China NMPA Product Recall - Disposable blood cell separator

Weimei (Shanghai) Management Co., Ltd., acting as the agent for manufacturer Haemonetics Corporation, initiated a voluntary Class III recall for specific batches of its disposable blood cell separators. This recall, formally reported on June 28, 2017, and published by the National Medical Products Administration (NMPA) on July 18, 2017, addresses a critical product defect. The main issue stems from a slight deviation in the outer diameter of the centrifuge cup's bottom. This manufacturing inconsistency prevents the cup from being properly fixed within the centrifuge chamber or necessitates excessive force during installation. Such improper fixation is problematic because the product is designed for collecting, cleaning, and separating blood into its components. If the centrifuge cup is not securely installed, the device becomes unusable, potentially leading to cup wear, detachment, or breakage during operation, thereby compromising the integrity of blood processing. The recall applies to 768 sets of model CSE-P-225, Batch No. 0416015, which were distributed internationally. Under NMPA's regulatory framework, the company is mandated to proactively notify all affected customers through written communication and promptly recall and replace the non-compliant products to mitigate any potential risks and ensure the safe and effective use of the medical device.