Recall Z-1239-2016— CareFusion 303, Inc.

Name: FDA recall Z-1239-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-12

Class II · Terminated

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2016-02-12, terminated 2017-06-23. It names one FDA 510(k) clearance: K051641. Product: Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092. 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)..

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-02-12
Terminated: 2017-06-23
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K051641 — ALARIS SYSTEM PC UNIT, MODEL 8001Cardinal Health, Alaris Products·cleared 2005-10-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.