Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N… recallZ-0950-2017 · CareFusion 303, Inc. · initiated Dec 2, 2016
Class I Terminated All recalls posted in January 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CareFusion 303, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.
FDA root cause category: Component change control
What the company is doing
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 [email protected]. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266, 24 hrs/day, 7days/wk. or email [email protected]. For questions regarding this recall call 858-617-2000.
Recall details
- Recall number
- Z-0950-2017
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Dec 2, 2016
- Posted by the FDA
- Jan 18, 2017
- Recalling firm
- CareFusion 303, Inc.
- Quantity
- 382,635 units
- Product code
- FRN
- FDA submissions
- K950419
- Distribution
- Nationwide Distribution
Product description
Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural
Code information (models, lots, serial numbers)
All products manufactured or serviced in the time period October 2011 through June 2015.
Other devices under the same FDA submission
1 device cleared under K950419 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Alaris 8100Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths650,218 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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