# China NMPA Product Recall - Mammary Implantable Paragel

Source: https://www.globalkeysolutions.net/records/china_product_recall/eurosilicone-sas/c318ce94-a414-450c-a675-205c2adb87ab/
Source feed: China

> China NMPA product recall for Mammary Implantable Paragel by EUROSILICONE S.A.S. published June 29, 2021. Recall level: Level 1 Recall. EUROSILICONE S.A.S., a manufacturer, has initiated a voluntary Class I recall of its Mammary Implant

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: EUROSILICONE S.A.S. is proactively recalling its Mammary Implantable Paragel.
- Company Name: EUROSILICONE S.A.S.
- Publication Date: 2021-06-29
- Product Name: Mammary Implantable Paragel
- Recall Level: Level 1 Recall
- Recall Reason: Textured implants may be associated with a higher risk of ALCL (non-Hodgkin's lymphoma).
- Discovering Company: Wuxi Lico Trading Co., Ltd.
- Manufacturing Company: EUROSILICONE S.A.S.
- Summary: EUROSILICONE S.A.S., a manufacturer, has initiated a voluntary Class I recall of its Mammary Implantable Paragel. The recall was reported by Wuxi Like Trading Co., Ltd. and is overseen by China's National Medical Products Administration (NMPA). The primary concern stems from a potential association between specific models and batches of textured implants and an elevated risk of Anaplastic Large Cell Lymphoma (ALCL), a form of non-Hodgkin's lymphoma. This proactive measure is taken to address patient safety regarding these medical devices. Consumers and healthcare providers are directed to the "Medical Device Recall Event Report Form" for comprehensive details on affected product models, specifications, and batch numbers. This action underscores the commitment to ensuring the safety and efficacy of medical products within the NMPA's regulatory purview.

Company: https://www.globalkeysolutions.net/companies/eurosilicone-sas/abf53528-be05-4c0a-ac21-87af8089f2ac/