Ref: 2024/2617 - 25 July 2024
Important Customer Notice: Field Safety Notice
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: 2024/2609 - 17 July 2024
Important Customer Notice: Field Safety Notice
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: Field Safety Notice
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: 2024/2598 - 11 July 2024
Important Customer Notice: Field Safety Notice
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: 2022/1968 - 8 July 2024
Important Customer Notice: Update
Smiths Medical has issued a second update, dated 1 July 2024 against FA2211-01 having identified further additional lot numbers of CADD™ Infusion System Infusion sets that are potentially affected by the issues listed in the initial Field Safety Notice.
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Ref: 2024/2596 - 4 July 2024
Important Customer Notice: Field Safety Notice
Zimmer Biomet has issued a medical device Field Safety Corrective Action (correction) for CPT Hip System Femoral Stem 12/14 Neck Taper products due to an increased risk of postoperative periprosthetic femoral fracture (PFF).
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Ref: 2024/2574 - 27 June 2024
Important Customer Notice: Field Safety Notice
Rocialle Healthcare has issued a Field Safety Notice regarding specific batches of RML228-023 – Bowl 6000ml Blue double wrapped and RML114-003 – XL Quiver Sterile.
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Ref: 2024/2569 - 24 June 2024
Important Customer Notice: Update
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: Field Safety Notice
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: 2024/2572 - 17 June 2024
Important Customer Notice: Field Safety Notice
Baxter has issued a Field Safety Correction Notice for the power cords used with the Welch Allyn ProBP 3400 Digital Blood Pressure Welch Allyn Spot Vision Screener following reports of an issue relating to the cord construction not meeting the insulation rating for international standards.
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Ref: 2024/2570 - 12 June 2024
Important Customer Notice: Field Safety Notice
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: Field Safety Notice
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: 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: 2023/2375 - 22 May 2024
Important Customer Notice: Update
Olympus has released an update to the Field Safety Notice relating to UHI-4 High Flow Insufflation Unit products.
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Ref: 2024/2548 - 20 May 2024
Important Customer Notice: 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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