China NMPA Product Recall - sterilizer

Getinge Trading (Shanghai) Co., Ltd., the responsible unit in China for manufacturer Getinge Sterilization AB, initiated a voluntary Level III recall. This action, reported on November 28, 2016, and publicly announced by the National Medical Products Administration (NMPA) on January 13, 2017, affects 59 units of sterilizers, including models HS6613, HS6617, and HS6620, distributed across Mainland China. The core issue was the application of expired product registration certificate numbers on the Chinese labels of these devices. While this labeling discrepancy posed no direct safety risk to operators or patients, it constituted a non-compliance with the regulatory requirements stipulated by the State Food and Drug Administration (SFDA), which governs medical device labeling in China. Getinge had already obtained and implemented new, valid product registration certificates for subsequent manufacturing batches. To address the violation, Getinge Trading (Shanghai) Co., Ltd. is performing on-site corrective measures. This involves notifying all affected users and sending technicians to their sites to remove the non-compliant Chinese labels and affix the correct ones, ensuring full adherence to national regulations.