China NMPA Product Recall - isolation gown

Jinjiang Xingde Textile Co., Ltd. has initiated a voluntary recall of its isolation gowns, as announced on June 2, 2022. This action follows a sampling inspection that identified a significant quality issue with the product. The primary violation found was that the isolation gowns did not meet their technical requirements regarding the sealing of needle holes. This defect compromises the protective barrier integrity, which is critical for medical isolation gowns.

Operating under the oversight of the National Medical Products Administration (NMPA), specifically NMPA Index No. JGXX-2022-10136, and reported through the Fujian Provincial Drug Administration, the company took swift action. Jinjiang Xingde Textile Co., Ltd. is actively recalling the affected products to ensure patient and user safety. Further detailed information, including specific product models, specifications, quantities, and batch numbers involved in the recall, is documented in the company's official 'Jinjiang Xingde Textile Co., Ltd. Recall Report'. This voluntary recall underscores the company's commitment to addressing product deficiencies and complying with regulatory standards.