China NMPA Product Recall - Disposable infusion pump
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Nanchang Beoite Medical Technology Co., Ltd. initiated a voluntary Class III recall of its disposable infusion pumps, as reported by the National Medical Products Administration (NMPA) on September 30, 2019. The company identified non-compliance with standard requirements as the primary reason for this action, prompting the retrieval of affected products from the market. While specific inspection dates are not detailed, the recall announcement reflects the company's proactive measure in response to identified quality issues. This action falls under the regulatory oversight of the NMPA, which is responsible for ensuring medical device safety and efficacy in China. Nanchang Beoite Medical Technology Co., Ltd. is required to provide further specific information regarding the affected product models, specifications, and batch numbers in an accompanying "Medical Device Recall Event Report Form" to address the non-compliance and facilitate the recall process effectively.
ID · e5fa1967-9e0c-4ed1-9a90-95ef1e55e567