# China NMPA Product Recall - Single-use peripherally inserted central venous catheters and infant umbilical artery and vein catheters

Source: https://www.globalkeysolutions.net/records/china_product_recall/prodimed-a-french-made-medical-catheter-research-group/e04fb87a-cd0f-4610-9670-a649f2853f4f/
Source feed: China

> China NMPA product recall for Single-use peripherally inserted central venous catheters and infant umbilical artery and vein catheters by PRODIMED, a French-made medical catheter research group published June 17, 2020. Recall level: Level 2 Recall. Prodimed Medical Catheter Development Group (France) initiated a voluntary Class II recall of specif

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: The French medical catheter manufacturing group, Medtecs, has initiated a voluntary recall of disposable peripherally inserted central venous catheters and infant umbilical arteriovenous catheters.
- Company Name: PRODIMED, a French-made medical catheter research group
- Publication Date: 2020-06-17
- Product Name: Single-use peripherally inserted central venous catheters and infant umbilical artery and vein catheters
- Recall Level: Level 2 Recall
- Recall Reason: In April 2020, the French manufacturer, Medtecs Medical Catheter Research Group, discovered during a re-evaluation of the ethylene oxide sterilization process that the weight of the sterilization tray was not being controlled.
- Discovering Company: Shandong Xinhua Ande Medical Supplies Co., Ltd.
- Manufacturing Company: PRODIMED, a French-made medical catheter research group
- Summary: Prodimed Medical Catheter Development Group (France) initiated a voluntary Class II recall of specific medical devices, as reported by the National Medical Products Administration (NMPA) in China. This recall, announced on June 17, 2020, followed an internal discovery in April 2020. The manufacturer found that during the reconfirmation of its ethylene oxide sterilization process, the weight of the sterilization tray was not consistently measured. This procedural lapse could potentially compromise the sterilization efficacy of the affected products.

The recall specifically targets single-use peripherally inserted central catheters (PICC) and infant umbilical artery and vein catheters, which are vital for drug infusion, blood sampling, and neonatal care. Shandong Xinhua Ande Medical Supplies Co., Ltd. managed the recall within China. Under the NMPA's regulatory framework, the required actions include the immediate withdrawal of all corresponding unused product batches from the market. Furthermore, all recalled products are mandated to be destroyed. This action aims to prevent potentially compromised medical devices from reaching patients across affected regions, which include France, the USA, Australia, and China, impacting thousands of units globally.

Company: https://www.globalkeysolutions.net/companies/prodimed-a-french-made-medical-catheter-research-group/7c8bfdc5-4dff-473b-97a5-b8c3092020d5/