FDA-Device2023-10-18Class I
2008T GEN 2 Bibag without CDX
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 GEN 2 Bibag without CDX
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0031-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief