2008T Hemodialysis SYS, with CDX
Reported: October 18, 2023 Initiated: September 6, 2023 #Z-0028-2024
Product Description
2008T Hemodialysis SYS, with CDX
Reason for Recall
Potential PCBA leaching from tubing of hemodialysis machines.
Details
- Recalling Firm
- Fresenius Medical Care Holdings, Inc.
- Units Affected
- 703 units
- Distribution
- Domestic: Nationwide Distribution.
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
2008T Hemodialysis SYS, with CDX. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 703 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-0028-2024.
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