Recall Z-1376-2022— Baxter Healthcare Corporation
Class I · Terminated
Class I FDA medical device recall by Baxter Healthcare Corporation, initiated 2022-06-22, terminated 2024-10-09. FDA's recall record names no specific 510(k) clearance for this event. 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).. Reason: There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2022-06-22
- Terminated
- 2024-10-09
- Firm location
- Deerfield, IL, United States
Product description
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).
Reason for recall
There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
Data sourced from openFDA. This site is unofficial and independent of the FDA.