China NMPA Product Recall - hydrocolloid dressings
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The National Medical Products Administration (NMPA) has announced a Class II voluntary recall for DuoDERM hydrocolloid dressings, initiated by the manufacturer, ConvaTec Limited. This action, detailed in NMPA Index No. JGXX-2025-10117 and published on August 29, 2025, addresses quality issues identified in specific production batches of the medical device. ConvaTec (China) Medical Supplies Co., Ltd. formally reported these concerns, prompting the manufacturer's decision to withdraw the affected products. A Class II recall signifies a situation where potential product use or exposure might lead to temporary or medically reversible adverse health consequences, or where the probability of serious health consequences is remote. Critically, the NMPA confirmed that the particular batches of DuoDERM dressings involved in this recall were not distributed or imported into the Chinese market. ConvaTec is required to furnish a comprehensive Medical Device Recall Event Report, detailing all relevant product models, specifications, and batch information. This measure underscores the company's commitment to product integrity and public health safety, in line with NMPA's regulatory oversight.
- Company
- ConvaTec Limited
ID · a40842c2-fcd4-4890-8f3f-244e7d04db63