China NMPA Product Recall - Vacutainer® Evacuated Blood Collection Tube

BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Level II recall for its BD Vacutainer® Evacuated Blood Collection Tubes, as reported on December 2, 2021, by the National Medical Products Administration (NMPA). This significant regulatory action was undertaken after the company received customer feedback highlighting critical issues with some ACD vacuum blood collection tubes. The primary concern identified was insufficient blood collection during their use, a deficiency that could potentially impact diagnostic accuracy and patient care.

Operating under the regulatory oversight of the NMPA and specifically the Shanghai Municipal Drug Administration, BD Medical Devices is addressing these product performance concerns proactively. A Level II recall indicates that the product may cause temporary or reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. The company has provided a "Medical Device Recall Event Report Form" with comprehensive details on the specific product models, specifications, and batches involved in this recall (Registration Certificate No.:

国械注20162220731). This action underscores the company's commitment to product quality and patient safety, ensuring compliance with established medical device regulations and promptly rectifying identified manufacturing or design issues to prevent further impact.