The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2205-2012·Announced 2012-08-29

CareFusion Recalls Alaris Pump Module 8100 Due to Keypad Overlay Separation

CareFusion 303, Inc. is recalling Alaris Pump Module 8100 units because the keypad overlay may separate from the assembly, posing a potential risk.

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 source text explicitly states the agency classification is Class I. Per the rubric, if the agency's own classification is FDA Class I, the score must never go below 4.

Plain-English summary

CareFusion 303, Inc. is recalling the Alaris Pump Module Model 8100 (formerly Medley Pump Module) due to a potential risk identified by the manufacturer. The issue involves the pump module door keypad overlay, which may separate from the keypad assembly.

The recall affects 43,862 units total, with 40,780 units distributed in the United States. The remaining units were distributed worldwide, including in Australia, the European Union, and South Africa. The product is intended for use in facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products to adults, pediatrics, and neonates.

The U.S. Food and Drug Administration has classified this as a Class I recall. Users should contact CareFusion 303, Inc. for instructions on how to address the defect.

The recalled product

Product
Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through…
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard

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 (2)

  • Model 8100
  • Lot/Serial numbers-various

Distribution

Distributed nationwide across the United States.

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