China NMPA Product Recall - Integrated membrane oxygenator, arterial filter, and venous blood storage device

Makvision (Shanghai) Medical Equipment Co., Ltd. initiated a Class II voluntary recall for specific batches of its integrated membrane oxygenators, arterial filters, and venous blood storage devices. This action was officially announced on December 7, 2017, under the regulatory oversight of the National Medical Products Administration (NMPA). The primary issue identified was that certain batches of these critical medical devices had undergone repeated sterilization procedures. This manufacturing deviation raised significant concerns regarding the potential compromise of product quality and, consequently, patient safety during their intended use.

The affected products include integrated membrane oxygenators, arterial filters, and venous blood reservoirs, specifically those registered under No. 20163454677. A Class II recall indicates that exposure to the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. Makvision's proactive measure underscores its commitment to maintaining rigorous product quality standards and ensuring the safety of its medical equipment. The company has detailed the specific models, specifications, and batch numbers of the impacted devices in the accompanying "Medical Device Recall Event Report Form," facilitating their effective identification and removal from the market to mitigate any associated risks.