China NMPA Product Recall - Hydrophilic coating guide sheath

The National Medical Products Administration (NMPA) issued an announcement on December 16, 2019, regarding a Class II voluntary recall initiated by Gore & Associates Co., Ltd. This action was reported locally by Gore Industrial Products Trading (Shanghai) Co., Ltd. The recall specifically targets certain batches of hydrophilic coated guiding sheaths, medical devices registered under certificate number Guoban 20193030356. The primary reason for this recall stems from a critical labeling error identified within a particular batch of these products. This error necessitates corrective action to ensure accurate product identification and usage. While the provided document does not specify inspection dates, it clearly outlines a voluntary recall process undertaken by the manufacturer, Gore & Associates, under the regulatory framework established by the NMPA. The required action involves the systematic removal of the affected devices from distribution. Comprehensive details regarding the specific models, specifications, and batch numbers of the recalled products are contained in the referenced "Medical Device Recall Event Report Form." This proactive measure underscores the commitment to maintaining high standards of product integrity and patient safety within the medical device industry.