China NMPA Product Recall - Vascular SheathCheck-Flo Performer Introducers

Cook Incorporated, facilitated by Cook (China) Medical Trading Co., Ltd., has initiated a voluntary Class II recall for its Check-Flo Performer Introducers vascular sheaths. The fundamental issue prompting this action is the discovery of incorrect product dimensions, a manufacturing discrepancy impacting the integrity and intended use of the devices. This recall, indexed as JGXX-2025-10051 and reported on May 8, 2025, falls under the regulatory purview of the National Medical Products Administration (NMPA). The affected Check-Flo Performer Introducers are identified by National Standard 20143036136. A significant detail is that the specific batches and models involved in this recall were not imported into the Chinese market, effectively limiting the recall's direct impact within China. The document provided does not specify any inspection dates related to this product issue. The required action for Cook Incorporated is to systematically remove the dimensionally incorrect vascular sheaths from distribution to ensure patient safety and adherence to product specifications globally, demonstrating a commitment to quality assurance under the NMPA's framework.