16 Devices Recalled in November; One Class I Recall

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16 Devices Recalled in November; One Class I Recall

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    NMPA announced Recall Notices for 16 imported medical devices in November.

    Class I recall (the most serious):

    • Edwards Lifesciences: Aortic perfusion cannula

    Class II and Class III recall:

    • GE: Patient monitor
    • GE: Endoscopic articular head linear cutting stapler and staple cartridge
    • Johnson & Johnson: Wire-absorbable bone anchor system
    • Johnson & Johnson: Diagnostic / Ablative elbow end catheter
    • Philips: Defibrillator / Monitor
    • Richard Wolf: Infusion pump
    • Electro Medical Systems: Ultrasonic scaler
    • Cook: Support catheter
    • BioMérieux: Automatic fluorescence immunoassay analyzer
    • Stryker: Tourniquet
    • B. Braun: Vena cava filter and guiding system
    • Intuitive Surgical: Endoscope surgery control system
    • Elekta: Cancer information management
    • Howmedica Osteonics: Joint surgery kit
    • Instrumentation Laboratory: HemosIL von Willebrand factor antigen

    For causes and model numbers of the recalls in November, please email info@ChinaMedDevice.com.

    For Decree 29 Measures for the Administration of Medical Device Recall, please email us also. We charge nominal fees for the translation.

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    About ChinaMed Device, LLC 

    ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.

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