# China NMPA Product Recall - Disposable capillary blood collection container

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-medical-devices-shanghai-co-ltd/13775548-65ef-4097-8216-c0b0cc04336c/
Source feed: China

> China NMPA product recall for Disposable capillary blood collection container by Smith Medical Devices (Shanghai) Co., Ltd. published June 05, 2019. Recall level: Level 2 Recall. BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its disposable peri

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: BD Medical Devices (Shanghai) Co., Ltd. is voluntarily recalling disposable capillary blood collection containers.
- Company Name: Smith Medical Devices (Shanghai) Co., Ltd.
- Publication Date: 2019-06-05
- Product Name: Disposable capillary blood collection container
- Recall Level: Level 2 Recall
- Recall Reason: Some disposable capillary blood collection containers may have insufficient or no additive content.
- Discovering Company: BD Medical Devices (Shanghai) Co., Ltd.
- Manufacturing Company: Smith Medical Devices (Shanghai) Co., Ltd.
- Summary: BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its disposable peripheral blood sampling containers on June 5, 2019. This action, reported under the oversight of the National Medical Products Administration (NMPA), addresses a critical quality concern with the medical devices. The primary issue identified involves the possibility that some manufactured disposable peripheral blood sampling containers may contain insufficient additive content or, in certain instances, completely lack the necessary additives. Such a deficiency could compromise the functionality and reliability of the product during medical procedures, potentially impacting patient care and diagnostic accuracy. The affected products are identified by Registration Certificate No. 20152412372, initially registered with the Shanghai Food and Drug Administration. While specific inspection dates are not provided in this announcement, the company's proactive voluntary recall demonstrates adherence to regulatory responsibilities under the NMPA framework governing medical device safety and quality in China. As required, BD Medical Devices (Shanghai) Co., Ltd. has issued a "Medical Device Recall Event Report Form" which contains detailed information regarding the models, specifications, and specific batches of the affected disposable peripheral blood sampling containers. This document serves as the primary resource for healthcare providers and distributors to identify and manage the recalled products effectively, ensuring their removal from distribution and use. The Class II classification indicates that use of the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. The company is responsible for communicating the recall details and ensuring the proper execution of corrective actions.

Company: https://www.globalkeysolutions.net/companies/smith-medical-devices-shanghai-co-ltd/a4f694b0-5671-4759-922c-b6adb96ecceb/