China NMPA Product Recall - Disposable blood cell separator

Weimei (Shanghai) Management Co., Ltd., acting as the agent for Haemonetics Corporation, initiated a voluntary Class III recall for its disposable blood cell separators (Registration No.: 国械注进20143456114). This recall, reported on June 28, 2017, and published by the National Medical Products Administration (NMPA) on July 19, 2017, addresses a manufacturing deficiency. The primary issue identified is a slight deviation in the centrifuge cup's bottom outer diameter, which prevents proper fixation within the centrifuge chamber or necessitates excessive force during installation. This defect affects 768 sets of model CSE-P-225, specifically batch number 0416015, distributed in China.

The NMPA's regulatory framework designates this as a Class III recall, signifying that while adverse health consequences are not likely, the defect compromises product functionality. The problem could render the centrifuge cup unusable, or lead to wear, detachment, or breakage during operation, impacting its critical function in blood processing. As required actions, Weimei (Shanghai) Management Co., Ltd. is obligated to proactively inform all affected customers through written notice and to facilitate the recall and replacement of all identified defective products to ensure device integrity and safe operation.