China NMPA Product Recall - Indwelling intravenous needle

Shanghai Shangyi Kangge Medical Equipment Co., Ltd. initiated a voluntary Level II recall of several batches of its Indwelling Intravenous Catheters, as reported to the National Medical Products Administration (NMPA) on December 15, 2016, and publicly announced on January 13, 2017. The company discovered errors and omissions in the production records of specific batches during an internal audit, which introduced a potential risk of contamination or unknown defects. The recall affects various models and specifications, identified by their CFDA and National Medical Device Registration Approval Numbers, including 20123150137 and 20163150452. The company promptly took several corrective actions. Production of all intravenous catheters was completely suspended to allow for internal corrective measures. Customers were informed in writing to address any used affected products, and all unused products were slated for recall. Furthermore, all recalled and unsold affected batches are to be destroyed. It is important to note that the company confirmed no customer feedback, complaints, or adverse events related to these issues had been received prior to the recall. This proactive measure demonstrates the company's commitment to product safety under NMPA's regulatory oversight.