# China NMPA Product Recall - Disposable needlestick-proof indwelling intravenous catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/becton-dickinson-infusion-therapy-systems-inc/92143fc9-6c95-4294-821c-e2a086e2d989/
Source feed: China

> China NMPA product recall for Disposable needlestick-proof indwelling intravenous catheter by Becton Dickinson Infusion Therapy Systems, Inc. published March 18, 2019. Recall level: Level 2 Recall. On March 18, 2019, the National Medical Products Administration (NMPA) published a notice regarding 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Becton Dickinson Infusion Therapy Systems, Inc. is voluntarily recalling its single-use needlestick-proof indwelling intravenous catheters.
- Company Name: Becton Dickinson Infusion Therapy Systems, Inc.
- Publication Date: 2019-03-18
- Product Name: Disposable needlestick-proof indwelling intravenous catheter
- Recall Level: Level 2 Recall
- Recall Reason: Some products in this batch may experience leakage at the isolation plug or rupture of the catheter seat during high-pressure injection, which could lead to occupational exposure (bloodborne exposure) risks for healthcare workers.
- Discovering Company: BD Medical Devices (Shanghai) Co., Ltd.
- Manufacturing Company: Becton Dickinson Infusion Therapy Systems, Inc.
- Summary: On March 18, 2019, the National Medical Products Administration (NMPA) published a notice regarding a voluntary Class II recall by Becton Dickinson Infusion Therapy Systems, Inc. This recall pertains to their single-use needle-punch-proof indwelling catheters (Registration Certificate No.: 20163151642). The main issue identified was a potential for catheter hub breakage during use. Further investigation revealed that specific batches of these devices could experience leakage at the isolator plug or rupture of the catheter seat during high-pressure injection. This defect poses a significant risk of occupational exposure, including bloodborne exposure, to healthcare workers.Operating under the NMPA's regulatory framework for medical devices, Becton Dickinson initiated this recall to address the safety concern. However, Becton Medical Devices (Shanghai) Co., Ltd., the agent, confirmed that the specific affected product batches were not imported into or sold within the Chinese market. Consequently, no corrective actions or handling measures are required in China for this recall, as the impacted products were distributed in other regions, such as the United States.

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