Reported Apr 1, 2020 · Terminated

Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis…

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?

  • Honeywell
  • Pressure Transducer- Part Number370506-22. It is a component used in 2008T
  • Common Name
    • Hemodialysis Delivery System
    • 2008T HD SYS. BLUE STAR
    • 2008K2
  • Common NameHemodialysis Delivery Equipment; 2008K@home
  • Common NameHemodialysis Delivery System
Lot codes and dates
  • Serial numbers

    2,684 of 2,684 codes

    • 9T0S238668
    • 9T0S238737
    • 9T0S238795
    • 9T0S238796
    • 9T0S238798
    • 9T0S239031
    • 9T0S239133
    • 9T0S239135
    • 9T0S239143
    • 9T0S239153
    • 9T0S239173
    • 9T0S239189
    • 9T0S239198
    • 9T0S239215
    • 9T0S239229
    • 9T0S239244
    • 9T0S239245
    • 9T0S239246
    • 9T0S239250
    • 9T0S239255
    • 9T0S239268
    • 9T0S239280
    • 9T0S239284
    • 9T0S239353
    • 9T0S239364
    • 9T0S239366
    • 9T0S239387
    • 9T0S240371
    • 9T0S239371
    • 9T0S239424
    • 9T0S239425
    • 9T0S239443
    • 9T0S239251
    • 9T0S239329
    • 9T0S239352
    • 9T0S239358
    • 9T0S239367
    • 9T0S239388
    • 9T0S239497
    • 9T0S239499
    • 9T0S243430
    • 9T0S243570
    • 9T0S243649
    • 9T0S239369
    • 9T0S239475
    • 9T0S239743
    • 9T0S239800
    • 9T0S239844
    • 9T0S239878
    • 9T0S239902
    • 9T0S239904
    • 9T0S239910
    • 9T0S239926
    • 9T0S239927
    • 9T0S239951
    • 9T0S239953
    • 9T0S239956
    • 9T0S239960
    • 9T0S239969
    • 9T0S239970
Amount recalled
3561 units

Where it was sold

  • Nationwide

Why it was recalled

The firm is replacing pressure transducers with an improved design due to an increase in customer complaints regarding lower long-term reliability of the part.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 6, 2021 · Data as of Sep 19, 6:51 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.