Recall archive / FDA device enforcement
ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (A... — FDA record Z-1376-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 22, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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), 8300-3392 (Abacus V3.3 SE), and 8300-3393 (Abacus V3.3 ME). Commonly used with ExactaMix automated compounding devices (ExactaMix 1200 and ExactaMix 2400).
- Reason
- There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
- Classification
- Class I
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 9 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-1376-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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, Release date 20-Sep-2019; Product Code 8300-3393, UDI (01)05413765577369(10)3.3.2.1, Release date 20-Sep-2019; Product Codes: 8300-0167, V3.1 CE, Release date 20-May-2013, 8300-0168, V3.1 SE, Release date 20-May-2013, 8300-0169, V3.1 ME, Release date 20-May-2013, 8300-0191, V3.2 CE, Release date 17-Dec-2015, 8300-0192, V3.2 SE, Release date 17-Dec-2015, 8300-0193, V3.2 ME, Release date 17-Dec-2015, No UDIs |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
United States (including Puerto Rico), Argentina, Bermuda, Chile, Colombia, Dominican Republic, Panama, Canada, Vietnam, Hong Kong, Singapore, and EMEA
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Aug 3, 2022
- Recall initiation date
- Jun 22, 2022
- Center classification date
- Jul 22, 2022
- Termination date
- Oct 9, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.