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Recall Observatory FDA recall evidence

Device product

Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092

Z-1239-2016

February 12, 2016

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 73315
Status
Terminated
Classification
Class II
Quantity
170 units
Official record key
device-enforcement:Z-1239-2016

Official wording

Reason: CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a "System Error" or "Missing Battery" error code (120.4630).

Code information: Serial No. 4044845 9950535 4064411 12475162 4045659 9899143 3606478 4021398 4093501 4043745 4063430 4094994 9907675 9945292 9922622 4043375 12409069 4020663 12498854 4044531 4058193 12351849 4064030 9925068 12426138 4063830 4063911 9945269

Distribution pattern: Nationwide in US: AR, AZ, CA, FL, GA, IN, KY, MD, MI, MN, MO, NJ, NM, NY, OH, OR, PA, SC, TN, TX, VA, WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a "System Error" or "Missing Battery" error code (120.4630).