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.