Drug recall
ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS…
FDA recall event 70946 · Class II · Baxter Corporation Englewood
Key facts
| Event ID | 70946 |
|---|---|
| Recall numbers | Z-1628-2015 |
| Recalling firm | Baxter Corporation Englewood |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Apr 8, 2015 |
| Report date | May 27, 2015 |
| Termination date | Dec 1, 2016 |
| City | Englewood |
| State | CO |
| Country | United States |
| FEI number | 3010293139 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: