Company: Smiths Medical ASD Inc.
Date of Enforcement Report: 12/16/2019
Class I
PRODUCT
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
- Recall Number: Z-0610-2020
REASON
There is an anomaly in the Medfusion 4000 Syringe Pump (Firmware version 1.7.0) that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption of therapy.
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD Inc. on 10/28/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
626 devices
DISTRIBUTION
CO, MD, NY