The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2185-2012·Announced 2012-08-22

CareFusion Recalls Alaris Pump Module 8100 Due to Motor Stalls

CareFusion 303, Inc. is recalling Alaris Pump Module model 8100 units due to reports of motor stalls during infusion.

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: "The recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module model 8100. Carefusion has received reports of customers experiencing motor stalls during infusion with Alaris Pump Module…"

Plain-English summary

CareFusion 303, Inc. is recalling the Alaris Pump Module model 8100, which is intended for the delivery of fluids, medications, blood, and blood products in clinical settings. The recall involves 102,248 units distributed worldwide, including the United States, Canada, South Africa, and the Netherlands.

The recall was initiated because CareFusion identified a potential risk associated with the device. The company has received reports from customers experiencing motor stalls during infusion with Alaris Pump Module model 8100 units manufactured between August 2010 and July 2011.

Healthcare facilities should identify affected units by checking the serial numbers and product codes listed in the official recall notice. Users should contact CareFusion for instructions on how to proceed with the recall.

The recalled product

Product
Alaris Pump Module model 8100. 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 clinically acceptable routes of…
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
102,248

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 (8)

  • 8100 Global Pump Module
  • 8100 IOC Pump Module V8.5.29.0
  • 8100 LVP Training Unit
  • 8100 Pump Module V8.5.29.0
  • 8100 Pump Module V8.5.29.0 (V9)
  • Medley Patient Care System LVP
  • Model 8100 Trade-In Material
  • RCND 8100 Pump Module V8.5.29.0

Distribution

Distributed nationwide across the United States.

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