China NMPA Product Recall - Disposable blood cell separator

Weimei (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall of its disposable blood cell separators, as announced by the National Medical Products Administration (NMPA) on July 14, 2017. The recall was prompted by a manufacturing deviation where the centrifuge cup's bottom outer diameter slightly differed from standard requirements. This critical flaw prevented the centrifuge cup from being properly secured within the centrifuge chamber, often requiring excessive force for installation or rendering it impossible to fix.

This issue could potentially compromise the safety and efficacy of the blood cell separation process, leading to operational difficulties and potential risks in a clinical setting. The affected products are identifiable by Registration No.: "国械注进20143456114". As a Class III recall, this indicates a situation where the use of or exposure to a violative product is not likely to cause adverse health consequences. Weimei (Shanghai) Management Co., Ltd. undertook this action to mitigate any potential risks and ensure product quality. Further specifics regarding the models, specifications, and batch numbers of the recalled devices are detailed in the accompanying "Medical Device Report Form" and related attachments provided by the NMPA.