China NMPA Product Recall - Non-absorbable nylon sutures

On June 27, 2019, Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its non-absorbable nylon sutures. The recall stemmed from an internal system failure to identify a design change made at a foreign manufacturing facility for products intended for the Chinese market. This critical oversight meant that import controls were not implemented, and the affected products were mistakenly shipped to China before obtaining the required domestic registration change approval.

This incident highlights a lapse in adherence to the regulatory framework overseen by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, which mandates pre-market approval for product design modifications. The main violation was the unauthorized import and distribution of medical devices that had undergone unapproved changes. As a required action, Covidien Medical Devices International Trading (Shanghai) Co., Ltd. is actively recalling the implicated non-absorbable nylon sutures (Registration Certificate No.: 国械注进20143025897) to ensure regulatory compliance and product safety. Further specifics regarding the affected models and batches are detailed in the accompanying Medical Device Recall Event Report Form.