Baxter Healthcare Corporation: 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), 8300-019

Is my product affected?

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),

• UPC 05413765577345
• UPC 05413765577352
• UPC 05413765577369

Check against the official notice below — it lists the full affected range.

What happened

Baxter Healthcare Corporation is recalling specific versions of ABACUS TPN (Total Parenteral Nutrition) Calculation software due to a potential risk of medication error when using the software. The affected product codes include versions 3.1 and 3.2 of the software (CE, SE, and ME variants), as well as three additional product codes released in September 2019. The software was distributed across the United States, Puerto Rico, Argentina, Bermuda, Chile, Colombia, Dominican Republic, Panama, Canada, Vietnam, Hong Kong, Singapore, and the EMEA region.

A total of 9 units were affected by this recall. The source record does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software. Distribution: United States (including Puerto Rico), Argentina, Bermuda, Chile, Colombia, Dominican Republic, Panama, Canada, Vietnam, Hong Kong, Singapore, and EMEA Quantity: 9 units Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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