China NMPA Product Recall - Pre-filled catheter flusher

Becton, Dickinson and Company, through its subsidiary Becton Medical Devices (Shanghai) Co., Ltd., has initiated a voluntary Class III recall of its pre-filled catheter flushing devices. This action, published by the National Medical Products Administration (NMPA) on October 29, 2019, addresses a product quality concern. The recall was prompted by the inadvertent mixing of a small quantity of products designated for packaging change testing with regularly packaged devices intended for market distribution. While the document does not elaborate on the specific risks associated with this mix-up, a Class III recall generally indicates that the use of or exposure to the affected product is not likely to cause adverse health consequences. The affected devices are identified by Registration Certificate No.: 20163142809, with specific models, specifications, and batch details provided in an attached Medical Device Recall Event Report Form. As the overseeing regulatory body, the NMPA is ensuring transparency and public awareness of this event. The required action for Becton, Dickinson and Company involves identifying, quarantining, and retrieving all affected units from the market to mitigate any potential issues and uphold product integrity. The document does not specify any particular inspection dates that directly led to this recall, suggesting it was initiated by the company upon discovering the internal discrepancy.