Reported May 21, 2014 · Terminated
Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use…
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?
- Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T)
- Part Number190234 Revision K
- Lot codes and dates
- Revision K Actuator
- Test Boards S/N of 2008 T Machines
79 of 79 codes
3T0S1249033T0S1249373T0S1249333T0S1249863T0S1249343T0S1249703T0S1248943T0S1249353T0S1249123T0S1249653T0S1249443T0S1249883T0S1249393T0S1249903T0S1249403T0S1249413T0S1249583T0S1248883T0S1249463T0S1249993T0S1249423T0S1249913T0S1250233T0S1249513T0S1249363T0S1248953T0S1249553T0S1250003T0S1249433T0S1250103T0S1248933T0S1249543T0S1248963T0S1248993T0S1249593T0S1250083T0S1249473T0S1250183T0S1249053T0S1249613T0S1248983T0S1249073T0S1249633T0S1248913T0S1249523T0S1250283T0S1249203T0S1249663T0S1249103T0S1249093T0S1249673T0S1249013T0S1249533T0S1250293T0S1249223T0S1249693T0S1249133T0S1249113T0S1249723T0S124902
- Amount recalled
- 79 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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