China NMPA Product Recall - pressure sensor

ICU Medical, Inc., in cooperation with its agent Beijing Jishibo Medical Device Co., Ltd., initiated a voluntary Level III recall of specific batches of its Pressure Sensors (Model 42640-06). This action, reported to the National Medical Products Administration (NMPA) in November 2018, was prompted by numerous reports detailing the separation of the blood collection port from the pressure tubing during product use. Affected batch numbers include 3514084, 3550279, 3529857, and 3543099, impacting approximately 5000 units sold in China, in addition to units distributed in the USA, Canada, and Asia. Under the NMPA's regulatory guidelines for medical device recalls, all stakeholders are mandated to immediately cease selling or using the recalled devices, conduct thorough inventory checks, and promptly notify all potential users. Furthermore, distributors and end-users must return any in-stock affected products, with ICU Medical, Inc. committed to providing replacements. This proactive recall aims to address the identified malfunction and ensure patient safety.