China NMPA Product Recall - 3M Steri-Drape surgical membrane
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3M Health Care has initiated a voluntary Class II recall for its 3M Steri-Drape surgical membrane, as reported by Minnesota Mining & Manufacturing (Shanghai) International Trading Co., Ltd. The National Medical Products Administration (NMPA) published this recall on November 14, 2022. The primary issue identified is difficulty in separating the release paper from the adhesive layer of a specific model and batch of the surgical membrane. This defect could potentially hinder the proper sterile application of the product in clinical settings. Under the NMPA's regulatory framework, 3M Health Care is undertaking this recall to address the functional flaw. The affected product carries Registration Certificate No.: 20172140937. Detailed information concerning specific models, specifications, and batch numbers is available in the associated "Medical Device Recall Event Report Form." This required action demonstrates the company's commitment to product quality and patient safety by proactively addressing a manufacturing issue that could impact the product's intended performance and use during surgical procedures.
- Company
- 3M Healthcare
ID · 52b62fa5-0a85-4856-b0f1-f1e599c6e040