CareFusion Alaris System PC Unit Model 8000 Infusion Pump Recall
CareFusion is recalling Alaris System PC Unit Model 8000 infusion pumps because loose or missing screws may cause power loss and therapy interruption.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the system may experience a power loss with a prolonged, non-silenceable alarm. Power…"
Plain-English summary
CareFusion 303, Inc. is recalling the Alaris System PC Unit Model 8000 modular infusion pump and monitoring system. The recall involves 37,141 units distributed across the United States and various international locations.
The recall is due to a potential issue where one or more screws or washers may be loose or missing. This can cause the battery to not be properly secured to the PC Unit. If the system is running on battery power, this condition may result in a power loss accompanied by a prolonged, non-silenceable alarm. Such a power loss may lead to an interruption of patient therapy or monitoring.
Healthcare facilities and users should check their devices for loose or missing screws or washers securing the battery. If the issue is present, the device should be taken out of service and the manufacturer contacted for further instructions.
The recalled product
- Product
- Alaris System PC Unit Model 8000 modular infusion pump and monitoring system
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 37,141
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Part of a larger recall action
This product is one of 2 recalled by CareFusion 303, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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