# China NMPA Product Recall - Angiography catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-corporation/da6c2c7d-5720-40eb-86b4-505ae81e8ace/
Source feed: China

> China NMPA product recall for Angiography catheter by Boston Scientific Corporation published January 13, 2017. Recall level: Level 2 Recall. Boston Scientific International Medical Trading (Shanghai) Co., Ltd., representing Boston Scientific

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Boston Scientific International Medical Trading (Shanghai) Co., Ltd. voluntarily recalls angiography catheters.
- Company Name: Boston Scientific Corporation
- Publication Date: 2017-01-13
- Product Name: Angiography catheter
- Recall Level: Level 2 Recall
- Recall Reason: The missing seal at the bottom of the packaging bag in this batch of products was caused by the alternating label printing process, resulting in a missing step in the packaging process.
- Discovering Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Manufacturing Company: Boston Scientific Corporation
- Summary: Boston Scientific International Medical Trading (Shanghai) Co., Ltd., representing Boston Scientific Corporation, initiated a voluntary Level II recall for specific batches of angiography catheters. This action was reported by the National Medical Products Administration (NMPA) on January 13, 2017. The primary issue identified was missing bottom seals on the packaging of the angiography catheters (NMPA Registration Certificate No. 20153774215), which was attributed to an error in the packaging process involving alternating label printing. The affected products are intended for delivering contrast agents to selected vascular sites. In response, Boston Scientific is recalling the identified batch, issuing advisory letters to customers detailing affected specifications and batch numbers, and will provide free replacement of all impacted products in the relevant regions. These measures aim to address the packaging defect and maintain product safety standards.

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