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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Ref: 2024/2493 - 5 August 2024
Important Customer Notice Status Update Type Product Alert
Philips Respironics has issued an update to the Field Safety Notice advising the release of a mandatory Software update, Version 1.06.10.00 and a User Manual addendum for the Trilogy Evo, Trilogy Evo O2, and the Trilogy EV300 ventilators.
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Ref: 2024/2617 - 25 July 2024
Important Customer Notice Status New Type Product Alert
Micsafe Medical has issued a Field Safety Notice following discovery that the blister level of the packaging for two sizes of their safety hypodermic needles, has the expiry and manufacture dates transposed.
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Ref: 2024/2586 - 19 July 2024
Important Customer Notice Status New Type Product Update
Due to the General Wound Care Nationally Contracted Products initiative coming to an end on 31 July 2024, we have taken the decision to revert to the originally awarded suppliers for the remainder of the framework agreement.
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Ref: 2024/2609 - 17 July 2024
Important Customer Notice Status New Type Product Alert
Nikkiso has issued a Field Safety Notice following discovery during product surveillance of a potential problem which could affect product performance.
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Ref: 2024/2600 - 17 July 2024
Important Customer Notice Status Update Type Product Recall
Argon Medical has issued a Field Safety Corrective Action Notice following complaints of holes in the sterile barrier of the tray packaging for a range of products.
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Ref: 2024/2553 - 15 July 2024
Important Customer Notice Status Update Type Delisting
The discontinuation due to a product update with Blood Collection products from Greiner Bio-One Ltd is continuing.
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Ref: 2024/2598 - 11 July 2024
Important Customer Notice Status New Type Product Recall
Boston Scientific has issued a Field Safety Notice recalling specific Lot numbers of Capio™ Slim Suture Capturing Devices following an increase in reports of the device not catching the suture needle/dart as expected during use.
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Ref: 2024/2569 - 24 June 2024
Important Customer Notice Status Update Type Product Recall
NHS Supply Chain has seen a significant increase in demand for the affected products.
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Ref: 2024/2528 - 19 June 2024
Important Customer Notice Status New Type Product Alert
Teleflex has issued an advisory Field Safety Corrective Action Notice for Teleflex Arrow FibreOptix and UltraFlex Intra-Aortic Balloon Catheter Kits.
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Ref: 2024/2570 - 12 June 2024
Important Customer Notice Status New Type Product Alert
Masimo has issued a Field Safety Notice having ascertained certain parts and Lot numbers of LNCS Disposable Sensors manufactured between March 2024 and the end of May 2024 are not compatible with older versions of Masimo technology boards used in both Masimo monitors and OEM monitors.
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Ref: 2024/2543 - 6 June 2024
Important Customer Notice Status New Type Product Recall
Fluoron GmbH has issued a Field Safety Notice regarding the silicone oil of the type Siluron® 1000, Siluron® 2000 and Siluron® Xtra.
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Ref: 2024/2554 - 23 May 2024
Important Customer Notice Status New Type Product Recall
The Surgical Company International BV (TSC Life) has issued a Field Safety Notice recalling specific batches of Fluido® Trauma Sets following a temporary change to a manufacturing technique resulted in the production of a number of individual Fluido® Trauma Sets with an unstable connection junction.
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Ref: 2024/2548 - 20 May 2024
Important Customer Notice Status New Type Product Recall
Megadyne Medical Products Inc. has initiated a voluntary medical device recall (removal) of all distributed Lots of the MEGADYNE™ MEGA SOFT™ Pediatric Patient Return Electrode.
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