China NMPA Product Recall - suture needle with thread

Ningbo Chenghe Microsurgical Instrument Factory initiated a voluntary Class III recall for its "Suture Needles with Insemination" (Registration Certificate No.: Zheshiyaojianxie (Zhun) Zi 2014 No. 2650501), specifically model 1/2 arc angle 3-04x12 double needle, batch number 18034, impacting 1800 packs. The recall stemmed from a national medical device supervision and spot check, which identified that the suture diameter of the product was 0.027mm smaller than specified. The factory received the non-conforming inspection report on September 8, 2018, and immediately began verification and initiated recall notices to affected distributors and hospitals via telephone or WeChat. Five units, including Jilin Changchun Hengyi Medical Device Co., Ltd. and Liaoning Chaoyang Changjiang Hospital, reported that all products from the affected batch had been used and no inventory remained. Importantly, no suspected adverse events, such as "special cracking," were reported in connection with this non-conformity. The Medical Device Recall Event Report Form was submitted to the Provincial Food and Drug Administration, dated January 17, 2019, under the National Medical Products Administration (NMPA) regulatory framework.