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Important Customer Notices (ICNs)

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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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Product Update Greiner Bio-One Ltd Blood Collection Products Notice of Alternative (ICN 2553)

Ref: 2024/2553 - 15 July 2024

Important Customer Notice Status Update Type Delisting

The discontinuation due to a product update with Blood Collection products from Greiner Bio-One Ltd is continuing.

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Field Safety Notice Boston Scientific Capio™ SLIM Suture Capturing Device Recall (ICN 2598)

Ref: 2024/2598 - 11 July 2024

Important Customer Notice Status New Type Product Recall

Boston Scientific has issued a Field Safety Notice recalling specific Lot numbers of Capio™ Slim Suture Capturing Devices following an increase in reports of the device not catching the suture needle/dart as expected during use.

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Field Safety Notice Smiths Medical Bivona® Neonatal/ Paediatric and Adult Tracheostomy Tubes (ICN 2569)

Ref: 2024/2569 - 24 June 2024

Important Customer Notice Status Update Type Product Recall

NHS Supply Chain has seen a significant increase in demand for the affected products.

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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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Field Safety Notice Masimo LNCS Disposable Sensors FBC119 (ICN 2570)

Ref: 2024/2570 - 12 June 2024

Important Customer Notice Status New Type Product Alert

Masimo has issued a Field Safety Notice having ascertained certain parts and Lot numbers of LNCS Disposable Sensors manufactured between March 2024 and the end of May 2024 are not compatible with older versions of Masimo technology boards used in both Masimo monitors and OEM monitors.

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Field Safety Notice Fluoron GmbH Distributed by Daybreak Medical Ophthalmic Syringe Siluron® Products IVZ871, IV872 and IVZ873 (ICN 2543)

Ref: 2024/2543 - 6 June 2024

Important Customer Notice Status New Type Product Recall

Fluoron GmbH has issued a Field Safety Notice regarding the silicone oil of the type Siluron® 1000, Siluron® 2000 and Siluron® Xtra.

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Field Safety Notice TSC Life Fluido® Trauma Sets VCB522Field Safety NoticeProduct Recall TSC Life Fluido® Trauma Sets VCB522 (ICN 2554)

Ref: 2024/2554 - 23 May 2024

Important Customer Notice Status New Type Product Recall

The Surgical Company International BV (TSC Life) has issued a Field Safety Notice recalling specific batches of Fluido® Trauma Sets following a temporary change to a manufacturing technique resulted in the production of a number of individual Fluido® Trauma Sets with an unstable connection junction.

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Field Safety Notice Johnson & Johnson MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrode FDJ3091 (ICN 2548)

Ref: 2024/2548 - 20 May 2024

Important Customer Notice Status New Type Product Recall

Megadyne Medical Products Inc. has initiated a voluntary medical device recall (removal) of all distributed Lots of the MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrode.

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