China NMPA Product Recall - Surgical patch

Sofradim Production, with the recall reported by Covidien Medical Devices International Trading (Shanghai) Co., Ltd., has initiated a voluntary Class II recall of its surgical patches. The recall, announced by the National Medical Products Administration (NMPA) on March 14, 2023, addresses a manufacturing defect where the collagen membrane was coated in an incorrect position on specific models and batches of the medical device. This issue impacts products registered under National Medical Device Registration Certificate No. 20173461165. While inspection dates are not detailed in the provided document, the regulatory framework involves the NMPA overseeing this voluntary action. A Class II recall signifies that the use of, or exposure to, the affected product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The required actions involve the company identifying and managing all affected batches as detailed in the "Medical Device Recall Event Report Form" to ensure the removal of non-compliant products and maintain patient safety standards.