FDA-Device2023-10-18Class I
2008T HD SYS. W/O CDX BLUESTAR
Fresenius Medical Care Holdings, Inc.
Hazard
Potential PCBA leaching from tubing of hemodialysis machines.
Sold states
Domestic: Nationwide Distribution.
Affected count
733 units
Manufactured in
920 Winter St Bld 920, N/A, Waltham, MA, United States
Products
2008T HD SYS. W/O CDX BLUESTAR
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0034-2024Don't want to check this manually?
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