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

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-corporation/42951178-5dea-4740-9116-ab3673831e60/
Source feed: China

> China NMPA product recall for Disposable hemostatic clip with pusher (Product name: Resolution) by Boston Scientific Corporation published June 01, 2011. Recall level: . Boston Scientific, through its Chinese subsidiary Boston Scientific International Medical Trading (S

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Boston Scientific is recalling disposable hemostatic clips with pushers.
- Company Name: Boston Scientific Corporation
- Publication Date: 2011-06-01
- Product Name: Disposable hemostatic clip with pusher (Product name: Resolution)
- Recall Reason: Boston Scientific is issuing a warning about a shipment of stolen gastroenterology and urology/gynecology instruments. These instruments were stolen between April 8 and April 11, 2011, en route to a sterilization facility. The instruments were labeled "sterilized"; however, they were stolen before sterilization and are therefore unsterilized. Use of unsterilized instruments could lead to infection.
- Discovering Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Manufacturing Company: Boston Scientific Corporation
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/boston-scientific-corporation/29488af7-a1d7-4d3b-a8ab-1f12fddb5e4b/