China NMPA Product Recall - Medical disposable protective clothing

Hefei Medipu Medical Products Co., Ltd., under the oversight of the National Medical Products Administration (NMPA), initiated a voluntary Class III recall of its disposable medical protective clothing on November 21, 2017. This action was prompted by the discovery of insufficient filtration efficiency at the seams in some product batches during a retrospective internal quality audit conducted by the company. The identified quality issue compromises the protective capabilities of the medical clothing. Although no external inspection dates were provided, the company's internal review system effectively identified the deviation, leading to this necessary corrective measure. The recall pertains to products registered under certificate number "皖食药监械（准）字2014第2640085号". A Class III recall indicates that the product defect is unlikely to cause severe adverse health consequences, but the potential for minor or temporary harm exists. Hefei Medipu Medical Products Co., Ltd. is committed to upholding product quality standards, and further detailed information regarding the specific affected models, specifications, and batches is available in the associated "Medical Device Notice" and "Medical Device Recall Event Report Form" attachments.