Z-1239-2016Class II

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

Name: Z-1239-2016 Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
Creator: CareFusion 303, Inc.
Published: 2016-02-12
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2016-02-12 / Terminated

FDA source

CareFusion 303, Inc. began a recall of Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092 on 2016-02-12. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1239-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-12
Posted: 2016-03-24
Terminated: 2017-06-23
Recalling firm: CareFusion 303, Inc
Product: Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
Product code: FRO Dressing, Wound, Drug
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).
FDA root cause: Under Investigation by firm
Action: A customer notification letter dated 2/25/16 will be sent to all their customers who purchased the Alaris PC unit (Model 8000) to inform them that CareFusion is recalling it because a component on the PC unit power supply board may cause a "System Error" or "Missing Battery" error code (120.4630). The letter informs the customers of the potential risk involved and the actions to be taken. Customers with recall related questions are instructed to call CareFusion Support Center at (888) 562-6018, 7am-4pm PST, Mon-Fri or email at [email protected]. Customers with clinical inquires, product complaints or clinical troubleshooting are instructed to contact customer advocacy at (888) 812-3266, 24 hrs/day, 7 days/wk or email at [email protected]. Customers with technical questions regarding the Alaris system are instructed to contact technical support at (888) 812-3229, 6am-5pm PST, Mon-Fri or email at [email protected].
Quantity in commerce: 170 units
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1239-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1239-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-24

Product code FRO

K051641Class IIAlaris System Pc Unit, Model 8001Cardinal Health, Alaris Products / cleared 2005-10-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)