Company: Baxter Healthcare Company
Date of Enforcement Report: 7/22/2022
Class I
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). less…
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
There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
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
