Alaris PC Unit, Model 8015
FDA device recall Z-2671-2017 · posted 2017-06-19 · Terminated
Recall details
- Recalling firm
- CareFusion 303, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 568,283 units
- Distribution
- Worldwide Distribution - USA (nationwide) and to the countries of : Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.
- Date initiated
- 2017-06-12
- Date posted
- 2017-06-19
- Date terminated
- 2018-10-26
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALARIS SYSTEM PC UNIT, MODEL 8001 (K051641) | Cardinal Health, Alaris Products | 2005-10-20 |