China NMPA Product Recall - Disposable hemostatic clip with pusher (Product name: Resolution)

Boston Scientific, through its Chinese subsidiary Boston Scientific International Medical Trading (Shanghai) Co., Ltd., initiated a voluntary product recall on June 1, 2011, for specific batches of its "Disposable Hemostatic Clips with Push-Active Devices," branded as Resolution. This action was prompted by the theft of a batch of these medical devices between April 8 and April 11, 2011, while they were en route to a sterilization facility. The primary issue is that these stolen devices, despite being unsterilized, were subsequently labeled as "sterilized," creating a significant infection risk for patients if used in gastrointestinal procedures. The recall falls under the regulatory purview of China's National Medical Products Administration (NMPA), which instructed provincial food and drug administrations to enhance product supervision. Boston Scientific is also collaborating with the U.S. FDA and law enforcement. Required actions include a comprehensive customer notification campaign, instructing all purchasers in affected regions (including China, Argentina, Australia, Brazil, and Canada) to check for and immediately isolate any identified affected products and notify Boston Scientific. The company aimed to complete these corrective measures by July 25, 2011, prioritizing patient safety by preventing the use of non-sterile instruments.