Agency classClass IOur severity:Severe FDA (Devices)·Z-0032-2024·Announced 2023-10-18

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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.
Category: Medical Device — Hemodialysis Equipment
Hazard: pcba-leaching
contamination-risk
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.

See all 8 products in this recall →

Same manufacturer · Fresenius Medical Care Holdings, Inc.

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Same hazard · pcba leaching