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Important Customer Notices (ICNs)

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Showing 38 ICNs only belonging to tag: Product Alert Clear filter

Field Safety Notice Terumo Gelsoft Plus, Gelweave and Thoraflex Hybrid Devices (ICN 3287)

Ref: 2026/3287 - 13 March 2026

Important Customer Notice Status New Type Product Alert

Terumo issued Field Safety Notice FSN2025-003 in December 2025 following customer feedback regarding expiry dates on certain device ranges. Further investigation which included a100% verification check of each MDR device labelling confirmed a deficiency in the shelf life.

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Field Safety Notice Rocket Medical Chest and Abdominal Drain Set (ICN 3279)

Ref: 2026/3279 - 11 March 2026

Important Customer Notice Status New Type Product Alert

Rocket Medical has issued a Field Safety Notice CUST-OCC665 Revision 2 dated 6 March 2026. This updates their Field Safety Notice GB-MF-000025375, released in November 2023.

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Field Safety Notice Philips Circuit Selection on Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal and Trilogy EV300 Platform User Interface (ICN 3012)

Ref: 2025/3012 - 2 March 2026

Important Customer Notice Status Update Type Product Alert

Philips Respironics has issued a Field Safety Notice due to a new issue related to the use of non-pneumatic nebulizers with Trilogy Evo Platform ventilators (Trilogy Evo, Trilogy Evo O2, and Trilogy EV300 ventilators collectively) as well as updates regarding two prior communications regarding these same devices.

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Field Safety Notice 3M Solventum Ranger High Flow and Irrigation Sets (ICN 2953)

Ref: 2025/2953 - 25 February 2026

Important Customer Notice Status Update Type Product Alert

3M and Solventum are notifying all customers and users regarding an update to the Instructions for Use (IFU) with respect to flow rates and fluid temperature for the Ranger High flow sets and the Ranger Irrigation sets, as well as the user manuals for the corresponding warming units.

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Field Safety Notice Becton Dickinson Update to Catheter Labelling (ICN 3252)

Ref: 2026/3252 - 10 February 2026

Important Customer Notice Status New Type Product Alert

Becton Dickinson has issued a customer letter to advise customers of an important update to their catheter labelling.

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Field Safety Notice Cardinal Healthcare Chest Drainage Units and Accessories Updated Instructions for Use (ICN 3211)

Ref: 2026/3211 - 30 January 2026

Important Customer Notice Status Update Type Product Alert

Please note the completed Customer Acknowledgement Form should be returned to: UKQRA@cardinalhealth.com not as previously informed to Cardinal Health’s Representative.

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Field Safety Notice Armstrong Medical Anaesthetic Circuit, AquaVENT® CPAP System and Ventilator Circuit for Non-Invasive Ventilation (ICN 3214)

Ref: 2026/3214 - 14 January 2026

Important Customer Notice Status New Type Product Alert

Armstrong Medical has issued a Field Safety Notice, CF-1573, to inform users of an update to the Instructions for Use (IFU) for Anaesthetic Circuits, AquaVENT® CPAP Systems and Ventilator Circuits for Non-invasive Ventilation devices.

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Field Safety Notice Olympus Triangle Tip Knife J – Single Use Electrosurgical Knives   (ICN 3210)

Ref: 2026/3210 - 13 January 2026

Important Customer Notice Status New Type Product Alert

Olympus has issued a Field Safety Notice pertaining to the KD-640L and KD-645L Triangle Tip Electrosurgical Knives.

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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 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 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 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 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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