Reported Nov 17, 2021 · Ongoing
Hemodialysis Delivery System, Software Version 2.x.
Baxter Healthcare Corporation
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: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- Hemodialysis Delivery System, Software Version 2.x.
- Lot codes and dates
- Software Version 2.x
- Product Code955626
- UDI
1,229 of 1,229 codes
0085412639499 (Lot/Serial #107208107209107210107211107378107379107380107381107382107383107384107385107386107387107483107484107485107486107487107488107489107490107491107492107493107494107495107496107497107498107499107500107501107502107503107504107505107506107507107508107509107510107511107512107818107819107820107821107822107823107824107825107826107827107878107879107880107881107882107883
- Product Code955558
- UDI
2,829 of 2,829 codes
7332414124359 (Lot/Serial #100382100383108868108869108870108871108872108873108874108875108876108877108878108880108881108912108913108914108915108916108917108918108919108920108921108922108923108924108925108926108927108928108929108930108931109031109032109033109034109035109036109037109038109039109040100384100388100389100390100406100407100409100412100413100414100427100428100429100431100432
- Amount recalled
- 4248
Where it was sold
Why it was recalled
If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription.
This product could cause temporary or reversible health problems — stop using it.
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