Z-1847-2014 Class II Terminated
FDA device recall Z-1847-2014 was initiated by Baxter Corporation Englewood on May 28, 2014 and is designated Class II. 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 in… The recall status is terminated (terminated August 8, 2016). Affected quantity: 42.
Recall Details
- Product Type
- Devices
- Report Date
- July 2, 2014
- Initiation Date
- May 28, 2014
- Termination Date
- August 8, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42
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.
Distribution Pattern
US Nationwide Distribution and the state of VA.
Code Information
Product Code: 8300-0167, 8300-0168, 8300-0169