China NMPA Product Recall - Disposable laser fiber optic conduit

Spectranetics Corporation, in conjunction with its distributor Philips (China) Investment Co., Ltd., has initiated a voluntary Class III recall of its single-use laser fiber optic catheters. This action, published by the National Medical Products Administration (NMPA) on December 5, 2023, addresses an essential labeling error. The primary issue identified is an incorrect product model printed on the outer packaging labels of the affected CLiRpath® Turbo & Turbo elite® Excimer Laser Ablation Catheters. These devices are registered under National Medical Device Registration Certificate 20163012942. While specific inspection dates are not detailed, the recall's publication date signifies the regulatory intervention. The comprehensive "Medical Device Recall Event Report Form" provides exhaustive information regarding the precise models, specifications, and batch numbers implicated in this recall. Spectranetics Corporation is tasked with correcting this labeling discrepancy to adhere to NMPA standards and safeguard the accuracy of medical device information. The Class III classification suggests that the use of or exposure to the mislabeled product is not anticipated to cause adverse health consequences, making this a proactive measure to prevent potential confusion or misuse in clinical settings.