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Important Customer Notices (ICNs)

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Field Safety Notice Olympus Everest Bipolar Cutting Forceps Broken Forceps Trays (ICN 2655)

Ref: 2024/2655 - 19 September 2024

Important Customer Notice Status New Type Product Recall

Olympus has issued a Field Safety Notice following reports from customers indicating fractures and breakages in packaging trays and Tyvek covers which may lead to a sterility breach.

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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 Smiths Medical CADD™ Medication Cassette Reservoirs (ICN 2662)

Ref: 2024/2662 - 9 September 2024

Important Customer Notice Status New Type Product Recall

Smiths Medical has issued a Field Safety Notice following discovery of a potential issue with specific models and Lot numbers of the 50 ml and 100 ml CADD Medication Cassette Reservoirs.

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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 Ossur Miami J Select PSA Hook Adhesion (ICN 2651)

Ref: 2024/2651 - 21 August 2024

Important Customer Notice Status New Type Product Recall

Ossur has issued a Field Safety Notice recalling two Miami J Select Cervical Collars following discovery that the pressure sensitive adhesive (PSA) hooks attached to the sides of the anterior collar panel can occasionally exhibit poor adhesion.

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Field Safety Notice Smiths Medical BLUSelect™ Pilot Balloon Detachment (ICN 2645)

Ref: 2024/2645 - 16 August 2024

Important Customer Notice Status New Type Product Recall

Smiths Medical has issued an Urgent Field Safety Notice having identified a manufacturing defect with the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific Lots of the BLUSelect®, BLUgriggs® and BLUperc® products.

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Field Safety Notice BioDesign Fistula Plug Labelled Expiration Date Incorrect (ICN 2641)

Ref: 2024/2641 - 15 August 2024

Important Customer Notice Status New Type Product Recall

Cook Medical has issued an Urgent Field Safety Notice following discovery of a discrepancy between the correct product shelf life and that printed on the finished product label.

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Field Safety Notice Cepheid Specimen Collection Devices for GX (ICN 2638)

Ref: 2024/2638 - 12 August 2024

Important Customer Notice Status New Type Product Recall

Following reports of leakage after the patient samples swabs had been inserted into the test tubes, Cepheid has issued an Urgent Medical Device Product Recall for the product code listed below.

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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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Product Update Nationally Contracted Products (NCP): General Wound Care (ICN 2586)

Ref: 2024/2586 - 19 July 2024

Important Customer Notice Status New Type Product Update

Due to the General Wound Care Nationally Contracted Products initiative coming to an end on 31 July 2024, we have taken the decision to revert to the originally awarded suppliers for the remainder of the framework agreement.

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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 Argon Medical Biopsy Instruments Multiple Products (ICN 2600)

Ref: 2024/2600 - 17 July 2024

Important Customer Notice Status Update Type Product Recall

Argon Medical has issued a Field Safety Corrective Action Notice following complaints of holes in the sterile barrier of the tray packaging for a range of products.

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