# China NMPA Product Recall - Closed-loop intravenous catheter to prevent needlestick injuries

Source: https://www.globalkeysolutions.net/records/china_product_recall/suzhou-frankman-medical-devices-co-ltd/90fbaf0c-962f-48db-8415-dcfe5dd8e2a9/
Source feed: China

> China NMPA product recall for Closed-loop intravenous catheter to prevent needlestick injuries by Suzhou Frankman Medical Devices Co., Ltd. published July 08, 2016. Recall level: Level 3 Recall. Suzhou BD Medical Device Co., Ltd., with BD Medical Devices (Shanghai) Co., Ltd. as the responsible 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Suzhou BD Medical Devices Co., Ltd. is voluntarily recalling its closed-system, needle-puncture-proof indwelling intravenous catheters.
- Company Name: Suzhou Frankman Medical Devices Co., Ltd.
- Publication Date: 2016-07-08
- Product Name: Closed-loop intravenous catheter to prevent needlestick injuries
- Recall Level: Level 3 Recall
- Recall Reason: The registration certificate number and registration standard number on the product packaging are incorrect.
- Discovering Company: BD Medical Devices (Shanghai) Co., Ltd.
- Manufacturing Company: Suzhou Frankman Medical Devices Co., Ltd.
- Summary: Suzhou BD Medical Device Co., Ltd., with BD Medical Devices (Shanghai) Co., Ltd. as the responsible unit, initiated a Class III voluntary recall for its Closed-Loop Anti-Needle-Punch Indwelling Catheter. The recall, reported on June 23, 2016, and published by the National Medical Products Administration (NMPA) on July 8, 2016, addressed critical packaging errors. The main issue involved incorrect printing of the product's registration certificate number (CFDA Approval No. 2013 3151686) and registration standard number on the outer and inner boxes of specific batches (models 383913, 383914, and 383934). Despite these labeling inaccuracies, the individual unit packaging was accurate, and the product's quality, performance, and safety were confirmed to be unaffected, ensuring it could still be used normally. Under the NMPA's regulatory framework, required actions included isolating and inspecting all unshipped inventory for rework and rectification before release. For products already distributed, customers were to be notified via letter about the packaging discrepancies, and appropriate corrective measures were to be implemented. The recall emphasized the continued usability and safety of the product itself.

Company: https://www.globalkeysolutions.net/companies/suzhou-frankman-medical-devices-co-ltd/d2978d94-ad1a-47c2-ad23-19a6a515135d/