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Important Customer Notices (ICNs)

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Field Safety Notice Boston Scientific CRETM Wireguided, CRE PROTM, and CRE PRO GITM Balloon Dilation Catheters (ICN 3345)

Ref: 2026/3345 - 3 June 2026

Important Customer Notice Status New Type Product Recall

Boston Scientific has issued Field Safety Notice 97593441-FA recalling CRETM Wireguided, CRE PROTM Wireguided, and CRE PRO GITM Wireguided balloon dilation catheters due to a potential sterile breach of the pouches in which the devices are packaged.

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Field Safety Notice Armstrong Medical Resuscitation Sets with Adjustable Pressure Limiting (APL) Valve (ICN 3281)

Ref: 2026/3281 - 2 June 2026

Important Customer Notice Status Update Type Product Alert

Armstrong Medical has issued an update, Version 2, and provided further Instructions for Use, (IFUs) for their Field Safety Notice CAPA-100 to extend the scope of products affected.

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Product Update Armstrong Medical Ltd CPAP Bonnets (ICN 3347)

Ref: 2026/3347 - 29 May 2026

Important Customer Notice Status New Type Delisting

The supplier Armstrong Medical Ltd has informed us of a discontinuation with its CPAP bonnets.

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Supply Issues Greiner Bio-One Ltd Blood Collection Products Regulatory Inform (ICN 2802)

Ref: 2025/2802 - 28 May 2026

Important Customer Notice Status Update Type Supplier Update

The derogation with blood collection products from Greiner Bio-One is continuing.

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Field Safety Notice Kimal Namic White Star Handle Manifolds and Namic Rotating Adaptor Syringes (ICN 3326)

Ref: 2026/3326 - 28 May 2026

Important Customer Notice Status Update Type Product Recall

NHS England has also issued a communication dated 23 April 2026, publication reference: PRN02516.

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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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Product Update Solventum (Formerly 3M Healthcare) Rebrand Changes to Product Packaging Multiple Products (ICN 3339)

Ref: 2026/3339 - 22 May 2026

Important Customer Notice Status New Type Product Update

The supplier 3M Healthcare became a standalone company called Solventum and is transitioning its branding in phases.

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Product Update Becton Dickinson Specimen Collection Kits HFL7371, HFL7349, HFL7350 and HFL7377 (ICN 3341)

Ref: 2026/3341 - 21 May 2026

Important Customer Notice Status New Type Delisting

The supplier Becton Dickinson has informed us of a discontinuation with its BD Probetec products.

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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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Contract Update Energy Devices (ICN 3324)

Ref: 2026/3324 - 12 May 2026

Important Customer Notice Status Update Type Contractual Change

The supply issue with energy devices within our Minimally Invasive Surgery framework due to a contractual change is continuing.

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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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Product Update Walters Medical Blood Pressure Cuff Single Patient Multi Use Neonatal FFE10220, FFE10221, FFE10222, FFE10223 and FFE10224 (ICN 3226)

Ref: 2026/3226 - 22 April 2026

Important Customer Notice Status Update Type Delisting

The discontinuation with blood pressure cuffs single patient multi use neonatal products is ongoing.

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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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