# China NMPA Product Recall - Ureteral dilation balloon catheter (ASCEND AQ), Nephrostomy balloon catheter (Ultraxx)

Source: https://www.globalkeysolutions.net/records/china_product_recall/cook-incorporated/39046c0d-10ab-4a35-9ba5-39f0c0f44bc4/
Source feed: China

> China NMPA product recall for Ureteral dilation balloon catheter (ASCEND AQ), Nephrostomy balloon catheter (Ultraxx) by Cook Incorporated published March 11, 2016. Recall level: . Cook Incorporated voluntarily recalled its Ureteral Dilatation Balloon Catheter (ASCEND AQ) and Neph

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Cook Incorporated is recalling its ureteral dilation balloon catheter (trade name: ASCEND AQ) and nephrostomy balloon catheter (trade name: Ultraxx).
- Company Name: Cook Incorporated
- Publication Date: 2016-03-11
- Product Name: Ureteral dilation balloon catheter (ASCEND AQ), Nephrostomy balloon catheter (Ultraxx)
- Recall Reason: The packaging label is incorrect. The label indicates that it is a nephrostomy balloon catheter and kit, but the actual product inside the package is a ureteral dilation balloon catheter. To avoid potential harm, please contact us.
- Discovering Company: Cook (China) Medical Trading Co., Ltd.
- Manufacturing Company: Cook Incorporated
- Summary: Cook Incorporated voluntarily recalled its Ureteral Dilatation Balloon Catheter (ASCEND AQ) and Nephrostomy Balloon Catheter (Ultraxx) due to critical packaging labeling errors. The recall report, initially dated February 16, 2016, and further documented on January 28, 2018, was overseen by China's National Medical Products Administration (NMPA), formerly CFDA.

The core issue stemmed from customer complaints indicating that product packaging for the nephrostomy balloon catheter and kit incorrectly contained a ureteral dilation balloon catheter. This significant mislabeling posed a potential risk of patient harm if an incorrect device was utilized during medical procedures. The company, through its Chinese entity Cook (China) Medical Trading Co., Ltd., confirmed the recall was initiated to prevent such adverse events.

While the specific recalled batches were not sold within the Chinese market, alleviating the need for direct corrective actions on these products in China, the NMPA's regulatory framework prompted a broader response. Provincial and municipal Food and Drug Administrations were directed to enhance their supervision and management over similar medical devices, ensuring continued public safety and compliance with regulatory standards.

Company: https://www.globalkeysolutions.net/companies/cook-incorporated/1824e76a-038e-4220-8016-501448925cf2/