Hemodialysis machines recalled due to potential circuit board material leaching
Fresenius Medical Care is recalling 733 units of 2008T hemodialysis systems nationwide due to potential leaching of printed circuit board assembly material from tubing. No illnesses or injuries have been reported.
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 FDA Class I medical device recall must be assigned a minimum severity score of 4 (Severe) per FDA classification rubric criteria. Although no reported injuries or illnesses have occurred, the potential for material leaching from hemodialysis tubing poses a serious risk to patient safety.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 733 units of the 2008T HD System without CDX BLUESTAR, distributed nationwide. The hemodialysis machines are identified by Model No. 191128 and specific serial numbers.
The recalled machines have a potential defect where printed circuit board assembly (PCBA) material may leach from the tubing during use. The FDA has classified this as a Class I recall, reflecting a serious potential risk to patient health. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- 2008T HD SYS. W/O CDX BLUESTAR
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- pcba-leaching
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: 191128
- UDI-DI: 00840861102105
- 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.
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