ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abac

FDA device recall Z-1376-2022 · posted 2022-07-22 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corporation

Reason for recall

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

Action taken

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

Status

Terminated

Product code

NEP

Quantity affected

9 units

Distribution

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

Date initiated

2022-06-22

Date posted

2022-07-22

Date terminated

2024-10-09

Location

Deerfield, IL