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Important Customer Notices (ICNs)

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Field Safety Notice Boston Scientific AXIOS™ Stent and Electrocautery Enhanced Delivery System (ICN 3198)

Ref: 2025/3198 - 29 December 2025

Important Customer Notice Status New Type Product Recall

Boston Scientific has issued an urgent Field Safety Notice initiating a removal of certain AXIOS™ Stent and Electrocautery Enhanced Delivery Systems.

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Product Update Ontex UK Ltd Bodyworn Disposable Continence Pads (ICN 3184)

Ref: 2025/3184 - 12 December 2025

Important Customer Notice Status New Type Product Update

The supplier Ontex UK Ltd has informed us of a product update with its Disposable Continence Pads.

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Product Update Johnson & Johnson Medical Ltd Surgiflo Haemostats ELS041, ELS061, ELS065 and ELS115 (ICN 3177)

Ref: 2025/3177 - 8 December 2025

Important Customer Notice Status New Type Product Update

The supplier Johnson & Johnson Medical Ltd has informed us of a product update with its Surgiflo Haemostats product range.

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Product Update Dakota Integrated Solutions Limited Thermal Wristband Cartridges (ICN 2869)

Ref: 2025/2869 - 21 November 2025

Important Customer Notice Status Update Type Product Update

The product update due to a new range of Thermal Wristband Cartridges from Dakota Integrated Solutions is continuing.

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Field Safety Notice CoClens Biocide Skin Disinfectant DMK034 and DEC85023 (ICN 2937)

Ref: 2025/2937 - 18 November 2025

Important Customer Notice Status Update Type Product Recall

The root cause was identified as trace calcium which interacted with the gluconate present in the formulation to form insoluble calcium gluconate, which crystallised out of solution under storage conditions.

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Field Safety Notice Rocket Medical Seldinger Chest Drain Kit (ICN 3149)

Ref: 2025/3149 - 17 November 2025

Important Customer Notice Status New Type Product Alert

Rocket Medical have issued a Field Safety Notice informing of an update to the Instructions for Use (IFU) (ZDOCK180) for affected Rocket Seldinger Chest Drain Kits.

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Field Safety Notice Dräger ErgoStar Catheter Mounts (ICN 3143)

Ref: 2025/3143 - 7 November 2025

Important Customer Notice Status New Type Product Recall

Drager has issued a Field Safety Notice having been made aware of instances where cracks have formed in the hose of some specific ErgoStar catheter mounts.

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Product Update Multiple Suppliers NRFit™ Connectors (ICN 890)

Ref: 2019/890 - 6 November 2025

Important Customer Notice Status Update Type Product Update

We would like to update you with all the available products within NRFit™ range.

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Field Safety Notice Pasante Healthcare Karex Ultrasound Probe Cover (ICN 3128)

Ref: 2025/3128 - 3 November 2025

Important Customer Notice Status New Type Product Alert

Karex, UK Distributor Pasante, has issued a Field Safety Notice for their Ultrasound Probe Cover following discovery that the QR Code expiry date differs from the printed date on the packaging for a single lot number.

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Field Safety Notice Fisher & Paykel Healthcare AirvoTM 2 and myAirvoTM 2 Disinfection Kit User Manual Update (ICN 3127)

Ref: 2025/3127 - 24 October 2025

Important Customer Notice Status New Type Product Alert

Fisher & Paykel Healthcare have issued a Field Safety Notice informing of an update to the Disinfection Kit User Manual for Airvo 2 and myAirvo 2 devices.

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Field Safety Notice Olympus Single Use Electrosurgical Snare SD-400 (ICN 3122)

Ref: 2025/3122 - 23 October 2025

Important Customer Notice Status New Type Product Recall

Olympus has issued a Field Safety Notice regarding specific lots of SD-400U-10 and SD-400U-15 Single Use Electrosurgical Snares.

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Field Safety Notice GORE® ACUSEAL Vascular Graft (ICN 3114)

Ref: 2025/3114 - 16 October 2025

Important Customer Notice Status New Type Product Alert

L. Gore & Associates (Gore) issued a Field Safety Notice in August 2025 regarding the updating of the Instructions for Use (IFU) related to the GORE® ACUSEAL Vascular Graft, all catalogue numbers, following a number of reports of delamination.

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Contract Update Baby Boards and Tube Filling Cannula Kwill Products (ICN 3054)

Ref: 2025/3054 - 3 October 2025

Important Customer Notice Status Update Type Contractual Change

We have been informed of a contractual change on Baby Boards and Tube Filling Cannula Kwill products.

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Field Safety Notice Intersurgical Various Clear-Therm™ Mini HMEF (ICN 3089)

Ref: 2025/3089 - 23 September 2025

Important Customer Notice Status New Type Product Alert

Intersurgical has issued a Field Safety Notice following reports that the two housings of some HMEF devices have been found to separate when a force is applied during handling of these products or movement and torsion due to repositioning of the patient.

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Contractual Update Multiple Products (ICN 3085)

Ref: 2025/3085 - 11 September 2025

Important Customer Notice Status New Type Contractual Change

We have been informed of a contractual change on Guidion, TrapIT, Nhancer Pro X and Recross products that will terminate on 30 September 2025.

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