# China NMPA Product Recall - Disposable central venous catheter kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/cook-incorporated/817a1bd2-8414-4c41-92f4-ec18d619fff1/
Source feed: China

> China NMPA product recall for Disposable central venous catheter kit by Cook Incorporated published February 25, 2016. Recall level: . Cook Incorporated, through its Chinese subsidiary Cook (China) Medical Trading Co., Ltd., initiated 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Cook Incorporated recalls single-use central venous catheter kits.
- Company Name: Cook Incorporated
- Publication Date: 2016-02-25
- Product Name: Disposable central venous catheter kit
- Recall Reason: Cook discovered internally that defects in the manufacturing process could cause catheter tips to crack or separate. Potential adverse events that could result from catheter tip cracking or separation include product failure, medical interventions to retrieve the separated portion, and complications caused by the separated tip blocking blood flow.
- Discovering Company: Cook (China) Medical Trading Co., Ltd.
- Manufacturing Company: Cook Incorporated
- Summary: Cook Incorporated, through its Chinese subsidiary Cook (China) Medical Trading Co., Ltd., initiated a voluntary global recall for specific batches of single-use central venous catheter kits. This action, reported by the National Medical Products Administration (NMPA) on February 25, 2016, stems from a manufacturing defect causing the catheter tip to crack or separate. This issue could lead to serious adverse events, including product failure, the need for medical intervention to retrieve separated fragments, and potential blood flow obstruction. The affected products, although registered in China under CFDA (Imported) No. 20133772188 and primarily manufactured in 2015, were confirmed by Cook (China) Medical Trading Co., Ltd. to have not been sold within the Chinese market. The NMPA has directed local food and drug administrations to supervise and manage these products in alignment with the recall, emphasizing patient safety through proactive risk mitigation.

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