FDAJune 30, 2020device
Alaris Pump Module Model 8100
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Broken elements on pump module platen such as broken upper hinge post, lower hinge, and membrane frame can occur when the door is forcefully closed on an object, the device is dropped, or if improper cleaners are used on the membrane frame assembly. These may prevent devices from delivering accurate amounts of fluid, which may result in an over infusion, free-flow conditions, or under infusion.
What to do
FDA enforcement status: Terminated
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 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 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 Pyxis MedStation ES REF: 323 Medication cabinet2026-04-30
- FDABD Pyxis Mini Main REF: 349 Medication cabinet2026-04-30
- FDABD Pyxis MedStation 4000 REF: 303 Medication cabinet2026-04-30
- FDABD Pyxis MedBank Tower REF: 1145-00 Medication cabinet2026-04-30
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