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Important Customer Notices (ICNs)

In response to customer feedback, you can now:

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Field Safety Notice Vygon Lifecath PICC and MST Kit FSU373 (ICN 2801)

Ref: 2025/2801 - 10 March 2025

Important Customer Notice Status Update Type Product Recall

Vygon has advised they are now able to fulfil orders of FSU373 with unaffected stock.

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Field Safety Notice Medtronic Pipeline Vantage Embolization Device Shield Technology (ICN 2829)

Ref: 2025/2829 - 17 February 2025

Important Customer Notice Status New Type Product Recall

Medtronic has issued a Field Safety Notice initiating a product recall of the Pipeline Vantage devices with the part numbers PED3-027-xxx-xx, which represents compatibility to 0.027inch (0.69mm) inner diameter microcatheters “Pipeline Vantage 027”.

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Product Update Multiple Suppliers NRFit™ Connectors (ICN 890)

Ref: 2019/890 - 10 February 2025

Important Customer Notice Status Update Type Product Update

NHS England has issued an update to the National Patient Safety Alert regarding the transition to NRFit™ Connectors for intrathecal and epidural procedures, and delivery of regional blocks.

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Field Safety Notice Zimmer Biomet NexGen LCCK Articular Surface with Locking Screw Products FJE4296 and FQN5777 (ICN 2819)

Ref: 2025/2819 - 6 February 2025

Important Customer Notice Status New Type Product Recall

Zimmer Inc. is conducting a batch specific medical device Field Safety Corrective Action (removal) for seven batches of the NexGen LCCK Articular Surface with Locking Screw products.

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Field Safety Notice Olympus Thunderbeat Jaw Breakage Issue FGE4025, FGE4026 and FGE4027 (ICN 2810)

Ref: 2025/2810 - 29 January 2025

Important Customer Notice Status New Type Product Alert

Olympus has issued a Field Safety Notice following customer feedback reporting the probe tips of the Thunderbeat type S hand instruments becoming damaged or breaking, also instances of pad damage or breaking.

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Field Safety Notice Greiner Bio-One VACUETTE® HOLDEX® Single-Use Holder PP Single-Packed Sterile KFK111 (ICN 2724)

Ref: 2024/2724 - 22 January 2025

Important Customer Notice Status Update Type Product Recall

Greiner Bio-one has advised NHS Supply Chain of four further affected Lot numbers to the ICN issued 31 October 2024.

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Field Safety Notice Altomed Kirwan Surgical Products 25-Gauge Disposable Bipolar Pencils FSP11614 (ICN 2752)

Ref: 2025/2752 - 20 January 2025

Important Customer Notice Status New Type Product Recall

Altomed has notified NHS Supply Chain about a product recall issued by the manufacturer Kirwan Surgical Products LLC regarding their 25-Gauge Disposable Bipolar Pencils.

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Field Safety Notice Baxter Healthcare Control-A-Flo Solution Administration Set with Needle Y-Site FSB874 (ICN 2794)

Ref: 2025/2794 - 15 January 2025

Important Customer Notice Status New Type Product Recall

Baxter Healthcare has issued a Field Safety Notice recalling specific Lots of Control-A-Flo Solution Administration Sets due to customer reports of separation at the junction between the drip chamber and tubing.

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Field Safety Notice Vernacare International Limited Woundcare Procedure Pack EVJ017 (ICN 2783)

Ref: 2025/2783 - 7 January 2025

Important Customer Notice Status New Type Product Alert

Vernacare International Limited has issued a Field Safety Notice regarding specific Lots of their Procedure Packs due to lack of appropriate symbology following the May 2024 EU Medical Device Regulation 2017/745 implementation.

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Field Safety Notice Sarstedt Blood Culture Adapter (ICN 2778)

Ref: 2024/2778 - 20 December 2024

Important Customer Notice Status New Type Product Alert

Sarstedt has issued a Field Safety Notice regarding specific batches of blood culture adapters 14.1209 and 14.1207.

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Field Safety Notice Trilogy Evo, Trilogy Evo 02, Trilogy EV300 Flow Sensor Nebulised Aerosol Deposition (ICN 2686)

Ref: 2024/2686 - 19 December 2024

Important Customer Notice Status Update Type Product Alert

Philips Respironics has issued an update to the Field Safety Notice, 2024-CC-SRC-013, regarding Trilogy Evo, Trilogy Evo O2, Trilogy EV300, Flow Sensor Nebulized Aerosol Deposition previously communicated in September 2024.

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Field Safety Notice Altomed Iris Retractors (ICN 2771)

Ref: 2024/2771 - 17 December 2024

Important Customer Notice Status New Type Product Alert

Altomed has issued a Field Safety Notice following a customer advising receipt of a box of Iris Retractors without an expiry date on the outer carton. The internal pouch had the correct expiry date.

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Field Safety Notice Coloplast Urology and Endourology Products (ICN 2768)

Ref: 2024/2768 - 16 December 2024

Important Customer Notice Status New Type Product Recall

Coloplast has issued a Field Safety Notice withdrawing from use a range of catheters, urethral bougies, and drainage devices from their Interventional Urology Portfolio.

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Field Safety Notice Baxter Healthcare Limited Welch Allyn Power Cords FFF3068 (ICN 2572)

Ref: 2024/2572 - 27 November 2024

Important Customer Notice Status Update Type Product Alert

Baxter has issued an updated Field Safety Correction Notice for the power cords used with the Welch Allyn ProBP 3400 Digital Blood Pressure Device and Welch Allyn Spot Vision Screener following reports of an issue relating to the cord construction not meeting the insulation rating for international standards.

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Field Safety Notice Nihon Kohden Recording Paper (ICN 2757)

Ref: 2024/2757 - 27 November 2024

Important Customer Notice Status New Type Product Alert

Nihon Kohden has issued a Field Safety Corrective Action for its Recording Paper models NKUK-A054 and NKUK-MLSC-125 for Electrocardiographs due to incorrect labelling.

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