# China NMPA Product Recall - Infusion System

Source: https://www.globalkeysolutions.net/records/china_product_recall/angiodynamics-inc/9e6944ec-d3c0-437f-8d0b-b8a09ec723cb/
Source feed: China

> China NMPA product recall for Infusion System by AngioDynamics Inc. published June 27, 2024. Recall level: Level 2 Recall. AngioDynamics, Inc. has initiated a voluntary Class II recall for certain infusion systems due to a 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: AngioDynamics, Inc. initiates proactive recall of its perfusion systems.
- Company Name: AngioDynamics Inc.
- Publication Date: 2024-06-27
- Product Name: Infusion System
- Recall Level: Level 2 Recall
- Recall Reason: Manufacturing defects in the O-ring of the rotary adapter may cause drug leakage during infusion.
- Discovering Company: Shanghai Meichuang Medical Devices Co., Ltd.
- Manufacturing Company: AngioDynamics Inc.
- Summary: AngioDynamics, Inc. has initiated a voluntary Class II recall for certain infusion systems due to a critical manufacturing defect. This action was reported by Shanghai Meichuang Medical Device Co., Ltd. and publicly announced by the National Medical Products Administration (NMPA) on June 27, 2024. The core issue involves a faulty rotating adapter O-ring within the infusion systems, which poses a significant risk of drug leakage during patient infusion. This defect could compromise the integrity of the medical procedure and potentially affect patient safety. Operating under the NMPA's regulatory framework for medical device oversight, AngioDynamics, Inc. is taking proactive steps to address this quality concern. The specific infusion systems impacted are those registered under National Medical Device Registration Certificate No. 20183031982; detailed model and batch information is available in the official "Medical Device Recall List." The required action involves the systematic voluntary recall of all affected units to prevent potential adverse events. Crucially, the NMPA has confirmed that the specific products involved in this recall were not imported into China, mitigating direct impact on the Chinese healthcare market. This recall underscores the continuous need for stringent quality control in medical device manufacturing and regulatory vigilance.

Company: https://www.globalkeysolutions.net/companies/angiodynamics-inc/ac6e9e52-94d3-4af8-bea5-de6d2fefc28f/