CareFusion Recalls Alaris PC Infusion Pump Units Due to Power Supply Error
CareFusion is recalling 170 Alaris PC Unit Infusion Pump Model 8000 devices because a power supply component may cause system error codes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional error code without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
CareFusion 303, Inc. is recalling 170 units of the Alaris PC Unit, Infusion Pump Model 8000 (Part No. TC10005092). The recall is being conducted because a component on the PC unit power supply may cause a "System Error" or "Missing Battery" error code (120.4630).
The affected devices were distributed nationwide in the United States, including in the states of AR, AZ, CA, FL, GA, IN, KY, MD, MI, MN, MO, NJ, NM, NY, OH, OR, PA, SC, TN, TX, VA, and WI. The recall is classified as Class II by the FDA.
Healthcare facilities and users should check their inventory for the specific serial numbers listed in the official recall notice. If a device is affected, users should stop using it and contact CareFusion for further instructions.
The recalled product
- Product
- Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 170
Distribution
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