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Important Customer Notices (ICNs)

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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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Field Safety Notice Olympus Single Use Biopsy Valve MAJ-1555 (ICN 2731)

Ref: 2024/2731 - 5 November 2024

Important Customer Notice Status New Type Product Alert

Olympus has issued a Field Safety Notice having become aware that five lot numbers may be missing product identification and an expiration date on the sterile packaging.

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Field Safety Notice Baxter Braun 6000 Instructions for Use Update (ICN 2689)

Ref: 2024/2689 - 17 October 2024

Important Customer Notice Status New Type Product Alert

NHS Supply Chain has been made aware of two Field Safety Notices issued by Baxter on 26 June 2024 and 26 September 2024, due to Baxter identifying that the Braun Thermoscan Pro 6000 ear thermometers issued between 15 September 2022 and 22 February 2024 were supplied with a compact disc (CD) containing an outdated version of the instructions for use (IFU).

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Field Safety Notice 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 Status New Type Product 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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Field Safety Notice 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 Status New Type Product 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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Field Safety Notice Medtronic Healthcare21 McGrath Mac Video Laryngoscope FDD2504 (ICN 2621)

Ref: 2024/2621 - 30 September 2024

Important Customer Notice Status Update Type Product Alert

In July 2024, Medtronic issued an Urgent Field Safety Notice for McGRATH™ MAC Video Laryngoscopes, item codes 300-000-000, which were within their useful life of 5 years (Serial numbers 366170 to 405673).

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Field Safety Notice 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 Status New Type Product 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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Field Safety Notice Ambu VivaSight 2DLT  (ICN 2673)

Ref: 2024/2673 - 19 September 2024

Important Customer Notice Status New Type Product Recall

Ambu has issued a Field Safety Notice following complaints regarding the design of the product Ambu® VivaSight™ 2 DLT, specifically referring to a hyper angulation of the distal end of the double lumen tube.

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Field Safety Notice Olympus Everest Bipolar Cutting Forceps Broken Forceps Trays (ICN 2655)

Ref: 2024/2655 - 19 September 2024

Important Customer Notice Status New Type Product 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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Field Safety Notice Intersurgical IPPB Flextube™ Breathing System (ICN 2671)

Ref: 2024/2671 - 17 September 2024

Important Customer Notice Status New Type Product Alert

Intersurgical has issued a Field Safety Notice following a report of a loose connection between the nebuliser and supply line T-piece IPPB Flextube™ breathing system.

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Field Safety Notice Smiths Medical CADD™ Medication Cassette Reservoirs (ICN 2662)

Ref: 2024/2662 - 9 September 2024

Important Customer Notice Status New Type Product Recall

Smiths Medical has issued a Field Safety Notice following discovery of a potential issue with specific models and Lot numbers of the 50 ml and 100 ml CADD Medication Cassette Reservoirs.

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

Ref: 2024/2596 - 5 September 2024

Important Customer Notice Status Update Type Product Alert

The Medicines and Healthcare products Regulatory Agency has issued the following device safety information update dated 4 September 2024.

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Field Safety Notice TSC Life Fluido Trauma Standard Sets VCB522 (ICN 2656)

Ref: 2024/2656 - 30 August 2024

Important Customer Notice Status New Type Product Alert

The supplier TSC Life have issued a Field Safety Corrective Action (FSCA) Notice following quality control testing which revealed a proportion of the tested samples to have elevated levels of non-toxic particulates in Fluido® single use sets.

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Field Safety Notice Ossur Miami J Select PSA Hook Adhesion (ICN 2651)

Ref: 2024/2651 - 21 August 2024

Important Customer Notice Status New Type Product Recall

Ossur has issued a Field Safety Notice recalling two Miami J Select Cervical Collars following discovery that the pressure sensitive adhesive (PSA) hooks attached to the sides of the anterior collar panel can occasionally exhibit poor adhesion.

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