FDA Medical Device Recalls (openFDA)
CareFusion 303, Inc.: Alaris Pump Module model 8100
- Recall number
- Z-2700-2017
- Recalling firm
- CareFusion 303, Inc.
- Product
- Alaris Pump Module model 8100
- Status
- Terminated
- Initiated
- 2017-06-12
- Posted
- 2017-06-19
- Terminated
- 2019-01-28
- Reason
- There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100.
- Root cause
- Device Design
- Action
- An Urgent Medical Device Recall letter will be sent on 6/12/17 to customers to inform them that BD is issuing this letter to inform you of a potential risk associated with the Alaris Pump module. Firm identified a specific scenario that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100. This scenario is reproducible under the following situations: a) the user does not close the roller clamp on the IV administration set before the pump door is opened as recommended, and b) opening the pump door using an atypical technique with the door latch with the centered sear design. The letter instructs customers If their device has a centered-sear that was manufactured between June 2002 to June 2004, clearly mark and sequester (e.g. Biomed department) the Alaris Pump module that exhibited the issue. Notify CareFusion Customer Advocacy at 888-812-3266 or customerfeedback@carefusion.com to coordinate an onsite remediation or send the devices to the BD Service Depot.
- Quantity
- 35,940 units
- Distribution
- US and Canada
- Lot, serial or model codes
- Notification will be distributed to all Alaris Pumps customers with pumps manufactured between June 2002 through June 2004.
- 510(k) numbers
- ["K950419"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 2016493
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28