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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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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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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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thermometers issued between 15 September 2022 and 22 February 2024 were supplied with a compact disc (CD) containing an outdated version of the instructions for use (IFU).
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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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