China NMPA Product Recall - Peel-off external guide tube

On February 9, 2021, Abbott Medical Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of specific batches of its peelable external guiding catheters (Registration Certificate No.:

国械注进20173771560). This action, overseen by the National Medical Products Administration (NMPA) and reported via the Shanghai Municipal Drug Administration website, stemmed from confirmed discrepancies between the packaging labels and the actual contents for two identified product batches. These issues were attributed to the product's manufacturing plant, St. Jude Medical CARDIAC RHYTHM MANAGEMENT DIVISION, following customer complaints. As a required action under the NMPA's regulatory framework, the company initiated the recall to address the critical labeling inaccuracies. A Class III recall indicates that the use of, or exposure to, the violative product is not likely to cause adverse health consequences. The recall ensures product integrity and patient safety by rectifying the mislabeling. Further details, including specific models, specifications, and batch numbers, are provided in the "Medical Device Recall Event Report Form" accessible to stakeholders.