# China NMPA Product Recall - Surgilon Coated Braided Nylon Suture

Source: https://www.globalkeysolutions.net/records/china_product_recall/covidien-llc/f864881c-3ea2-46ff-b919-b47a5b0f5fdb
Source feed: China

> China NMPA product recall for Surgilon Coated Braided Nylon Suture by Covidien llc published January 04, 2024. Recall level: Level 1 Recall. The National Medical Products Administration (NMPA) announced on January 4, 2024, a voluntary Class 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Covidien LLC is voluntarily recalling non-absorbable nylon sutures.
- Company Name: Covidien llc
- Publication Date: 2024-01-04
- Product Name: Surgilon Coated Braided Nylon Suture
- Recall Level: Level 1 Recall
- Recall Reason: The sterilization dose of a specific batch of non-absorbable nylon sutures exceeded the approved range, which may have affected the tensile strength of the sutures in question.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien llc
- Summary: The National Medical Products Administration (NMPA) announced on January 4, 2024, a voluntary Class I recall initiated by Covidien LLC. This recall pertains to specific batches of Covidien's Surgilon Coated Braided Nylon Nonabsorbable Sutures. The primary issue identified is that the sterilization dose applied to these sutures exceeded the approved range. This deviation could potentially compromise the product's tensile strength, a critical attribute for surgical sutures. Covidien Medical Devices International Trading (Shanghai) Co., Ltd. reported this issue, prompting the high-level Class I recall. A Class I recall signifies that there is a reasonable probability of serious adverse health consequences or death if the product is used. The required action involves Covidien LLC actively retrieving the affected products from the market to mitigate any potential risks to patient safety. Further details regarding specific models, specifications, and batch numbers are available in the official Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/covidien-llc/5111c5da-0a3d-4895-b59e-e49f0ad3547d