Agency classClass IOur severity:Severe FDA (Devices)·Z-0034-2024·Announced 2023-10-18

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.

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 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.
Category: Medical Device — Hemodialysis Equipment
Hazard: pcba-leaching
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: 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.

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