Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a lar
FDA device recall Z-0950-2017 · posted 2017-01-18 · Terminated
Recall details
- Recalling firm
- CareFusion 303, Inc.
- Reason for recall
- During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.
- Action taken
- Carefusion (BD) sent a Medical Device Safety Notification letter dated December 2, 2016, to all affected customers. The letter informed customers that BD has identified an issue with the Alaris Pump module. The letter informs the customers that the firm has received reports of Air-In-Line (AIL) alarms that have occurred when no air is observed in the line. Customers were informed of the issue and of the potential risk involved. The letter informs the customers of the actions for users and additional actions for biomedical engineering. Customers with questions regarding recall related questions were instructed to contact BD Support Center at (888) 562-6018, 7-4pm PT, M-F or email supportcenter@carefusion.com. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266, 24 hrs/day, 7days/wk. or email customerfeedback@carefusion.com. For questions regarding this recall call 858-617-2000.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 382,635 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2016-12-02
- Date posted
- 2017-01-18
- Date terminated
- 2018-07-24
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS (K950419) | Imed Corp. | 1995-06-21 |