Company: CareFusion Corp..
Date of Enforcement Report 12/8/2010
Class ll:
PRODUCT
Alaris PC unit Model 8000 only when used with Alaris Pump module or Alaris Syringe module. Recall # Z-0492-2011
REASON
Issue: PC Unit model 8000, when used with Pump or Syringe modules, may under certain conditions display an incorrect total dose when programmed to deliver a bolus dose. The Pump or Syringe module delivers the actual programmed bolus dose (and associated volume to be infused) regardless of the displayed total bolus dose. Potential Risk: If the display of an incorrect total dose is detected, it has a potential to confuse clinicians and may lead to a delay in therapy or over- or underinfusion of a therapy, which may result in serious injury and/or death.
RECALLING FIRM/MANUFACTURER
CareFusion Corp., San Diego, CA, beginning August 24, 2010. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
94,146 units
DISTRIBUTION
Nationwide, Canada, Mexico, and the European Union
