China NMPA Product Recall - Transdermal implant

Cook (China) Medical Trading Co., Ltd. initiated a voluntary Level II recall for specific transdermal implant devices, as announced on May 5, 2019, under the National Medical Products Administration (NMPA) framework (Index No. JGXX-2019-10282). The recall was prompted by distributors identifying three products with compromised sterilization packaging, specifically missing bottom seals. Following this discovery, Cook conducted a thorough internal investigation, reviewing all product models and packaging-related complaints spanning from January 1, 2016, to April 14, 2019. This review confirmed that only batch number 8373482 of the transdermal implant devices (Registration Certificate No.: 20163772344) was affected by the packaging integrity issue. Operating under the regulatory requirements established by the NMPA, the company is undertaking this recall to address the potential sterility compromise. Detailed information regarding the affected products' models, specifications, and batches is provided in the "Medical Device Recall Event Report Form."