China NMPA Product Recall - Breast localization needle (trade name: Ghiatas)

Bard Peripheral Vascular, Inc., through its agent Bard Medical Technology (Shanghai) Co., Ltd., initiated a voluntary Class III recall of its Ghiatas Breast Positioning Needle, as announced by the National Medical Products Administration (NMPA) on October 31, 2018. The recall, formally reported on September 27, 2018, was prompted by an incorrect product specification. Identified units were found to potentially contain a 5cm introducer needle instead of the intended 9cm length, which is designed to guide surgeons during breast lesion removal procedures. The product is regulated under the National Food and Drug Administration Medical Device (Imported) Registration Certificate No. 20143151392.

The regulatory framework required immediate cessation of distribution and use of affected products, quarantine measures, and the dissemination of recall notifications. However, a crucial aspect of this recall is that no products from the identified affected batch were distributed within the Chinese market. Therefore, the stipulated recall actions, such as stopping distribution or quarantining, were not implemented in China, as there were no units requiring such intervention domestically. This demonstrates the manufacturer's proactive identification of a potential issue prior to the product's market availability in China.