Field Safety Notices (FSNs): 01/05/26

Manufacturers’ Field Safety Notices

Circulation

DL1 NHS Incidents and alerts Safety Officers

DL2 Local Authority Incidents and alerts Safety Officers

DL3 Specialist Liaison Group

DL4 Product Specialists

DL5 General list (internal)

DL7 General list (external)

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 Safety Report: Bababing UNA Highchair (2604-0210)

Section 2: medical devices 01/05/26

1. Kimal PLC: Namic White Star Handle Manifolds included in Medline’s Namic Systems (UPDATED FSN) 46143 Kimal Ref: GLB101838 – Issue 2 Kimal Procedure packs Model: Namic White Star Handle Manifolds MHRA reference: 39391570   2026/004/017/601/053
2. Kimal PLC: Angiograph Control Syringe with Rotating Adaptor (RA) fitting in Kimal Procedure Pack (UPDATED FSN) 46143 Kimal Ref: GLB101836 – Issue 3 Kimal Procedure packs Model: Angiograph Control Syringe with Rotating Adaptor (RA) MHRA reference: 39392623   2026/004/017/601/048
3. Medline Industries: Namic Systems with Namic White Star Handle Manifolds included 46143 Model: Refer to FSN MHRA reference: 39398626  2026/003/009/601/004

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)

Public Services Delivery Scotland

Gyle Square | 1 South Gyle Crescent

Edinburgh | EH12 9EB

e: nss.iric@nhs.scot

m: 0131 275 7575

publicservicesdelivery.scot

FAC406-212, 8B(i), Rev 7

——————————————————————————————————————————————————–
This email is intended for the named recipient only. If you have received it by mistake,
please (i) contact the sender by email reply; (ii) delete the email from your system; .
and (iii) do not copy the email or disclose its contents to anyone.

——————————————————————————————————————————————————–