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Fresenius Medical Care Holdings, Inc. Recall 90411

Description: 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)

Fresenius Medical Care Holdings, Inc. Recall 90411 Information

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberZ-1364-2022
Event ID90411
Event DescriptionAquaBplus 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)
Product TypeDevices
DistributionUS Nationwide distribution in the states of NC and WV.
Quantity2 units
Recall ReasonAquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2000 device. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation
Device Classification20220720
Device Code InfoUDI-DI: (01)04251285200227, (01)04251285200289, (01)0425128520; Serial Numbers: 7BPS1621 7BDS0783 7BFS0517 7BPS1611 7BDS0776 7BFS0502
Center Classification Date20220711
Recall Initiation Date20210803
Recalling FirmFresenius Medical Care Holdings, Inc.
Initial Notification Telephone
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