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Terminated

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).

FDA Recall Z-1376-2022 · Posted 2022-07-22

Recall StatusTerminated
Product CodeNEP
Date Initiated2022-06-22
Date Terminated2024-10-09
Product Quantity9 units

Reason for Recall

There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.

Firm 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 include pharmacy checks during the compounding process as well as a nursing check. Baxter will communicate to customers when the software upgrade becomes available. At that time additional instructions to obtain the software upgrade will be provided.

Root Cause

Software design

Distribution Pattern

United States (including Puerto Rico), Argentina, Bermuda, Chile, Colombia, Dominican Republic, Panama, Canada, Vietnam, Hong Kong, Singapore, and EMEA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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