Alaris Pump Module model 8100 recallZ-2700-2017 · CareFusion 303, Inc. · initiated Jun 12, 2017
Class II Terminated All recalls posted in June 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
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.
FDA root cause category: Device Design
What the company is doing
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 [email protected] to coordinate an onsite remediation or send the devices to the BD Service Depot.
Recall details
- Recall number
- Z-2700-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 12, 2017
- Posted by the FDA
- Jun 19, 2017
- Recalling firm
- CareFusion 303, Inc.
- Quantity
- 35,940 units
- Product code
- FRN
- FDA submissions
- K950419
- Distribution
- US and Canada
Product description
Alaris Pump Module model 8100
Code information (models, lots, serial numbers)
Notification will be distributed to all Alaris Pumps customers with pumps manufactured between June 2002 through June 2004.
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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