# China NMPA Product Recall - Laparoscopic linear stapler (trade name: ENDOPATH®)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ethicon-endo-surgery-llc/61d115f0-a605-45b2-947c-19093b2d08ea/
Source feed: China

> China NMPA product recall for Laparoscopic linear stapler (trade name: ENDOPATH®) by Ethicon Endo-Surgery, LLC published January 19, 2012. Recall level: . The National Medical Products Administration (NMPA) in China, referencing Index No. JGXX-2012-10014 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ethicon Endo-Surgery, LLC is recalling its endoscopic linear stapler (brand name: ENDOPATH).
- Company Name: Ethicon Endo-Surgery, LLC
- Publication Date: 2012-01-19
- Product Name: Laparoscopic linear stapler (trade name: ENDOPATH®)
- Recall Reason: The blister packaging of the ENDOPATH® laparoscopic linear cutting stapler may be damaged, which may affect the aseptic packaging of the instrument.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Ethicon Endo-Surgery, LLC
- Summary: The National Medical Products Administration (NMPA) in China, referencing Index No. JGXX-2012-10014 and a January 19, 2012, publication, reported a voluntary global recall initiated by Ethicon Endo-Surgery, LLC. The recall, handled in China by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., pertains to specific models (CTS45, CTS45NK) of the ENDOPATH® laparoscopic linear anastomosis device. The core issue identified was potential damage to the product's blister packaging, which could compromise the instrument's sterility. While this recall was global, the manufacturer confirmed that the affected batches were neither imported into nor sold within the Chinese market. Consequently, the company indicated that specific corrective actions for China were "Not Applicable." However, the NMPA proactively directed provincial and municipal food and drug administrations to enhance their oversight and management of similar medical devices to maintain public safety, despite the product not entering the local supply chain.

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