Risk of Medication Label Errors

Company: Baxter Healthcare Corporation
Date of Enforcement Report: June 22, 2022
Class: I

PRODUCT

Abacus Order Entry and Calculation Software

Recall Number: Z-1376-2022

 

REASON

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

RECALLING FIRM/MANUFACTURER

Baxter Healthcare Corporation

VOLUME OF PRODUCT IN COMMERCE

9 units

DISTRIBUTION

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

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.