# China NMPA Product Recall - Vascular sheath group

Source: https://www.globalkeysolutions.net/records/china_product_recall/terumo-co-ltd/78e88fb7-7902-4ac4-9c5a-f7b72a8add50/
Source feed: China

> China NMPA product recall for Vascular sheath group by Terumo Co., Ltd. published July 19, 2017. Recall level: Level 2 Recall. Terumo Corporation, through its subsidiary Terumo (China) Investment Co., Ltd., initiated a Class II

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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: 2017-07-19
- Product Name: Vascular sheath group
- Recall Level: Level 2 Recall
- 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 subsidiary Terumo (China) Investment Co., Ltd., initiated a Class II global voluntary recall of its Vascular Sheath Kits. This action was reported on May 26, 2017, following a routine factory inspection that revealed potential damage to product packaging, which could compromise the sterility of the medical devices. The National Medical Products Administration (NMPA) published details of this recall on July 19, 2017, operating under its regulatory framework. The affected products, registered under CFDA (Imported) No. 20143773235, included 211,460 units in China across multiple models and batch numbers. At the time of the recall, no customer complaints or patient harm were reported. Required actions include the comprehensive recall and destruction of all sold but unused batches from distributors, resellers, and hospitals. For units already utilized by hospitals, distributors are mandated to provide usage lists and feedback to Terumo (China) Investment Co., Ltd., ensuring full accountability and mitigation of any potential health risks associated with the compromised packaging.

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