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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 Safety Report: JINTN Giraffe and Swan Baby Hugging Sleeping Pillow sold via Amazon (2312-0020)
2. Product Safety Report: Baby Sleep Bags sold via Amazon (2312-0024)
3. Product Safety Report: Baby Swaddle Hooded Sleep Bag sold via Amazon (2312-0026)
4. Product Safety Report: Baby Knitted Swaddle Sleep Bag sold via Amazon (2312-0027)
5. Product Safety Report: Baby Swaddle Blanket Sleep Bag sold via Amazon (2312-0029)
6. Product Recall: ISC UltraLink LK100A1.2 and ISC UltraLink LK101A1.2 (2312-0081)
Section 2: medical devices 11/12/23 – 15/12/23
- Cardinal Health: Dover 100% Silicone Foley Catheter 45271 Indwelling urethral drainage catheter MHRA reference: 27716781
- Cook Medical: MINC+ Benchtop Incubator 45273 Assisted reproduction heater/incubator Model: K-MINC-2000 MHRA reference: 27687200
- Invacare: Gloss 45274 Basic walker, foldable Model: Gloss 450 / Gloss 520 / Gloss 600 / Gloss 680 MHRA reference: 27701462
- MERU: Bugzi 45278 Model: E3 MHRA reference: 27687105
- Molnlycke: Z-Flo Fluidized Positioner, Neo and Peds 45174 Freestanding patient positioning mould, single-use MHRA reference: 27704531
- Olympus: HIGH FLOW INSUFFLATION UNIT 45252 MHRA reference: 27694555
- Renishaw Mayfield: neuromate stereotactic surgery system 45273 MHRA reference: 27704571
- VOSTRA: Rhinotamp 45266 Nasal haemostatic balloon Model: RHINOTAMP 70 x 17 x 10 mm MHRA reference: 27668173
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)
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 6
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