China NMPA Product Recall - Microstream CO2 sampling lines

Oridion Medical 1987 Ltd. initiated a voluntary Class II recall of its Microstream CO2 sampling lines, as reported by Covidien Medical Devices International Trading (Shanghai) Co., Ltd. The primary issue identified was the difficulty in disconnecting the sampling lines from a patient's endotracheal tube, which could potentially impact patient care or safety during medical procedures. This action falls under the regulatory oversight of the National Medical Products Administration (NMPA), referencing National Medical Device Registration Certificate No. 20182070157. The document did not specify any inspection dates. The recall document, published on February 25, 2025, details this event (Index No.: JGXX-2025-10021). It is important to note that the specific products implicated in this recall were not imported into the Chinese market, limiting the direct impact within China. The required action by Oridion Medical 1987 Ltd. is a voluntary recall to address the identified product defect. Further comprehensive details, including product numbers, specifications, and batch numbers, are documented in the "Medical Device Recall Event Report Form" attached to the official NMPA notice. The NMPA mandates such reporting to ensure medical device safety and compliance.