# China NMPA Product Recall - Vacuum blood collection tubes

Source: https://www.globalkeysolutions.net/records/china_product_recall/becton-dickinson-and-company/70299798-464a-4962-a323-84f01f9c9298/
Source feed: China

> China NMPA product recall for Vacuum blood collection tubes by Becton, Dickinson and Company published July 04, 2017. Recall level: Level 3. BD Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its vacuum blood c

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: BD Medical Devices (Shanghai) Co., Ltd. initiates voluntary recall of vacuum blood collection tubes
- Company Name: Becton, Dickinson and Company
- Publication Date: 2017-07-04
- Product Name: Vacuum blood collection tubes
- Recall Level: Level 3
- Recall Reason: Visible foreign objects were found in the vacuum blood collection tube.
- 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 its vacuum blood collection tubes (Registration No.: 20152410400), as reported to the National Medical Products Administration (NMPA) on May 12, 2017, and publicly announced on July 4, 2017. The recall was prompted by the discovery of visible foreign matter within the tubes, which impaired the product's normal functionality for clinical venipuncture blood sample collection. The affected product, specifically the Separating Adhesive/Silica Additive type with gold safety caps (3.5ml, 13x75mm, Batch Number: 6166824, Item Number: 367957), saw approximately 943,000 units sold in China out of 1,000,000 imported units, impacting regions including Europe and Asia Pacific. Under the NMPA's regulatory framework, BD Medical Devices (Shanghai) Co., Ltd. undertook corrective actions. These included proactively informing customers through written communication about the incident and implementing a process for the recall and replacement of affected products. The company also outlined procedures for handling and destroying the returned products, ensuring compliance with regulatory requirements.

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