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Important Customer Notices (ICNs)

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Showing 39 ICNs only belonging to tag: Product Alert Clear filter

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 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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Field Safety Notice Olympus Single Use Biopsy Valve MAJ-1555 (ICN 2731)

Ref: 2024/2731 - 5 November 2024

Important Customer Notice Status New Type Product Alert

Olympus has issued a Field Safety Notice having become aware that five lot numbers may be missing product identification and an expiration date on the sterile packaging.

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Field Safety Notice Baxter Braun 6000 Instructions for Use Update (ICN 2689)

Ref: 2024/2689 - 17 October 2024

Important Customer Notice Status New Type Product Alert

NHS Supply Chain has been made aware of two Field Safety Notices issued by Baxter on 26 June 2024 and 26 September 2024, due to Baxter identifying that the Braun Thermoscan Pro 6000 ear thermometers issued between 15 September 2022 and 22 February 2024 were supplied with a compact disc (CD) containing an outdated version of the instructions for use (IFU).

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Field Safety Notice Medtronic Healthcare21 McGrath Mac Video Laryngoscope FDD2504 (ICN 2621)

Ref: 2024/2621 - 30 September 2024

Important Customer Notice Status Update Type Product Alert

In July 2024, Medtronic issued an Urgent Field Safety Notice for McGRATH™ MAC Video Laryngoscopes, item codes 300-000-000, which were within their useful life of 5 years (Serial numbers 366170 to 405673).

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Field Safety Notice Intersurgical IPPB Flextube™ Breathing System (ICN 2671)

Ref: 2024/2671 - 17 September 2024

Important Customer Notice Status New Type Product Alert

Intersurgical has issued a Field Safety Notice following a report of a loose connection between the nebuliser and supply line T-piece IPPB Flextube™ breathing system.

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Field Safety Notice Zimmer Biomet CPT® Hip System Femoral Stem 12/14 Neck Taper (ICN 2596)

Ref: 2024/2596 - 5 September 2024

Important Customer Notice Status Update Type Product Alert

The Medicines and Healthcare products Regulatory Agency has issued the following device safety information update dated 4 September 2024.

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Field Safety Notice TSC Life Fluido Trauma Standard Sets VCB522 (ICN 2656)

Ref: 2024/2656 - 30 August 2024

Important Customer Notice Status New Type Product Alert

The supplier TSC Life have issued a Field Safety Corrective Action (FSCA) Notice following quality control testing which revealed a proportion of the tested samples to have elevated levels of non-toxic particulates in Fluido® single use sets.

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Field Safety Notice Philips Trilogy Evo, Evo O2, EV300 Failing to Meet Obstruction Alarm Standards Requirement (ICN 2627)

Ref: 2024/2627 - 6 August 2024

Important Customer Notice Status New Type Product Alert

Philips Respironics has become aware that Trilogy Evo, Trilogy Evo O2, and Trilogy EV300 devices do not comply with the Obstruction Alarm requirements specified within ISO 80601-2-12 Clause 201.12.4.108 and ISO 80601-2-72 Clause 201.12.4.107.

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Field Safety Notice Philips Trilogy Evo, Evo O2, EV300 Loss of Power Alarm (ICN 2493)

Ref: 2024/2493 - 5 August 2024

Important Customer Notice Status Update Type Product Alert

Philips Respironics has issued an update to the Field Safety Notice advising the release of a mandatory Software update, Version 1.06.10.00 and a User Manual addendum for the Trilogy Evo, Trilogy Evo O2, and the Trilogy EV300 ventilators.

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Field Safety Notice Micsafe GBUK Safety Hypodermic Needles Printing Error on Packaging (ICN 2617)

Ref: 2024/2617 - 25 July 2024

Important Customer Notice Status New Type Product Alert

Micsafe Medical has issued a Field Safety Notice following discovery that the blister level of the packaging for two sizes of their safety hypodermic needles, has the expiry and manufacture dates transposed.

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Field Safety Notice Nikkiso Aqualine, Aquaset and Citraset Tubing Sets and Filters (ICN 2609)

Ref: 2024/2609 - 17 July 2024

Important Customer Notice Status New Type Product Alert

Nikkiso has issued a Field Safety Notice following discovery during product surveillance of a potential problem which could affect product performance.

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Field Safety Notice Teleflex Arrow FibreOptix and UltraFlex Intra-Aortic Ballon Catheter Kits (ICN 2528)

Ref: 2024/2528 - 19 June 2024

Important Customer Notice Status New Type Product Alert

Teleflex has issued an advisory Field Safety Corrective Action Notice for Teleflex Arrow FibreOptix and UltraFlex Intra-Aortic Balloon Catheter Kits.

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