China NMPA Product Recall - Breathing circuit

Covidien Medical Devices International Trading (Shanghai) Co., Ltd., a Medtronic company, initiated a voluntary Level III recall of its Breathing Circuits (Model 300/13315) in China, as reported to the National Medical Products Administration (NMPA). The recall, published on December 29, 2016, was prompted by a significant discrepancy: the product's instruction manual and technical requirements incorrectly stated that the breathing circuits were sterilized with ethylene oxide. In reality, the products were non-sterile, although their Chinese labels accurately indicated this non-sterile status. This inconsistency between documentation and actual product condition, despite the correct label, led to the recall. The affected product quantities included 1270 boxes produced and 1168 boxes sold in China, encompassing various specific batch numbers. As corrective action, Covidien notified all distributors to identify and return the affected inventory for centralized destruction. Medtronic affirmed that no adverse impact on patient safety or product efficacy had been identified, and therefore, no specific actions were deemed necessary for products already in use, with standard patient management advised.