Two Class I Recalls Announced in December

NMPA: Industry Standards Changes in December
January 9, 2020
NMPA News Roundup December 2019
January 14, 2020

Two Class I Recalls Announced in December

NMPA announced 25 recalls in December 2019, including two Class I recalls.

Class I recall (the most serious):

  • Johnson & Johnson: Multiaxial pedicle fixation system
  • Boston Scientific: Guiding catheter

Class II and Class III recall:

  • Boston Scientific: Pelvic floor repair system
  • Boston Scientific: Self-expanding stent system
  • Gore: Hydrophilic coating guide sheath
  • Gore: Thoracic aorta stent endovascular stent system
  • Biocomposites: Absorbable artificial bone powder
  • Biocomposites: Calcium sulfate
  • Maquest: Heart-lung machine-heat exchange water tank
  • Maquest: Integrated membrane oxygenator
  • Siemens: High sensitivity C reactive protein calibrator
  • Philips: X-ray computer tomography equipment
  • Roche: Automatic biochemical immunology analyzer
  • Smith & Nephew: Bone needle
  • Zimmer: Hip surgery kit
  • Beckman Coulter: Fully automatic slide dyeing system
  • Howmedica Osteonics: Hip joint prosthesis-polyethylene liner
  • Datex-Ohmeda: Infant incubator
  • Kawasumi Laboratories: Hollow fiber dialyzer
  • Ortho Clinical Diagnostics: Phenytoin reagent kit
  • Diasorin: Cardiopulmonary circulation centrifugal pump
  • Covidien: Arc staple cartridge for disposable cutting stapler under endoscope
  • Instrumentation Laboratory: Prothrombin time and fibrinogen assay kit
  • Stryker Instruments: High vacuum bone cement mixer
  • Biotronik: Self-expanding nickel-titanium alloy peripheral vascular stent system

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.