China NMPA Product Recall - Digital electronic blood pressure monitor

Dongguan Dekang Medical Products Co., Ltd. initiated a voluntary Level III recall of its Digital Electronic Blood Pressure Monitors, specifically batch number 20140616001. The recall, reported to the National Medical Products Administration (NMPA) on July 29, 2019, was triggered by findings during a 2019 National Medical Device Spot Check. The inspection revealed that the instruction manual for the affected blood pressure monitors was incomplete. The primary violation involved the manual's failure to comply with specific sections of the industry standard YY0670-2008 for "Non-invasive Automatic Blood Pressure Meters," as well as the company's own registered product standard. Although 800 units of the affected batch were produced, the company reported zero sales in China, indicating that no non-compliant products reached the market. In response to these deficiencies, Dongguan Dekang Medical Products Co., Ltd. is undertaking several corrective actions. These include immediately revising and updating the instruction manual, reprinting new versions for replacement, and scrapping all existing non-compliant manuals currently in stock. Furthermore, all unsold blood pressure monitor products will have their instruction manuals updated to ensure full compliance.