—#143857

Product

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

FDA product code: FRO — Dressing, Wound, Drug
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K051641
Affected lot / code info: 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

Why it was recalled

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).

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 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.

Recalling firm

Firm: CareFusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

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.

Timeline

Recall initiated: 2016-02-12
Posted by FDA: 2016-03-24
Terminated: 2017-06-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143857. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.