China NMPA Product Recall - Hydrophilic coated guidewire

Cook (China) Medical Trading Co., Ltd. has initiated a voluntary Level II recall of specific Hydrophilic Coated Guidewires in China, as reported to the National Medical Products Administration (NMPA) on August 30, 2016. The recall stems from a notification received on June 14, 2016, from raw material supplier DSM Biomedical B.V., indicating contamination by glass fragments (ranging from 4-280µm) in critical materials, specifically DSM substrate P41002 and hydrophilic coating TC43003. This contamination impacted 15 batches across several guidewire models. Of the 421 boxes imported into China, 331 had been sold. Although no patient injuries or adverse events related to this issue have been reported, the presence of glass fragments in the guidewires, which are used to assist in peripheral vascular catheter delivery, poses potential health risks including vascular injury, bleeding, and the introduction of particles into the circulatory system. Under NMPA regulations, Cook (China) Medical Trading Co., Ltd. is responsible for the recall within the country. Required actions include notifying distributors in writing within three days to return all unused affected products. Distributors are also mandated to inform their client institutions. Cook (China) will destroy the recalled devices and provide appropriate compensation. For patients who have already used the product without experiencing adverse events, no special medical follow-up is deemed necessary.