China NMPA Product Recall - Non-transparent marking ruler

LeMaitre Vascular, Inc. initiated a voluntary Class III recall for its Radiopaque Marking Ruler (Registration Certificate No.: 20152313815) following a critical labeling discrepancy. The recall, reported to the National Medical Products Administration (NMPA) on September 23, 2018, and published on October 30, 2018, addresses an inconsistency where the expiration date on the inner packaging bag differed from the correct expiration date displayed on the outer packaging box. This issue was identified internally by the company.

The recall specifically impacts product batches SGL1262 and SGL1263, encompassing 177 boxes globally; however, none of these affected products were imported or sold within China. LeMaitre Vascular, Inc. confirmed through internal inspection that no other product batches exhibited this specific labeling error.

In response to this violation of labeling accuracy, LeMaitre Vascular, Inc. has implemented several corrective actions under the NMPA regulatory framework. These include issuing recall notices, instructing distributors to return all affected devices, halting further shipments of potentially problematic stock, and conducting an internal Corrective and Preventive Action (CAPA) meeting to determine the root cause and establish preventative measures. This proactive approach demonstrates the company's commitment to product integrity and compliance.