China NMPA Product Recall - Hydrophilic coating guide sheath

On December 11, 2019, the National Medical Products Administration (NMPA) in China announced a Class II voluntary recall initiated by Gore & Associates Co., Ltd. This action, reported by Gore Industrial Products Trading (Shanghai) Co., Ltd., pertained to specific batches of hydrophilic coated guiding sheaths. The primary issue identified was a labeling error affecting these medical devices, which necessitated the recall. While no specific inspection dates were provided, the recall represents a proactive measure undertaken by the manufacturer to address the discrepancy. This regulatory action falls under the NMPA's oversight, which ensures medical product safety and quality. The Class II designation indicates that the product defect may lead to temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. As a result, Gore & Associates Co., Ltd. voluntarily recalled the affected products, with detailed information on specific models, specifications, and batch numbers available in the attached "Medical Device Recall Event Report Form." This recall highlights the manufacturer's commitment and the NMPA's role in maintaining accurate medical device information for patient safety.