China NMPA Product Recall - Medical disposable protective clothing

The National Medical Products Administration (NMPA) announced on June 9, 2022, that Putian Puxin Medical Technology Co., Ltd. initiated a voluntary recall of specific batches of its disposable medical protective clothing. The recall was prompted by an identified quality issue described as an "uneven fracture degree" in the affected garments, which could compromise their protective integrity. The specific products subject to this recall include disposable medical protective clothing from batch number 20210828 (sterile one-piece in sizes 170, 175, 180, and 185) and batch number 20201022 (sterile one-piece in size 180). While the document does not specify inspection dates, the company's proactive decision to recall these items underscores its commitment to product quality and patient safety, operating under the regulatory framework of the NMPA. The required action by the company is the immediate voluntary recall of the identified batches to mitigate potential risks. More detailed information, including exact quantities and models, is available in the company's "Puxin Recall Report," demonstrating adherence to medical device vigilance principles for addressing product deficiencies.