China NMPA Product Recall - Pig tail drainage tube

Baguang Trading (Shanghai) Co., Ltd. has voluntarily initiated a Class III recall for its 7Fr*300mm locking type pig tail drainage tubes. This recall, reported to the National Medical Products Administration (NMPA) on June 29, 2020, addresses a critical discrepancy in the product’s official documentation. The main issue identified is an inconsistency between the storage conditions described in the product instructions and those outlined in the product’s technical requirements. Specifically, while the technical requirements mandate storage in an environment “free from corrosive gases,” the product manual omits this crucial detail, only advising against high moisture, direct sunlight, or high temperature and humidity. This omission could potentially lead to inappropriate storage and impact product quality or efficacy. As a required action under NMPA oversight, Baguang Trading (Shanghai) Co., Ltd. is recalling all affected pig tail drainage cannulas (Registration Certificate No.: 20173666996). Detailed information regarding specific product models, specifications, and batches involved in this recall is available in the “Medical Device Recall Event Report Form.”