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Important Customer Notices (ICNs)

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Field Safety Notice Boston Scientific EXPO Angiographic Catheter Products (ICN 2494)

Ref: 2024/2494 - 8 May 2024

Important Customer Notice Status New Type Product Recall

Boston Scientific is initiating a removal of certain batches of EXPO 5F Angiographic Catheters due to an increase in complaints related to an inability to advance the guidewire through the lumen of the device.

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Field Safety Notice Intersurgical Mapleson F Anaesthetic Breathing Systems Containing 0.05L Reservoir Bags with Open Tails (ICN 2520)

Ref: 2024/2520 - 29 April 2024

Important Customer Notice Status New Type Product Alert

Intersurgical has issued a Field Safety Notice having identified a potential safety concern relating to various Mapleson F Anaesthetic Breathing Systems.

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Field Safety Notice Medicina IV Syringe Luer Slip for Insulin Use FSW773 (ICN 2516)

Ref: 2024/2516 - 24 April 2024

Important Customer Notice Status New Type Product Alert

Medicina has issued a Field Safety Notice to inform users that although the primary packaging of the affected batches of the 1ml luer slip IV insulin syringe listed below, and in the Field Safety Notice, is orange, the printing on the barrel is black.

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Field Safety Notice Healthcare 21 Niti-S Tracheobronchial Uncovered Stent (ICN 2479)

Ref: 2024/2479 - 17 April 2024

Important Customer Notice Status New Type Product Recall

HealthCare 21 has circulated a Field Safety Notice issued by Taewoong recalling all unexpired Lot numbers of a range of Niti-S Tracheobronchial Uncovered Stents, (BRxxxxW).

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Field Safety Notice 3M Tegaderm™ CHG Chlorhexidine Gluconate IV Securement Dressing ELW294 (ICN 2492)

Ref: 2024/2492 - 17 April 2024

Important Customer Notice Status Update Type Product Alert

The supplier 3M has made us aware they are relabelling the affected product boxes.

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Field Safety Notice Crest Medical Blue Dot Irrigation Fluid 0.9% Sodium Chloride Solution Pod 20ml MRB1140 (ICN 2476)

Ref: 2024/2476 - 9 April 2024

Important Customer Notice Status Update Type Product Recall

The MHRA has issued Devise Safety Information (DSI) relating to Legency Remedies Private Ltd Field Safety Notice (FSN) Product Recall for sodium chloride 0.9% w/v solutions for irrigation, inhalation and eye wash.

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Field Safety Notice Medex Secufill Contrast Media Injector Options Secufill JAH328 (ICN 2406)

Ref: 2024/2406 - 5 April 2024

Important Customer Notice Status Update Type Product Recall

Guerbet are currently facing challenges with supplying Secufill JAH328.

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Field Safety Notice Olympus Triangular Tip Electrosurgical Knives (ICN 2471)

Ref: 2024/2471 - 15 March 2024

Important Customer Notice Status New Type Product Alert

Olympus has issued a Field Safety Notice following an increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use.

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Field Safety Notice Convatec Carboflex™ Dressings 8 x 15cm and 15 x20cm ELV021 and ELV020 (ICN 2459)

Ref: 2024/2459 - 14 March 2024

Important Customer Notice Status New Type Product Recall

Convatec has issued a precautionary Field Safety Corrective Action Notice for specific Lots and dressing sizes of CarboFlex™ due to routine testing not meeting Convatec’s product sterility assurance level of <10-6.

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Field Safety Notice Applied Medical Epix® Universal Clip Applicator FGE771 (ICN 2463)

Ref: 2024/2463 - 14 March 2024

Important Customer Notice Status New Type Product Recall

Applied Medical is conducting a Field Safety Corrective Action affecting specific Lot numbers of the Epix® Universal Clip Applier due to a nonconformance that may result in a clip not loading into the jaws after the trigger is actuated.

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Field Safety Notice Johnson & Johnson CEREBASE DA Guide Sheath (ICN 2446)

Ref: 2024/2446 - 27 February 2024

Important Customer Notice Status New Type Product Recall

Medos International Sarl (Medos) has issued a Field Safety Notice regarding specific Lots of CEREBASE DA Guide Sheath.

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Field Safety Notice Teleflex Arrow® QuickFlash® Radial Artery Catheterisation Kits and Sets (ICN 2433)

Ref: 2024/2433 - 16 February 2024

Important Customer Notice Status Update Type Product Recall

Teleflex has issued a Field Safety Notice for their Arrow® QuickFlash® Radial Artery Catheterisation Kits and Sets & Arrow® QuickFlash® Radial Artery/Arterial Line Catheterisation Kit.

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Field Safety Notice B Braun Original Perfusor® Line (ICN 2423)

Ref: 2024/2423 - 15 February 2024

Important Customer Notice Status New Type Product Recall

B Braun has issued a Field Safety Notice regarding specific batches of their Original Perfusor® Line

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Field Safety Notice Premier Foods Ambrosia My Mini Rice and Custard Pots AKM020 (ICN 2424)

Ref: 2024/2424 - 8 February 2024

Important Customer Notice Status New Type Product Recall

Premier Foods has issued a Field Safety Notice for their Ambrosia My Mini Rice and Custard Pots.

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Field Safety Notice GBUK Banana Patient Clip Slings (ICN 2408)

Ref: 2024/2408 - 30 January 2024

Important Customer Notice Status Update Type Product Recall

GBUK has requested an additional email address for the return of the completed FSCA Acknowledgement form.

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