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).
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Baxter Healthcare Corporation
- Reason for Recall:
- There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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).
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1376-2022
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