# China NMPA Product Recall - X-Force N30 Nephrostomy Balloon Dilation Catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/cr-bard-inc/ef8f745a-8289-4198-beb4-7fbf5b3b38b6/
Source feed: China

> China NMPA product recall for X-Force N30 Nephrostomy Balloon Dilation Catheter by C.R. Bard, Inc. published December 07, 2016. Recall level: Level 3 Recall. Bard Medical Technology (Shanghai) Co., Ltd., a subsidiary of manufacturer C.R. Bard, Inc., initiate

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Bard Medical Technology (Shanghai) Co., Ltd. is voluntarily recalling its nephrostomy balloon dilation catheter.
- Company Name: C.R. Bard, Inc.
- Publication Date: 2016-12-07
- Product Name: X-Force N30 Nephrostomy Balloon Dilation Catheter
- Recall Level: Level 3 Recall
- Recall Reason: The product, a nephrostomy balloon dilation catheter (trade name: N30), model number 996081, was incorrectly packaged with a 30Fr sheath; the correct size should be 24Fr.
- Discovering Company: Bard Medical Technology (Shanghai) Co., Ltd.
- Manufacturing Company: C.R. Bard, Inc.
- Summary: Bard Medical Technology (Shanghai) Co., Ltd., a subsidiary of manufacturer C.R. Bard, Inc., initiated a voluntary Class III product recall for its X-Force N30 Nephrostomy Balloon Dilation Catheter. This action was reported to the National Medical Products Administration (NMPA), formerly CFDA, on October 25, 2016, with public notification on December 7, 2016. The primary issue involved a packaging error for product code 996081, where a 30Fr sheath was incorrectly included in packages that should have contained a 24Fr sheath. This error affects 177 units globally, with 170 units distributed within the Chinese market. The X-Force Nephrostomy Balloon Dilation Catheter is designed for dilating the nephrostomy tract and facilitating working sheath placement. Required actions for this recall include immediately stopping the distribution and use of all affected products, quarantining them, and notifying relevant distributors and hospitals to ensure the prompt return of all identified faulty items to the company.

Company: https://www.globalkeysolutions.net/companies/cr-bard-inc/a7ce11fc-82cf-46f7-96eb-b80625da02e3/