# China NMPA Product Recall - Disposable sterile syringes

Source: https://www.globalkeysolutions.net/records/china_product_recall/becton-dickinson-and-company/7eadfb55-1859-412e-83ff-75c51627ac27/
Source feed: China

> China NMPA product recall for Disposable sterile syringes by Becton, Dickinson and Company published September 25, 2015. Recall level: Level III. BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class III recall of various disposable

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: BD Medical Devices (Shanghai) Co., Ltd. is voluntarily recalling disposable sterile syringes.
- Company Name: Becton, Dickinson and Company
- Publication Date: 2015-09-25
- Product Name: Disposable sterile syringes
- Recall Level: Level III
- Recall Reason: Our US headquarters has discovered that some syringes in the United States are being used beyond their registered intended use: some combination pharmacies and repackagers' outpatient drug preparation centers are using these syringes as sealed containers for pre-administration drug storage. Our US headquarters has received feedback from customers stating that storing certain combination or repackaged medications in these syringes may reduce their efficacy. We confirm that we have not encountered/received any customer feedback related to this usage in China. However, as a socially responsible company, BD wants to proactively communicate this issue to ensure our customers are fully aware of it and take note in their daily operations.
- Discovering Company: BD Medical Devices (Shanghai) Co., Ltd.
- Manufacturing Company: Becton, Dickinson and Company
- Summary: BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class III recall of various disposable sterile syringes, as reported to the National Medical Products Administration (NMPA) on September 25, 2015. The recall stems from findings by the company's US headquarters, Becton Dickinson and Company, which identified that some users in the United States were utilizing the syringes outside their approved scope. Specifically, these syringes were being employed as sealed containers for pre-administration drug storage, a practice confirmed to potentially diminish drug efficacy for certain medications. The affected products, imported under registration certificate CFDA (Imported) 2014 No. 3154648, include millions of units sold in China. However, the company confirmed no related customer feedback or issues have been reported within China. As a proactive measure, BD Medical Devices (Shanghai) Co., Ltd. is issuing customer letters to communicate the proper intended use and the potential risks of off-label storage. Importantly, this recall does not necessitate product returns or replacements, and the syringes are permitted to continue being sold in China, as the issue pertains to misuse rather than a product defect affecting their primary intended use for injections.

Company: https://www.globalkeysolutions.net/companies/becton-dickinson-and-company/584ebc66-20ed-4c0c-8447-169c00c667fd/