China NMPA Product Recall - Pulsed arteriovenous pneumatic compression therapy device

Anhui Aerospace Biotechnology Co., Ltd. initiated a voluntary Class III recall of its Pulsating Arteriovenous Pneumatic Compression Therapy Device. The recall, reported to the Provincial Food and Drug Administration on August 27, 2017, was prompted by a significant discrepancy between the product's accompanying "User Guide" and its official product registration certificate. Specifically, the indications for use described in the user guide did not align with the approved scope of application registered with the National Medical Products Administration (NMPA). This regulatory non-compliance affects multiple batches of the device, identified by product numbers such as 00117, 00317, 00417, 00717, 00817, 00917, 01017, 01117, 01217, 01317, 01417, 01517, 01617, 01717, 01817, 01917, 02017, and 02117. The company has identified and is recalling 12 sold units. The required action involves the collection and proper handling of these affected devices to address the inconsistencies and ensure compliance with NMPA regulations regarding product labeling and approved uses. The recall aims to rectify the misrepresentation of the device's intended applications, upholding regulatory standards.