FDAApril 8, 2015device
ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based order entry software application for comprehensive total parenteral nutrition (TPN) calculations and label printing.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Baxter Corporation is conducting a field action for the ABACUS SE and ME models due to the possibility that the compounder will load the incorrect formula upon scanning the bag label when two or more different formula files have been created with the same order number.
What to do
FDA enforcement status: Terminated
Brands named
baxter corporation englewoodbaxterbaxter corporation
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABrand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing sets with push-on connector on one end (to attach to the Fluid Selector Valve) and a spike or other appropriate connector on the opposite end to attach the source container.2026-04-22
- FDABrand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit per package2026-02-18
- FDABlue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.2026-02-18
- FDABrand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A2026-01-13
- FDASterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.2025-12-22
- FDASIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX22025-11-28
- FDAIKM Aluminum Saucepan 9" with Wooden Handle. Sticker label: ALUMINIUM PAN 2 SIDE POUTED WOODEN HANDLE 9" UPC 7 023672 411878 US $ 17.99 Sticker label: IKM INDIAN KITCHEN MART2025-11-21
- FDAAluminum Kadai with Metal Handles Size 5. A-Cook MADE IN INDIA SIZE 5 Sticker label: $$24.99+TX2025-11-21
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