Hemodialysis Machines Recalled Due to Potential PCBA Leaching
Fresenius Medical Care is recalling 733 hemodialysis machines nationwide due to potential printed circuit board material leaking from tubing.
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 device has been classified by the FDA as Class I, the agency's highest recall classification. Although no illnesses or injuries have been reported, the potential for material leaching from tubing in a life-critical medical device warrants a Severe rating.
Plain-English summary
The FDA is recalling 733 units of the Fresenius Medical Care 2008T HD SYS. CDX BLUESTAR hemodialysis machine nationwide. The recall is due to potential leaching of printed circuit board assembly (PCBA) material from the machine's tubing. PCBA is an electrical component used in the machine's control systems.
These machines have been distributed nationwide. The affected units can be identified by their serial numbers; specific units with serial number prefixes 1T0S, 2T0S, 8T0S, 0T0S, and 9T0S are listed in the recall notice.
Healthcare facilities and providers using these machines should contact Fresenius Medical Care immediately for further instructions. Affected machines should not be used until the manufacturer has provided specific guidance on remediation or replacement.
The recalled product
- Product
- 2008T HD SYS. CDX 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: 191124
- UDI-DI: 00840861102082
- 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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