China NMPA Product Recall - Cranial surgical membrane

Jiangxi 3L Medical Products Group Co., Ltd. initiated a voluntary Class III recall of its cranial surgical film, as announced on December 10, 2018. This action falls under the regulatory purview of the National Medical Products Administration (NMPA). The primary reason for the recall was the product's failure to meet standard requirements for water vapor transmission rate, a critical quality attribute for medical films. This deviation suggests a potential compromise in the product's integrity and barrier function, which is essential for its intended surgical application. The affected product is identified by Medical Device Registration Certificate 20152640230. Although specific inspection dates are not detailed in the public announcement, the company proactively reported the issue leading to this recall. The Class III classification indicates that while the defect is unlikely to cause serious adverse health consequences, corrective measures are necessary. Jiangxi 3L Medical Products Group Co., Ltd. is required to provide comprehensive information, including specific models, specifications, and batch numbers of the impacted cranial surgical film, within a detailed "Medical Device Recall Event Report Form." This voluntary recall underscores the company's commitment to product quality and compliance with NMPA's regulatory standards to safeguard public health.