China NMPA Product Recall - Injection pump
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Guangxi Weili Ark Technology Co., Ltd. has initiated a voluntary Level III recall of its injection pumps following an inspection during the 2019 Guangxi medical device supervision and spot check. The recall was prompted by the discovery of a non-compliant alarm function in the manufactured devices. The National Medical Products Administration (NMPA) document, indexed as JGXX-2020-10065 and published on January 22, 2020, details the company's action. Affected products include injection pumps of Model/III-B, specifically from Batch No. 33119015, and with Product Numbers WC-BAIXC0005, WC-BAIXC0022, and WC-BAIXC0027. The company is required to retrieve these products from the market to address the identified safety concern. This measure underscores the NMPA's commitment to ensuring the safety and compliance of medical devices within its regulatory framework.
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