China NMPA Product Recall - Infusion connector (trade name: Tego)

The National Medical Products Administration (NMPA) announced on November 14, 2016, a voluntary Class III recall initiated by ICU Medical Inc. for its infusion connector, marketed under the trade name Tego. The recall was reported by Beijing Jishibo Medical Device Co., Ltd. due to a critical safety concern. The primary issue identified was a potential leakage risk associated with specific batches of the Tego infusion connector. This risk specifically pertains to its use as a component entering the dialysis cannula during hemodialysis procedures. Such a leakage could compromise patient safety and the efficacy of dialysis treatment. The product was initially registered under the China Food and Drug Administration (CFDA), now known as the NMPA, indicating its regulatory approval for import and use in the Chinese market. The regulatory framework requires medical device manufacturers to address safety concerns promptly through actions like voluntary recalls. In response to the identified risk, ICU Medical Inc. voluntarily initiated the recall of the affected product models. A Class III recall indicates that the use of or exposure to a violative product is not likely to cause adverse health consequences. This action ensures that potentially defective products are removed from circulation to safeguard public health, adhering to the NMPA's standards for medical device safety and quality.