FDA recall Z-0032-2024
Fresenius Medical Care Holdings, Inc. · Class I · device
Product
2008T HD SYS. CDX BLUESTAR
Reason for recall
Potential PCBA leaching from tubing of hemodialysis machines.
Distribution
Domestic: Nationwide Distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2023-09-06
- Report date
- 2023-10-18
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Waltham, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0032-2024