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Important Customer Notices (ICNs)

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Field Safety Notice Laborie Medical Technologies UK Ltd Kiwi Complete Vacuum Delivery System FFK019 (ICN 3297)

Ref: 2026/3297 - 20 March 2026

Important Customer Notice Status New Type Product Recall

Laborie Medical Technologies UK Ltd has issued a Field Safety Notice following customer reports of failure of handle break at the Traction Force Indicator handle joint.

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Field Safety Notice Fresenius Stay Safe Disinfection Cap FHE85316 (ICN 3295)

Ref: 2026/3295 - 17 March 2026

Important Customer Notice Status New Type Product Alert

Fresenius Medical Care has issued an update to a Field Safety Notice dated October 2023 to advise users of the potential side effects of hypothyroidism and hypersensitivity in relation to the use of Stay Safe Disinfection Cap.

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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 Cook Medical Labelling Expiration Dates Various Products (ICN 3277)

Ref: 2026/3277 - 11 March 2026

Important Customer Notice Status New Type Product Recall

Cook Medical has issued Field Safety Notice FSN (FSCA Ref: 2026FA0001) having identified a number of products, listed in ‘Attachment 1 - Product Information Table’ have been labelled with expiration dates that exceed the true 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 Cook Medical Instinct Plus Endoscopic Clipping Device (ICN 3272)

Ref: 2026/3272 - 4 March 2026

Important Customer Notice Status New Type Product Recall

Cook Medical has issued Field Safety Notice FSN and FSCA Ref: 2026FA0002 recalling Instinct Plus Endoscopic Clipping Devices manufactured 2023-02-09 through 2025-04-20, following reports of a malfunction that occurs when the user attempts to open the clip jaws by actuating the handle.

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Field Safety Notice Armstrong Medical Anaesthetic Circuit, AquaVENT® CPAP System, Ventilator Circuit for Non-Invasive Ventilation (ICN 3247)

Ref: 2026/3247 - 27 February 2026

Important Customer Notice Status New Type Product Recall

Armstrong Medical have issued a revision to their Field Safety Notice, CF-1573 Version 4, to inform users this is now a Product Recall for Anaesthetic Circuits, AquaVENT® CPAP Systems and Ventilator Circuits for Non-invasive Ventilation 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 Optimed Tentos 4FBare Metal Self Expanding Stents (ICN 3231)

Ref: 2026/3231 - 23 February 2026

Important Customer Notice Status New Type Product Recall

Optimed has issued a Field Safety Notice RE-25-021 recalling specific batch numbers of Tentos 4Fbare metal self-expanding stents following reports of internal catheter breakage.

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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 Becton Dickinson Hickman™/ Broviac™ Central Venous Catheters (ICN 3228)

Ref: 2026/3228 - 4 February 2026

Important Customer Notice Status New Type Product Recall

Becton Dickinson has issued a Field Safety Notice PI-26-06013 to remove specific lots of Hickman™/ Broviac™ Central Venous Catheters following internal inspection discovered possible damage present on the outer tray.

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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 Poly Medicure Fannin Double Chambered Blood Sets (ICN 3217)

Ref: 2026/3217 - 29 January 2026

Important Customer Notice Status New Type Product Recall

Poly Medicure has issued Field Safety Notice LET/QA/2026/007  following customer feedback reporting leakage of the Fannin Double Chambered Blood Set during use.

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Field Safety Notice Becton Dickinson Alaris™ VP Infusion Sets (ICN 3235)

Ref: 2026/3235 - 29 January 2026

Important Customer Notice Status Update Type Product Recall

A supply disruption ICN related to this issue has been published please refer to ICN 3244.

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Field Safety Notice Olympus Thunderbeat Jaw Thunderbeat Probe Fracture and Tissue Pad Detachment (ICN 3209)

Ref: 2026/3209 - 27 January 2026

Important Customer Notice Status Update Type Product Recall

Olympus has updated their Field Safety Notice QIL FY26-EMEA-17-FY25-009-A to amend the Unique Device Identification (UDI) on page one for two products listed in the Material ID column.

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