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Important Customer Notices (ICNs)

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Showing 11 ICNs only belonging to tag: Product Recall Clear filter

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Personal Protective Equipment (PPE) Increased Demand Update (ICN 2790)

Ref: 2025 / 2790 - 9 January 2025

Important Customer Notice: Product Update

Type IIR and FFP3 face masks have been placed on demand management.

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Supply Issues ICU Medical International Ltd Blood Gas Syringes (ICN 2722)

Ref: 2024/2722 - 6 January 2025

Important Customer Notice: Update

The supply issue with Blood Gas Syringes from ICU Medical International Ltd is continuing.

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

Ref: 2024/2523 - 12 December 2024

Important Customer Notice: Update

Demand management has been removed from all Ecolab and Essity products.

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Product Recall Rocket Medical Thoracentesis Catheters R51551-08-00 and Thoracentesis Catheter R51551 (ICN 2737)

Ref: 2024/2737 - 15 November 2024

Important Customer Notice: 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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Product Recall Abbott Rapid Diagnostics Actim® Partus Test (ICN 2734)

Ref: 2024/2734 - 12 November 2024

Important Customer Notice: 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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Product Recall Ebrington Medical Non-Sterile Ultrasound Gel FDK1429 (ICN 2707)

Ref: 2024/2707 - 11 November 2024

Important Customer Notice: Update

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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Product Recall Ideal Medical Solutions MeriGlu Skin Adhesive (ICN 2715)

Ref: 2024/2715 - 6 November 2024

Important Customer Notice: Recall

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

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Product Recall Smith Medical Reusable Tracheal Tube Introducers and Guides (ICN 2730)

Ref: 2024/2730 - 5 November 2024

Important Customer Notice: 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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Product Recall Advanced Medical Solutions Sterile Dressings (ICN 2718)

Ref: 2024/2718 - 5 November 2024

Important Customer Notice: 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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Product Recall Greiner Bio-One VACUETTE® HOLDEX® Single-Use Holder PP Single-Packed Sterile KFK111 (ICN 2724)

Ref: 2024/2724 - 31 October 2024

Important Customer Notice: Recall

Greiner Bio-One has notified us about a Lot specific product recall regarding their single packed, sterile VACUETTE® HOLDEX® Single-Use Holder.

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Product Recall Intersurgical Ltd Flextube Resus Breathing Systems 10mm for use with Neopuff® Resuscitators with Variable Peep (ICN 2690)

Ref: 2024/2690 - 10 October 2024

Important Customer Notice: Recall

Intersurgical Ltd has issued a Field Safety Notice following a customer report and subsequent investigation identified a potential safety concern with five of their 10mm resuscitation breathing systems for use with the Neopuff® Resuscitator.

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Product Recall Smiths Medical Nasopharyngeal Airway Double Swivel Connector 15mm Y Piece Portex™ Orator Speaking Valve Thermovent™ 1200 (ICN 2688)

Ref: 2024/2688 - 7 October 2024

Important Customer Notice: Recall

Smith Medical has issued a Field Safety Notice having identified a potential issue with the packaging sterile seals on specific Nasopharyngeal Airway, Double Swivel Connector, 15mm Y Piece, Portex™ Orator Speaking Valve, Thermovent™ 1200 products packaged between 20 January 2021 and 27 August 2021.

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Product Recall Rocket Medical Safety Needle Drain 8fg x 16cm Paracentesis Catheter with Blunt Obturator Needle (ICN 2682)

Ref: 2024/2682 - 26 September 2024

Important Customer Notice: Recall

Rocket Medical has issued a Field Safety Notice withdrawing a single Lot number of their 8fg Safety Needle having identified that during production the adhesive/glue used to secure the drainage line to the stitch plate was not correctly applied.

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Product Recall Olympus Everest Bipolar Cutting Forceps Broken Forceps Trays (ICN 2655)

Ref: 2024/2655 - 19 September 2024

Important Customer Notice: 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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