Reported Jun 19, 2024 · Ongoing
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers:…
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 920 · Waltham, MA · 02451-1521
Is this the product you have?
- US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used
- for hemodialysis Vivonic Part NumbersG02020110
- Fresenius Part Number24-090A-1
- Lot codes and dates
- UDI-DI04251285200357
- Serial Numbers2AAV0003 2AAV0029 2AAV0037 3AAV0087
- Amount recalled
- 4 units
Where it was sold
Why it was recalled
Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new packaged foods recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.