# China NMPA Product Recall - Non-absorbable polyester sutures (brand name: Esteban)

Source: https://www.globalkeysolutions.net/records/china_product_recall/thicon-llc/e00ab2c6-5529-4862-9bff-b012f0ed4046/
Source feed: China

> China NMPA product recall for Non-absorbable polyester sutures (brand name: Esteban) by THICON, LLC published March 11, 2019. Recall level: Level 3 Recall. Ethicon LLC initiated a voluntary Class III recall of its non-absorbable polyester sutures, specific

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ethicon LLC is voluntarily recalling its non-absorbable polyester sutures.
- Company Name: THICON, LLC
- Publication Date: 2019-03-11
- Product Name: Non-absorbable polyester sutures (brand name: Esteban)
- Recall Level: Level 3 Recall
- Recall Reason: The issue involves the potential for products to be mixed with other products. Specifically, some sales packages of Esteban EXCEL products may contain products with Priline stitching. The sales packaging for Esteban EXCEL products should be orange, but the affected sales packaging is blue.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: THICON, LLC
- Summary: Ethicon LLC initiated a voluntary Class III recall of its non-absorbable polyester sutures, specifically the Ethicon EXCEL product line. The recall, overseen by the National Medical Products Administration (NMPA) and reported through its agent Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., stemmed from the discovery that some sales packages intended for Ethicon EXCEL sutures potentially contained Prilin sutures. A significant indicator of the issue was the incorrect sales packaging color; Ethicon EXCEL products should have orange packaging, but affected units were found in blue packaging. While the individual Prilin sutures had correct internal labeling, the external packaging discrepancy prompted the action. The recall, reported on February 27, 2019, and published on March 11, 2019, impacted various countries including the Czech Republic, UK, and India, for specific models and batch numbers like MBM232. Crucially, the affected batches were not imported into China, thus no direct corrective actions were required within the country. This voluntary recall represents Ethicon LLC's proactive measure to ensure product integrity and address potential mix-ups in the global supply chain.

Company: https://www.globalkeysolutions.net/companies/thicon-llc/1cf766f6-0a1e-45f9-94d7-03ceb0f19cb1/