# China NMPA Product Recall - Vascular sheath group

Source: https://www.globalkeysolutions.net/records/china_product_recall/terumo-co-ltd/7777ed0c-2ad9-48a1-b85c-ba206bdb5a79/
Source feed: China

> China NMPA product recall for Vascular sheath group by Terumo Co., Ltd. published July 18, 2017. Recall level: Level 2. Terumo Corporation, through its agent Terumo (China) Investment Co., Ltd., initiated a voluntary Cla

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Terumo Corporation initiates voluntary recall of vascular sheath kits
- Company Name: Terumo Co., Ltd.
- Publication Date: 2017-07-18
- Product Name: Vascular sheath group
- Recall Level: Level 2
- Recall Reason: The integrity of the product packaging may be compromised, potentially affecting the product's sterility.
- Discovering Company: Terumo (China) Investment Co., Ltd.
- Manufacturing Company: Terumo Co., Ltd.
- Summary: Terumo Corporation, through its agent Terumo (China) Investment Co., Ltd., initiated a voluntary Class II global recall of its vascular sheath kits (Registration No.: 20143773235). This action, reported on May 26, 2017, and published by the National Medical Products Administration (NMPA) on July 18, 2017, stems from a routine factory inspection. The inspection revealed a potential for compromised product packaging integrity, which could affect the sterility of the medical devices. There have been no reported customer complaints or instances of patient harm related to this issue. The affected products include various models and batches, with 211,460 units identified for recall in China. Under the NMPA's oversight, Terumo has outlined clear corrective actions. For all recalled batches of products that have been sold but remain unused by distributors, resellers, and hospitals, the company requires their full recall and subsequent destruction. Furthermore, for products already utilized by hospitals, distributors are mandated to provide lists and feedback to Terumo. This recall highlights the manufacturer's commitment to product safety and compliance with regulatory standards.

Company: https://www.globalkeysolutions.net/companies/terumo-co-ltd/e2ac55cf-c50d-4a2f-864c-af16ec3bcab6/