Recalls / —
—#154930
Product
Alaris PC Unit, Model 8015
- FDA product code
- FRN — Pump, Infusion
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K051641
- Affected lot / code info
- Notification will be distributed to all Alaris PC Unit model 8015 customers with software versions greater than 9.12.
Why it was recalled
BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions.
Root cause (FDA determination)
Software design
Action the firm took
BD sent an Medical Device Safety Notification Letter dated June 12, 2017 , to customers to inform them that BD is issuing this Safety Notification letter to inform you of reports of customers experiencing a System Error (error code: 255-16-275) with Alaris System PC unit model 8015 that can result in interruption of infusions. Customers are informed of the issue, potential risk, and required actions to be taken by users and by BD. Customers with questions with the safety notification are instructed to call (888) 562-6018 or email supportcenter@carefusion.com. Customers with adverse event reports are instructed to call (888) 812-3266 or email customerfeedback@carefusion.com. Customers with technical questions are instructed to call (888) 812-3229 or email dl-us-inf-techsupport@carefusion.com. For further questions, please call (858) 617-5925.
Recalling firm
- Firm
- CareFusion 303, Inc.
- Address
- 10020 Pacific Mesa Blvd, San Diego, California 92121-4386
Distribution
- Distribution pattern
- Worldwide Distribution - USA (nationwide) and to the countries of : Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.
Timeline
- Recall initiated
- 2017-06-12
- Posted by FDA
- 2017-06-19
- Terminated
- 2018-10-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #154930. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.