Reported Oct 21, 2020 · Terminated
AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and…
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. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. AquaBplus 1500 - Typ USA - 3
- x 208V / 60Hz -Fresenius Part Number24-1500-1 AquaBplus B2 2000 / B1 2500 (Bplus DUO 2000) - 3
- x 208V / 60Hz- Fresenius Part Number24-2000-0
- Lot codes and dates
9BDS151508D51544OBDS1596OBPS28649BDS1529OBDS1545OBPS2799OBPS28849BPS2735OBDS1551OBPS2800OBPS29039BPS276708D51590OBPS2810
- Amount recalled
- 15 units
Where it was sold
Why it was recalled
Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connections could become loose and may adversely affect the electrical safety of the products, potentially resulting in electrical shock to the Biomed Technician or clinic staff.
This product could cause temporary or reversible health problems — stop using it.
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