# China NMPA Product Recall - Disposable retractable intravenous catheters (BD Insyte® Autoguard® Intravenous Catheters)

Source: https://www.globalkeysolutions.net/records/china_product_recall/becton-dickinson-infusion-therapy-systems-inc/511fb4a5-a746-4cb4-bcb5-cd18cbe1c813/
Source feed: China

> China NMPA product recall for Disposable retractable intravenous catheters (BD Insyte® Autoguard® Intravenous Catheters) by Becton Dickinson Infusion Therapy Systems, Inc. published July 02, 2025. Recall level: Level 2 Recall. Becton Dickinson Infusion Therapy Systems, Inc. has initiated a voluntary Class II recall of its BD 

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Becton Dickinson Infusion Therapy Systems, Inc. is voluntarily recalling its single-use retractable intravenous catheters.
- Company Name: Becton Dickinson Infusion Therapy Systems, Inc.
- Publication Date: 2025-07-02
- Product Name: Disposable retractable intravenous catheters (BD Insyte® Autoguard® Intravenous Catheters)
- Recall Level: Level 2 Recall
- Recall Reason: In certain batches of products, the needle retracts slowly or fails to retract during use.
- Discovering Company: BD Medical Devices (Shanghai) Co., Ltd.
- Manufacturing Company: Becton Dickinson Infusion Therapy Systems, Inc.
- Summary: Becton Dickinson Infusion Therapy Systems, Inc. has initiated a voluntary Class II recall of its BD Insyte
 Autoguard
 Intravenous Catheters. This action, published by Becton Medical Devices (Shanghai) Co., Ltd. on July 2, 2025, through the National Medical Products Administration (NMPA), addresses critical performance issues identified in specific batches of these single-use retractable intravenous catheters.
The primary concern leading to the recall is the reported malfunction where the needle retraction mechanism operates slowly or fails entirely during product use. This defect poses potential safety risks to both patients and healthcare professionals, as effective needle retraction is crucial for preventing needlestick injuries and ensuring safe medical procedures.
Under the regulatory oversight of the NMPA, which granted the product National Medical Device Registration Certificate No. 20163142184, Becton Dickinson is taking proactive steps to mitigate these risks. The Class II recall designation indicates that the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote.
The required action involves the comprehensive recall of all affected models, specifications, and batches of the BD Insyte
 Autoguard
 Intravenous Catheters. Detailed information regarding the scope of the recall is provided in an accompanying Medical Device Recall Event Report Form. This voluntary recall underscores the manufacturer's commitment to product safety and compliance with regulatory standards, aiming to protect public health by removing potentially faulty devices from circulation.

Company: https://www.globalkeysolutions.net/companies/becton-dickinson-infusion-therapy-systems-inc/57abd79e-ea1c-4d23-85ba-750e06ee12d4/