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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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