Reported Jul 20, 2022 · Terminated
AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 -…
Fresenius Medical Care Holdings, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Medical Care Holdings, Inc. · 920 Winter St Bld 950 · Waltham, MA · 02451-1521
Is this the product you have?
AquaBplus Water Purification SystemPart Number 24-2000-0AquaBplus 2500 - Typ USA (G02040108-US)AquaBplus 2000 - Typ USA (G02040114-US)AquaBplus HF -Typ USA (G02040120FMC-US)
- Lot codes and dates
- UDI-DI
(01)04251285200227(01)04251285200289(01)0425128520
- Serial Numbers7BPS1621 7BDS0783 7BFS0517 7BPS1611 7BDS0776 7BFS0502
- UDI-DI
- Amount recalled
- 2 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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