Reported Sep 28, 2022 · Ongoing
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems.…
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?
- AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems
- Fresenius Part Number24-10VA-1
- Vivonic Part NumberG02000970-US
- Lot codes and dates
- UDI(01)4251285200234(11)210628(21)1CHS5379 (01)4251285200234(11)160927(21)6CHS1270 (01)4251285200234(11)161109(21)6CHS1394 (01)4251285200234(11)161109(21)6CHS1435 (01)4251285200234(11)170131(21)7CHS1569 (01)4251285200234(11)170201(21)7CHS1583 (01)4251285200234(11)170213(21)7CHS1619 (01)4251285200234(11)170314(21)7CHS1641 (01)4251285200234(11)170519(21)7CHS1790 (01)4251285200234(11)170807(21)7CHS1953 (01)4251285200234(11)180326(21)8CHS2197 (01)4251285200234(11)181010(21)8CHS2608 (01)4251285200234(11)181102(21)8CHS2633 (01)4251285200234(11)181107(21)8CHS2644
- Serial Numbers
1CHS53796CHS11926CHS11946CHS11956CHS11966CHS11976CHS11986CHS11996CHS12006CHS12016CHS12336CHS12706CHS13946CHS14357CHS15697CHS15837CHS16197CHS16417CHS17907CHS19538CHS21978CHS26088CHS26338CHS2644
- Amount recalled
- 24 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
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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