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
• 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@inspirativemed.com

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