# China NMPA Product Recall - Curved, visual, bidirectional adjustable curved guide sheath

Source: https://www.globalkeysolutions.net/records/china_product_recall/biosense-webster-inc/d5ba546a-a0d6-41a7-bf89-7d87964a7e5e/
Source feed: China

> China NMPA product recall for Curved, visual, bidirectional adjustable curved guide sheath by Biosense Webster Inc. published March 19, 2024. Recall level: Level 2 Recall. Biosense Webster, Inc., the manufacturer, along with its reporting entity, Johnson & Johnson (Shangh

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Biosense Webster, Inc. is proactively recalling its curved, visually adjustable, bidirectional curved guide sheath.
- Company Name: Biosense Webster Inc.
- Publication Date: 2024-03-19
- Product Name: Curved, visual, bidirectional adjustable curved guide sheath
- Recall Level: Level 2 Recall
- Recall Reason: For certain models and batches of curved, visually adjustable, bidirectional curved guide sheaths, the actual length may differ from the labeled length.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Biosense Webster Inc.
- Summary: Biosense Webster, Inc., the manufacturer, along with its reporting entity, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., has initiated a voluntary Class II recall of its bent-type visual bi-directional adjustable bend-type guided sheaths. This recall, overseen by the National Medical Products Administration (NMPA) and published on March 19, 2024, addresses a critical product issue. The main violation identified is a significant discrepancy between the actual length and the labeled length of certain batches of these medical devices. Such an inconsistency could potentially impact the device's intended function, accuracy, and ultimately, patient safety during medical procedures. Operating under the NMPA's stringent regulatory framework for medical devices, the company is required to take proactive measures to mitigate risks. Consequently, Biosense Webster, Inc. is voluntarily recalling the affected products. The detailed scope, including specific models and specifications, is further elaborated in the "Medical Device Recall Event Report Form." While the provided document does not mention specific inspection dates, the recall itself serves as a crucial corrective action to ensure the integrity and reliability of medical products in the market.

Company: https://www.globalkeysolutions.net/companies/biosense-webster-inc/1e41796e-2ddf-4c5f-ba8b-efc71a994f80/