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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 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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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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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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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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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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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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