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Important Customer Notices (ICNs)

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Showing 110 ICNs only belonging to tag: Field Safety Notice Clear filter

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Product Update GOJO Industries Hand Hygiene and Associated Products and Services (ICN 2523)

Ref: 2024/2523 - 19 July 2024

Important Customer Notice: Update

GOJO Industries Europe Ltd - the European production site based in France - went into liquidation on 15 July 2024 and all production has ceased. We will not be receiving any further products from France.

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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: Field Safety Notice

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: Field Safety Notice

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: Field Safety Notice

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

Ref: 2024/2598 - 11 July 2024

Important Customer Notice: Field Safety Notice

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 CADD™ Infusion System Infusion Sets for use with CADD Pumps (ICN 1968)

Ref: 2022/1968 - 8 July 2024

Important Customer Notice: Update

Smiths Medical has issued a second update, dated 1 July 2024 against FA2211-01 having identified further additional lot numbers of CADD™ Infusion System Infusion sets that are potentially affected by the issues listed in the initial Field Safety Notice.

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

Ref: 2024/2596 - 4 July 2024

Important Customer Notice: Field Safety Notice

Zimmer Biomet has issued a medical device Field Safety Corrective Action (correction) for CPT Hip System Femoral Stem 12/14 Neck Taper products due to an increased risk of postoperative periprosthetic femoral fracture (PFF).

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Field Safety Notice Rocialle Healthcare XL Quiver Sterile EVD183 (ICN 2574)

Ref: 2024/2574 - 27 June 2024

Important Customer Notice: Field Safety Notice

Rocialle Healthcare has issued a Field Safety Notice regarding specific batches of RML228-023 – Bowl 6000ml Blue double wrapped and RML114-003 – XL Quiver Sterile.

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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: Update

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: Field Safety Notice

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

Ref: 2024/2572 - 17 June 2024

Important Customer Notice: Field Safety Notice

Baxter has issued a Field Safety Correction Notice for the power cords used with the Welch Allyn ProBP 3400 Digital Blood Pressure 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 Masimo LNCS Disposable Sensors FBC119 (ICN 2570)

Ref: 2024/2570 - 12 June 2024

Important Customer Notice: Field Safety Notice

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: Field Safety Notice

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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Product Recall TSC Life Fluido® Trauma Sets VCB522 (ICN 2554)

Ref: 2024/2554 - 23 May 2024

Important Customer Notice: 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 Olympus UHI-4 High Flow Insufflation Unit (ICN 2375)

Ref: 2023/2375 - 22 May 2024

Important Customer Notice: Update

Olympus has released an update to the Field Safety Notice relating to UHI-4 High Flow Insufflation Unit products.

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Product Recall Johnson & Johnson MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrode FDJ3091 (ICN 2548)

Ref: 2024/2548 - 20 May 2024

Important Customer Notice: 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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