FDA Recalls Fresenius 2008T Hemodialysis Systems Due to PCBA Leaching
Fresenius Medical Care is recalling 703 units of the Fresenius 2008T Hemodialysis System nationwide due to potential PCBA (printed circuit board assembly) leaching from machine tubing.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This recall carries a FDA Class I classification, which per FDA regulations indicates a serious health hazard where there is reasonable probability that the product could cause serious adverse health consequences or death.
Plain-English summary
The FDA has issued a Class I recall of the Fresenius 2008T Hemodialysis System with CDX (Model 190713), affecting 703 units distributed nationwide. The recall addresses a potential hazard where printed circuit board assembly (PCBA) materials may leach from the machine's tubing.
Hemodialysis machines are critical medical devices used to filter waste from patient blood. Contamination of the dialysis circuit through material leaching could potentially compromise patient safety. Fresenius Medical Care Holdings, Inc. initiated this recall in response to the identified hazard.
Patients currently using affected units should contact their dialysis provider or Fresenius Medical Care immediately. Healthcare facilities and dialysis centers should review the full FDA recall notice and check whether they operate any units matching the affected serial numbers listed in the recall.
For more information, including the complete list of affected serial numbers and UDI identification, patients and providers can contact Fresenius Medical Care or visit the FDA's official recall database.
The recalled product
- Product
- 2008T Hemodialysis SYS, with CDX
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 703
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: 190713
- UDI-DI: 00840861100897
- 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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