The Recall Desk
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.

What this means for you

Illness, injury, or structural failure has been reported. 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 cl
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.

Related recalls

Same manufacturer · CareFusion 303, Inc.

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Same hazard · component separation

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