China NMPA Product Recall - Medical surgical masks

On November 16, 2020, Foshan Rehabilitation Medical Equipment Factory initiated a Level III voluntary recall of its Medical Surgical Masks, as reported to the National Medical Products Administration (NMPA) and the Guangdong Provincial Drug Administration. This action followed inspections by the Guangzhou Medical Device Quality Supervision and Inspection Center, which identified two main compliance issues.

Specifically, batch number 20030602, encompassing 14,060 units, was found to have a bacterial filtration efficiency that did not meet required standards. Additionally, batch number 20061502, involving 4,360 units, failed to meet established pressure difference standards during a random inspection.

As part of the corrective actions, Foshan Rehabilitation Medical Equipment Factory is required to recall and replace all existing stock and previously sold units for both affected batches. To prevent recurrence of the bacterial filtration issue, the company committed to purchasing comprehensive testing equipment, including particle filtration efficiency, synthetic blood penetration, flame retardancy, and gas exchange pressure difference testers. For the pressure difference non-compliance, the factory must conduct thorough testing of retained samples, raw materials, semi-finished products, and finished masks from batch 20061502. These measures aim to ensure product quality and adherence to regulatory standards.