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

Ref: 2026/3211 - 28 January 2026

Important Customer Notice Status New Type Product Alert

Cardinal Health has issued a Field Safety Notice US-MF-000006765, Event-2024-06422, to advise customers that the Instructions for Use (IFUs)) for the Cardinal Health Chest Drainage Units, (CDUs) and accessories listed have been updated to clarify the intended target patient population as adults, 18 years and older.

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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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Field Safety Notice Philips Visions PV.014P, PV.014P RX and PV.018 Digital IVUS Catheters Instructions for Use (IFU) Precaution Update (ICN 3008)

Ref: 2025/3008 - 11 July 2025

Important Customer Notice Status New Type Product Alert

Philips has issued a Field Safety Notice to advise of an update to the Instructions for Use (IFU), for Visions PV.014P, PV.014P RX and PV.018 Digital IVUS Catheters.

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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 - 7 July 2025

Important Customer Notice Status New Type Product Alert

Philips Respironics has issued a Field Safety Notice relating to a potential issue that can occur when using preset circuit calibration settings with certain Fisher & Paykel (F&P) single limb circuits.

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Field Safety Notice Baxter Healthcare Welch Allyn Non-Automated Blood Pressure Gauges Correct Storage Temperature (ICN 2948)

Ref: 2025/2948 - 12 June 2025

Important Customer Notice Status Update Type Product Alert

Please see the updated product listing now showing 11 devices available via NHS Supply Chain affected by Field Safety Notice FA2024 071.

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Field Safety Notice Intersurgical Various BVM Resuscitators (ICN 2987)

Ref: 2025/2987 - 11 June 2025

Important Customer Notice Status New Type Product Alert

Intersurgical has issued a Field Safety Notice regarding specific lots of various BVM Resuscitators.

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

Ref: 2025/2953 - 11 June 2025

Important Customer Notice Status New 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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