# China NMPA Product Recall - Central venous catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/b-braun-melsungen-ag/86d42bed-3fd6-423f-bf22-57e5cbd6abe8/
Source feed: China

> China NMPA product recall for Central venous catheter by B. Braun Melsungen AG published March 15, 2019. Recall level: Level 1 Recall. B. Braun Melsungen AG, via its agent B. Braun Medical (Shanghai) International Trading Co., Ltd., in

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: B. Braun Melsungen AG actively recalls central venous catheters.
- Company Name: B. Braun Melsungen AG
- Publication Date: 2019-03-15
- Product Name: Central venous catheter
- Recall Level: Level 1 Recall
- Recall Reason: The dead space between the lateral opening and the catheter tip of the central venous catheter is sealed with a plug to prevent blood or fluid retention. Due to a supplier component deviation, this plug may have shifted during internal quality control and post-market surveillance. Although no injuries have been reported to date, the manufacturer has decided to initiate a voluntary recall due to the potential risk of plug displacement causing catheter obstruction or embolism. The recall is limited to the aforementioned model and batch number of four-lumen central venous catheters.
- Discovering Company: B. Braun Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: B. Braun Melsungen AG
- Summary: B. Braun Melsungen AG, via its agent B. Braun Medical (Shanghai) International Trading Co., Ltd., initiated a Class I voluntary recall of specific Central Venous Catheters (Registration Certificate No. 20143775019) on March 12, 2019. This action, overseen by the National Medical Products Administration (NMPA) of China, concerns 36,410 units imported since 2016.

The primary issue stems from a potential deviation in a supplier-provided component: a packing material intended to seal the dead space between the catheter's lateral opening and tip. This material may have shifted, creating a risk of infusion obstruction or embolism, although no patient injuries have been reported to date. The recall specifically targets various batch numbers of the CERTOFIX QUATTRO V 820 Four-lumen Central Venous Catheter.

As required by the NMPA, B. Braun must undertake several critical actions. These include verifying and freezing all remaining affected product inventory within China, issuing recall notices to all customers to ensure comprehensive awareness, and retrieving all unused recalled products from customers for local destruction, alongside any frozen stock. This proactive measure aims to mitigate potential patient safety hazards associated with the identified component issue.

Company: https://www.globalkeysolutions.net/companies/b-braun-melsungen-ag/46498a35-a987-48f4-b58c-bc7d230215df/