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Important Customer Notices (ICNs)

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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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Field Safety Notice Smiths Medical BLUSelect™ Pilot Balloon Detachment (ICN 2645)

Ref: 2024/2645 - 16 August 2024

Important Customer Notice Status New Type Product Recall

Smiths Medical has issued an Urgent Field Safety Notice having identified a manufacturing defect with the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific Lots of the BLUSelect®, BLUgriggs® and BLUperc® products.

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Field Safety Notice BioDesign Fistula Plug Labelled Expiration Date Incorrect (ICN 2641)

Ref: 2024/2641 - 15 August 2024

Important Customer Notice Status New Type Product Recall

Cook Medical has issued an Urgent Field Safety Notice following discovery of a discrepancy between the correct product shelf life and that printed on the finished product label.

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Field Safety Notice Cepheid Specimen Collection Devices for GX (ICN 2638)

Ref: 2024/2638 - 12 August 2024

Important Customer Notice Status New Type Product Recall

Following reports of leakage after the patient samples swabs had been inserted into the test tubes, Cepheid has issued an Urgent Medical Device Product Recall for the product code listed below.

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Field Safety Notice Philips Trilogy Evo, Evo O2, EV300 Failing to Meet Obstruction Alarm Standards Requirement (ICN 2627)

Ref: 2024/2627 - 6 August 2024

Important Customer Notice Status New Type Product Alert

Philips Respironics has become aware that Trilogy Evo, Trilogy Evo O2, and Trilogy EV300 devices do not comply with the Obstruction Alarm requirements specified within ISO 80601-2-12 Clause 201.12.4.108 and ISO 80601-2-72 Clause 201.12.4.107.

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