China NMPA Product Recall - Single-use sampler

The National Medical Products Administration (NMPA), through the Shandong Provincial Drug Administration, reported a voluntary Class III recall of disposable samplers. This recall, initiated by Shandong Sukang Medical Technology Co., Ltd. and communicated by Shandong Guangda Intelligent Technology Co., Ltd., was officially published on December 29, 2021, under index number JGXX-2021-10727. The primary issues necessitating this action involve critical quality deficiencies observed in the medical devices. Specifically, the recall addresses the detection of foreign objects contaminating individual product packages, the omission of essential specifications from the smallest packaging units, and significant leakage issues identified with the 6mL I sampling tubes. These violations pose potential risks to product integrity and user safety, warranting prompt corrective measures. The affected disposable samplers are registered under Luhe Medical Device Registration 20210260. A comprehensive "Medical Device Recall Event Report Form" provides detailed information concerning the specific models, specifications, and batch numbers of the products subject to this recall. This Class III recall signifies that while the product defects may not cause serious adverse health consequences, they are important quality control issues that must be rectified. The NMPA's oversight ensures that medical device manufacturers comply with stringent quality and safety standards, prompting immediate actions like this voluntary recall to protect public health.