# China NMPA Product Recall - Central venous catheter (trade name: Cytofi)

Source: https://www.globalkeysolutions.net/records/china_product_recall/b-braun-medical-shanghai-international-trading-co-ltd/c0123a0b-f8e8-4426-b94b-15a27feb3924/
Source feed: China

> China NMPA product recall for Central venous catheter (trade name: Cytofi) by B. Braun Medical (Shanghai) International Trading Co., Ltd. published March 12, 2019. Recall level: Level 1 Recall. On March 12, 2019, B. Braun Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: B. Braun Medical (Shanghai) International Trading Co., Ltd. has initiated a voluntary recall of its central venous catheters (trade name: Cytofil).
- Company Name: B. Braun Medical (Shanghai) International Trading Co., Ltd.
- Publication Date: 2019-03-12
- Product Name: Central venous catheter (trade name: Cytofi)
- Recall Level: Level 1 Recall
- Recall Reason: The product in question uses a packing material to seal the dead space between the lateral opening and the catheter tip of the central venous catheter to prevent blood or fluid retention. Due to a discrepancy in the supplier's components, this packing material may have shifted during internal quality control and post-market surveillance. Considering the potential risk of packing material displacement causing tubing blockage, leading to infusion obstruction, or even embolism, this product is subject to further investigation.
- Discovering Company: B. Braun Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: B. Braun Medical (Shanghai) International Trading Co., Ltd.
- Summary: On March 12, 2019, B. Braun Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class I recall of its Cytofel brand central venous catheters. This action, reported to the National Medical Products Administration (NMPA) and referencing the Shanghai Food and Drug Administration, stemmed from a critical manufacturing issue. A deviation in supplier parts led to a potential shift in the filler material used to seal the dead space between the catheter's lateral opening and its tip. This filler displacement creates a significant risk of catheter blockage or displacement, which could subsequently lead to infusion obstruction or a serious embolism in patients. Despite no injuries being reported to date, the company proactively conducted this high-risk recall to safeguard patient safety. The detailed models, specifications, and affected batches were outlined in a "Medical Device Recall Event Report Form," indicating the comprehensive nature of the required action under regulatory oversight. This incident highlights the importance of robust quality control and post-market surveillance in medical device manufacturing, ensuring product integrity and mitigating potential patient hazards.

Company: https://www.globalkeysolutions.net/companies/b-braun-medical-shanghai-international-trading-co-ltd/58112c52-92f6-4aa8-acd6-c5efd892653b/