2008T Hemodialysis System recalled for potential PCBA leaching from tubing
Fresenius Medical Care is recalling 733 units of the 2008T Hemodialysis System due to potential leaching of printed circuit board material from machine tubing. Patients using affected devices should contact their healthcare provider.
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 of a critical medical device. FDA Class I recalls cannot be scored below 4 in severity. Although no illnesses or injuries have been reported in the source material, the device's critical role in patient care and the agency's classification justify this assessment.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 733 units of the 2008T Hemodialysis System with Bibag due to potential leaching of printed circuit board assembly (PCBA) material from the machine's tubing.
The recalled devices were distributed nationwide throughout the United States. Affected units can be identified by Model No. 190766 and the specific serial numbers provided in the official recall notice.
Patients currently undergoing dialysis treatment with these machines should contact their healthcare provider or treatment facility immediately to determine if their equipment is affected. Healthcare facilities should verify whether any affected serial numbers are in use at their location and take appropriate steps to address the potential hazard.
The recalled product
- Product
- 2008T Hemodialysis System w/Bibag
- 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: 190766
- UDI-DI: 00840861100910
- 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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