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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 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 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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Field Safety Notice Baxter Healthcare MiniCap Extended Life PD Transfer Sets (ICN 2714)

Ref: 2024/2714 - 10 June 2025

Important Customer Notice Status Update Type Product Alert

We have received a further update to the Field Safety Notice dated 23 October 2024 issued by Baxter.

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Field Safety Notice Drager Filter/HME Slow Increase of CO2-Curve (ICN 2978)

Ref: 2025/2978 - 5 June 2025

Important Customer Notice Status New Type Product Alert

Drager has issued a Field Safety Notice regarding the slow increase of CO2-curve when using of the sampling port of Draeger Filter/HME for the products affected.

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Field Safety Notice Rocket Medical Copeland Fetal Scalp Electrodes (ICN 2973)

Ref: 2025/2973 - 3 June 2025

Important Customer Notice Status New Type Product Alert

Rocket Medical has issued a Field Safety Notice, updating the Instructions For Use (IFU) for Rocket Copeland Fetal Scalp Electrodes.

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Product Update GenX Open Suction Catheters (ICN 2966)

Ref: 2025/2966 - 30 May 2025

Important Customer Notice Status New Type Product Alert

NHS Supply Chain has made the decision to quarantine four Open Suction Catheters supplied by GenX whilst we explore a potential issue.

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Field Safety Notice Medtronic Evolut™ PRO+/FX/FX+ Bioprosthesis (ICN 2924)

Ref: 2025/2924 - 21 May 2025

Important Customer Notice Status New Type Product Alert

Medtronic has issued a Field Safety Notice regarding updates to the Instructions for Use (IFU) and Physician/Healthcare Practitioner Training related to potential damage to the bioprosthesis container (jar) upon opening.

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Field Safety Notice Philips Microstream Intubated Filter Lines (ICN 2929)

Ref: 2025/2929 - 15 May 2025

Important Customer Notice Status New Type Product Alert

Philips has issued a Field Safety Notice: 2025-CC-HPM-011, updating the instructions for use, (IFU), for the Microstream Advance Intubated CO2 Filter Line, VitaLine Intubated CO2 Filter Line and FilterLine Intubated CO2 Filter Line.

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