Hemodialysis machines recalled for potential printed circuit board contamination
Fresenius Medical Care is recalling 733 2008T Hemodialysis Systems without CDX due to potential PCBA leaching from tubing. This FDA Class I recall affects units distributed nationwide.
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: The FDA classified this as a Class I medical device recall, the most serious category. Per the recall severity rubric, FDA Class I classification requires a minimum severity score of 4 (Severe), indicating serious potential harm to patients.
Plain-English summary
Fresenius Medical Care is recalling 733 units of the 2008T Hemodialysis System without CDX due to potential printed circuit board assembly (PCBA) material leaching from hemodialysis machine tubing.
The FDA classified this as a Class I recall, its most serious medical device recall category. Class I recalls indicate that use of the product will cause serious harm or death, or that there is a reasonable probability that it will.
The affected units were distributed nationwide domestically. The recall involves specific serial numbers across multiple production batches as documented in the FDA's Medical Device Recall database.
Patients and healthcare providers using affected machines should verify their device serial numbers against the FDA's official recall list. Those with affected units should contact Fresenius Medical Care Holdings, Inc. for remediation information.
The recalled product
- Product
- 2008T Hemodialysis System without CDX
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- pcba-leaching
- device-contamination
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: 190858
- UDI-DI: 00840861100903
- 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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