—#155608

Product

Alaris Pump Module model 8100

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K950419
Affected lot / code info: Notification will be distributed to all Alaris Pumps customers with pumps manufactured between June 2002 through June 2004.

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: CareFusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern: US and Canada

Timeline

Recall initiated: 2017-06-12
Posted by FDA: 2017-06-19
Terminated: 2019-01-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #155608. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.