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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. Product Recall: CareCo Allure Folding Shower Chair (2401-0143)
2. Product Recall: Portable Electric Space Heater sold via Temu (2402-0315)
3. Product Recall: Polypropylene Full Body Rock Climbing Safety Belt sold via AliExpress (2309-0148)
4. Product Safety Report: Astro and Canyon Guide Harnesses (2402-0115)
5. Product Safety Report: Belsa Bed (2401-0006)
6. Product Recall: Black Polyester Protective Safety Harness sold via AliExpress (2311-0145)
7. Product Recall: Red 3.5 Metre Adjustable Safety Belt sold via AliExpress (2311-0110)
8. Product Recall: Black Climbing Harness Anti-Fall Protection Safety Beltsold via AliExpress (2311-0146)
9. Product Safety Report: Petzl Grillon Climbing Equipment – Lanyards/Temporary Lifelines/Anchors/Hook/MGO (2401-0020)
10. Product Recall: Chest Support Waist Harness sold via AliExpress (2311-0108)
11. Product Recall: Climbing/Mountaineering Outdoor Safety Belt/Full Body Harness sold via AliExpress (2311-0149)
12. Product Recall: Orange and Grey Adjustable Full Body Harness sold via AliExpress (2311-0148)
Section 2: medical devices 04/03/24 – 08/03/24
- Abbott: HeartMate Touch Communication System 45292 Multiple active implantable device programmer Model: HMT1150 MHRA reference: 28055755
- B Braun: NOVOSYN 45356 Sutures, Polyglactin Model: C0068041N1 MHRA reference: 28055322
- Baxter: PERI-GUARD; SUPPLE PERI-GUARD 01 March 2024 FA-2024-008 MHRA reference: 28050497 Letter MHRA reference: 28050497 FSN
- Baxter: PERI-GUARD; SUPPLE PERI-GUARD 01 March 2024 FA-2024-010 MHRA reference: 28050499 Letter MHRA reference: 28050499 FSN
- Bio-Rad: Anti-k 45342 Anti-k (KEL002) red blood cell grouping IVD, antib Model: 50260 MHRA reference: 28051325
- Draeger: Perseus A500 45352 Anesthesia Units MHRA reference: 28050490
- Epic Systems Corporation: Regulated Decision Support Framework 45352 Clinical Management Support Software MHRA reference: 28050485
- Globus Medical: ExcelsiusGPS 45357 Robot, surgical, navigation unit Model: 6143.2844 MHRA reference: 28061611
- NuVasive: MAGEC System 45352 MHRA reference: 28064971
- QIAGEN: EZ2 Connect MDx 45323 An electrically-powered instrument MHRA reference: 28053750
- Symbios: ORIGIN 45355 MHRA reference: 28053783
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
| Page summary | Change(s) made |
| None | n/a |
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)
Facilities Division
NHSScotland Assure
NHS National Services Scotland
Tel: 0131 275 7575|nss.iric@nhs.scot | Report an incident | Find safety alerts | IRIC | Turas Learn
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 about our services at www.nss.nhs.scot
FAC406-212, 8B(i), Rev 7
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