PlainRecalls
FDA Devices Critical Class I Ongoing

2008T HD SYS. W/O CDX W/BIBAG BLUESTAR

Reported: October 18, 2023 Initiated: September 6, 2023 #Z-0035-2024

Product Description

2008T HD SYS. W/O CDX W/BIBAG BLUESTAR

Reason for Recall

Potential PCBA leaching from tubing of hemodialysis machines.

Details

Units Affected
733 units
Distribution
Domestic: Nationwide Distribution.
Location
Waltham, MA

Frequently Asked Questions

What product was recalled?
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 733 units.
Why was this product recalled?
Potential PCBA leaching from tubing of hemodialysis machines.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 18, 2023. Severity: Critical. Recall number: Z-0035-2024.