Recall Z-1847-2014— Baxter Corporation Englewood
Class II · Terminated
Class II FDA medical device recall by Baxter Corporation Englewood, initiated 2014-05-28, terminated 2016-08-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding.. Reason: Baxter Corporation is initiating a field correction following an upgrade to ABACUS Software v3.1, when Clinimix 4.25110 is used in an order, the Nutritional Summary and any labels containing energy information may display 1,000 times less protein than is actually present in the solution..
- Recalling firm
- Baxter Corporation Englewood
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-05-28
- Terminated
- 2016-08-08
- Firm location
- Englewood, CO, United States
Product description
Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding.
Reason for recall
Baxter Corporation is initiating a field correction following an upgrade to ABACUS Software v3.1, when Clinimix 4.25110 is used in an order, the Nutritional Summary and any labels containing energy information may display 1,000 times less protein than is actually present in the solution.
Data sourced from openFDA. This site is unofficial and independent of the FDA.