China NMPA Product Recall - Disposable high-pressure injectors and accessories

Liebel-Flarsheim Company LLC has initiated a voluntary recall for specific models and batches of its disposable high-pressure injectors and associated accessories. This action was announced by the National Medical Products Administration (NMPA) on May 18, 2021, following reports from Jiabai Medical Devices (Shanghai) Co., Ltd. The primary issue identified is a manufacturing defect where certain product connectors may exhibit insufficient or incomplete soldering. This flaw poses a significant safety risk, as it could lead to the connectors failing under high pressure during clinical use, potentially causing serious damage. This voluntary recall, managed under the regulatory framework of the NMPA, is classified as a Level II recall. This categorization suggests that the use of the affected products could cause temporary or medically reversible adverse health consequences, or where the likelihood of serious adverse health consequences is remote. Liebel-Flarsheim Company LLC is undertaking efforts to remove the impacted devices from the market. Comprehensive details, including the specific models, specifications, and batch numbers subject to this recall, are provided in the accompanying "Medical Device Recall Event Report Form."