The Recall Desk
HighFDA (Devices)·Z-2736-2020·Announced 2020-08-12

CareFusion Alaris Pump Module Model 8100 Recalled for Broken Platen Elements

CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units because broken platen elements can cause inaccurate fluid delivery, leading to over-infusion, free-flow, or under-infusion.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a defect can lead to over-infusion or under-infusion, which are significant risks of harm. However, the source text does not report any injuries or illnesses, and the agency classification is Class I, which typically corresponds to a lower risk of adverse health consequences, placing this in the 'High' category for risk-of-harm products where injury has not yet been reported.

Plain-English summary

CareFusion 303, Inc. is recalling 1,093,588 units of the Alaris Pump Module Model 8100. The recall affects all serial numbers of the device. The product was distributed across all 50 U.S. states, the District of Columbia, and several U.S. territories, as well as numerous international locations including Canada, the United Kingdom, Germany, and Australia.

The recall is due to a risk that elements on the pump module platen, such as the upper hinge post, lower hinge, and membrane frame, may break. This damage can occur if the device door is forcefully closed on an object, if the device is dropped, or if improper cleaners are used on the membrane frame assembly. These broken elements may prevent the device from delivering accurate amounts of fluid.

Inaccurate fluid delivery may result in over-infusion, free-flow conditions, or under-infusion. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.

The recalled product

Product
Alaris Pump Module Model 8100
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
1,093,588

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

Distributed in 54 states:

Related recalls

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