China NMPA Product Recall - Continuous blood purification equipment

Baxter Medical Supplies Trading (Shanghai) Co., Ltd. has initiated a voluntary Class III recall of its Continuous Blood Purification Equipment. This action, reported to the National Medical Products Administration (NMPA) on May 8, 2017, follows reports from markets outside China concerning patient harm. The reported issues stemmed from the improper removal and installation of consumables, indicating a failure by users to adhere to the operational manual and equipment screen prompts.

There are no inspection dates specified in the provided document, as this is a company-initiated voluntary recall rather than a regulatory inspection outcome. The regulatory framework for this recall is governed by the NMPA, which oversees medical device recalls in China. A Class III recall typically addresses situations where the probability of serious adverse health consequences from product use is remote. The required action by Baxter is the recall of specific models, specifications, and batches of the Continuous Blood Purification Equipment, with detailed information found in the "Medical Device Recall Event Report Form." This highlights the importance of user compliance with device instructions for patient safety.