China NMPA Product Recall - AQUACEL™ Foam Hydrofiber™ Dressing

On January 20, 2022, the National Medical Products Administration (NMPA) announced a voluntary Class III recall by ConvaTec Inc. concerning specific models and batches of its AQUACEL Foam Hydrofiber Dressing (Registration Certificate No.: 20173640956). The recall was reported by ConvaTec (China) Medical Supplies Co., Ltd.

The primary issue identified is that the affected products may contain incorrect versions of the instructions for use. This discrepancy necessitates the recall to ensure that users have accurate guidance for the medical device. While specific inspection dates are not provided, the company initiated this action proactively to address the manufacturing oversight.

Under the regulatory framework of the NMPA, ConvaTec Inc. is required to remove the non-compliant products from the market. A Class III recall typically indicates a situation where exposure to the product is not likely to cause adverse health consequences, but the company is taking this measure to correct the instructional error and uphold product integrity and user safety. Details on specific models and batches are available in the attached Medical Device Recall Event Report Form.