Reported Dec 28, 2022 · Ongoing
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare…
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?
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models
4 of 4 products
| # | Product as published |
|---|---|
| 1 | (1) 190713 2008T HEMODIALYSIS SYS., with CDX |
| 2 | (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX |
| 3 | (3) 191124 2008T HD SYS. CDX BLUESTAR |
| 4 | (4) 191126 2008T HD SYS. CDX W/BIBAG BLUESTAR |
- Lot codes and dates
- Software issue in SW versions 2.72 and earlier with CDX
- UDI
(1) 00840861100897(2) 00840861100910(3) 00840861102082(4) 00840861102099
- Amount recalled
- 2008T with CDX= 70,552 2008T Bluestar with CDX= 25,205
Where it was sold
- Nationwide
Why it was recalled
(1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false alarm "Remove USB 2 Device".
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.
Free recall alerts
Get alerted about new Fresenius Medical Care Holdings, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.