Hemodialysis Systems Recalled for Potential PCBA Tubing Leaching
Fresenius Medical Care is recalling 733 hemodialysis machines nationwide due to potential leaching of circuit board material from tubing. Affected equipment may contaminate blood or dialysate during treatment.
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: FDA Class I recalls require a minimum severity score of 4 per rubric guidelines. Though no illnesses or injuries are currently reported, potential leaching of circuit board material in tubing of a life-critical hemodialysis device poses serious patient safety risk.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling the 2008T HD System without CDX with BiBAG BLUESTAR hemodialysis machines nationwide. The recall affects 733 units with Model No. 191130.
The tubing in affected machines may leach material from the printed circuit board assembly (PCBA). This could potentially contaminate the dialysate or bloodline during hemodialysis treatment.
The recall applies nationwide to hemodialysis centers and patients using equipment with the affected serial numbers.
This is an FDA Class I recall, indicating the seriousness of the potential patient safety hazard.
The recalled product
- Product
- 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- 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: 191130
- UDI-DI: 00840861102112
- 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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