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Important Customer Notices (ICNs)

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Field Safety Notice Boston Scientific Carotid WALLSTENT™ Monorail Endoprosthesis (ICN 3068)

Ref: 2025/3068 - 3 September 2025

Important Customer Notice Status New Type Product Recall

Boston Scientific has issued a Field Safety Notice regarding batches of Carotid WALLSTENT™ Monorail Endoprosthesis (Carotid WALLSTENT) devices.

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Field Safety Notice ICU Medical CADD™ Medication Cassette Reservoirs (ICN 3077)

Ref: 2025/3077 - 2 September 2025

Important Customer Notice Status New Type Product Recall

ICU Medical has issued a Field Safety Notice regarding a potential issue with specific models and Lots of 50ml and 100ml CADD Medication Cassette Reservoirs.

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Field Safety Notice Mediplus Silicone 2 Way Foley (Open Tip) Catheter Kit 18FR FUS85043 (ICN 3072)

Ref: 2025/3072 - 29 August 2025

Important Customer Notice Status New Type Product Recall

Mediplus has issued a Field Safety Notice regarding specific Lot numbers of their 5775 Silicone 2 Way Foley (open tip) Catheter Kit, 18Fr. 10cc, Standard, 42cm - FUS85043 due to a labelling error.

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Product Update Globus (Shetland) Limited Surgical Gloves Callisto, Syntis, and Syntis PX (ICN 3075)

Ref: 2025/3075 - 28 August 2025

Important Customer Notice Status New Type Delisting

The supplier Globus (Shetland) Limited has informed us of a discontinuation with its Surgical Gloves Ranges; Callisto, Syntis, and Syntis PX.

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Field Safety Notice Cook Medical Instinct Plus Endoscopic Clipping Device FAL85003 (ICN 3039)

Ref: 2025/3039 - 20 August 2025

Important Customer Notice Status New Type Product Alert

Cook Medical has issued a Field Safety Notice following reports of a malfunction that occurs when the user attempts to open the clip jaws by actuating the handle of the Instinct Plus Endoscopic Clipping Device.

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Field Safety Notice Rocialle RSET5003 Pack Minor Op (Bronze) (ICN 3050)

Ref: 2025/3050 - 12 August 2025

Important Customer Notice Status New Type Product Recall

Rocialle has issued a Field Safety Notice withdrawing specific lot numbers of their RSET5003 Pack Minor Op (Bronze) due to a labelling error.

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Field Safety Notice Integra Sciences MediHoney® Wound and Burn Products (ICN 3049)

Ref: 2025/3049 - 12 August 2025

Important Customer Notice Status New Type Product Recall

Integra Sciences has issued a Field Safety Notice having identified packaging failures related to the MediHoney® Wound and Burn product range, which could lead to a breach in the sterile barrier.

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Field Safety Notice Baxter Healthcare Q-Link 13 Adapter Kit LikoScale and LIKO UNO 102 EE Mobile Lifts (ICN 3040)

Ref: 2025/3040 - 12 August 2025

Important Customer Notice Status New Type Product Recall

Baxter Healthcare Corporation has issued a Field Safety Notice urgently recalling the Q-Link 13 lift component following customer reports related to improper attachment of the Q-Link 13 (false latching) with the quick-release hook.

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Field Safety Notice Boston Scientific RELIANCE ePTFE Defibrillation Lead Gradual Rise in Shock Impedance (ICN 3044)

Ref: 2025/3044 - 11 August 2025

Important Customer Notice Status New Type Product Alert

Boston Scientific has issued a Field Safety Notice to provide important information about RELIANCE ePTFE (Gore) defibrillation leads with an increased potential to exhibit a pattern of gradual rise in LVSI which is associated with calcification of the shocking coil(s).

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Product Update Greiner Bio-One Ltd Blood Collection Products Notice of Alternative (ICN 2553)

Ref: 2024/2553 - 1 August 2025

Important Customer Notice Status Update Type Delisting

The discontinuation due to a product update with Blood Collection products from Greiner Bio-One Ltd is continuing.

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Field Safety Notice Insight Health BD ChloraPrep™ Clear 1ml Applicator DMK000 (ICN 2952)

Ref: 2025/2952 - 31 July 2025

Important Customer Notice Status Update Type Product Recall

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 Medicines Recall: EL(25)A/36 following Becton Dickinson UK Ltd informing the MHRA of an additional batch of potentially affected products (batch number 4255106) which may exhibit an open seal on the packaging of the applicator.

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Field Safety Notice Abbott Diagnostics Infectious Diseases Analyser Test Covid-19 2.0 (ICN 3028)

Ref: 2025/3028 - 28 July 2025

Important Customer Notice Status New Type Product Recall

Abbott Diagnostics has issued a revised Field Safety Notice affecting their infection diseases analyser ancillaries ID NOW™ COVID-19 2.0, and ID NOW™ RSV and ID NOW™ Influenza A and B 2 having discovered specific lot numbers where there is a higher occurrence of invalid rates when compared to the product Instructions for Use.

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Field Safety Notice LeMaitre TufTex®  Over the Wire Embolectomy Catheter and Pruitt®  Occlusion and Irrigation Occlusion Catheter (ICN 2942)

Ref: 2025/2942 - 21 July 2025

Important Customer Notice Status New Type Product Recall

LeMaitre has issued a Field Safety Notice following discovery of inadequate tray seals during testing.

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Safety Alert Aurum Pre-Filled Syringes Phased Introduction of New 10ml CONNECT Syringe Barrel: Importance of Selecting Compatible Needle Free Connectors to Minimise the Risk of Syringe Blockage (ICN 3015)

Ref: 2025/3015 - 16 July 2025

Important Customer Notice Status New Type Safety Alert

The MHRA has issued a Device Safety Information Notice, DSI 2025 02, to make healthcare professionals aware of the importance of using connectors which are compatible with the Aurum new connect syringe barrel.

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Supply Issues Greiner Bio-One Ltd Blood Collection Products Regulatory Inform (ICN 2802)

Ref: 2025/2802 - 15 July 2025

Important Customer Notice Status Update Type Supplier Update

The derogation with Blood Collection products from Greiner Bio-One Ltd is continuing.

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