# China NMPA Product Recall - septal puncture needle

Source: https://www.globalkeysolutions.net/records/china_product_recall/cook-incorporated/56913a76-d7f7-45c1-80b7-069cd238fe90/
Source feed: China

> China NMPA product recall for septal puncture needle by Cook Incorporated published October 15, 2021. Recall level: Level 1. Cook Incorporated, through its subsidiary Cook (China) Medical Trading Co., Ltd., initiated a volunt

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Cook Incorporated voluntarily recalls atrial septal puncture needles
- Company Name: Cook Incorporated
- Publication Date: 2021-10-15
- Product Name: septal puncture needle
- Recall Level: Level 1
- Recall Reason: The problem of rust inside or outside the puncture needle
- Discovering Company: Cook (China) Medical Trading Co., Ltd.
- Manufacturing Company: Cook Incorporated
- Summary: Cook Incorporated, through its subsidiary Cook (China) Medical Trading Co., Ltd., initiated a voluntary Class I recall of specific models and batches of its atrial septal puncture needles on October 15, 2021. This action was prompted by the discovery of rust both inside and outside the puncture needles, a critical issue that could compromise patient safety and product efficacy. The National Medical Products Administration (NMPA) oversaw this recall, designating it as Class I, which signifies that there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. The recall details, including affected product models, specifications, and batch numbers, were documented in a "Medical Device Recall Event Report Form." Cook Incorporated's proactive voluntary recall aims to address the product defect and ensure compliance with regulatory standards set by the NMPA, protecting public health and safety.

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