The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1768-2019·Announced 2019-07-24

CareFusion Recalls Alaris Pump Model 8100 Due to Bezel Plastic Weakening

CareFusion is recalling Alaris Pump Model 8100 units manufactured between April 2011 and June 2017 because the bezel plastic may weaken, potentially causing infusion errors.

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 recall involves a medical device defect that can lead to over-infusion or under-infusion of medication, which constitutes a significant injury risk and aligns with the 'Severe' criteria for significant injury reports or high-risk device defects.

Plain-English summary

CareFusion 303, Inc. is recalling Alaris Pump, Model 8100, and associated pump assemblies with bezels manufactured between April 2011 and June 2017. The recall involves approximately 607,618 units distributed worldwide, including across the United States and various international locations. The affected products are large volume infusion pumps used to deliver medication and fluids via intravenous or epidural routes.

The recall is due to a manufacturing issue with the FR-110 plastic resin used in the bezel mechanical assemblies. The manufacturing process may have weakened the plastic, which can lead to external cracking or the separation of bezel posts over time. If one or more bezel posts separate, the pump may experience free flow, over-infusion, under-infusion, or interruption of infusion.

Healthcare facilities and users should identify affected pumps by checking the manufacturing dates and bezel assembly part numbers (P/N 10942012, P/N 49000007, P/N 49000203, P/N 10964559, and P/N 49000204). Users should contact CareFusion for instructions on how to address the defect and ensure patient safety.

The recalled product

Product
Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this recall as they are pumps or pump assemblies with bezels manufactured between April 2011 and June 2017 with the FR-110 plastic.…
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
607,618

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 pumps manufactured between April 2011 and June 2017

Distribution

Distributed nationwide across the United States.

The notice also names 54 states specifically:

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