Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central program
FDA device recall Z-1811-2015 · posted 2015-06-16 · Terminated
Recall details
- Recalling firm
- CareFusion 303, Inc.
- Reason for recall
- An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. An infusion may start that is greater than or less than the hospital established limits for the specific medication.
- Action taken
- CareFusion sent an Urgent Medical Device Recall Notification letter dated May 13, 2015 to customers. The letter identified the affected product, problem and the recommended actions to be taken. Customers are informed that CareFusion has released a software upgrade to address this issue. CareFusion will contact all affected customers within 60 days to initiate the scheduling process for the software upgrade installation. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018, 7am-4pm PT, supportcenter@carefusion.com. Customers with adverse event report questions are instructed to contact customer advocacy at (888) 812-3266, 24 hrs/day, 7 days a week, customerfeedback@carefusion.com. Customers with technical questions regarding the Alaris System are instructed to contact Technical Support at (888) 812-3229, 6am-5pm PT, Mon-Fri, dl-us-inf-techsupport@carefusion.com.
- Root cause
- Software design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 63 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2015-05-13
- Date posted
- 2015-06-16
- Date terminated
- 2016-05-20
- 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 |