# China NMPA Product Recall - Aquarius Continuous Blood Purification Equipment

Source: https://www.globalkeysolutions.net/records/china_product_recall/edwards-lifesciences-llc/77fbe9df-6713-47de-97ab-58308e408737/
Source feed: China

> China NMPA product recall for Aquarius Continuous Blood Purification Equipment by Edwards Lifesciences LLC published January 19, 2012. Recall level: . Edward Lifesciences LLC, in conjunction with its Chinese responsible unit, Baxter Medical Supplies T

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Edward Lifesciences LLC is recalling its Aquarius continuous blood purification equipment.
- Company Name: Edwards Lifesciences LLC
- Publication Date: 2012-01-19
- Product Name: Aquarius Continuous Blood Purification Equipment
- Recall Reason: Wheel damage during machine movement may be caused by moving the equipment on steps, stairs, or uneven ground, or by moving the machine with the front wheels locked, causing the equipment to lose balance. In the most serious cases, the equipment may tip over or even cause personal injury.
- Discovering Company: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Edwards Lifesciences LLC
- Summary: Edward Lifesciences LLC, in conjunction with its Chinese responsible unit, Baxter Medical Supplies Trading (Shanghai) Co., Ltd., initiated a voluntary global recall of specific Aquarius Continuous Blood Purification Equipment models (GE-F082-00/GE-F095-00/GE-F096-00/GE-F097-00). This recall, announced by the National Medical Products Administration (NMPA) on January 19, 2012, addresses a critical safety concern.
The primary issue identified is wheel damage occurring during the machine's movement, particularly on uneven surfaces or when wheels are locked. This defect can lead to the equipment losing balance, tipping over, and potentially causing personal injury to users or patients. The recall affects 539 units imported into China, with serial numbers ranging from 101 to 3534.
Under the regulatory oversight of the NMPA (formerly CFDA), Edward Lifesciences LLC is implementing corrective actions. These include deploying local service engineers to inspect all affected Aquarius machines. During the next scheduled routine maintenance, engineers will ensure proper wheel installation, verify that wheel torque is within defined specifications, and confirm that helical grooves effectively prevent unexpected sprocket axle release, following detailed technical bulletins. Provincial Food and Drug Administrations were also requested to enhance supervision of such products.

Company: https://www.globalkeysolutions.net/companies/edwards-lifesciences-llc/d78876e8-6a4a-49b4-8cb5-30579a7ed097/