Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1550-2015·Announced 2015-05-06

Fresenius 2008T Hemodialysis Machines Recalled for Acetate Display Error

Fresenius Medical Care is recalling 2008T hemodialysis machines because the Select Concentrate screen incorrectly displays the GranuFlo acetate value as 4mEq/l instead of 8mEq/l.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a display error where the correct value is available on a different screen, representing a low-risk contamination or labeling issue without reported injuries.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling 2008 Series Hemodialysis Machines, specifically the 2008T model, due to a software display error. The affected units are the 2008K at Home Systems, including first and second generation models, as well as units with Bibag. The recall covers 133,751 units distributed in the United States, Canada, and Mexico.

The issue involves the Acetate value for GranuFlo on the Select Concentrate screen, which is displayed as 4mEq/l instead of the correct 8mEq/l. The source text notes that the correct value is shown on the dialysate screen. The 2008K is indicated for acute and chronic dialysis therapy.

Affected serial numbers range from 0T0S100031 to 135408, with specific exceptions listed in the recall documentation. Consumers and healthcare providers should verify their device serial numbers against the provided list and contact the manufacturer for instructions on remediation.

The recalled product

Product: 2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395…
Manufacturer: Fresenius Medical Care Holdings, Inc.
Category: Medical Device — Hemodialysis
Hazard: mis-labeling

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 (10)

Serial Numbers: 0T0S100031- 101358
1T0S101359- 127938
2T0S109489- 118130
3T0S118131- 126163
4T0S126164- 135408
9T0S100002
9T0S100004
9T0S100007- 100010
9T0S100012
9T0S100014- 100016

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · Fresenius Medical Care Holdings, Inc.

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