# China NMPA Product Recall - Hollow fiber dialysis machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/gambro-dialysatoren-gmbh/e34415f3-3d87-41dd-870a-ca40f773b43c/
Source feed: China

> China NMPA product recall for Hollow fiber dialysis machine by Gambro Dialysatoren GmbH published August 13, 2015. Recall level: Level II. On August 13, 2015, the National Medical Products Administration (NMPA) publicized a voluntary Class

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Jinbao Kidney Care Products (Shanghai) Co., Ltd. is voluntarily recalling hollow fiber dialyzers.
- Company Name: Gambro Dialysatoren GmbH
- Publication Date: 2015-08-13
- Product Name: Hollow fiber dialysis machine
- Recall Level: Level II
- Recall Reason: Air bubbles were present in the polyurethane encapsulation material, causing leakage between the blood side and the dialysate side.
- Discovering Company: Jinbao Kidney Care Products (Shanghai) Co., Ltd.
- Manufacturing Company: Gambro Dialysatoren GmbH
- Summary: On August 13, 2015, the National Medical Products Administration (NMPA) publicized a voluntary Class II recall initiated by Gambro Kidney Care Products (Shanghai) Co., Ltd. for the Hollow Fiber Dialyzer, model Polyflex 14L, manufactured by Gambro Dialysatoren GmbH. This recall, affecting 15,120 units imported and sold in Mainland China, addresses a critical quality issue: the presence of air bubbles in the polyurethane encapsulation material. This defect can cause leakage between the blood and dialysate sides, potentially compromising the safety and efficacy of hemodialysis treatment for patients with renal failure. The product was registered under CFDA (Imported) No. 2012 3454528. As part of the recall actions, Gambro Kidney Care Products (Shanghai) Co., Ltd. committed to issuing recall notices to all affected customers and retrieving all remaining unused problematic products from the market for destruction. This measure was undertaken to mitigate risks and ensure compliance with medical device quality standards.

Company: https://www.globalkeysolutions.net/companies/gambro-dialysatoren-gmbh/5cf8f7b2-b364-438d-b1a1-3a0cb277c731/