AquaBplus Water Purification System installation guideline error reduces disinfection
AquaBplus 2000 water purification systems for dialysis have an installation guideline error that may reduce heat disinfection effectiveness. Patients using affected units may be at risk.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall without reported hospitalizations or injuries. The hazard is an installation error that may reduce heat disinfection effectiveness in dialysis water systems. Per the severity rubric, this qualifies as High (Score 3): risk-of-harm product where injury has not yet been reported.
Plain-English summary
AquaBplus Water Purification System for dialysis, including models 2500, 2000, and HF, is being recalled due to an error in the US Installation Guideline. The guideline incorrectly instructed that 3-ring mains could be installed instead of 2-ring mains on the AquaBplus 2000 device.
When 3-ring mains are used with the AquaBplus 2000, the heat disinfection system may not be as effective as with the correct 2-ring main installation. This compromises the effectiveness of the water purification process.
The recall affects dialysis systems distributed nationwide in North Carolina and West Virginia. Affected systems can be identified by the serial numbers provided by the manufacturer.
Healthcare facilities and patients using these systems should immediately contact Fresenius Medical Care Holdings, Inc., to verify their equipment installation and determine if corrective action is needed.
The recalled product
- Product
- AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ USA (G02040114-US), AquaBplus HF -Typ USA (G02040120FMC-US)
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI-DI: (01)04251285200227
- (01)04251285200289
- (01)0425128520
- Serial Numbers: 7BPS1621 7BDS0783 7BFS0517 7BPS1611 7BDS0776 7BFS0502
Distribution
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