China NMPA Product Recall - Medical disposable protective clothing
Discuss this record with AI
Anhui Tiankang Medical Technology Co., Ltd. has initiated a voluntary Level III recall for specific batches of its disposable medical protective clothing. This action follows a finding that products with batch numbers 220302 and 220303 failed to meet quality standards during a routine random inspection. The recall was announced on July 8, 2022, and communicated by the Anhui Provincial Drug Administration, with oversight from the National Medical Products Administration (NMPA) under index JGXX-2022-10178. The main issue identified was a quality defect that led to the non-compliance of the protective clothing. As a result, Anhui Tiankang Medical Technology Co., Ltd. is undertaking this recall to remove the affected items from circulation. A Level III recall signifies that while the product issue is unlikely to cause severe adverse health consequences, it still necessitates action to ensure product integrity and consumer safety. The company is required to provide detailed information on affected models, specifications, and batches through official Medical Device Recall Report Forms, demonstrating their adherence to regulatory frameworks. This measure highlights the company's commitment to maintaining product quality and complying with the standards established by Chinese medical product regulatory bodies.
ID · 2462ecc6-a8de-43c3-9ce7-4b6a67486bb4