China NMPA Product Recall - Medical disposable protective clothing

Anhui Fumei Medical Technology Co., Ltd. initiated a voluntary recall of its disposable medical protective clothing on June 29, 2021. The recall was prompted by the product's non-compliance with appearance requirements, specifically concerning "stitch spacing." This manufacturing deviation was identified by the company itself, leading to their proactive decision to remove the affected products from the market. The recall pertains to products registered under No. 皖械注准20182640101.

The company reported this recall event to the Anhui Provincial Drug Administration, operating under the oversight of the National Medical Products Administration (NMPA), which sets the regulatory framework for medical devices in China. While the document does not specify inspection dates, it highlights the company's commitment to product quality and patient safety by voluntarily addressing the identified issue. Affected models, specifications, and batches are detailed in a separate Medical Device Recall Event Report Form. This voluntary action demonstrates adherence to NMPA's stringent quality control expectations for medical device manufacturers, ensuring immediate corrective measures are taken when non-conformities are discovered to safeguard public health.