Alaris PC units, Model No. 8015. Infusion pump.
FDA device recall Z-1311-2015 · posted 2015-03-23 · Terminated
Recall details
- Recalling firm
- CareFusion 303, Inc.
- Reason for recall
- CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur upon power on during the "Power-On Self Test" due to a keypad issue.
- Action taken
- CareFusion sent an Urgent: Medical Device Recall Notification letter dated March 12, 2015, to all affected customers. The letter informs the customers that CareFusion has received service reports of a system error on the Alaris PC unit 8015. The letter informs customers of the problems identified and the actions to be taken. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018, supportcenter@carefusion.com. Customers with adverse event reports are instructed to contact customer advocacy at (888) 812-3266, customerfeedback@carefusion.com. Customers with technical questions regarding the Alaris system are instructed to contact technical support at (888) 812-3229, DL-US-INF-TechSupport@carefusion.com.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 56,015 units
- Distribution
- Worldwide Distribution - USA (nationwide), Canada, European Union, Singapore and Australia.
- Date initiated
- 2015-03-12
- Date posted
- 2015-03-23
- Date terminated
- 2017-09-25
- 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 |