Hemodialysis machines recalled for potential PCBA leaching from tubing
Fresenius Medical Care is recalling 733 units of 2008T HD hemodialysis machines nationwide due to potential PCBA leaching from tubing. The FDA classified this as a Class I recall.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. The agency's classification requires a minimum severity score of 4 per the recall severity rubric. Although no illnesses or injuries have been reported, PCBA leaching from a life-sustaining hemodialysis machine represents a serious potential health hazard.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 733 units of the 2008T HD SYS. CDX W/BIBAG BLUESTAR hemodialysis machine (Model No. 191126) due to potential leaching of PCBA material from the machine tubing.
The FDA has classified this as a Class I recall, indicating a serious potential health hazard. The affected units have been distributed nationwide in the United States.
Patients and healthcare facilities operating these machines should contact Fresenius Medical Care to verify whether their specific units are affected and for guidance on appropriate actions, based on the serial numbers provided in the recall notice.
The recalled product
- Product
- 2008T HD SYS. CDX W/BIBAG BLUESTAR
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 733
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No: 191126
- UDI-DI: 00840861102099
- Serial No. 1T0S261032
- 1T0S261004
- 1T0S261029
- 1T0S260995
- 1T0S260937
- 1T0S260739
- 1T0S260687
- 1T0S260573
- 2T0S263945
- 2T0S263947
- 2T0S263959
- 2T0S263924
- 2T0S263962
- 2T0S263956
- 2T0S263951
- 2T0S263950
- 2T0S263707
- 2T0S263692
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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