Recall – Syringe Infusion Pump recalled over firmware issues, CL I

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

Upcoming Training

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Dates:  February 4-6, 2020
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QSS Software Validation
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Dates:  June 2-4, 2020
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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.