FDA Enforcement
Class II
Terminated
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)
Recall: Z-1364-2022
·
Reported July 20, 2022
Enforcement
- Recall Number
- Z-1364-2022
- Event ID
- 90411
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Fresenius Medical Care Holdings, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- July 20, 2022
- Initiation Date
- August 3, 2021
- Classification Date
- July 11, 2022
- Termination Date
- April 10, 2024
- Address
- 920 Winter St Bld 950, Waltham, MA, 02451-1521, United States
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)
Reason
AquaBplus 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
Code Info
UDI-DI: (01)04251285200227, (01)04251285200289, (01)0425128520; Serial Numbers: 7BPS1621 7BDS0783 7BFS0517 7BPS1611 7BDS0776 7BFS0502
Distribution
US Nationwide distribution in the states of NC and WV.
Quantity
2 units