010/008/601/087
  11. Philips: Patient Monitor 6500 Ref. 2025-CC-HPM-032, FCO86202071 Model: 867315 MHRA reference: 37298518   2025/010/008/601/053
  12. Rocialle Healthcare Limited: RSET5003 Pack Minor Op (Bronze) 45875 FSN 2025-01 LOT: W556093 MHRA reference: 37274239   2025/010/004/601/001 
  13. Rocialle Healthcare Limited: Sheet Polythene – Brompton 45895 FSN 2025-04 Model: RML013-004   MHRA reference: 37267635   2025/010/006/601/050
  14. Rocialle Healthcare Limited: RSPU500-202(40) – Forceps Dissecting Adson Toothed 12.5cm (5”) 26.09.2025 FSN 2025-05 Model: RSPU500-202 LOT: W556372 MHRA reference: 37266954   2025/010/006/601/052
  15. Rocialle Healthcare Limited: RSPU500-627(24) – Mayo Scissors Straight – 23cm (9”) 26.09.2025 FSN 2025-06 Model: Refer to FSN MHRA reference: 37299182   2025/010/006/601/058
  16. Rocialle Healthcare Limited: RFEO06-1064 Bulb Syringe 60ml 45896 FSN 2025-03 Model: Refer to FSN MHRA reference: 37254655   2025/010/004/601/003
  17. Sectra AB: All Sectra RIS(E) versions Ref. DOC-EMAO-DLVFAU Model: Refer to FSN MHRA reference: 37298258   2025/010/008/601/074
  18. Tandem Diabetes Care: t:slim X2 Insulin Pump 45915 Ambulatory Insulin Infusion pump, electronic Malfunction 16 – Speaker SRN: US-MF-000031791 MHRA reference: 37303371   2025/008/005/601/063

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

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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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