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Important Customer Notices (ICNs)

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Field Safety Notice Hamilton Medical AG Device Breathing Circuit Set, Coaxial (ICN 3342)

Ref: 2026/3342 - 26 May 2026

Important Customer Notice Status New Type Product Alert

Hamilton Medical has issued Field Safety Corrective Notice FSCA-2026-05-03 following post market surveillance highlighting an issue with certain breathing circuits set, coaxial.

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Field Safety Notice Bayer Avanta Multi-Patient Administration Tube Sets (ICN 3335)

Ref: 2026/3335 - 21 May 2026

Important Customer Notice Status New Type Product Recall

Bayer has issued a Field Safety Notice SA-2026-RAD-03 regarding specific lots of the Multi-Patient Disposable Set used in conjunction with MEDRAD® Avanta Fluid Management Injection System.

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Field Safety Notice Poly Medicure Fannin IV Fluid Infusion Set FSB2116 (ICN 3333)

Ref: 2026/3333 - 13 May 2026

Important Customer Notice Status New Type Product Recall

Poly Medicure has issued a Field Safety Notice following reports of leakage of the Fannin IV Fluid Infusion Set during use. The leakage was observed at the junction between the Back Check Valve (BCV) and stopcock of the extension line.

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Field Safety Notice Teleflex Arrow Haemodialysis Catheters Multiple Products (ICN 3314)

Ref: 2026/3314 - 7 May 2026

Important Customer Notice Status New Type Product Recall

Teleflex Arrow has issued a precautionary Field Safety Notice EIF-000605, recalling a number of Arrow Haemodialysis Kits and Sets.

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Field Safety Notice Olympus Single Use Ligating Device PolyLoop (ICN 3328)

Ref: 2026/3328 - 5 May 2026

Important Customer Notice Status New Type Product Alert

Olympus has issued a Field Safety Notice FY26-006-F-1 to inform customers of an update to the instructions for use (IFU), for their ligating device MPC - N5382130.

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Field Safety Notice Boston Scientific POLARx, POLARx FIT Cryoablation Balloon Catheters and SMARTFREEZE Cryoablation System Consoles (ICN 3311)

Ref: 2026/3311 - 21 April 2026

Important Customer Notice Status New Type Product Recall

Boston Scientific has issued Field Safety Notice 97251520D-FA initiating the recall of POLARx™ and POLARx™ Fit Cryoablation Balloon Catheters and POLARSHEATH™ Steerable Sheaths, and the decommissioning of SMARTFREEZE™ Cryoablation System consoles.

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Product Update GenX Open Suction Catheters (ICN 2966)

Ref: 2025/2966 - 1 April 2026

Important Customer Notice Status Update Type Product Alert

We advised customers on the 30 May 2025 to quarantine four Open Suction Catheters supplied by GenX whilst we explore a potential issue.

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Field Safety Notice Nutshell MOMA Foods Porridge and Cereal Products (ICN 3301)

Ref: 2026/3301 - 31 March 2026

Important Customer Notice Status Update Type Product Recall

MOMA Foods is taking the precautionary step to expand their product recall to cover all MOMA Porridge and Cereal products on the market with a Best Before Date (BBE) between 24 April 2026 and 12 March 2027 due to potential contamination.

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Field Safety Notice GBUK Safety Hypodermic Needle 25G FTR3356 (ICN 3299)

Ref: 2026/3299 - 26 March 2026

Important Customer Notice Status Update Type Product Recall

GBUK has issued a Field Safety Notice regarding specific lots of Safety Hypodermic Needle 25G x 5/8" (0.5 x 16mm) Orange.

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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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