China NMPA Product Recall - negative pressure wound therapy device

Shanghai Kaixier Medical Device Trading Co., Ltd. initiated a voluntary Level II recall for its ACTIV.A.C. negative pressure trauma therapy device. This action was reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration on July 20, 2020. The recall addresses a critical malfunction where the device may, in rare cases, unexpectedly shut off power without providing any alarm or warning to the user. This unnotified cessation of negative pressure wound therapy poses significant patient safety risks, potentially leading to injuries such as reversible maceration, localized infections, or a deterioration of the wound condition. The company acknowledges that these accidental shutdowns could result in adverse patient outcomes. Under the guidance of the NMPA and Shanghai Municipal Drug Administration, Shanghai Kaixier Medical Device Trading Co., Ltd. is recalling the affected devices (Registration Certificate No.: 国械注进20192142442) to mitigate these potential risks. Detailed information concerning the specific models, specifications, and batch numbers is available in the associated "Medical Device Recall Event Report Form." This voluntary recall emphasizes the company's dedication to patient safety and product integrity.