Recall Z-1376-2022 ยท NEP System/Device, Pharmacy Compounding
Baxter Healthcare Corporation
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 (Exa
| Date | Jul 22, 2022 (initiated Jun 22, 2022) |
| Status | Terminated |
| Reason | There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software. |
| Root cause | Software design |
| Action | Baxter sent an Urgent Medical Device Correction notice on 06/22/2022 by letter. The notice explained the problem and the hazard and recommended the following: customers refrain from making updates to bag label templates and to contact Baxter Technical Support if updates to bag label templates are needed. Please continue to follow the instructions in the Abacus User and Abacus Configuration Guides when creating an order, and have a pharmacist thoroughly review all order outputs including the printed label for accuracy and safety. As mentioned above, please ensure your facility processes incl |
| Quantity | 9 units |
| Distribution | United States (including Puerto Rico), Argentina, Bermuda, Chile, Colombia, Dominican Republic, Panama, Canada, Vietnam, Hong Kong, Singapore, and EMEA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.