China NMPA Product Recall - pressure pump

Condis (Shanghai) Medical Devices Co., Ltd., acting as the agent for manufacturer ArcRoyal, initiated a voluntary Class II recall of pressure pumps (Registration No.: 20153662367) under the National Medical Products Administration (NMPA) framework. The recall, reported on June 15, 2017, and published on July 27, 2017, addressed a critical issue: damaged inner plastic packaging of the pressure pumps, which compromised the products' aseptic performance. This defect affected products manufactured between April 2015 and December 2016, with 22 batches totaling 1286 boxes imported into China. The root cause was attributed to insufficient protection during a new transport route from Mauritius to France, coupled with potential thermal stress during winter shipments. ArcRoyal implemented 100% inspection processes from January 2017 and enhanced transport protection measures by March 2017 to prevent further defects. Required actions for distributors included thoroughly inspecting current and downstream inventory for damaged packaging, notifying hospitals to cease use of compromised products, and following a complaint and return/exchange process. Distributors were also mandated to complete a 'Distributor Confirmation Chart' and return all defective products for unified destruction, while undamaged products could continue to be used or sold.