China NMPA Product Recall - Disposable blood transfusion set with needle

Changzhou Huichun Medical Equipment Co., Ltd. initiated a voluntary Class III recall of its disposable blood transfusion sets with needles. The company identified product leakage during use as the primary issue. This recall was reported to the Provincial Food and Drug Administration, operating under the regulatory framework of the National Medical Products Administration (NMPA). The company issued a recall notice on August 20, 2021, with the recall report officially submitted in September 2021 and published on September 13, 2021. The affected products belonged to batch number 200813, with 1800 units sold within China, specifically distributed in the Xinjiang Kashgar region. As a required action, Changzhou Huichun Medical Equipment Co., Ltd. informed its distributors, Xinjiang Kashgar Medical Device Co., Ltd. and Xinjiang Kashgar Wanbo Trade Co., Ltd., via written and telephone notifications on August 20, 2021, to facilitate the prompt removal of the defective devices and mitigate potential patient safety risks.