China NMPA Product Recall - Pulse flushing pump and accessories

The National Medical Products Administration (NMPA) issued a notice on July 6, 2015, regarding a voluntary recall initiated by Stryker Instruments for its Pulse Irrigation Pumps and Accessories. The core issue identified was the presence of pinhole-like gaps in the product packaging, which posed a potential risk to the sterility of the medical devices. This discovery stemmed from updates to the manufacturer's measurement standards, leading to re-evaluation through bubble emission tests and visual inspection. The affected models included 0210-312-000, 0210-318-000, 0210-318-100, and 0210-318-200, which are clinically used for irrigation during surgery. Stryker (Beijing) Medical Devices Co., Ltd., the responsible entity in China, reported that none of the implicated products were ever sold or imported into the Chinese market. Consequently, beyond reporting the recall to the State Food and Drug Administration (SFDA), the company stated no further actions were required within China. The NMPA, operating under its regulatory framework for medical devices (with products registered under CFDA/SFDA No. 20092541054), urged provincial, autonomous region, and municipal food and drug administrations to enhance their supervision and management, emphasizing vigilance despite the products not being present in China.