China NMPA Product Recall - Disposable sterile surgical gown

Henan Kelong Medical Device Co., Ltd., operating under the oversight of the National Medical Products Administration (NMPA), issued a voluntary Level III recall for a specific batch of its disposable sterile surgical gowns. This corrective action, announced on November 9, 2017, was initiated after the company discovered that the water resistance performance in the non-critical areas of these gowns did not comply with established standard requirements. The regulatory framework requires manufacturers to ensure their medical devices meet specified quality and safety standards. In response to this identified product defect, Henan Kelong Medical Device Co., Ltd. proactively decided to remove the affected products from circulation. This voluntary recall highlights the company's commitment to maintaining product quality and ensuring patient safety by addressing non-conforming items in the market, aligning with NMPA's directives for medical device integrity.