China NMPA Product Recall - Disposable intestinal flushing bags

Yangzhou Mingxing Medical Equipment Co., Ltd. initiated a voluntary recall of its Disposable Intestinal Irrigation Bags, as announced on April 9, 2021, by the National Medical Products Administration (NMPA) through the Jiangsu Provincial Drug Administration. The recall was prompted by a critical manufacturing defect involving the adhesive (cyclohexanone) used in the product. Specifically, an incorrect amount of adhesive caused blockages at the connection point between the pressure bladder and the infusion tube, rendering the device ineffective and potentially unsafe for clinical use. The affected products belong to production batch number 20200612, with approximately 4800 units distributed within China. This action aligns with the NMPA's "Implementation of Advice Notices and Medical Device Recall Regulations." As part of the corrective measures, the company is required to inform all distributors and users to cease using the product immediately and ensure its destruction. Furthermore, the recall process must meticulously trace the product to its final user units. Yangzhou Mingxing Medical Equipment Co., Ltd. is also mandated to conduct retraining for relevant personnel and establish a robust system for proactively collecting adverse event reports to prevent future occurrences and enhance patient safety.