Reported May 21, 2014 · Terminated
Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines…
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 · Waltham, MA · 02451-1521
Is this the product you have?
- Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T)
- Part Number190713 Revision K
- Lot codes and dates
- Revision K Actuator Test Boards
- Amount recalled
- 39 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
- Nationwide
Why it was recalled
2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump
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.
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