# China NMPA Product Recall - Tissue suture device (trade name: ENSEAL G2)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ethicon-endo-surgery-llc/2e749a93-0ebc-493f-b642-f0f987be05ae/
Source feed: China

> China NMPA product recall for Tissue suture device (trade name: ENSEAL G2) by Ethicon Endo-Surgery, LLC published January 14, 2013. Recall level: . Ethicon Endo-Surgery, LLC, in coordination with its Chinese responsible unit, Johnson & Johnson (Sha

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ethicon Endo-Surgery, LLC, Inc. of the United States is recalling its tissue suture devices.
- Company Name: Ethicon Endo-Surgery, LLC
- Publication Date: 2013-01-14
- Product Name: Tissue suture device (trade name: ENSEAL G2)
- Recall Reason: The affected products may have a potential for spontaneous combustion during use, which could cause burns to patients or users.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Ethicon Endo-Surgery, LLC
- Summary: Ethicon Endo-Surgery, LLC, in coordination with its Chinese responsible unit, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary global recall of its ENSEAL G2 tissue sutures. The recall was reported to the National Medical Products Administration (NMPA) on December 24, 2012, and publicly announced on January 14, 2013.The primary concern involves a potential for spontaneous reactivation of the tissue sutures during surgical use. This malfunction poses a significant risk, as it could lead to burns for both patients and medical users. The specific affected product batch identified is J4C187.Under the regulatory oversight of the NMPA, it was confirmed that the ENSEAL G2 product had not received marketing approval in China, and consequently, no units were sold within the country. As such, the recall in China does not necessitate direct market actions, such as product retrieval or notifications to consumers, from the company. However, the NMPA issued a directive requesting Food and Drug Administrations across all provinces, autonomous regions, and municipalities to enhance their oversight and management of similar medical devices. Due to the absence of sales in China, Ethicon Endo-Surgery, LLC will not be providing subsequent recall implementation reports or investigation summaries to the NMPA.

Company: https://www.globalkeysolutions.net/companies/ethicon-endo-surgery-llc/dfce5be3-6a9d-4239-8ba0-5d5283b81a02/