# China NMPA Product Recall - Ureteral stent

Source: https://www.globalkeysolutions.net/records/china_product_recall/cook-ireland-ltd/a1250270-d24e-44cd-8c12-7944c56e6966/
Source feed: China

> China NMPA product recall for Ureteral stent by Cook Ireland Ltd. published September 17, 2020. Recall level: Level 3 Recall. Cook (China) Medical Trading Co., Ltd., on September 17, 2020, announced a voluntary Level III recal

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Cook (China) Medical Trading Co., Ltd. voluntarily recalls ureteral stents.
- Company Name: Cook Ireland Ltd.
- Publication Date: 2020-09-17
- Product Name: Ureteral stent
- Recall Level: Level 3 Recall
- Recall Reason: The porcine tail-end retention force (fixation strength) of the ureteral stent does not meet the standard defined in its product technical requirements.
- Discovering Company: Cook (China) Medical Trading Co., Ltd.
- Manufacturing Company: Cook Ireland Ltd.
- Summary: Cook (China) Medical Trading Co., Ltd., on September 17, 2020, announced a voluntary Level III recall of specific ureteral stents manufactured by Cook Ireland Ltd. This action stemmed from a random inspection by the National Medical Products Administration (NMPA), which identified that the porcine tail retention force of the ureteral stent model USI-526-CE (batch C1704636) did not conform to its established product technical requirements. Cook Ireland Ltd.'s subsequent investigation determined that this non-compliance was a textual error in the product's technical documentation, posing no health risk to patients or end users, and did not involve design or process deficiencies. However, in adherence to the NMPA's "Regulations on the Management of Medical Device Recalls" (Order No. 29, Article 4, Section II), which mandates recalls for products not meeting mandatory standards or registered technical specifications, Cook Ireland Ltd. proactively expanded the recall to include all affected 5Fr models. Cook (China) Medical Trading Co., Ltd. promptly issued advisory notices to all impacted customers and initiated the recall of the affected ureteral stents, fulfilling its responsibilities. Detailed information on the affected products is available in an accompanying Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/cook-ireland-ltd/17210f6c-80d3-4eeb-95b2-a19236e05c54/