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U.S. Department of Health and Human Services

Class 2 Device Recall Alaris PC Unit, Model 8000, Infusion Pump power supply board part Part No. TC10005092.

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 Class 2 Device Recall Alaris PC Unit, Model 8000, Infusion Pump power supply board part Part No. TC10005092.see related information
Date Initiated by FirmFebruary 12, 2016
Date PostedMarch 24, 2016
Recall Status1 Terminated 3 on June 23, 2017
Recall NumberZ-1239-2016
Recall Event ID 73315
510(K)NumberK051641 
Product Classification Dressing, wound, drug - Product Code FRO
ProductAlaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
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 
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information Contact
858-617-2000
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionA 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 supportcenter@carefusion.com. 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 customerfeedback@carefusion.com. 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 DL-US-INF-TechSupport@carefusion.com.
Quantity in Commerce170 units
DistributionNationwide in US: AR, AZ, CA, FL, GA, IN, KY, MD, MI, MN, MO, NJ, NM, NY, OH, OR, PA, SC, TN, TX, VA, WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FRO
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