China NMPA Product Recall - Breathing circuit

Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Level III recall of specific breathing circuit models (15K1561FAX and 15J0992FAX) in China, with the recall reported on December 7, 2016. The primary issue stemmed from a discrepancy where the materials used in the imported breathing circuits differed from those officially registered with the National Medical Products Administration (NMPA).

For instance, the registered interface for model 300/6042 included DEHP plasticizer, which was absent in the imported versions. Similarly, for model 306/6948, the registered product specified Styrolux for its water collection cup, while the imported products utilized polypropylene. While Covidien stated these material variations did not compromise product performance or safety, they represented a non-compliance with the established regulatory requirements for registered product specifications.

Under the NMPA regulatory framework, Covidien, acting through Medtronic, directed all affected customers via email to verify their inventory for the identified batch numbers. Customers are required to return any affected products to Medtronic for centralized destruction, ensuring adherence to regulatory standards and preventing further distribution of non-conforming items.