China NMPA Product Recall - Disposable hemodialysis tubing kit

On April 30, 2015, Covidien Medical Devices International Trading (Shanghai) Co., Ltd., a subsidiary of Covidien LLC (now integrated with Medtronic), initiated a voluntary global recall for several models of its Disposable Hemodialysis Tube Kits, including the Palindrome Ruby and Palindrome Sapphire series, along with various Palindrome SI/HSI Chronic Catheter Kits. This action was documented by the National Medical Products Administration (NMPA).

The primary issue identified through internal testing was that affected products, specifically those with an expiration date before February 2018, might not maintain the minimum silver ion release standard over a complete 30-day cycle. While initial silver ion levels met specifications, a decline was observed after nine days. Silver ions are intended to reduce microbial colonization on the catheter surface.

Despite this technical non-conformance, the company reported no additional safety concerns for patients with implanted devices and had not received any adverse reaction reports related to the issue, characterizing the recall as a precautionary measure. Critically, none of the affected products were sold within the Chinese market. Therefore, no further corrective actions were required from the company by the NMPA within China.