China NMPA Product Recall - TMQ Series Tabletop Pulsating Vacuum Steam Sterilizer

Lianyungang Qianying Medical Equipment Co., Ltd. initiated a voluntary Level III recall for its TMQ series tabletop pulsating vacuum steam sterilizers (Registration Certificate Code: Su Shi Yao Jian Xie (Zhun) Zi 2014 No. 2570986). This action, under the regulatory framework of the National Medical Products Administration (NMPA), was prompted by a critical malfunction discovered during the 2018 national medical device spot check.

The main issue involved the sterilizer failing to operate correctly during inspection. A test sample submitted to the Hangzhou Center on May 28, 2018, malfunctioned and could not be properly tested, leading to an unqualified status report on September 24, 2018. A subsequent retest at the Jiangsu Provincial Medical Device Testing Institute also confirmed the malfunction on November 7, 2018, rendering the sample untestable and unqualified.

Notably, the recall pertains to a single unit used as a test sample, as no units from this specific batch were sold domestically. The required corrective actions include returning the original sample unit, performing maintenance until it passes inspection, and then submitting it for a new inspection. The recall event report was officially submitted on November 20, 2018.