China NMPA Product Recall - Disposable high-pressure injector and accessories - drug suction device

The National Medical Products Administration (NMPA) has publicized a voluntary recall initiated by Liebel-Flarsheim Company concerning specific models of its disposable high-pressure injectors and accessory aspirators. The recall, reported by Tyco Medical Devices International Trading (Shanghai) Co., Ltd. around December 2011, stems from critical reports of incomplete sealing in the sterile packaging of these medical devices. This issue compromises product sterility, which is essential for safe medical procedures such as angiography, computed tomography, or MRI contrast agent injections. While the manufacturer stated that no affected products from the identified batches (e.g., 9288021, 0011122) were imported into or sold within the Chinese market, the NMPA, operating under its regulatory framework (referencing CFDA Approval Number 2009 No. 3150516), mandated a public notification. The required actions include the immediate recall and return of all affected products to the manufacturer from international markets like Singapore, Japan, and Canada. Additionally, Chinese provincial, autonomous region, and municipal food and drug administrations are instructed to strengthen their oversight and management of similar medical devices to proactively safeguard public health, reinforcing the NMPA's commitment to product safety standards.