Recall Z-0534-2014— CareFusion 303, Inc.
Class I · Terminated
Class I FDA medical device recall by CareFusion 303, Inc., initiated 2013-12-05, terminated 2016-06-02. It names 2 FDA 510(k) clearances: K051641, K041241. Product: Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia) pump is one of the modules offer under the Alaris System. The Auto ID is a barcode scanner.. Reason: CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message..
- Recalling firm
- CareFusion 303, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-12-05
- Terminated
- 2016-06-02
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia) pump is one of the modules offer under the Alaris System. The Auto ID is a barcode scanner.
Reason for recall
CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message.
Data sourced from openFDA. This site is unofficial and independent of the FDA.