Agency classClass IOur severity:Severe FDA (Devices)·Z-1376-2022·Announced 2022-08-03

ABACUS TPN Calculation Software recalled for medication error risk

Baxter Healthcare's ABACUS TPN calculation software poses a potential risk of medication error. The FDA issued a Class I recall; healthcare providers should contact the manufacturer for guidance.

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: FDA Class I classification requires a minimum severity score of 4. The recall addresses a potential risk of medication error in a drug delivery and calculation system, which could cause serious patient harm.

Plain-English summary

ABACUS TPN (Total Parenteral Nutrition) Calculation software is manufactured by Baxter Healthcare Corporation and is used with ExactaMix automated compounding devices to calculate formulations for parenteral nutrition preparations. Multiple software versions are affected, including versions 3.1, 3.2, and 3.3.

The FDA has classified this as a Class I recall due to a potential risk of medication error when using the software. Medication errors in parenteral nutrition calculations could result in serious health consequences for patients.

This recall affects 9 units distributed internationally, including the United States (including Puerto Rico), Canada, Argentina, Chile, Colombia, Bermuda, Dominican Republic, Panama, Vietnam, Hong Kong, Singapore, and EMEA regions.

Healthcare providers using ABACUS TPN software should contact Baxter Healthcare Corporation or consult FDA guidance regarding this recall. Healthcare facilities should review their use of affected software versions and follow manufacturer guidance for any corrections or updates.

The recalled product

Product: ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1 SE), 8300-0169 (Abacus V3.1 ME), 8300-0191 (Abacus V3.2 CE), 8300-0192 (Abacus V3.2 SE), 8300-0193 (Abacus V3.2 ME), 8300-3391 (Abacus V3.3 CE)…
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Medication Calculation Software
Hazard: medication-error
Affected units: 9

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)

Product Code 8300-3391
UDI (01)05413765577345(10)3.3.2.1
Release date 20-Sep-2019
Product Code 8300-3392
UDI (01)05413765577352(10)3.3.2.1
Product Code 8300-3393
UDI (01)05413765577369(10)3.3.2.1
Product Codes: 8300-0167
V3.1 CE
Release date 20-May-2013
8300-0168
V3.1 SE
8300-0169
V3.1 ME
8300-0191
V3.2 CE
Release date 17-Dec-2015
8300-0192
V3.2 SE
8300-0193

Distribution

Distributed in 1 state:

Same manufacturer · Baxter Healthcare Corporation

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