In the third quarter of 2020, the NMPA posted recall notices regarding 26 medical devices and IVDs. Here we provide the analysis of the recalls.
According to Decree No. 1 Administrative Measures of Medical Device Adverse Event Monitoring and Re-evaluation (published on Aug 13, 2018, effective since Jan 1, 2019), a Periodic Risk Evaluation Report (PRER)is required to be submitted to NMPA. The report submission date varies based on when the initial NMPA approval has been obtained. Since a China PRER became mandatory on September 30, 2020, It is the obligation of each Market Authorization Holder to fulfill this post-market requirement and submit the report at the appropriate time in order to be compliant with the regulation. re.
We are experienced in dealing with the issues involved in recalls, domestic & overseas quality inspections. We also have formulated templates for the Periodic Risk Evaluation Report. Email info@ChinaMedDevice.com to get a copy.
complete recall list (manufacturers are listed in alphabetical order)
| manufacturer | device | recall class | date |
| Arrow International | Epidurals Sets and Kits for Epidurals Sets | II | 18-Aug |
| Beckman Coulter | unsaturated iron binding capability test kit | III | 2-Sep |
| Becton Dickinson | Disposable Sterile Syringe | III | 18-Aug |
| BIOMERIEUX S.A. | Chocolate AGAR medium (without antibiotics) | III | 4-Sep |
| Biomet | Knee Replacement System | II | 18-Aug |
| Biomet | inverted shoulder joint system | II | 18-Sep |
| Biomet | Acetabular System of Hip Prostheses | II | 18-Sep |
| Boston Scientific | Angiographic Catheter | I | 17-Aug |
| Boston Scientific | Disposable Poly Lifters, Disposable Electric Traps | III | 18-Aug |
Cook | ureter stent tube | II | 2-Sep |
| Cook | percutaneous nephrostomy catheter set | II | 18-Sep |
| Datex-Ohmeda | ventilator | II | 18-Sep |
| Epocal Inc. | Blood Gas System | III | 4-Sep |
| Hitachi | fully automatic bio-chemical analyzer | III | 2-Sep |
| Inpeco S.A. | Automatic sample processing system | III | 4-Sep |
| Irvine Biomedical | Inquiry Steerable Diagnostic Catheters | II | 4-Sep |
| Maquet Critical Care | ventilator | II | 18-Sep |
| Philips | X-ray Computerized Tomography Equipment | III | 18-Aug |
| Physio-Control | Automated External Defibrillator | III | 18-Aug |
| Smith & Nephew | Hip Surgical Tools | II | 18-Aug |
| Smith & Nephew | Knee Surgical Tools | III | 18-Aug |
| Stryker Medical | Automatic Patient Bed | II | 18-Aug |
| Synthes | Locking Bone Plates | II | 18-Sep |
| Synthes | intracranial maxillofacial surgical fixation system | III | 2-Sep |
| Xerox | Endoscopy Manual Tools for Endoscopy Surgery | II | 18-Aug |
| Zimmer | Elbow Prosthetics | II | 18-Aug |
Indication
Among the 26 recalls, there were five for cardiovascular devices and five for IVDs (clinical chemistry). Seven are related to orthopedic devices which takes up 27% of all recalls from last quarter.
Recall Reason Analysis
The predominant cause of device recalls was the quality issue, which accounts for 46% among all of the recalls, followed by packaging issue and mislabeling.
For more information on cause(s) of any specific device recall, please email info@ChinaMedDevice.com.