# China NMPA Product Recall - septal puncture needle

Source: https://www.globalkeysolutions.net/records/china_product_recall/cook-china-medical-trading-co-ltd/5a825c24-b51b-4ec4-a568-22bbea1b72d2/
Source feed: China

> China NMPA product recall for septal puncture needle by Cook (China) Medical Trading Co., Ltd. published October 08, 2021. Recall level: Level 1 Recall. On October 8, 2021, Cook (China) Medical Trading Co., Ltd. initiated a voluntary Class I recall of i

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Cook (China) Medical Trading Co., Ltd. has initiated a voluntary recall of its transseptal puncture needles.
- Company Name: Cook (China) Medical Trading Co., Ltd.
- Publication Date: 2021-10-08
- Product Name: septal puncture needle
- Recall Level: Level 1 Recall
- Recall Reason: The defect of puncture needle having rust inside or outside.
- Discovering Company: Cook (China) Medical Trading Co., Ltd.
- Manufacturing Company: Cook (China) Medical Trading Co., Ltd.
- Summary: On October 8, 2021, Cook (China) Medical Trading Co., Ltd. initiated a voluntary Class I recall of its atrial septum puncture needles (model TSNC-18-71.0, Registration Certificate No.: 国械注进 20143155640). This action was taken due to a potential critical defect involving rust observed both inside and outside the affected medical devices. The recall was announced under the regulatory oversight of the National Medical Products Administration (NMPA) and specifically reported by the Shanghai Municipal Drug Administration. A Class I recall indicates the highest risk level, signifying a strong probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. The company is required to provide detailed information on the specific models, specifications, and batch numbers of the affected products in a "Medical Device Recall Event Report Form" to ensure comprehensive management of the recall process. This proactive measure aims to mitigate potential health risks to patients resulting from the identified product defect.

Company: https://www.globalkeysolutions.net/companies/cook-china-medical-trading-co-ltd/1ed3054b-44a7-4626-85e1-6402cb7ef9e0/