Reported May 19, 2021 · Terminated
AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to…
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 and AquaBplus B2 Water
- Purification System - Product UsageIntended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. Fresenius P/N 24-2500-0 All 3 units make up
- the AquaBplus 2500Fresenius Part NumberG02040109-US AquaBplus 3000 - Typ USA G02040115-US AquaBplus 2500 - Typ USA G02040120FMC-US AquaBplus HF- Typ USA
- Lot codes and dates
- Serial number first stage (AquaBplus)Serial number second ¿stage(B2):
5BPS06016BPS09337BPS14577BPS15267BPS14587BPS15278BPS18018BPS18008BPS18708BPS18838BPS18988BPS18858BPS18848BPS19187BPS144438BPS19308BPS19288BPS19298BPS19378BPS19278BPS20528BPS20818BPS21088BPS21579BPS22347BPS14419BPS2512.
5BDS01946BDS0677BDS06927BDS07267BDS06437BDS07228BDS09078BDS09098BDS09588BDS09608BDS09648BDS09638BDS09658BDS09787BDS06848BDS09898BDS09978BDS09958BDS09988BDS09928BDS10758BDS10878BDS11028BDS11399BDS11817BDS06839BDS1373
- Serial number HF option
5BFS01256BFS02417BFS04137BFS04567BFS04467BFS04868BFS05418BFS06098BFS06448BFS06658BFS06638BFS05778BFS06218BFS06167BFS04398BFS06868BFS07028BFS07038BFS06958BFS06768BFS07278BFS07578BFS07768BFS08059BFS08457BFS04779BFS0997
- Serial number first stage (AquaBplus)
- Amount recalled
- 27 units
Where it was sold
Why it was recalled
AquaBplus HF module on the AquaBplus 2500 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 2500 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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