FDA-Device2022-07-20Class II
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.
Hazard
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
Sold states
US Nationwide distribution in the states of NC and WV.
Affected count
2 units
Manufactured in
920 Winter St Bld 950, Waltham, MA, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1364-2022Don't want to check this manually?
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