China NMPA Product Recall - Adjustable negative pressure suction tube

Hangzhou Jingleng Medical Device Co., Ltd. initiated a Class III voluntary recall for its Adjustable Negative Pressure Suction Tubes, model SG.Y03 2mm(6F)×400, specifically batch number 82111711. This action, reported to the National Medical Products Administration (NMPA) on November 27, 2018, and publicized on November 30, 2018, stemmed from a random inspection. Findings revealed that the residual vacuum level of 18,800 units in the affected batch did not comply with the product's established technical specifications, indicating a performance deficiency.

Under the NMPA's regulatory framework, the company implemented several corrective measures. These included issuing immediate notices to cease the use and sale of the specified products and recalling all sold but unused units from the substandard batch. Additionally, Hangzhou Jingleng committed to enhancing its production processes by integrating residual vacuum testing requirements to prevent future non-conformities. All recalled products were scheduled for retesting before being appropriately disposed of through pulverization, underscoring the company's commitment to product quality and patient safety.