China NMPA Product Recall - Respiratory humidification therapy device

Fisher & Paykel Healthcare has initiated a voluntary Level III recall of specific respiratory humidifiers distributed in China. The National Medical Products Administration (NMPA) announced this recall on November 25, 2021. The issue stems from the company's discovery that the Ingress Protection (IP) rating (IP22) printed on the Chinese nameplate of certain product batches did not match the IP protection rating specified in the product's official technical requirements. This discrepancy prompted Fisher & Paykel Healthcare to take proactive measures to ensure product labeling accuracy and compliance within the Chinese market. Although no specific inspection dates are provided, this voluntary action by the manufacturer addresses the identified inconsistency. The regulatory framework for this recall is overseen by the NMPA, with the announcement originating from the Guangdong Provincial Drug Administration Website. The required action involves the voluntary recall of the affected respiratory humidifiers, with details on specific models, specifications, and batches provided in an attached "Medical Device Recall Event Report Form." This ensures consistency between product labeling and technical specifications.