# China NMPA Product Recall - Disposable hemodialysis tubing kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/covidien-llc/b2260152-d51d-4776-b1c6-486dc1620aa5/
Source feed: China

> China NMPA product recall for Disposable hemodialysis tubing kit by Covidien llc published April 30, 2015. Recall level: . On April 30, 2015, Covidien Medical Devices International Trading (Shanghai) Co., Ltd., a subsidiary

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Covidien Medical Devices International Trading (Shanghai) Co., Ltd. has initiated a voluntary recall of disposable hemodialysis tubing kits.
- Company Name: Covidien llc
- Publication Date: 2015-04-30
- Product Name: Disposable hemodialysis tubing kit
- Recall Reason: Medtronic is voluntarily recalling these products because internal testing revealed that the affected products may not meet the minimum silver ion release criteria for a full 30-day cycle. The silver ions eluted from the cannula are used to reduce microbial colonization on the catheter surface and in subcutaneous cavities. Testing showed that the initial silver ion release levels met the criteria, but decreased after 9 days. No additional safety risks have been reported in patients who have already had the device implanted. We have not received any reports of adverse reactions related to this issue. This voluntary recall is solely a precautionary measure.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien llc
- Summary: On April 30, 2015, Covidien Medical Devices International Trading (Shanghai) Co., Ltd., a subsidiary of Covidien LLC (now integrated with Medtronic), initiated a voluntary global recall for several models of its Disposable Hemodialysis Tube Kits, including the Palindrome Ruby and Palindrome Sapphire series, along with various Palindrome SI/HSI Chronic Catheter Kits. This action was documented by the National Medical Products Administration (NMPA).

The primary issue identified through internal testing was that affected products, specifically those with an expiration date before February 2018, might not maintain the minimum silver ion release standard over a complete 30-day cycle. While initial silver ion levels met specifications, a decline was observed after nine days. Silver ions are intended to reduce microbial colonization on the catheter surface.

Despite this technical non-conformance, the company reported no additional safety concerns for patients with implanted devices and had not received any adverse reaction reports related to the issue, characterizing the recall as a precautionary measure. Critically, none of the affected products were sold within the Chinese market. Therefore, no further corrective actions were required from the company by the NMPA within China.

Company: https://www.globalkeysolutions.net/companies/covidien-llc/5111c5da-0a3d-4895-b59e-e49f0ad3547d/