# China NMPA Product Recall - bidirectional guiding sheath

Source: https://www.globalkeysolutions.net/records/china_product_recall/johnson-johnson-shanghai-medical-devices-co-ltd/19ed5b9d-56e3-43a1-a886-b76a421af583/
Source feed: China

> China NMPA product recall for bidirectional guiding sheath by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. published July 14, 2017. Recall level: Level 2 Recall. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall of its 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. voluntarily recalls bidirectional guiding sheaths.
- Company Name: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Publication Date: 2017-07-14
- Product Name: bidirectional guiding sheath
- Recall Level: Level 2 Recall
- Recall Reason: If one side of the product packaging bag is not sealed, the sterile barrier of the packaging bag may be compromised.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall of its bidirectional guiding sheath (Note: 20153771320), as announced on July 14, 2017, by the National Medical Products Administration (NMPA). The recall was prompted by the discovery that one side of the product's packaging bag was not properly sealed. This manufacturing defect raised concerns about the integrity of the sterile barrier, potentially compromising the sterility of the medical device and posing a risk to patient safety. The company proactively reported the issue and took corrective action by recalling the affected products. Detailed information regarding specific models, specifications, and batch numbers was provided in the accompanying "Medical Device Recall Event Report Form" attachments. This action underscores the regulatory framework's commitment to ensuring the safety and quality of medical devices available in the market.

Company: https://www.globalkeysolutions.net/companies/johnson-johnson-shanghai-medical-devices-co-ltd/c552b533-9bb4-43a8-858a-e58faf1dd14e/