Field Safety Notices (FSNs): 30/09/24 – 04/10/24

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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 30/09/24 – 04/10/24

1. Product Recall: Wurth Stretch X Electric SB P E FO WRU Safety Shoe (2408-0116)

2. Product Recall: Venicci Engo Car Seat (2404-0105) updated

Reissued links from w/b 16/09/24

Section 2: medical devices 30/09/24 – 04/10/24

Siemens Healthineers: ACUSON Juniper and ACUSON Juniper Select Ultrasound systems 45330 General-purpose ultrasound imaging system Model: 11335791, 11653093 (System IVK: 11335791) MHRA reference: 32819130 2024/002/027/601/057
Aidence: Veye Lung Nodules 45349 Model: 3.22.0 MHRA reference: 28038186
Arjo: IndiGo Intuitive Drive Assistance 45336 Accessory for basic electric hospital beds Model: INDI-XXX MHRA reference: 28028412
Baxter: Flo-Rester, Flo-Thru, Vascular Probe, Ma Recette 45351 Surgical intravascular shunt MHRA reference: 28043281 Letter MHRA reference: 28043281 FSN
BD: BodyGuard MicroSet 45348 Electric infusion pump admin set,single use MHRA reference: 28028023
Beckman Coulter: DxA Automation System / DxA Aliquoter 23 February 2024 FSN-24006 Specimen processing instrument IVD, automated MHRA reference: 28043275
Beckman Coulter: Access Substrate 45345 Chemiluminescent substrate reagent IVD Model: 81906 MHRA reference: 28043269
bioMérieux: BIOFIRE Pneumoniaplus (PNplus) Panel 45330 Multiple-type respiratory pathogen nucleic acid Model: RFIT-ASY-0142 (PNplus, 30-pack), RFIT-ASY-0143 (PNplus, 6-pack) MHRA reference: 27943715
bioMérieux: MUELLER HINTON E AGAR 44952 Mueller-Hinton agar antimicrobial susceptibility MHRA reference: 27942675
BVI: 581012 – IRRIGATION HANDLE (20/SP) 45335 MHRA reference: 28029327
CONMED: HIP PRESERVATION SYSTEM SIGNATURE SERIES 45331 Arthroscopic shaver system blade, single-use MHRA reference: 28043125
Cook: Dilators – Coons Taper, EntuitSecure Adjustable Gastrointestinal Suture Anchor Sets, Chiba Biopsy Needles 45350 Model: JCD22.0-38-20-COONS, GIAS-SRM-ADJ-2, DCHN-22-15.0, DCHN-22-15.0-U MHRA reference: 28028797
LINK: OptiStem, Rasp Handle Stainless Steel 45349 Model: 17-5220/01 MHRA reference: 28040570
Luminex: NxTAG Respiratory Pathogen Panel 45316 MHRA reference: 28038177 Letter MHRA reference: 28038177 FSN
Medicina: ENFit double-lumen polyurethane “Replogle” tube 45334 Model: NF02L MHRA reference: 28030507
Olympus: SOLTIVE SuperPulsed Laser System 45350 General/multiple surgical solid-state laser system Model: TFL-PLS, TFL-SLS MHRA reference: 28029779
Randox: MICROALBUMIN CALIBRATOR SERIES (mALB CAL) 45322 Microalbumin IVD, calibrator MHRA reference: 28028402
RaySearch Laboratories: RayStation 45345 Model: 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A MHRA reference: 28043273
Roche: t 511/ t 711: PT-aPTT 45017 MHRA reference: 27919638
Siemens Healthineers: ACUSON Redwood ultrasound system Ref: US005-24-S + US011-12-24-S General-purpose ultrasound imaging system Model: 11503314 MHRA reference: 28037799
Trinity Biotech: Premier Hb9210 HbA1c Analyzer 45565 Product Code: 42790 Model: Refer to FSN MHRA reference: 32787346 2024/009/030/601/081
Smiths Medical: Nasopharyngeal Airway, Double Swivel Connector, 15mm Y Piece, Portex™ Orator Speaking Valve, Thermovent™ 1200 45568 Model: Refer to FSN MHRA reference: 32773880 2024/009/030/601/011
Boston Scientific: Model L331 ACCOLADE™, L231 PROPONENT™, and L131 ESSENTIO™ DR EL pacemakers 45547 Pacemakers Model: Refer to FSN MHRA reference: 32773671 2024/009/020/601/083
Baxter: PST 500 U Precision Surgical Table 45475 Universal operating table, electromechanical Model: 4080100 MHRA reference: 32795725 2024/007/002/601/080
Siemens Healthineers: IMMULITE 2000 and IMMULITE 2000 XPi Analyzer 45536 Lot Number: 438, 439, 440 MHRA reference: 32802893 2024/010/001/601/085
Drägerwerk AG: Atlan Family 45566 Atlan anaesthesia workstations Model: Refer to FSN MHRA reference: 32802744 2024/010/002/601/022

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
n/a	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/

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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Field Safety Notices (FSNs): 30/09/24 – 04/10/24

1. Product Recall: Wurth Stretch X Electric SB P E FO WRU Safety Shoe (2408-0116)

2. Product Recall: Venicci Engo Car Seat (2404-0105) updated

IHEEM

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