# China NMPA Product Recall - septal puncture needle

Source: https://www.globalkeysolutions.net/records/china_product_recall/cook-incorporated/3f17df9e-4817-42db-aab7-5c2ae2e86e93/
Source feed: China

> China NMPA product recall for septal puncture needle by Cook Incorporated published March 26, 2019. Recall level: Level 1. Cook Incorporated and its Chinese agent, Cook (China) Medical Trading Co., Ltd., initiated a volunta

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Cook Incorporated changes recall level for its transseptal puncture needles.
- Company Name: Cook Incorporated
- Publication Date: 2019-03-26
- Product Name: septal puncture needle
- Recall Level: Level 1
- Recall Reason: The lack of a bevel on the needle tip may cause the puncture needle to damage the inside of the insertion sheath device during the intervention process.
- Discovering Company: Cook (China) Medical Trading Co., Ltd.
- Manufacturing Company: Cook Incorporated
- Summary: Cook Incorporated and its Chinese agent, Cook (China) Medical Trading Co., Ltd., initiated a voluntary recall of atrial septal puncture needles (Registration Certificate No. 20143155640) due to a critical manufacturing defect. The National Medical Products Administration (NMPA) published this update on March 26, 2019, detailing the recall's escalation from level two to level one, following an initial announcement on February 19, 2019. The core issue, identified through customer complaint analysis, is a potential defect where the needle tip lacks a proper bevel. This critical flaw poses a significant risk as it could damage the internal components of an insertion sheath during cardiac interventional procedures, potentially leading to adverse patient outcomes. The recall specifically targets batch number 8833687 of model TSNC-18-71.0. While the recall report was submitted to the Provincial Food and Drug Administration in China, the affected 100 products from this specific batch were sold exclusively in the United States and Canada. Consequently, Cook Medical stated that no direct corrective actions or product recalls are required within China for this particular batch, as it was not imported into the country. The upgrade to a Class I recall level underscores the serious nature of the potential patient harm identified by the company and the regulatory authority.

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