FDAJune 30, 2020device
Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
LED display, which provides infusion or patient monitoring values, on the module may have segments that appear dim.
What to do
FDA enforcement status: Ongoing
Brands named
carefusion 303carefusion
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.2026-05-28
- FDABD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.2026-05-28
- FDABD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.2026-05-28
- FDABD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.2026-05-28
- FDABD Pyxis MedStation 4000 REF: 303 Medication cabinet2026-04-30
- FDABD Pyxis MedStation ES REF: 323 Medication cabinet2026-04-30
- FDABD Pyxis Mini Main REF: 349 Medication cabinet2026-04-30
- FDABD Pyxis MedBank Tower REF: 1145-00 Medication cabinet2026-04-30
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