# China NMPA Product Recall - Introducer Sheath System with hydrophobic coating

Source: https://www.globalkeysolutions.net/records/china_product_recall/contract-medical-international-gml/19a7cdc0-b699-4978-b0a9-2b7d37f5130f
Source feed: China

> China NMPA product recall for Introducer Sheath System with hydrophobic coating by Contract Medical International, Gml published August 07, 2025. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) has announced a Class III voluntary recall initi

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Contract Medical International, GmbH is voluntarily recalling its guiding sheath system.
- Company Name: Contract Medical International, Gml
- Publication Date: 2025-08-07
- Product Name: Introducer Sheath System with hydrophobic coating
- Recall Level: Level 3 Recall
- Recall Reason: Some products may have incorrect labels on the inner packaging bags.
- Discovering Company: Baiduli (Beijing) Medical Devices Co., Ltd.
- Manufacturing Company: Contract Medical International, Gml
- Summary: The National Medical Products Administration (NMPA) has announced a Class III voluntary recall initiated by Contract Medical International, GmbH, concerning its Introducer Sheath System with hydrophobic coating (National Medical Device Registration Certificate No. 20182030226). This recall, reported by Baidu (Beijing) Medical Device Co., Ltd., stems from a potential issue involving incorrect labeling on the inner packaging of certain product batches. Identified under NMPA Index No. JGXX-2025-10107 and published on August 7, 2025, this action addresses a critical quality control concern impacting medical device accuracy. Despite the nature of labeling inaccuracies, it is explicitly stated that the affected products were not imported into China, thus mitigating direct risk to the Chinese market. The manufacturer is taking proactive measures by initiating this recall, indicating adherence to regulatory expectations for product safety and quality. Detailed information, including specific product specifications and batch numbers, is available in the accompanying "Medical Device Recall Event Report Form" attachment, which provides further context for stakeholders. This action underscores the NMPA's commitment to overseeing medical device safety and ensuring manufacturers address potential product deficiencies promptly.

Company: https://www.globalkeysolutions.net/companies/contract-medical-international-gml/1772bf96-284d-4ed6-9bcf-324d852753d3