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Important Customer Notices (ICNs)

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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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Product Update ICU Medical International Limited Epidural Products FSQ307, FTR393, FTR463 and FYP001 (ICN 2775)

Ref: 2024/2775 - 13 December 2024

Important Customer Notice Status New Type Delisting

The supplier ICU Medical International Limited has informed us of a discontinuation with its Epidural products.

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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 Pajunk GmbH Rectus Sheath NRFit Assembly Issue (ICN 2743)

Ref: 2024/2743 - 27 November 2024

Important Customer Notice Status New Type Product Recall

Pajunk has issued a Field Safety Notice having identified an issue with assembly during manufacture of the Rectal Sheath Block MPC 0731163-49 (product code FTR85093).

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Contract Change Novation from Medline Scientific Limited to Sciquip Limited Laboratory Consumables (ICN 2675)

Ref: 2024/2675 - 26 November 2024

Important Customer Notice Status Update Type Contractual Change

The contractual change due to a novation from Medline Scientific Limited to Sciquip Limited is continuing.

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Field Safety Notice Rocket Medical Thoracentesis Catheters R51551-08-00 and Thoracentesis Catheter R51551 (ICN 2737)

Ref: 2024/2737 - 15 November 2024

Important Customer Notice Status New Type Product Recall

Rocket Medical has issued a Field Safety Notice having identified a manufacturing issue affecting specific Lot numbers for two Chest Drainage Devices.

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Field Safety Notice Abbott Rapid Diagnostics Actim® Partus Test (ICN 2734)

Ref: 2024/2734 - 12 November 2024

Important Customer Notice Status New Type Product Recall

Abbott Rapid Diagnostics has received a Field Safety Notice from Actim Oy the manufacturer of Actim® Partus Test, withdrawing one Lot number following stability testing showing the Lot number does not fulfil the required criteria.

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Field Safety Notice Ebrington Medical Non-Sterile Ultrasound Gel FDK1429 (ICN 2707)

Ref: 2024/2707 - 11 November 2024

Important Customer Notice Status Update Type Product Recall

Ebrington Medical has issued an updated Field Safety Notice following discovery of the potential risk of contamination in additional Lots, therefore the scope of the recall has widened to include Lot number 2024.06 expiry date 2027.06.

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Contract Update Multiple Suppliers Examination Gloves (ICN 2571)

Ref: 2024/2571 - 6 November 2024

Important Customer Notice Status Update Type Contractual Change

We have an update to the contractual change on Examination Gloves from multiple suppliers.

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Field Safety Notice Ideal Medical Solutions MeriGlu Skin Adhesive (ICN 2715)

Ref: 2024/2715 - 6 November 2024

Important Customer Notice Status New Type Product Recall

Ideal Medical Solutions has issued a precautionery Field Safety Notice following a report of poor product performance.

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Field Safety Notice Smith Medical Reusable Tracheal Tube Introducers and Guides (ICN 2730)

Ref: 2024/2730 - 5 November 2024

Important Customer Notice Status New Type Product Recall

Smith Medical has issued a Field Safety Notice affecting three endotracheal tube introducers having identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube.

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Field Safety Notice Advanced Medical Solutions Sterile Dressings (ICN 2718)

Ref: 2024/2718 - 5 November 2024

Important Customer Notice Status New Type Product Recall

Advanced Medical Solutions (AMS) has issued a Field Safety Notice initiating a precautionary recall having become aware of a defect on primary packaging pouches, in which minor missing patches of Polyethylene have been detected.

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