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U.S. Department of Health and Human Services

Class 1 Device Recall Abacus

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  Class 1 Device Recall Abacus see related information
Date Initiated by Firm June 22, 2022
Create Date July 22, 2022
Recall Status1 Open3, Classified
Recall Number Z-1376-2022
Recall Event ID 90212
Product Classification System/device, pharmacy compounding - Product Code NEP
Product 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).
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
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 9 units
Distribution United States (including Puerto Rico), Argentina, Bermuda, Chile, Colombia, Dominican Republic, Panama, Canada, Vietnam, Hong Kong, Singapore, and EMEA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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