China NMPA Product Recall - pressure pump

Condis (Shanghai) Medical Devices Co., Ltd. initiated a Class II voluntary recall of its pressure pumps (Registration No. 201536623) on July 27, 2017, as reported by the National Medical Products Administration (NMPA). The primary issue identified was potential damage to the inner plastic packaging of the devices, which compromises their aseptic integrity. This defect primarily stems from insufficient protection during the transfer of the pressure system production line by manufacturer ArcRoyal from France to Mauritius between April 2015 and December 2016, leading to product movement and packaging stress during transport, especially during European winters. Although the defect rate was low (0.001%), affecting 22 batches globally, 1286 boxes were imported into China. The regulatory framework mandates a structured recall process, including submitting a Medical Device Recall Event Report Form. Required actions included Condis notifying all distributors to inspect existing inventory for damaged packaging and initiate returns or exchanges for affected units. Distributors were also instructed to contact downstream partners and hospitals. Hospitals were advised to inspect products prior to use and refrain from using any with compromised packaging. ArcRoyal, the manufacturer, had already implemented 100% product inspections since January 2017 and enhanced transport packaging protection since March 2017 to prevent further defective products from entering the market.