Reported Oct 18, 2023 · Ongoing
2008T Hemodialysis System w/Bibag
Fresenius Medical Care Holdings, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 920 · Waltham, MA · 02451-1521
Is this the product you have?
- 2008T Hemodialysis System w/Bibag
- Lot codes and dates
- Model No190766
- UDI-DI
208 of 208 codes
00840861100910Serial No. 1T0S2610321T0S2610041T0S2610291T0S2609951T0S2609371T0S2607391T0S2606871T0S2605732T0S2639452T0S2639472T0S2639592T0S2639242T0S2639622T0S2639562T0S2639512T0S2639502T0S2637072T0S2636922T0S2636902T0S2636822T0S2637002T0S2640842T0S2639442T0S2639542T0S2639572T0S2640872T0S2641442T0S2641322T0S2640732T0S2641392T0S2640612T0S2639792T0S2639832T0S2639732T0S2639772T0S2639892T0S2639382T0S2639602T0S2639432T0S2639682T0S2639412T0S2639402T0S2639392T0S2639342T0S2639332T0S2639322T0S2639312T0S2639302T0S2639272T0S2639262T0S2639252T0S2639232T0S2639222T0S2639212T0S2639202T0S2639192T0S2639182T0S2639162T0S263912
- Amount recalled
- 733 units
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Potential PCBA leaching from tubing of hemodialysis machines.
Using this product could cause serious injury, illness or death — stop using it now.
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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