Agency classClass IIOur severity:High FDA (Devices)·Z-1963-2014·Announced 2014-07-09

Baxter Exactamix Compounder Recall Due to Software Configuration Error

Baxter Healthcare is recalling Exactamix 1200 and 2400 Compounders because a software error may prevent pump tube flushing, risking cross-contamination of IV solutions.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device where a software defect could lead to cross-contamination of IV solutions. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).

Plain-English summary

Baxter Healthcare Corp. is recalling 1,758 units of the Exactamix 1200 and 2400 Compounders, including specific model numbers and replacement displays. These devices are automated pumping systems used to compound multiple sterile ingredients into a finished solution in a single patient IV administration bag. The recall covers units distributed nationwide in the United States.

The recall was initiated because a software defect exists in the Configuration Editor. If the universal ingredient (UI) in an active configuration is changed using this tool, the software fails to initiate a flush of the outlet pump tube. This failure could result in the original universal ingredient remaining in the tube and being delivered into the next bag, potentially causing cross-contamination of the IV solution.

Healthcare facilities and users of these devices should contact Baxter Healthcare for instructions on how to resolve the issue or replace the affected units. The source text does not report any specific illnesses or injuries associated with this defect.

The recalled product

Product: EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds…
Manufacturer: Baxter Healthcare Corp.
Category: Medical Device — IV Compounding Systems
Hazard: cross-contamination
software-defect
Affected units: 1,758

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 (6)

model numbers 1200-DY
1200-DX
1200-DYR and 1200-DXR
EXACTAMIX 2400 Compounder model numbers 2400-DY
2400-DX
2400-DYR and 2400-DYX

Distribution

Distributed nationwide across the United States.

Same manufacturer · Baxter Healthcare Corp.

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Same hazard · cross contamination