16 Devices Recalled in November; One Class I Recall


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
  • BioM√©rieux: 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.

For webinar on China PMS, please click HERE.

To keep up to date on NMPA (CFDA) changes, please opt in our monthly newsletter https://ChinaMedDevice.com/cmd-blogs/

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.