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Important Customer Notices (ICNs)

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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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Contract Update NRS Healthcare Aids for Daily Living Full Product Range (ICN 3052)

Ref: 2025/3052 - 17 October 2025

Important Customer Notice Status Update Type Contractual Change

The supply issue with products on the Aids for Daily Living framework following a contractual change with NRS Healthcare (Nottingham Rehab Limited) is continuing.

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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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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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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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