Z-1376-2022 Class I Terminated
FDA device recall Z-1376-2022 was initiated by Baxter Healthcare Corporation on Jun 22, 2022 and is designated Class I. Reason for recall: There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software. The recall status is terminated (terminated Oct 9, 2024). Affected quantity: 9 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 3, 2022
- Initiation Date
- Jun 22, 2022
- Termination Date
- Oct 9, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
Product Description
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 for Recall
There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
Distribution Pattern
United States (including Puerto Rico), Argentina, Bermuda, Chile, Colombia, Dominican Republic, Panama, Canada, Vietnam, Hong Kong, Singapore, and EMEA
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1376-2022
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026